AbbVie receives draft NICE guidance on VENCLYXTO®▼(venetoclax) plus rituximab for treating relapsed or refractory chronic lymphocytic leukaemia

Press Releases   •   Oct 26, 2018 14:59 BST

MAIDENHEAD, Friday 26th October 2018 – AbbVie today received the draft guidance from the National Institute for Health and Care Excellence (NICE) not recommending venetoclax plus rituximab for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) in adults.

Jérôme Bouyer, General Manager, AbbVie UK, said: “We are disappointed with the outcome of the draft decision, however this is not the final step in the appraisal and we are pleased NICE has recognised that venetoclax plus rituximab could be an important treatment option with an acceptable safety profile. We are also pleased to learn that patient experts would welcome a therapy with a fixed treatment duration in this setting. We remain committed to ensuring that patients with relapsed or refractory CLL have access to an important chemotherapy-free option.”

“Our priority now will be to work collaboratively with NICE to ensure they have all the necessary data to inform a robust evaluation and our aim remains to facilitate NHS access to venetoclax plus rituximab as quickly as possible via routine commissioning or the Cancer Drugs Fund (CDF).”

Over 3,500 people are diagnosed with CLL in the UK each year and the incidence has risen by 18% in less than 30 years.1 For those patients living with CLL requiringtreatment, the majority will eventually have their disease recur.2

-Ends -

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

For the CHMP positive opinion for venetoclax in combination with rituximab, please visit:

https://www.ema.europa.eu/documents/smop/chmp-summary-positive-opinion-venclyxto-ii/08_en.pdf

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

For further information:

AbbVie UK Media:

Joanna Jones

07795590344

Joanna.jones@abbvie.com

Francesca Morley

07795360167

Francesca.Morely@virgohealth.com

Notes to editors

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.

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 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: October 2018

2 American Cancer Society. (2013) Leukemia – Chronic Lymphocytic. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed October 2018

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AbbVie announces the introduction of an interim commercial offer to the NHS for HUMIRA® (adalimumab) from 1st November 2018

Press Releases   •   Oct 18, 2018 14:33 BST

INTENDED FOR TRADE AND PHARMACEUTICAL PRESS ONLY

Maidenhead, UK, 18th October 2018, AbbVie welcomes the intention expressed by NHS England on 15th October 2018, to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

AbbVie supports the entry of new competitors and the approval of biosimilars that have demonstrated they are as safe and efficacious as their reference products. We remain committed to ensuring that our medicine remains a best value biologic option for the NHS, both now and in the future, and will introduce an interim commercial offer to the NHS to start from the 1st November. It is our position that patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.

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 announces the introduction of an interim commercial offer to the NHS for HUMIRA® (adalimumab) from 1st November 2018

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AbbVie’s response* to NHS England’s announcement to switching to new versions of adalimumab

Press Releases   •   Oct 16, 2018 13:22 BST

AbbVie today (16th October 2018) welcomes the intention expressed by NHS England to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

Whilst we welcome the introduction of biosimilars that have demonstrated they are as safe and efficacious as their reference products, we remain committed to ensuring that our medicine remains a best value biologic option for the NHS, both now and in the future, and it is our position that patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.

Furthermore building on the strength of our continuous 20 years of investment and a strong foundation in immunology, we are advancing an extensive portfolio, with several molecular compounds being evaluated across multiple immune-mediated conditions. These investigational medicines are designed to target different immune system pathways. We believe that these compounds will provide us with a competitive portfolio in immunology that will help us maintain our therapeutic leadership, drive continued growth and make an ongoing impact on patients’ lives.

*This statement is provided in direct response to the NHS England press release ‘NHS set to save £150 million by switching to new versions of most costly drug’, issued 15th October 2018, during which time the tender process is still on-going. 

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 today (16th October 2018) welcomes the intention expressed by NHS England to maintain HUMIRA® (adalimumab); a specialised biologic medicine for treating a number of inflammatory conditions, as an ongoing treatment option for physicians and patients, as part of the adalimumab tendering strategy, which will start on 1st December 2018.

