AbbVie UK Publishes 2019 Transparency Data; Supporting Collaboration of Medical Opinion Towards Advancing Patient Care and the Development of New Medicines

Press releases   •   Jun 30, 2020 09:00 BST

Maidenhead, UK, 30 June 2020 – Each year AbbVie discloses individual and aggregated transfers of value to healthcare professionals (HCPs) and healthcare organisations (HCOs) to the Association of the British Pharmaceutical Industry (ABPI).

Due to the unprecedented demands on the NHS as a result of the COVID-19 pandemic, the ABPI provided guidance to companies to submit only their aggregated transfers of value data for 2019 for publication on its central platform, Disclosure UK, and to publish their disaggregated data on their company websites. AbbVie has adopted this guidance and our disaggregated data is available at http://eutransparency.abbvie.com/2019_AbbVie_UK_EFPIA_Report_Final.pdf. We will work with and be guided by the ABPI as it continues to explore how the full disaggregated 2019 data can be submitted to Disclosure UK in line with data from previous years.

We are pleased to confirm that 71% of healthcare professionals who received sponsorship, fees or ‘in-kind’ support from AbbVie in 2019, opted-in for their individual data to be made public.

The collaboration of medical opinion is essential to advance patient care, gain insights into unmet medical needs and progress the development of new medicines. We believe interactions with HCPs, HCOs and patient organisations bring value to patient care.

AbbVie is proud of its collaboration with HCPs and HCOs which has contributed to delivering innovative medicines and has changed the way many diseases impact on patients’ lives. Open communication about these interactions increases understanding of this important collaboration.

Overall, the total sum that AbbVie invested in 2019 in working with and supporting UK healthcare organisations and healthcare professionals is £9.4 m. Of this figure, nearly 63% is on the administration of clinical trials – demonstrating the enduring importance of the UK as a centre of excellence in the development of new medicines.

-ENDS-

Note to editors:

1.AbbVie’s acquisition of Allergan completed in Q2, 2020. As such, Allergan and AbbVie will maintain separate reporting mechanisms in respect of their 2019 transfers of value to HCOs, HCPs and patient organisations.

2.AbbVie’s transparency disclosure methodological notes for 2019 can be accessed at http://eutransparency.abbvie.com/2019_AbbVie_UK_Supporting_Document_Final.pdf

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New VENCLYXTO®▼(venetoclax) Data Demonstrate Utility Across Acute Myeloid Leukaemia (AML) Patients and Chronic Lymphocytic Leukaemia (CLL)

Press releases   •   Jun 13, 2020 12:00 BST

  • Phase III VIALE-A study showed a 34% reduction in the risk of death in AML patients who were ineligible for intensive chemotherapy treated with venetoclax plus azacitidine compared with azacitidine plus placebo1
  • Patients in the venetoclax arm showed improved median overall survival (14.7 months) versus azacitidine alone (9.6 months) and improved rate of composite complete remission (CR + CRi) (66.4%) versus those treated with azacitidine alone (28.3%)1
  • Notable data in CLL patients include Phase III results from the CLL14 trial2 and Phase III sub-analysis from the MURANO trial3

Maidenhead, UK, 13 June 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the positive results from the VIALE-A (M15-656) trial. They demonstrated that previously untreated patients with acute myeloid leukaemia (AML) who were ineligible for intensive chemotherapy treated with VENCLYXTO® (venetoclax) plus azacitidine (n=286) achieved a 34% reduction in the risk of death compared with azacitidine in combination with placebo (n=145) (hazard ratio [HR] = 0.66 [95% confidence interval {CI}: 0.52–0.85]; P=0.001).1

The study met its primary endpoints of statistically significant improvement of overall survival (OS), with the patients in the venetoclax combination arm achieving improved median OS (14.7 months versus 9.6 months in the placebo arm). The study also met its secondary endpoints of composite complete remission [complete remission (CR) + CR with incomplete count recovery (CRi)], with the venetoclax combination arm resulting in a CR rate of 36.7% (versus 17.9% in the placebo arm), a CR with partial hematologic recovery (CRh) rate of 64.7% (versus 22.8% versus the placebo arm) and a composite complete remission rate (CR + CRi) of 66.4% (versus 28.3% in the placebo arm).1

The study observed a safety profile generally consistent with the known safety profiles of venetoclax combined with azacitidine and of the two medications alone.1

AML is the most common acute blood cancer in the world.4 In the UK alone, there are around 3,200 new cases every year, that is more than eight every day.5 AML is also one of the most aggressive and difficult-to-treat blood cancers. It spreads quickly, and due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy.6 Only approximately 28% of patients will survive 5 years or more.7

“I am greatly encouraged by the VIALE-A data, which demonstrate that the venetoclax-azacitidine combination could have the potential to significantly improve the lives of people with AML who aren’t eligible for intensive chemotherapy,” said Belinda Byrne, Medical Director at AbbVie UK.

“As a company, we’re very proud of the data being presented at this year’s EHA meeting, which highlights the broad utility of venetoclax in treating the blood cancers AML and CLL. These data are a testament to our commitment to discovering and developing medicines that drive transformational improvements in blood cancer treatment.”

Venetoclax is not currently licensed for AML in the UK. These Phase III data will be submitted to global regulatory authorities. The data set was presented for the first time as late-breaking data during the virtual 25th European Hematology Association (EHA) Annual Congress today (abstract #LB2601).

Additional data presented at EHA includes research from venetoclax in patients who are previously untreated and patients with BIRC3-mutated relapsed/refractory (R/R) CLL, highlighting the medicines broad potential and utility across difficult to treat blood cancers.

