AbbVie Receives CHMP Positive Opinion for SKYRIZI™ ▼ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis in adults

Press Releases   •   Mar 01, 2019 12:13 GMT

CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission1-3

–In Phase 3 trials, risankizumab achieved significantly greater response of clear or almost clear skin (sPGA 0/1 and PASI 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 with every 12-week dosing after initial start dosing1-3

–Risankizumab (under the trade name SKYRIZI) is an investigational, humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit4


NORTH CHICAGO, Ill., March 1, 2019– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI™ (risankizumab , an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patientswho are candidates for systemic therapy.

The CHMP positive opinion is supported by data from the global Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies.1-3 Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, all co-primary and ranked secondary endpoints were met, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 (depending on study design).1-3 The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.5 Most reported adverse reactions were mild or moderate in severity.5

"Plaque psoriasis can have a significant physical, psychological and social burden on people living with the condition,” said Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited that the CHMP has recognized risankizumab’s potential to significantly reduce the signs and symptoms of psoriasis and provide an improved quality of life. In clinical studies, risankizumab demonstrated consistently high rates of skin clearance with a favorable benefit/risk profile. This is an important regulatory milestone in our relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions."

The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision, valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. The Commission decision is anticipated within 67 days following the CHMP opinion.

About the SKYRIZI (risankizumab) Phase 3 Psoriasis Program1-3

The global Phase 3 psoriasis program evaluated more than 2,000 patients with moderate to severe plaque psoriasis throughout four pivotal studies. The studies include assessments of efficacy and safety of risankizumab at 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4 and every 12 weeks thereafter. Key measures of efficacy include measures of disease activity and skin clearance, including sPGA 0/1, PASI 90, and PASI 100 and health-related quality of life. 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.4 IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.6

Risankizumab is under review with health authorities globally and is currently not approved by regulatory authorities. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

###


References
:

  • 1.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.
  • 2.Reich, K., et al.Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 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.Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
  • 5.Leonardi, et al. Poster #9891. 2019 American Academy of Dermatology Annual Meeting. 2019.
  • 6.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.

CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission1-3

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NICE recommends VENCLYXTO®▼(venetoclax) in combination with rituximab on the NHS in England for people with previously treated Chronic Lymphocytic Leukaemia

Press Releases   •   Jan 18, 2019 10:33 GMT

  • Positive recommendation for VENCLYXTO (venetoclax) in final appraisal determination (FAD) means that, for the first time, people in England with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a chemotherapy-free option with a fixed treatment duration of 24 months.
  • NICE approval is based on the MURANO Phase 3 clinical trial, in which venetoclax plus rituximab (VenR) reduced the risk of disease progression or death by eighty-three percent compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).1
  • Over 3,500 people in the UK are diagnosed with CLL every year, the most common type of blood cancer.2,3

MAIDENHEAD, 18th January, 2019– AbbVie today announces that the National Institute for Health and Care Excellence (NICE) has published a positive final appraisal determination (FAD) recommending that VENCLYXTO® (venetoclax) in combination with rituximab (VenR) is made available for routine use by the National Health Service (NHS) in England for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. Please see the NICE website for the eligibility criteria here.

David Innes, Chair of the CLL Support Association said: “The decision by NICE is extremely positive news for people living with relapsed or refractory CLL in England and has the potential to change the way we treat the disease. For many, a relapsed or refractory diagnosis can be daunting as when the disease comes back or progresses, prognosis can be poor. So to have NHS access to an effective chemotherapy-free option that is supported by robust clinical data and which patients do not have to take continuously is a welcome step forward. Patients will now have the chance to live longer with the added prospect of a treatment-free period.”

CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,4 Over 3,500 people are diagnosed with CLL in the UK each year.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur.5

Professor Peter Hillmen, Consultant Haematologist, Leeds Teaching Hospitals NHS Trust and Coordinating Investigator of venetoclax studies in the UK, said: “NICE’s decision to recommend routine NHS access to venetoclax plus rituximab in the relapsed/refractory CLL setting now gives treating clinicians a new weapon in the fight against CLL. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. The demonstration of improved survival outcomes after cessation of therapy signals an important move to defined duration of targeted therapy. The cessation of therapy is a key advance in the treatment of CLL.”