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AbbVie Receives Positive CHMP Opinion for a Novel, Chemo-free Combination of VENCLYXTO®▼ (venetoclax) with Rituximab as a Treatment with a Fixed Duration for Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy

Press Releases   •   Sep 21, 2018 13:22 BST

  • If approved by the European Commission (EC), venetoclax plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
  • The positive opinion is based on the MURANO Phase 3 clinical trial, in which venetoclax plus rituximab met the primary endpoint of prolonged progression-free survival and eighty-three percent (n=162/194) of patients achieved undetectable minimal residual disease in the peripheral blood, compared to twenty-three percent (n=45/195) with a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.1
  • The safety profile of the combination of venetoclax plus rituximab is consistent with the known safety profile of each medicine alone.1

MAIDENHEAD, 21 September, 2018 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO® (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy.The positive CHMP opinion is a scientific recommendation for marketing authorisation to the European Commission (EC), which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.2 Over 3,500 people are diagnosed with CLL in the UK each year and the incidence has risen by 18% in less than 30 years.For those patients living with CLL requiringtreatment, the majority will eventually have their disease recur.4 In the relapsed/refractory setting, there are currently limited treatments available. 50% of patients who fail on current treatments can face survival as short as three months.5,6

Professor Peter Hillmen, Consultant Haematologist, Leeds Teaching Hospitals NHS Trust and Coordinating Investigator of venetoclax studies in the UK said; “The CHMP’s positive opinion of venetoclax plus rituximab is a key step towards the use of this novel combination for patients with relapsed/refractory chronic lymphocytic leukaemia in the UK, and underlines the significance of the MURANO phase three trial data. Venetoclax plus rituximab represents an important option for patients with relapsed and refractory CLL which is superior to a commonly used chemotherapy-based combination and prolongs progression-free survival. In addition, this new combination offers patients a fixed treatment duration allowing the cessation of therapy after two-years followed by a treatment-free interval.”

“This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The combination of venetoclax with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course.”

The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death7) for patients who received venetoclax plus rituximab compared with bendamustine plus rituximab.1

In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint. Eighty-three percent (n=162/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus twenty-three percent (n=45/195) in the control group who received a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.1 Undetectable minimal residual disease, 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.7

In 2016, venetoclax was approved by the EC as a monotherapy for the treatment of 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, and for the treatment of CLL in the absence of these mutations in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.8

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other haematological cancers.9,10,11,12

-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

For further information:

AbbVie UK Media:

Joanna Jones

07795590344

Joanna.jones@abbvie.com

Francesca Morley

07795360167

Francesca.Morely@virgohealth.com

Notes to editors

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.8 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein.8 Venetoclax in combination with rituximab is not currently approved for use in the UK.

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.

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

2. NCI dictionary. NCI Dictionary of Terms. Chronic Lymphocytic Leukemia. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed September 2018.

3. Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: September 2018.

4. American Cancer Society. (2013) Leukemia – Chronic Lymphocytic. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed September 2018. 

5. Follows G. Outcomes for UK CLL patients post ibrutinib therapy. UK CLL Forum poster presented at BSH. 2017

6. Jain PW et al. Outcomes of patients with chronic lymphocytic leukemia after discontinuing ibrutinib. Blood. 2015; 125: 2062-2067.

7. 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; 131(25):2745-2760. 

8. Venclyxto Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/32650. Accessed September 2018. 

9. Clinicaltrials.gov. NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia with the 17p deletion. Accessed May 2018.

10. Clinicaltrials.gov. NCT01994837: A Phase 2 study of ABT-199 in subjects with acute myelogenous leukemia (AML). Accessed May 2018. 

11. Clinicaltrials.gov. NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory multiple myeloma. Accessed May 2018. 

12. Clinicaltrials.gov. NCT01328626: A Phase 1 study evaluating the safety and pharmacokinetics of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia and non-Hodgkin lymphoma. Accessed May 2018.