The Phase III CLL14 trial evaluated the combination of fixed duration venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab, a commonly used chemoimmunotherapy, in previously untreated CLL patients off treatment for at least 2 years. At Year 3, data confirmed sustained progression free survival (PFS) of the venetoclax combination versus chemoimmunotherapy. The estimated PFS rate for the venetoclax combination (n=216) was 81.9% compared with 49.5% for patients on chemoimmunotherapy (n=216) (median not reached vs 35.6 months; HR = 0.31 [CI: 0.22–0.44]; P<0.001).2

In addition, subgroup analyses from the Phase III MURANO trial, evaluating BIRC3-mutated R/R CLL patients treated with a fixed duration of venetoclax plus rituximab, reported PFS (primary endpoint) and undetectable minimal residual disease (uMRD) responses (secondary endpoint) based on the 4-year follow-up. The analyses found that there was no PFS reduction observed, and nearly half of the patients were able to achieve and maintain uMRD (HR = 1.5 [95% CI: 0.5–4.3; P=0.44 adjusted for TP53, 17pdel and IGHV status).3 This analysis supports the use of time-limited, chemotherapy-free venetoclax plus rituximab in R/R CLL patients with BIRC3 mutations.

The safety profiles in both studies were consistent with previous results.8

Venetoclax is being developed by AbbVie and Roche. It is commercialised by AbbVie outside of the U.S. and jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S.

-End-

For the venetoclax Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

▼Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com.

AbbVie UK Media:

Rupal Antoniou

+44 (0)7870 678 084

Rupal.Antoniou@abbvie.com

Ben Lewry

+44 020 3900 6075

Ben.Lewry@virgohealth.com 

Notes to editors:

About the VIALE-A (M15-656) Phase III trial

A total of 443 treatment-naïve, intensive chemotherapy ineligible AML patients were randomised in this double-blind, placebo-controlled Phase III VIALE-A trial. The trial was designed to evaluate the efficacy and safety of venetoclax in combination with azacitidine (n = 286) compared with placebo in combination with azacitidine (n = 145).1,9

The study met its primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi). OS and CR + CRi were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries.1

The study also met secondary endpoints with the venetoclax combination arm resulting in a CR rate of 36.7%, a CR with partial haematological recovery (CRh) rate of 64.7% and a CR + CRi of 66.4%, compared with 17.9% CR, 22.8% CRh and 28.3% CR + CRi in the placebo arm.1

The most common (occurring in >10% of patients) Grade 3/4 adverse events in patients receiving venetoclax plus azacitidine were thrombocytopenia (45%), neutropenia (42%), febrile neutropenia (42%), anaemia (26%), leukopenia (21%), pneumonia (20%) and hypokalaemia (11%).1

About venetoclax

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.9 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.8

In 2018, the European Commission approved venetoclax plus rituximab for the treatment of patients with relapsed or refractory (R/R) CLL.8 Venetoclax monotherapy was previously approved in the EU for R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. It was approved for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.8

In March 2020, venetoclax received its third indication marketing authorisation, granting venetoclax for use in previously untreated CLL.

About AbbVie in oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners—scientists, clinical experts, industry peers, advocates and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, the AbbVie oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

References

1. DiNardo CD, Jonas BA, Pullakart V, et al. A Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax With Azacitidine Vs. Azacitidine In Treatment-Naïve Patients with Acute Myeloid Leukemia Ineligible For Intensive Therapy: The Phase 3 VIALE-A Trial [online]. Poster presented at the virtual 25th European Hemotology Association (EHA) Annual Conference; 11–21 June 2020. Available from: https://library.ehaweb.org/eha/2020/eha25th/303390/courtney.dinardo.a.randomized.double-blind.placebocontrolled.study.of.htmlf=menu%3D6%2Abrowseby%3D8%2Asortby%3D2%2Amedia%3D3%2Ace_id%3D1766%2Aces_id%3D27014%2Amarker%3D794%2Afeatured%3D16775 [Last accessed: June 2020].

2. Al-Sawaf O, Zhang C, Tandon M, et al. Fixed-Duration Venetoclax-Obinutuzumab For Previously Untreated Chronic Lymphocytic Leukemia: Follow-Up of Efficacy and Safety Results from the Multicenter, Open-Label, Randomized Phase 3 CLL14 Trial. Presented at the 25th EHA Annual Congress; 11–21 June 2020.

3. Kater A P, Wu J, Wang J, et al. Extended Follow-Up in BIRC3-Mutated Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients Treated With Fixed-Duration Venetoclax Plus Rituximab: Subgroup Analyses of the MURANO Trial. Presented at the virtual 25th EHA Annual Congress; 11–21 June 2020.

4. Puty, T.C., Sarraf, J.S., Do Carmo Almeida, T.C. et al. Evaluation of the impact of single-nucleotide polymorphisms on treatment response, survival and toxicity with cytarabine and anthracyclines in patients with acute myeloid leukaemia: a systematic review protocol. Syst Rev 8, 109 (2019).

5. Cancer Research UK. Acute myeloid leukaemia (AML) statistics. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-aml#heading-Zero [Last accessed: June 2020].

6. Pettit K, Odenike O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015;5:250.

7. National Cancer Institute (2018). Acute Myeloid Leukemia – SEER Stat Fact Sheets. Available from: https://seer.cancer.gov/statfacts/html/amyl.html[Last accessed: June 2020].

8. AbbVie Deutschland GmbH & Co. KG. Venclyxto® (venetoclax): Summary of Product Characteristics [online] 21 April 2020. Available from: https://www.medicines.org.uk/emc/medicine/32650 [Last accessed: June 2020].

9. ClinicalTrials.gov. NCT02993523. A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy [online] 2019. Available from: https://clinicaltrials.gov/ct2/show/NCT02993523 [Last accessed: June 2020].

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AbbVie Presents New Late-Breaking Data Showing SKYRIZI▼® (risankizumab) Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® (secukinumab) at 52 Weeks

Press releases   •   Jun 12, 2020 20:05 BST

-New head-to-head data from the IMMerge Phase 3b open-label study show SKYRIZI demonstrated superiority to COSENTYX at week 52, with 66percent of SKYRIZI patients achieving completely clear skin (PASI100) versus 40 percent of COSENTYX patients1

-No new safety signals were observed for SKYRIZI through 52 weeks1

-Results presented at the American Academy of Dermatology virtual annual meeting

MAIDENHEAD, UK, June 12, 2020– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI▼® (risankizumab)to COSENTYX® (secukinumab) at week 52. Particularly, 66 percent of psoriasis patients receiving risankizumab achieved completely clear skin (PASI100 in the Psoriasis Area and Severity Index) versus 40 percent of patients receiving secukinumab at week 52 (p<0.001).1

These new head-to-head results from the IMMerge Phase 3b open-label study were shared today during an online late-breaking presentation by the American Academy of Dermatology (AAD).