The NICE recommendation is based on results from the pivotal phase 3 MURANO clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared with a standard of care chemoimmunotherapy regimen of bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature).1

In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint. At the nine-month time point, sixty-two percent (n=121/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus thirteen percent (n=26/195) who received 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.6

Recent post treatment follow-up data has provided evidence on long terms outcomes for VenR. Of the 130 patients who completed rituximab plus the 24 month fixed duration of venetoclax, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively.7

Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to delivering breakthrough therapeutic options in CLL, an area where more treatments are urgently needed for patients. We have worked closely with NICE and the clinical and patient communities to ensure the timely appraisal of venetoclax plus rituximab in a concerted effort to bring much needed options to patients as quickly as possible. Alongside this, we have worked collaboratively with NHS England so that patients can access venetoclax plus rituximab without delay. We welcome this decision by NICE, and remain committed to improving patient outcomes in blood cancer.”

The European Commission approved venetoclax plus rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who have received at least one prior therapy on 1st November 2018.8

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.

- Ends -

The final NICE guidance can be accessed here: https://www.nice.org.uk/guidance/gid-ta10160/documents/final-appraisal-determination-document

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.Morley@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.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.9

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

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 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: January 2019.

3 Cancer Research UK. Chronic lymphocytic leukaemia (CLL): Risks and causes. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/risks-causes Accessed: January 2019.

4 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: January 2019.

5 National Cancer Institute. Living as a Chronic Lymphocytic Leukemia Survivor. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/after-treatment/follow-up.html. Accessed: January 2019.

6 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.

7 Seymour J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.

8 AbbVie News Centre. AbbVie receives European Commission Approval of Venetoclax Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy. Available at: https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-venetoclax-plus-rituximab-for-treatment-patients-with-chronic-lymphocytic-leukemia-who-have-received-at-least-one-prior-therapy.htm. Accessed January 2019.

9 Venclyxto Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/32650. Accessed January 2019.

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HUMIRA® (adalimumab) 80 mg/0.8 mL Presentation intended as an Alternative Option for Therapy Induction and Maintenance Therapy is Now Available

Press Releases   •   Dec 03, 2018 09:25 GMT

Maidenhead, UK, 1st December 2018 – AbbVie a global research and development-based biopharmaceutical company, today announced the launch of HUMIRA® (adalimumab) 80 mg/0.8 mL. The presentation is designed as an alternative option for therapy induction for approved indications (Ps, CD, HS and Uveitis, and paed CD , HS and uveitis) and convenient dosing for patients that require a dose escalation (RA, Ps, CD, and HS, andpaed CD and adol HS).

As with HUMIRA 40 mg/0.4 mL, which AbbVie introduced in 2016, the citrate buffer and other inactive ingredients have been removed and the formulation concentration increased allowing a reduction in injection volume by half. The formulation contains the same active ingredient, adalimumab and the efficacy and safety profile remains unchanged.1 A new presentation of HUMIRA 80 mg/0.8 mL is now available in England.

"The launch of the HUMIRA 80 mg/0.8 mL formulation underscores our ongoing dedication to improving the patient experience through research and product enhancements,” said Alice Butler, Medical Director, AbbVie. “We remain committed to innovation in immunology and continue to strive to improve upon the therapeutic experience for patients and physicians.”

Use of this presentation decreases the number of injections necessary by half, for the induction doses in the approved indications.1 In addition for patients that require a dose escalation to 40 mg weekly the availability of an 80 mg presentation allows patients to maintain their usual “every other week” dosing schedule.

Both HUMIRA 40 mg/0.4 ml and HUMIRA 80 mg/0.8 mL contain the same active ingredient, adalimumab, meaning that the efficacy and safety profile remains unchanged.1

-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.

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.