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AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

Press Releases   •   Sep 13, 2018 14:22 BST

– Across all doses, a significantly greater proportion of patients who remained on upadacitinib showed continuous improvements in skin lesions and pruritus (itch) at week 32 compared to patients re-randomized to placebo1

– At week 32, patients who switched from placebo to upadacitinib 30 mg at week 16 showed greater improvements in skin lesions and itch compared to those remaining on placebo1

– Results from an additional analysis of a subset of patients receiving upadacitinib 30 mg reported greater improvements in itch and sleep disturbance compared to those receiving placebo at week 162

Maidenhead, UK, 13th September 2018 – AbbVie, a research-based global biopharmaceutical company, today announced new results from the ongoing Phase 2b study including longer-term (32-week) efficacy and safety data and patient-reported outcomes data evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis.1,2 Results from a pre-specified, interim analysis from the Phase 2b dose-ranging study showed that treatment with upadacitinib 7.5 mg, 15 mg or 30 mg resulted in greater improvements in itch and skin lesions, with statistically significant differences observed versus placebo at week 32 (n=167).1 Additionally, results from a further analysis of a subset of patients (n=44) showed that upadacitinib improved patient-reported itch and impact on sleep due to atopic dermatitis in patients receiving upadacitinib (30 mg, once-daily) compared to placebo at week 16.2 Data from these two analyses will be presented today at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

“Results from this study increase our understanding of upadacitinib’s potential to be an important treatment option for patients living with atopic dermatitis,” said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. “At AbbVie, we continuously strive to discover and develop innovative medicines for patients who are in need of more treatment options that advance standards of care and improve quality of life. Data from the mid-stage clinical study support the recent advancement of upadacitinib into Phase 3 clinical studies and underscore our commitment to patients with atopic dermatitis.”

Atopic dermatitis is a common chronic, relapsing, inflammatory skin disease with associated comorbidities.4 One-third of atopic dermatitis patients have moderate to severe disease, which manifests as a debilitating, itchy rash with significant physical, psychological and economic burden.4,5 There is a large unmet need for therapies that are effective to manage the signs and symptoms of moderate to severe atopic dermatitis.

“The symptoms associated with atopic dermatitis can have a profound impact on patients’ quality of life, causing serious discomfort and pain, and impacting their ability to sleep,” said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology, Medical Social Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine and lead study investigator. “The patient-reported outcome results presented at EADV are encouraging, and provide further insight into the improvement provided by upadacitinib in patients with moderate to severe atopic dermatitis.”

Longer-Term Results at Week 321

These results are from an interim analysis at week 32 of an ongoing Phase 2b study entitled, “Efficacy and Safety of Upadacitinib Treatment Over 32 Weeks for Patients with Atopic Dermatitis from a Phase 2b, Randomized, Placebo-Controlled Trial” (P0236). 1 At week 16, patients in each upadacitinib group were re-randomized in a 1:1 ratio to continue on the Period 1 dose (7.5[n=16] /15[n=18] /30[n=19] mg once-daily) or to placebo (withdrawal) (n=15/19/19 subjects in UPA 7.5/15/30 mg period 1 dose), while the Period 1 placebo group was re-randomized to receive upadacitinib 30 mg once-daily (n=10) or placebo (n=10).1 Four weeks following re-randomization (week 20), blinded rescue therapy with upadacitinib 30 mg once-daily was provided after the first instance of a less than EASI 50 response.1

Results showed that patients treated with upadacitinib across all dose groups (7.5/15/30 mg once-daily) achieved significant improvement in extent and severity of atopic dermatitis, as measured by the mean percent improvement from baseline in the Eczema Area and Severity Index (EASI) score.1 For patients receiving upadacitinib, the mean percent improvement from baseline in the EASI score was 48/44/69 percent for the 7.5/15/30 mg doses, respectively, compared to 34 percent for patients receiving placebo.1 Among patients receiving placebo in Period 1 and re-randomized to receive the upadacitinib 30 mg dose in Period 2, the mean percent improvement from baseline in the EASI score was 97 percent at week 32.1

Additionally, significant improvement in pruritus (itch) from baseline was observed across all upadacitinib treatment groups at week 32.1 Patients re-randomized to upadacitinib achieved a 53/44/61 percent improvement in itch across the 7.5/15/30 mg doses, respectively, compared to 6 percent worsening in itch for patients receiving placebo, as measured by the pruritus numerical rating scale (NRS).1