"I’ve seen first-hand how achieving and maintaining completely clear skin can have an incredibly positive impact on the lives of my psoriasis patients,” said chief investigator and professor Richard B. Warren, M.D., Ph.D., professor and honorary consultant dermatologist at the Dermatology Centre Salford Royal NHS Foundation Trust, University of Manchester. “These new data are critical as they underscore that complete skin clearance is a realistic treatment goal for people living with psoriasis.”

Risankizumab met both PASI90 primary endpoints of non-inferiority to secukinumab at week 16 and superiority to secukinumab at week 52.1 At week 16, 74 percent of risankizumab-treated patients achieved PASI90 compared to 66 percent of secukinumab-treated patients.1 Of patients treated with risankizumab, 87 percent achieved PASI90 at week 52 compared to 57 percent of patients treated with secukinumab (p<0.001).1

Additional results demonstrated a significantly higher proportion of patients treated with risankizumab achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) compared to those treated with secukinumab at week 52 (88 percent versus 58 percent, respectively, p<0.001).1

Current safety data available demonstrated that the safety profile of risankizumab was consistent with that seen in previously reported studies, with no new safety signals observed through week 52.1-4 The rates of adverse events (AEs) were comparable between risankizumab and secukinumab.1 The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhoea.1 The rates of serious AEs were 5.5 percent in the risankizumab group and 3.7 percent in the secukinumab group.1 Adverse events leading to discontinuation of the study drug were 1.2 percent in the risankizumab group and 4.9 percent in the secukinumab group.1 There were no deaths in either treatment group.1

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

About the IMMerge Phase 3b Study1,5

IMMerge is a Phase 3b, multicentre, randomised, open-label (both arms), efficacy assessor-blinded, active-comparator study designed to evaluate the safety and efficacy of risankizumab compared to secukinumab in adult patients with moderate to severe plaque psoriasis. Patients were randomised 1:1 to risankizumab (n=164) (150 mg), given as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks thereafter, or to secukinumab (n=163) (300 mg), given as two 150 mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, and then every four weeks thereafter. The study has two primary endpoints (non-inferiority at week 16 as well as superiority to secukinumab at week 52, both at PASI90) and three ranked secondary endpoints (PASI100 at week 52, sPGA 0/1 at week 52 and PASI75 at week 52). Safety was assessed in all patients.

More information on this trial can be found at www.clinicaltrials.gov (NCT03478787).

About risankizumab in the European Union6

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information6

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 21 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Dermatology

For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial programme, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.

###

UK Media: Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

1.Warren, R.B., et al., Risankizumab Versus Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial. 2020 AAD Meeting (Virtual). American Academy of Dermatology Annual Meeting. 2020.

2.Gordon K, et al., Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25; 392(10148):650-661.

3.Reich, K., et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.

4.Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. Poster #478. 24th World Congress of Dermatology. 2019.

5.Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03478787.

6.SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu

COSENTYX is a registered trademark of Novartis AG

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New Long-term Data from RINVOQ® ▼(upadacitinib). Phase 3 Studies in Rheumatoid Arthritis Presented at Annual European E-Congress of Rheumatology (EULAR)

Press releases   •   Jun 08, 2020 09:00 BST

  • Long-term results from the SELECT-COMPARE and SELECT-MONOTHERAPY studies showed that upadacitinib continued to improve signs and symptoms in patients with rheumatoid arthritis through 72 and 84 weeks, respectively1,2
  • Results from SELECT-EARLY and SELECT-COMPARE showed upadacitinib inhibited structural joint damage in rheumatoid arthritis patients receiving upadacitinib as monotherapy or in combination with MTX at almost two years3
  • Upadacitinib’s safety profile was consistent across the pivotal Phase 3 programme, with no new safety signals identified1-5

MAIDENHEAD, UK, June 8, 2020– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new long-term results showing that once-daily RINVOQ®(upadacitinib) continued to improve signs and symptoms in patients with rheumatoid arthritis at 72 and 84 weeks in the SELECT-COMPARE (15 mg in combination with methotrexate [MTX]) and SELECT-MONOTHERAPY (15 mg and 30 mg) Phase 3 clinical trials, respectively.1,2The safety profile of upadacitinib (15 mg and 30 mg) monotherapy or upadacitinib (15 mg) in combination with MTX was consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.

Additionally, approximate two-year data (96 weeks) from the SELECT-EARLY and SELECT-COMPARE clinical trials showed that upadacitinib was effective in inhibiting structural joint damage in patients receiving upadacitinib as monotherapy or in combination with MTX.3 Full results were presented today at the 2020 Annual European E-Congress of Rheumatology (EULAR).

Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is approved as an oral, once-daily, 15 mg therapy for adults with moderate to severe active rheumatoid arthritis 1-5.

“These new long-term data showcase the potential of upadacitinib to provide relief from the signs and symptoms of rheumatoid arthritis, both as a monotherapy and in combination with methotrexate,” said Isidro Villanueva, vice president, medical affairs immunology, AbbVie. “We are excited to share these results with the rheumatology community reinforcing upadacitinib as an important treatment option that may help more patients living with rheumatoid arthritis reach their goals in disease management.”

SELECT-COMPARE Results at 72 Weeks

Results of this Long-Term Extension (LTE) of the SELECT-COMPARE study show that upadacitinib plus MTX maintained higher levels of clinical response, including remission compared to adalimumab plus MTX through week 72.

SELECT-COMPARE Results at 72 Weeks*,†,1
Upadacitinib 15 mg plus MTX(n=651) Adalimumab plus MTX(n=327)
ACR20a 64% 53%
ACR50a 51% 38%
ACR70a 38% 25%
Clinical Remissionb 41% 26%
Low Disease Activityc 49% 32%

*Efficacy data reported based on randomised treatment. For patients who were rescued, non-responder imputation (NRI) was used for binary endpoints. All reported endpoints achieved p-values of ≤0.001 for upadacitinib plus MTX versus adalimumab plus MTX through week 72, except for ACR20 at week 72 (p≤0.01).