• HUMIRA citrate-free 80 mg/0.8 mL formulation reduces the number of injections required to initiate HUMIRA therapy by half • Convenient 80 mg every other week dosing for patients that require dose escalation

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AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLYXTO®▼ (venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory CLL Who Completed the Fixed Treatment Course

Press Releases   •   Dec 01, 2018 22:45 GMT

– The data demonstrated that VENCLYXTO® in combination with rituximab (VenR) reduced the risk of disease progression or death compared to a standard of care bendamustine plus rituximab (BR) after a median three-year follow-up1

– Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax and remained off therapy for a median of 9.9 months, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively1

– Three-year estimated overall survival (OS) was 87.9 percent in patients treated with VenRversus 79.5 percent in patients receiving BR1

– Full results were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition

MAIDENHEAD, 1ST December, 2018 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company today presented updated data from the pivotal Phase 3 MURANO trial of venetoclax (VENCLYXTO®) in combination with rituximab (VenR). The results at median follow-up of 36 months demonstrated continued substantial benefit with PFS and OS for patients with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL), treated with VenR having completed the fixed duration of therapy and stopped treatment, compared to patients treated with a standard of care regimen of bendamustine plus rituximab (BR).1 The estimated PFS rate in those 130 patients at 36 months was 71.4 percent (95% confidence interval [CI]: 0.64, 0.78) for patients treated with VenR compared with 15.2 percent (95% CI: 0.09, 0.21) for patients who completed treatment with a standard of care combination of BR (hazard ratio [HR]:0.16; 95% CI: 0.12, 0.23).1 The data were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition.

Of the 130 patients who completed the two-year treatment course of venetoclax and remained off therapy for a median of 9.9 months (range: 1.4 to 22.5), six- and 12-month PFS estimates were 92 percent (95% CI: 0.87, 0.96) and 87 percent (95% CI: 0.81, 0.93), respectively. 1 At the time of analysis, the overall survival (OS) benefit estimated at three years was 8 percent higher in the VenR arm (87.9 percent) than in the BR arm (79.5 percent) (HR: 0.50; 95% CI: 0.30, 0.85).1

“There is a need for a chemo-free option with a fixed treatment duration that can potentially provide prolonged progression-free survival, along with minimal residual disease negativity, in patients with relapsed or refractory chronic lymphocytic leukaemia,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of the Department of Hematology at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. “The results of this analysis showed that a high proportion of patients with relapsed or refractory chronic lymphocytic leukaemia who were treated with venetoclax in combination with rituximab maintained minimal residual disease negativity and progression-free survival well after completing the fixed treatment duration.”

In the MURANO clinical trial, 78 percent of patients who completed the two-year treatment course of VenR without disease progression (N=114) also demonstrated minimal residual disease (MRD)-negativity in peripheral blood.1 MRD-negativity was a secondary endpoint assessed at the end of combination therapy (nine-month assessment1,2,3). MRD-negativity (also known as undetectable MRD) is an objective measure 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.4 Earlier prospective clinical trials in CLL patients have provided evidence that achieving MRD-negativity is associated with improved clinical outcomes.5

“This analysis of the MURANO clinical trial showed that after patients had completed rituximab and a two-year course of venetoclax, and were off treatment for a median of 9.9 months, the disease did not progress in a substantial number of patients with relapsed or refractory chronic lymphocytic leukaemia, and in many of those patients the disease was undetectable in peripheral blood,” said Neil Gallagher, M.D., Ph.D., Head of Global Oncology Development, AbbVie. “These findings continue to support the use of venetoclax plus rituximab as a treatment with a fixed duration for patients with relapsed or refractory chronic lymphocytic leukaemia and are encouraging as we continue to advance the research and development of transformative medicines in blood cancers.”

Safety data were consistent with the known safety profiles of each medicine alone. During the venetoclax single-agent treatment phase (N=171), 10 percent of patients had an adverse event (AE) leading to drug withdrawal, 4 percent had an AE leading to dose reduction, 26 percent had an AE leading to dose interruption, and 4 percent had a fatal AE (four other cancers, two cardiac, one pneumonia). Grade 3/4 AEs occurred in 35 percent of patients. The most common Grade 3/4 AEs were neutropenia (12 percent), anaemia (3 percent) and thrombocytopenia (2 percent). Seven percent of patients had a Grade 3/4 infection during the single-agent phase.1

Venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by AbbVie and Roche. It is jointly commercialised 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.

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.Morley@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. Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax in combination with rituximab is not currently approved for use in the UK.3

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 J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.

2. VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.

3. Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

4. 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.

5. 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.

Read more »

Efforts to Improve Patient Safety and Care Recognised in National Health Awards

Press Releases   •   Nov 20, 2018 15:27 GMT

South Tees NHS Foundation Trust, Lymphoma Action and Arthur’s Choice win 2018 AbbVie Big Ideas for Better Health Awards

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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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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