Efficacy Results at Week 321
Period 1 Dose PBO UPA 7.5 mg UPA 15 mg UPA 30 mg
Period 2 Dose PBO (n=10) UPA 30 mg (n=10) PBO (n=15) UPA 7.5 mg (n=16) PBO (n=19) UPA 15 mg (n=18) PBO (n=19) UPA 30 mg (n=19)
Mean Percent Improvement from Baseline in EASI Scorea 34% 97%*** 9% 48%* 12% 44%* 22% 69%**
Mean Percent Improvement from Baseline in Pruritus/Itch Numerical
Rating Scaleb
-6% 94%*** -6% 53%** 3% 44%** -13% 61%***
*p<0.05, **p<0.01, ***p<0.001aEczema Area and Severity Index (EASI) score is a tool used to measure the extent (area) and severity of atopic dermatitis

bItch was rated from 0 (no itch) to 10 (worst imaginable itch)

In this study, no new safety signals were detected.1 There were 2 serious adverse events in the placebo group re-randomized to receive upadacitinib 30 mg, including one serious infection and one case of non-melanoma skin cancer.1 No cardiovascular events (adjudicated), malignancies other than non-melanoma skin cancer, deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred through week 32 in the Phase 2b study.1

Patient-reported Outcomes at Week 16: Itch, Skin Pain and Impact on Sleep Due to Atopic Dermatitis2

Results from an additional analysis in a subset of patients through week 16 showed that patients treated with upadacitinib had improvements on patient-reported outcomes covering itch and the impact of atopic dermatitis on sleep.2 In the study, patients (n=14/6/9 subjects receiving UPA 7.5/15/30 mg and n+15 receiving placebo) completed a symptom and impact questionnaire daily, which included three items to assess itch and skin pain (itch during sleep, itch while awake, skin pain) and three items to assess impact on sleep (difficulty falling asleep, sleep impact, bother from waking up at night).2

Improvements on all measures were observed as early as week 2 for all upadacitinib dose groups compared to placebo.2 At week 16, only the upadacitinib 30 mg group showed improvements on all measures except skin pain.2

Patient-reported outcomesare an important component of understanding how patients perceive the physical, psychological and social burden of their disease.6 Using patient-reported outcomes data to assess the impact of the disease allows patients to take an active role in their treatment journey providing valuable insight to their healthcare teams.

About the Phase 2b Upadacitinib Study1

Interim results were reported from an ongoing, 88 week dose-ranging, randomized, double-blind, parallel-group, placebo-controlled multicenter Phase 2b study designed to evaluate the safety and efficacy of upadacitinib in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable. In Period 1 (16 weeks), subjects were randomized in a 1:1:1:1 ratio to one of four treatment groups (three upadacitinib dosing groups, 30/15/7.5 mg once-daily, and one placebo group). In Period 2 (72 weeks), each upadacitinib group was re-randomized in a 1:1 ratio to continue the Period 1 dose or placebo (withdrawal). Patients randomized to placebo in Period 1 were re-randomized at week 16 to either upadacitinib 30 mg once-daily or placebo. After four weeks of re-randomization (week 20), rescue therapy with upadacitinib 30 mg once-daily was provided after the first instance of a less than EASI 50 response. The primary endpoint of the study was the mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks. Secondary endpoints included the proportion of patients achieving EASI 90, EASI 75, Investigator Global Assessment (IGA) of 0 or 1 and percent change in pruritus/itch numerical rating scale (NRS). More information on this trial can be found at www.clinicaltrials.gov (NCT02925117).

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is a once-daily oral, small molecule JAK1-selective inhibitor being developed for moderate to severe atopic dermatitis and other immune-mediated diseases.1-3

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

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 Media Contacts

Matthew Worrall, Senior Brand Communications and Patient Relations Manager, AbbVie

matthew.worrall@abbvie.com

+44 (0) 7464 652 626

References

  • 1.Guttman-Yassky, E et al. ePoster #P0236. 27th European Academy of Dermatology and Venerology (EADV) Congress. September 2018.
  • 2.Silverberg, J et al. Presentation#FC04.03. 27th European Academy of Dermatology and Venerology (EADV) Congress. September 2018.
  • 3.Voss, J, et al. Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10.
  • 4.Nutten S, Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8-16 2. Accessed on September 6, 2018.
  • 5.Wei, W, et al. Discordance Between Physician- and Patient-Reported Disease Severity in Adults with Atopic Dermatitis: A US Cross-Sectional Survey. Am J Clin Dermatol. 2017; 18(6): 825–835.
  • 6.Deshpande, PR et al. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct-Dec; 2(4): 137–144.