Patients who received adalimumab were switched to receive 15 mg of upadacitinib, and vice versa if they did not achieve at least a 20 percent improvement in both tender and swollen joint count at weeks 14, 18 or 22, or if Clinical Disease Activity Index (CDAI) was greater than 10 at week 26. Non-responder imputation (NRI) was used for rescue prior to Week 26 and last observation carried forward (LOCF) was used for rescue at Week 26.

aACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five remaining American College of Rheumatology core set measures: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

bClinical remission is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than 2.6.

cLow disease activity (LDA) is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than or equal to 3.2.

The safety profile of upadacitinib (15 mg) in combination with MTX was generally consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.1 Through the data cut-off, serious adverse events occurred at 12.7 events/100PY (per 100 patient years) on upadacitinib 15 mg in combination with MTX, compared to 15.9 events/100PY on adalimumab in combination with MTX.1,4 The rate of serious infections was 3.7 events/100PY on upadacitinib 15 mg plus MTX and 4.3 events/100PY on adalimumab plus MTX.1 There were eight deaths on upadacitinib (0.6/100PY) and six deaths on adalimumab (1.2/100PY), including non-treatment emergent deaths.1 There were eight major adverse cardiac events (MACE) through the study duration, including five on upadacitinib (0.4/100PY) and three on adalimumab (0.6/100PY).1 There were four patients with venous thromboembolism events (VTE) reported on upadacitinib (0.3/100PY) and five reported on adalimumab (1.0/100 PY).1

The safety profile of upadacitinib (15 mg) in combination with MTX was generally consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.1 Through the data cut-off, serious adverse events occurred at 12.7 events/100PY (per 100 patient years) on upadacitinib 15 mg in combination with MTX, compared to 15.9 events/100PY on adalimumab in combination with MTX.1,4 The rate of serious infections was 3.7 events/100PY on upadacitinib 15 mg plus MTX and 4.3 events/100PY on adalimumab plus MTX.1 There were eight deaths on upadacitinib (0.6/100PY) and six deaths on adalimumab (1.2/100PY), including non-treatment emergent deaths.1 There were eight major adverse cardiac events (MACE) through the study duration, including five on upadacitinib (0.4/100PY) and three on adalimumab (0.6/100PY).1 There were four patients with venous thromboembolism events (VTE) reported on upadacitinib (0.3/100PY) and five reported on adalimumab (1.0/100 PY).1

SELECT-MONOTHERAPY Results at 84 Weeks

In this LTE of the SELECT-MONOTHERAPY study, patients who received continued MTX in the first phase of the study were switched to receive blinded upadacitinib 15 mg or 30 mg at week 14 based on pre-specified assignment at baseline.2Results of this LTE show that upadacitinib monotherapy resulted in continued improvements in rheumatoid arthritis signs and symptoms through 84 weeks.

SELECT-MONOTHERAPY Results* at 84 weeks†2
cMTX to Upadacitinib 15 mg (n=108) cMTX to Upadacitinib30 mg (n=108) Continuous Upadacitinib15 mg (n=217) Continuous Upadacitinib30 mg (n=215)
ACR20a 86% 90% 88% 96%
ACR50a 71% 68% 71% 78%
ACR70a 49% 50% 54% 66%
Clinical Remissionb 56% 63% 60% 77%
Low Disease Activityc 80% 79% 76% 85%

*Results are based on AS Observed analyses; †Upadacitinib 30 mg is not an approved dose.; aACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five remaining American College of Rheumatology core set measures: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant; bClinical remission is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than 2.6; cLow disease activity (LDA) is defined as Disease Activity Score with 28 joint counts C-reactive protein (DAS28-CRP) less than or equal to 3.2.

The safety profile of upadacitinib (15 mg and 30 mg) monotherapy at week 84 was generally consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.2 Through week 84, serious adverse events occurred at 18.5 events/100PY (per 100 patient years) on upadacitinib 15 mg and 16.9 events/100PY on upadacitinib 30 mg.2 The most common serious adverse event was pneumonia.2,4Events of herpes zoster, hepatic disorder and creatine phosphokinase elevations were higher among patients receiving upadacitinib 30 mg, while rates of serious infection and malignancy were comparable between upadacitinib 30 mg and 15 mg.2 Seven patients experienced MACE (15 mg, 0.5/100 PY; 30 mg, 1.2/100 PY) and there were five VTE (15 mg, 0.9/100 PY; 30 mg, 0.2/100 PY).2 All MACE and VTE events occurred in patients with underlying risk factors.2There were three deaths each (0.7/100PY) on upadacitinib 15 mg and 30 mg, including non-treatment emergent deaths.

Radiographic Inhibition at Approximately Two Years: SELECT-EARLY and SELECT-COMPARE

Both SELECT-EARLY and SELECT-COMPARE enrolled rheumatoid arthritis patients at high risk for progressive structural damage with baseline erosive joint damage and/or seropositivity.3

Upadacitinib inhibited structural joint damage in MTX naïve patients receiving upadacitinib monotherapy and in patients with an inadequate response to MTX in combination with MTX.3

Radiographic Inhibition at Approximately 2 Years (96 weeks)*3
SELECT-EARLY SELECT-COMPARE
upadacitinib 30 mg (n=231) upadacitinib 15 mg (n=238) MTX(n=186) Continuous upadacitinib 15 mg plus MTX(n=327) Placebo plus MTX to upadacitinib 15mg plus MTX(n=529) Continuous adalimumab plus MTX(n=125)
No Radiographic Progressiond 91% 89% 76% 82% 77% 75%

* upadacitinib 30 mg is not an approved dose; d No radiographic progression is defined as a change in modified Total Sharp Score (mTSS)≤0

###

UK Media:

Natalie Bennett

AbbVie

T: 07818 428074
E: natalie.bennett@abbvie.com

Notes to Editors

About RINVOQ® (upadacitinib) in the European Union5

Discovered and developed by AbbVie scientists, upadacitinib is a selective and reversible JAK inhibitor. In December 2019, upadacitinib was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for upadacitinib in rheumatoid arthritis is 15mg.

Upadacitinib is currently undergoing review by the National Institute for Health and Care Excellence (NICE) for its the routine use across the NHS.

For full upadacitinib Summary of Product Characteristics visit: https://www.medicines.org.uk/emc/product/10972

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com

About SELECT-COMPARE1

SELECT-COMPARE is a Phase 3, multicenter, randomised, double-blind study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with moderate to severe active rheumatoid arthritis who had an inadequate response to methotrexate and continued a stable background of MTX. Patients received background MTX and were randomized 2:2:1 to receive upadacitinib (15 mg once-daily), placebo or adalimumab (given as a subcutaneous injection of 40 mg every other week).

The primary endpoints of the first phase included the percentage of subjects achieving ACR20 and clinical remission (based on DAS28-CRP) after 12 weeks of treatment compared to placebo. Ranked secondary endpoints included change in the mTSS compared to placebo and a comparison versus adalimumab in percentage of subjects achieving ACR50, low disease activity, changes in pain as measured by the Patient's Assessment of Pain (based on VAS) and changes in physical function, as measured by the HAQ-DI. The trial is ongoing and included a 48 week randomised, double-blind treatment period followed by a long-term extension study of up to five years. More information on this trial can be found at www.clinicaltrials.gov (NCT02629159).

About SELECT-MONOTHERAPY2

SELECT-MONOTHERAPY is a Phase 3, multicenter, randomized, double-blind, parallel-group study designed to evaluate the safety and efficacy of upadacitinib monotherapy in adult patients with moderate to severe active rheumatoid arthritis and an inadequate response to a stable dose of methotrexate. Patients were randomised to switch from MTX to upadacitinib monotherapy (15 mg or 30 mg once-daily) or continue on their prior stable dose of MTX in a blinded manner.

The primary endpoints of the first phase included the percentage of patients achieving an ACR20 response and low disease activity after 14 weeks of treatment. Secondary endpoints included proportion of patients achieving ACR50, ACR70 and clinical remission at week 14, HAQ-DI, duration of morning stiffness and health-related quality of life (QoL) by SF-36. The trial is ongoing, and the second phase is a blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of the two once-daily doses (15 mg and 30 mg) of upadacitinib monotherapy in patients who have completed the first phase. More information on this trial can be found at www.clinicaltrials.gov (NCT02706951).

About SELECT-EARLY3

SELECT-EARLY is a Phase 3, multicentre, randomised, double-blind, parallel-group, active comparator controlled study designed to evaluate the safety and efficacy of upadacitinib monotherapy compared to methotrexate (MTX) monotherapy in adult patients with moderate to severe active rheumatoid arthritis who are MTX-naïve. In the first phase of the study, patients were randomized 1:1:1 to receive upadacitinib (15 mg or 30 mg, once-daily) or MTX. It includes a Japan sub-study in which subjects were randomised 2:1:1:1 to receive RINVOQ (7.5 mg, 15 mg or 30 mg, once-daily) or MTX.

The primary endpoints included the percentage of subjects achieving ACR50 response and clinical remission (based on DAS28-CRP) compared to MTX after 12 weeks and 24 weeks of treatment, respectively. Ranked secondary endpoints included the percentage of patients achieving ACR20 response, ACR70 response and low disease activity, as well as changes in the modified total Sharp score (mTSS) and the Health Assessment Questionnaire-Disability-Index (HAQ-DI). The trial is ongoing and includes a 48 week randomised, double-blind treatment period followed by a long-term extension period for up to an additional four years.

More information on this trial can be found at www.clinicaltrials.gov (NCT02706873).

About HUMIRA® (adalimumab) in the European Union6

Adalimumab, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.

For full adalimumab Summary of Product Characteristics visit:

https://www.medicines.org.uk/emc/product/7986/smpc

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals

References:

  1. Fleischmann R, et al. Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 weeks from the SELECT-COMPARE Study. 2020 EULAR E-Congress; THU0201
  2. Smolen J, et al. Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks From the SELECT-MONOTHERAPY Study. 2020 EULAR E-Congress; THU0213
  3. Peterfy CG, et al. Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 years from the SELECT-COMPARE and SELECT-EARLY Studies. 2020 EULAR E-Congress; THU0211
  4. Cohen S, et al. Safety Profile of Upadacitinib Up to 3 Years of Exposure in Patients With Rheumatoid Arthritis. EULAR 2020; THU0197.
  5. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; March 2019. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
  6. HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Accessed May 18, 2020.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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AbbVie host shared decision making showcase in Parliament to highlight importance of patients being involved in decisions about their care

Press releases   •   Mar 10, 2020 10:00 GMT

MAIDENHEAD, UK, 10th March, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today hosted a Showcase on Shared Decision Making, which highlighted the importance of patients being involved in decisions made about their care.

The showcase took place just over one year after the launch of the NHS Long Term Plan and Universal Personalised Care Plan which established ambitious targets to put shared decision making at the heart of patient care.

The showcase provided a platform for patient groups, NHS Trusts, and healthcare providers to share their innovative work. With projects from therapy areas such as MS, arthritis, Lymphoma, Autism, Hepatitis C, kidney dialysis and more. All focused on empowering patients to take an active part in decisions about their treatment and care.

The event was attended by Parliamentarians, policy makers and national NHS bodies.

Professor Matthew Cripps, Director of Sustainable Healthcare at NHS England & NHS Improvement who opened the event said, “Chapter one of the NHS Long Term Plan makes personalised care business as usual across the health and care system. At NHS England, we’re working to make this a reality, and shared decision making is a key component of this. This showcase has demonstrated how putting patients at the center of their care has a significant impact on outcomes for patients.”

Todd Manning, UK General Manager, AbbVie stated: “AbbVie is committed to working with key partners across the health and care system, with the aim of ensuring patients are involved in the decisions made about their care. For example, we’ve supported projects to develop patient information and those like the Picker Institute survey on shared decision making in dermatology which identified a lack of patients’ involvementin decisions about their care, as showcased at this year’s Shared Decision Making Showcase. In 2020 we will call for policy reform with an aim to embed shared decision making across the NHS.”

-Ends-

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

AbbVie hosts a Showcase on Shared Decision Making, which highlights the importance of patients being involved in decisions made about their care.