Date of preparation: September 2018

Job code: AXUPC181173

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 Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

Press Releases   •   Sep 13, 2018 11:34 BST

AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

  • Pooled analyses from ultIMMa-1 and ultIMMa-2 studies showed significantly more patients treated with risankizumab were symptom-free (psoriasis symptom scale [PSS] score of 0) compared to placebo and STELARA (ustekinumab) after 16 weeks and at one year (52 weeks) compared to ustekinumab1
  • In the IMMvent study, significantly more patients treated with risankizumab self-reported a Dermatology Life Quality Index score of 0 or 1 compared with HUMIRA® (adalimumab)-treated patients after 16 weeks2
  • Risankizumab-treated patients reported significant improvements in measures of health-related quality of life, mental health and work productivity1,2

Maidenhead, UK, 13th September, 2018– AbbVie, a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in health-related quality of life, mental health and work productivity measures when treated with risankizumab.1,2Data from these studies will be presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

At week 16, significantly more risankizumab-treated patients reported a psoriasis symptom scale (PSS) score of 0, indicating they were symptom-free based on a score assessing pain, redness and itchiness, compared with STELARA (ustekinumab) and placebo in ultIMMa-1 and ultIMMa-2.1 Significantly more patients treated with risankizumab continued to report a PSS score of 0 at one year (52 weeks) compared to ustekinumab.1 In IMMvent, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had impact on their life quality, compared to HUMIRA® (adalimumab) at week 16.2 Risankizumab-treated patients maintained reported outcomes at week 44 in IMMvent.2 Improvements in hospital anxiety and depression scales (HADS) and work limitation questionnaire (WLQ), a measure of work productivity, were also reported.1,2

Safety results from all three Phase 3 trials have been previously reported.3,4

“Patients treated with risankizumab reported significant improvements in severity of psoriasis symptoms and measures of quality of lifecompared to current standards of care, as consistently demonstrated by the results of all three Phase 3 pivotal trials,” said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. “Patients with psoriasis are seeking new treatment options that help them not only to achieve and maintain clear skin, but may also improve their quality of life. These results add to the growing body of evidence demonstrating that risankizumab has the potential to be an important additional treatment option for patients with plaque psoriasis.”

Patient-reported outcomesare an important component of understanding how patients perceive the physical, psychological and social impact of their disease.5 Using patient-reported outcomes to assess disease activity helps patients to take an active role in their treatment journey, providing valuable insights to their healthcare team.5

“Psoriasis can impact many aspects of a person’s life, both physically and psychologically,” said Prof. Matthias Augustin, Director, Institute and German Center for Health Services Research in Dermatology and Nursing IVDP, University Medical Center Hamburg. “Improvements in quality of life reported by patients as early as week 16 and up to one year show risankizumab’s potential to significantly reduce the burden of psoriasis on daily life and adds to our knowledge about its clinical efficacy in psoriasis patients.”

Psoriasis Symptom Scale (PSS)1

  • In pooled analyses from ultIMMa-1 and ultIMMa-2, significantly more patients treated with risankizumab (n=598) reported a PSS of 0 compared to placebo (n=200) and ustekinumab (n=199), indicating they were symptom-free based on pain, redness, itchiness and burning. At week 16, 30 percent of patients receiving risankizumab had a PSS score of 0, compared with 15 and 1 percent of patients receiving ustekinumab and placebo, respectively (p<0.001). At one year, 56 percent of risankizumab-treated patients reported being symptom free (PSS = 0), compared with 30 percent of patients receiving ustekinumab (p<0.001).

Dermatology Life Quality Index (DLQI)2

  • Dermatology Life Quality Index is a measure of a patient's health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality. In IMMvent, risankizumab (n=301) was associated with significantly greater improvement in DLQI score from baseline than adalimumab (n=304) at week 16 (with an 11.5 point reduction in DLQI score versus 9.7 points, p<0.001). Significantly more patients treated with risankizumab achieved a DLQI score of 0 or 1 (66 percent) compared to adalimumab (49 percent) at week 16 (p<0.001). At week 44 patients maintained benefit, with 66 percent of risankizumab-treated patients achieving a DLQI score of 0 or 1 and the percentage of adalimumab-treated patients was 57 percent.