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RINVOQ® ▼(upadacitinib) Granted EU Marketing Authorisation for the Treatment of Eligible Adults with Moderate to Severe Active Rheumatoid Arthritis

Press releases   •   Dec 18, 2019 16:20 GMT

  • Marketing authorisation supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis programme evaluating nearly 4,400 patients1-5
  • In five pivotal Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis1-5
  • Upadacitinib offered patients improved rates of clinical remission* or low disease activity** compared to treatment with placebo; methotrexate monotherapy; and adalimumab plus methotrexate 1-5
  • An estimated 400,000 people in the UK are living with rheumatoid arthritis, the majority of whom don’t achieve remission 6,7

MAIDENHEAD, UK, 18 December, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorisation for RINVOQ® (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate (MTX).

“Over the past two decades important advances in the treatment of rheumatoid arthritis have been made, making clinical remission a possibility for more people living with rheumatoid arthritis”, said Alice Butler, UK Medical Director, AbbVie. “We are proud to have been at the forefront of this and to now be able to offer people with moderate to severe RA a new oral treatment option.”

The EC authorisation of upadacitinib was supported by data from the global Phase 3 SELECT rheumatoid arthritis programme, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY.1-5 The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to MTX.1-5

“In the SELECT programme upadacitinib has shown notable consistency in efficacy in clinical trials of patient populations from across the globe”, said Prof Andrew Cope, Head of the Centre for Rheumatic Diseases at King’s College London. “The resuts of these studies mean that patients with active disease have another treatment option with an acceptable safety profile that may induce disease remission even when they have had an inadequate response to drugs such as methotrexate or anti-TNF therapy. Upadacitinib can be used as a single agent and so could benefit many patients who have struggled to tolerate alternative therapies”.

Highlights from the Phase 3 SELECT rheumatoid arthritis programme

Across the SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. Notably, upadacitinib demonstrated consistent efficacy with or without methotrexate and achieved consistent remission* rates across patient populations studied.1-4

Highlights included:

  • In SELECT-COMPARE, upadacitinib plus MTX (n=651) demonstrated significantly higher remission rates* versus placebo plus MTX (n=651) (29 percent vs. 6 percent at week 12; p≤0.001) and HUMIRA® (adalimumab) plus MTX (n=327) (29 percent vs 18 percent at week 12; nominal p≤0.001).4
  • More patients treated with upadacitinib alone (n=217) achieved remission* than MTX (n=216) in SELECT-MONOTHERAPY (28 percent vs 8 percent at week 14; p≤0.0001) and in SELECT-EARLY (48 percent vs 19 percent at week 24; p≤0.001) (n=317 and 314 respectively).3,5
  • In SELECT-EARLY upadacitinib monotherapy (n=317) demonstrated significant inhibition of structural damage***compared to methotrexate (n=314) (0.1 vs 0.7 at week 24; p≤0.01). Upadacitinib +MTX (n=651) also demonstrated significant inhibition of joint damage*** when compared to placebo + MTX (n=651) in SELECT-COMPARE (0.2 vs 0.9 at week 26; p≤0.001).4,5
  • The most commonly reported adverse drug reactions were upper respiratory tract infections (13.5 percent), nausea (3.5 percent), increased blood creatine phosphokinase (2.5 percent) and cough (2.2 percent). The most common serious adverse reactions were serious infections.1-5

More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951).

Earlier this year, upadacitinib received authorisation from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to MTX.

*assessed by DAS28-CRP<2.6 and CDAI≤2.8 

**assessed by DAS28-CRP≤3.2 

*** as measured by modified total Sharp score from baseline

-ENDS-

UK Media:

Natalie Bennett
AbbVie
T: 07818 428074
 natalie.bennett@abbvie.com


Becky Wright
Four Health Communications
T:020 3761 4495
Becky.Wright@fourhealthcommunications.com

 

About upadacitinib in the European Union8

Upadacitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more

disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

Important EU safety information8

Upadacitinib is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Use in combination with other potent Immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥ 75 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunisation guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count < 1000 cells/mm3, absolute lymphocyte count < 500 cells/mm3, or haemoglobin levels < 8 g/dL were reported in <1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care. Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions are upper respiratory tract infections (13.5%), nausea (3.5%), increased blood creatine phosphokinase (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com.

This is not a complete summary of all safety information. See upadacitinib full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About HUMIRA® (adalimumab) in the European Union9

Adalimumab, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.

Important EU safety information9

Adalimumab is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of adalimumab increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with adalimumab. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with adalimumab. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. Please see the full SmPC for complete prescribing information at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information. 

  

References

  1. Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 13.
  2. Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13.
  3. Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. pii: S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
  4. Fleischmann R, et al. Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double&dash;Blind, Randomized Controlled Trial: Arthritis and Rheumatology. 2019. Jul 9; 71 (11):1788-1800
  5. van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
  6. NICE. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375). January 2016
  7. Bergstra SA et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registryAnn Rheum Dis. 2018; 77:1413-1420
  8. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG
  9. HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Accessed November 12, 2019.
     

 About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

UK-UPAD-190114

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AbbVie Presents New Long-Term Data From VENCLYXTO®▼ (venetoclax) Chemotherapy-Free Combination Regimen in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Press releases   •   Dec 09, 2019 17:26 GMT

  • Four-year updated analysis from the MURANO trial showed an 81% reduction in the risk of disease progression or death in patients treated with venetoclax plus rituximab (VenR) and higher rates of undetectable minimal residual disease (uMRD) compared to bendamustine plus rituximab(BR)1
  • Sustained overall survival (OS) benefit was demonstrated with VenR over BR (with a hazard ratio of 0.41), despite 79% of patients in the BR arm who went on to receive a novel targeted treatment. Median OS was not reached for either treatment group1
  • 68% of the 130 patients who completed the treatment course were free of disease progression and maintained OS benefit 24 months after being off venetoclax therapy1
  • Full results are being highlighted today in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition

MAIDENHEAD,UK, December 8, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented long-term data from a post-hoc analysis further supporting the clinical benefit of a fixed treatment duration with venetoclax in combination with rituximab (VenR) in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) compared with a standard of care regimen of bendamustine plus rituximab (BR). The updated data from the Phase 3 MURANO trial four-year analysis (median follow-up of 48 months with all patients off venetoclax treatment for a median of 22 months) showed that patients with R/R CLL who completed the chemotherapy-free combination regimen of venetoclax plus rituximab with a two year fixed treatment duration maintained progression-free survival (PFS) and overall survival (OS) compared to BR.1

Patients who completed treatment with the venetoclax combination also achieved higher rates of uMRD and complete remissions compared to those treated with bendamustine plus rituximab.1 uMRD is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. The full results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition (abstract h#355).

“These results support the benefits of a fixed duration of treatment with venetoclax and rituximab to reduce the risk of disease progression or death in patients with chronic lymphocytic leukemia,” said Mohammed Zaki, M.D., Ph.D., vice president, global head of hematology development at AbbVie. “We remain committed to understanding the full utility of venetoclax combinations.”

“In the four-year analysis from the MURANO trial, treatment with the venetoclax combination resulted in an 81 percent reduction in the risk of progression or death compared to the standard of care,” said Professor John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and director of the Department of Hematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Australia. “The sustained efficacy and manageable safety profile observed in the study further support the clinical benefits of fixed treatment in patients with relapsed or refractory chronic lymphocytic leukemia.”

In the post-hoc analysis, median follow-up for patients who completed two years of treatment with venetoclax plus rituximab without progressive disease (n=130) was 22 months (range: 1 to 35 months). PFS (HR, 0.19, 95% CI: 0.14, 0.25, descriptive p<0.0001) and OS (HR 0.41, 95% CI: 0.26, 0.65, descriptive p<0.0001) was sustained for patients taking VenR compared to those taking BR. 24 months after patients were off therapy, the investigator (INV)-assessed estimated PFS was 68.0% (95% CI 57.6, 78.4). Additionally, the four year OS was 85.3% (95% CI: 89.2, 99.0) in the venetoclax arm compared to 66.8% for BR (medians not reached). Improvements in both PFS and OS were observed in the VenR arm despite 79% of patients in the control arm receiving an additional targeted CLL treatment after disease progression.1

By the end of treatment, 64% of patients had achieved uMRD, and 87% of those patients remained free of disease progression two years post-treatment.1 Achieving uMRD was assessed as a secondary endpoint because it is associated with improved clinical outcomes.2 Higher rates of uMRD were observed off treatment in patients taking VenR than in those taking standard of care BR.1

The safety profile of the combination is consistent with the known safety profile of each individual therapy alone. There were no new serious safety issues observed in the MURANO study since the last update. Excluding non-melanoma skin cancer, there was one report of melanoma in the standard of care cohort, and one report of melanoma and one report of breast cancer in the venetoclax combination cohort.1

Venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of Roche Group, in the U.S. and by AbbVie outside the U.S.

- Ends -

For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com

AbbVie UK Media: 

Joanna Jones 

07795590344

Joanna.jones@abbvie.com


Francesca Morley

07795360167

Francesca.Morley@virgohealth.com

Notes to editors

Design and Results of MURANO Phase 3 Trial

A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized Phase 3 MURANO trial. The trial was designed to evaluate the efficacy and safety of venetoclax in combination with rituximab (N=194) compared with bendamustine in combination with rituximab (N=195). The median age of patients in the trial was 65 years (range: 22 to 85).3

The primary efficacy endpoint was INV-assessed PFS. At the time of the primary analysis, median PFS with venetoclax in combination with rituximab was not reached compared with 17.0 months for bendamustine in combination with rituximab (HR: 0.17; 95% CI: 0.11, 0.25; p<0.0001). In the primary efficacy analysis, the median follow-up for PFS was 23.8 months (range: 0 to 37.4). Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), OS and rates of MRD-negativity.3

About venetoclax

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis.

Venetoclax is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

In January 2019, venetoclax in combination with rituximab was recommended by NICE (The National Institute for Health and Care Excellence) for the treatment of relapsed/refractory CLL on the NHS. Following this, VenR was accepted by the SMC (Scottish Medicines Consortium) for use by the NHS in Scotland in August 2019. These decisions were based on the pivotal results from the Phase 3 MURANO clinical trial. It is the first 24-month fixed treatment duration, chemotherapy-free combination approved for use in this patient population.4

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types. For more information, please visit www.abbvie.co.uk/our-science/therapeutic-focus- areas/Oncology.html

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

References

1. Seymour JF, et al. Four-Year Analysis of Murano Study Confirms Sustained Benefit of Time-Limited Venetoclax- Rituximab (VenR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL). Presented at the 2019 American Society of Hematology Annual Meeting & Exposition: December 8, 2019; Orlando.

2. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018;806398.

3. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.

4. National Institute for Health and Care Excellence. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. 2019. Available at: https://www.nice.org.uk/guidance/ta561/chapter/1-Recommendations

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AbbVie UK Announces Collaboration With NorthWest EHealth to Generate Real World Evidence to Drive Improvements in Patient Care

Press releases   •   Nov 27, 2019 09:00 GMT

  • AbbVie and NorthWest EHealth intend to explore the underlying associations between autoimmune conditions, using technology to interrogate data from NHS general practices
  • Greater Manchester’s population makes the region the ideal location to conduct the work
  • This project is an example of the partnership approach envisaged by the UK Government’s Life Sciences Industrial Strategy, which stresses the importance of collaboration to generate real-world data

MAIDENHEAD, UK, 27 November, 2019 – AbbVie, a research-based global biopharmaceutical company, together with NorthWest EHealth, a world leader in the innovative and trustworthy use of routinely collected healthcare data for clinical evaluation, today announces their partnership to explore the underlying associations between autoimmune conditions.

The collaboration between AbbVie’s UK business and North West EHealth will harness NorthWest EHealth’s proprietary FARSITE software, a cohort finding tool that utilises primary care data.

The North West is an ideal region for this type of investment due to Greater Manchester’s diverse population and its open approach to collaboration with industry, as reflected by the Memorandum of Understanding between the Association of the British Pharmaceutical Industry and the Greater Manchester Combined Authority. It is a prime example of the collaboration approach recommended by the UK Government’s Life Sciences Industrial Strategy.