Hospital Anxiety and Depression Scale (HADS)1

  • Hospital Anxiety and Depression Scale is a self-assessment scale designed to measure depression, anxiety and emotional distress, with scores ranging from 0 to 21 (increasing in severity). In pooled analyses from ultIMMa-1 and ultIMMa-2, risankizumab-treated patients reported significantly greater improvements from baseline on the HADS anxiety and depression scales (scores reduced by 3 points for anxiety and 2.7 points for depression, respectively) compared to ustekinumab (scores reduced by 2.2 points for anxiety and 2 points for depression, respectively) and placebo (scores reduced by 0.8 points for anxiety and 0.2 points for depression, respectively) at week 16 (p<0.01).

Work Limitation Questionnaire (WLQ)2

  • The Work Limitation Questionnaire measures the degree to which health problems interfere with aspects of job performance and the productivity impact of these work limitations. Work Limitation Questionnairescores range from 0 to 100, with lower scores indicating less amount of time that health interferes with job demands and productivity. In IMMvent, patients receiving risankizumab showed a significantly larger improvement in WLQ total productivity loss from baseline compared to those receiving adalimumab at week 16 (score reduced by 2.8 percent versus 1.9 percent, p<0.05). The benefits gained were maintained at week 44, with risankizumab-treated patients WLQ productivity loss score reduced by 3.3 percent and adalimumab-treated patients score reduced by 2.6 percent, based on a mean reduction from baseline. Work Limitation Questionnaire subscales were also presented.

About the Phase 3 ultIMMa-1 and ultIMMa-2 studies3

ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab (150 mg) was given as a subcutaneous injection at week 0, 4, 16, 28, 40. Ustekinumab 45 mg or 90 mg, based on screening weight, was delivered as a subcutaneous injection at week 0, 4, 16, 28, 40. The active comparator used for these studies was sourced from the European Union. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16 compared to placebo. Key secondary endpoints included PASI 90 and sPGA score of clear or almost clear (0/1) compared to ustekinumab at Week 16 and achievement of PASI 90 and PASI 100 at week 52 compared to ustekinumab. These Phase 3 studies have been conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on these trials can be found at www.clinicaltrials.gov (ultIMMa-1: NCT02684370; ultIMMa-2: NCT02684357).

About the Phase 3 IMMvent study4

The IMMvent study is a Phase 3 randomized, double-blind, double-dummy, active-controlled study designed to evaluate the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis. In the first phase patients were randomized 1:1 to either risankizumab (150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter or adalimumab, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16.

Patients originally randomized to risankizumab received it throughout the study. Those originally randomized to adalimumab followed a treatment course based on week 16 response: those with less than PASI 50 at week 16 switched to risankizumab; those with PASI 90 continued adalimumab; and those with a PASI 50 but less than PASI 90 response were re-randomized to switch to risankizumab or continue adalimumab. For this phase, PASI 90 at week 44 was the primary endpoint for those patients re-randomized at week 16. PASI 100 at week 44 was the ranked secondary endpoint. This Phase 3 study has been conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on this trial can be found at www.clinicaltrials.gov (NCT02694523).

About the Risankizumab Phase 3 Psoriasis Program3,4,6

The global risankizumab Phase 3 psoriasis program evaluates more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal studies. The studies include assessments of efficacy, safety and tolerability of risankizumab. Key measures of efficacy include measures of disease activity and skin clearance, including PASI 90, PASI 100 and sPGA 0/1, as well as long-term clinical outcomes. More information on this program can be found at www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

About Risankizumab

Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit. IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.7

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. Risankizumab is not approved by regulatory authorities. Safety and efficacy have not been established.

###

UK Media Contacts

Matthew Worrall, Senior Brand Communications and Patient Relations Manager, AbbVie

matthew.worrall@abbvie.com

+44 (0) 7464 652 626

References:

1.Augustin, M., et al. ePoster #1996. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.

2.Crowley, J., et al. ePoster #P1947. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.

3.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.

4.Reich, K., et al. ePoster #P1813. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.