Alice Butler, AbbVie UK Medical Director commented: “Harnessing the power of NHS data sets offers a significant opportunity to expand our collective knowledge of disease and ultimately work together to raise standards of care. We hope that the partnership model we have developed with NorthWest EHealth could serve as a best practice exemplar for future industry-NHS collaborations.”

Julie Millar, Head of Community Services, NorthWest EHealth, added: “We are delighted to collaborate with AbbVie. Using our FARSITE tool and expertise in interrogating health records, we hope to provide a valuable contribution to advancing scientific understanding of the associations between autoimmune conditions.”

-ENDS-

UK media contacts:

Sarah Beck

+44(0)7818 428111

sarah.beck@abbvie.com

Notes to editors:

About North West EHealth

NorthWest EHealth provides technology to enable regulatory standard real world, data enabled, trials for the life sciences industry. The UK is uniquely placed to perform these types of study due to our single payer system and patient level identifiers which enables linking of the entire longitudinal care records. NorthWest EHealth has developed its own suite of applications and a real-world trial platform (validated to regulatory standard and aligned with FDA framework for real world evidence). These technologies facilitate rapid feasibility, recruitment and delivery of real-world trial study data using linked electronic health resources for consented patients. These technologies are scalable across all coded data sources. The technologies have been designed to operate to international data standards. For more information about NorthWest EHealth, visit www.nweh.co.uk. Follow @NWEHealth on Twitter.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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AbbVie’s SKYRIZI™▼(risankizumab) accepted for use within NHS Scotland

Press releases   •   Oct 07, 2019 17:16 BST

– Positive SMC Detailed Advice Document (DAD)1 for SKYRIZI™ (risankizumab)

- Adult patients in Scotland with plaque psoriasis who have failed, are intolerant to, or contraindicated to conventional systemic therapies, will have NHS access to treatment with high rate of skin clearance at 16 weeks that is maintained through to one year (52 weeks)2

SMC recommendation based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis2-5

– Plaque psoriasis is a chronic condition affecting an estimated 100,000 people in Scotland

and many patients still do not reach treatment goals or lose treatment response over time6,7,8

MAIDENHEAD, UK, 7 October, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Scottish Medicines Consortium (SMC) has published a positive Detailed Advice Document (DAD), confirming that SKYRIZI™▼(risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patientswho have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments.1

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

In clinical studies, risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).2

Psoriasis is a chronic skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. These patches normally appear on the elbows, knees, scalp and lower back, but can appear anywhere on the body9. Psoriasis affects around 1.5-3 percent of people in Scotland8.

Helen McAteer, Chief Executive of The Psoriasis Association, said: “Psoriasis is a difficult to treat, lifelong condition that can affect all parts of an individual’s life. Although there have been advancements in therapy, there are always individuals who find existing treatments either do not work or begin to fail. With the availability of risankizumab within NHS Scotland, patients will now have access to another treatment option that could lead to an improved quality of life, allowing them to experience a life that is not impacted or restricted by the impact of the physical and mental aspects of psoriasis.”

Professor David Burden, Consultant Dermatologist, University of Glasgow, said: “The SMC’s recommendation to offer routine NHS access to risankizumab gives clinicians a new treatment option in the management of moderate to severe psoriasis. The mode of action involves inhibition of the p19 subunit of the IL-23 cytokine, which is known to be important in the pathogenesis of psoriasis. Risankizumab addresses a remaining unmet need for people with moderate to severe psoriasis by enhancing our ability to achieve high levels of lasting skin clearance with a 12-weekly injection.”

The SMC DAD is based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.2-5 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.2-5

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.5 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.5

Alice Butler, AbbVie UK Medical Director commented, “AbbVie is committed to developing and delivering therapeutic options in psoriasis, an area where there is high unmet need. We have worked closely with the SMC to bring risankizumab to patients in Scotland as quickly as possible.”

The European Commission granted Marketing Authorisation for risankizumab on 26 April 2019.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information5

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-ENDS-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

SKYRIZI™▼(risankizumab) Receives NICE Positive Technology Appraisal Guidance for the Treatment of Plaque Psoriasis in Adults

Press releases   •   Aug 21, 2019 09:19 BST

MAIDENHEAD, UK, 21 August 2019 - AbbVie (NYSE: ABBV), a research-based biopharmaceutical company, announces that eligible patients in England and Wales with plaque psoriasis who have failed conventional systemic therapies will have access to SKYRIZI™▼(risankizumab) following the issuing by the National Institute for Health and Care Excellence (NICE) of the Technology Appraisal Guidance (TAG) recommending the treatment1.

The TAG represents the completion of the final step of NICE assessment and follows a positive recommendation by NICE through its Fast Track Appraisal process, which has an accelerated timeframe of 30 days for implementation rather than the usual 90 days associated with a Single Technology Appraisal.

Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time2-4. In clinical studies risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).5

This announcement means that risankizumab will be made available to eligible patients almost two months earlier than would have been the case via other NICE assessment routes.

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information6

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-Ends-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

1 The Technology Appraisal Guidance (TAG) can be accessed via the NICE website

2 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019

3 Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10

4 National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed August 2019)

5 Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30

6 SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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Contacts 5 contacts

For general press enquiries please contact the AbbVie Corporate Communications team at UKMediaRelations@abbvie.com or call us on 01628 925200

  • Press Contact
  • Head of Brand Communications and Patient Relations
  • jocaanjqnajt.jbtonhvesbt@agqbbbgviize.spcoahmsx
  • 07795 590 344

  • Press Contact
  • Senior Corporate Communications Manager
  • Internal and Corporate Communications
  • chimerziyltg.pbiitunchraerfd@ajkbbbyvikle.lecoqbmqh
  • 07500 786 466

  • Press Contact
  • Senior Communications and Patient Relations Manager
  • Immunology - Gastroenterology & Rheumatology
  • naqttaazliume.lwbelfnnmxetwvt@ihablkbvbriecy.cqnomgu
  • 07818 428 074

  • Press Contact
  • Senior Brand Communications and Patient Relations Manager, Dermatology
  • Dermatology
  • sawurazwh.skbepnckpk@alabbtpviqce.sfcozqmnu
  • 07818 428 111

About AbbVie UK

We're a company that takes on the toughest health challenges.

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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