5.Deshpande, P.R. et al. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct-Dec; 2(4): 137–144.

6.Blauvet, A., et al. Presentation # FC29. Psoriasis Gene to Clinic – 8th International Congress. October 2017.

7.Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

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 UK publishes 2017 transparency data

Press Releases   •   Jun 29, 2018 12:25 BST

AbbVie annual transparency publication of transfer of value data to healthcare professionals, healthcare organisations and patient organisation goes live 29 June 2018.

AbbVie UK Launches Third Annual ‘Big Ideas for Better Health’ Awards

Press Releases   •   May 22, 2018 05:00 BST

-Awards celebrate forward-thinking individuals and teams who are championing innovation and supporting the NHS to become more resilient and sustainable -Independent judging panel led by Patients Association -Winning teams receive £3000 bursary to spread their work

AbbVie Submits Marketing Authorisation Application to the European Medicines Agency for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

Press Releases   •   May 02, 2018 10:10 BST

• Application supported by four pivotal Phase 3 trials evaluating patients with moderate to severe plaque psoriasis (refs 1-3) • Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit (ref 4) and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing

New Presentation, HUMIRA® (adalimumab) 20 mg/0.2 mL for Injection in Pre-filled Syringe (PFS) Launched for Paediatric Patients, together with the Introduction of Fixed Weight Dosing

Press Releases   •   Mar 29, 2018 16:06 BST

Maidenhead, UK, 29th March 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA® (adalimumab) 20 mg/0.2 mL presentation. The presentation is designed for injection in a pre-filled syringe specifically in paediatric patients for approved indications (paediatric polyarticular juvenile idiopathic arthritis, paediatric enthesitis related arthritis, paediatric Crohn’s disease, paediatric plaque psoriasis and paediatric Uveitis).

The formulation contains the same active ingredient, adalimumab, and the efficacy and safety profile remains unchanged. In 2016 AbbVie introducted a citrate free adalimumab 100 mg/mL formulation and launched Humira 40 mg/0.4 mL. The HUMIRA 20 mg/0.2 mL will be available to the UK Market at the beginning of quarter two (April 2018).

"The launch of the HUMIRA 20 mg/0.2 mL presentation underscores our ongoing dedication to improving the patient experience through research and enhancements,” said Alice Butler, Medical Director, AbbVie. “We remain committed to innovation in immunology in order to improve upon the therapeutic experience of patients and physicians.”

Professor Ramanan, Consultant Paediatric Rheumatologist, Bristol Royal Hospital for Children & Royal National Hospital for Rheumatic Diseases, said: “The introduction of HUMIRA 20 mg/0.2 mL is welcome news for paediatric patients, that will provide significant reduction in pain on administration for paediatric patients”.

Kit Tranter, Lead Paediatric Rheumatology Nurse Specialist at Jenny Lind Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust said: “This will be met positively by the Paediatric Nursing community as the implications for empowering young people and their families, improving quality of life by reducing the technical nature of administering paediatric doses, reducing waste whilst maintaining good control of long term conditions shouldn’t be underestimated. I’m delighted that the specific needs of the paediatric rheumatology patient group have been recognised and acted upon to improve the overall experience”.

The paediatric dosing has been simplified. Instead of using body surface area as a calculation of dose required, the calculation is based on age and weight and will utlilise the newly available HUMIRA 20 mg/0.2mL and current HUMIRA 40 mg/0.4 mL.

-ENDS-


Notes to editors

About HUMIRA® (adalimumab)

For further information, and recommended dosing of HUMIRA for each paediatric indication, please see the Summary of Product Characteristics: http://www.medicines.org.uk/emc.

Important EU Safety Information

HUMIRA 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. The use of HUMIRA 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 HUMIRA. 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. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

###

UK Media Contacts

Cheryl Pitcher Email: cheryl.pitcher@abbvie.com

Tel: 07500 786 466

References:

1) HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: https://www.medicines.org.uk/emc/search?q=humira. Accessed 28th March 2018.

Date of preparation: March 2018

Zinc reference no: AXHUM180208

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.

Maidenhead, UK, 29th March 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA® (adalimumab) 20 mg/0.2 mL presentation. The presentation is designed for injection in a pre-filled syringe specifically in paediatric patients for approved indications.

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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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