AbbVie Reinforces Leadership in Gastroenterology with New Data Showcasing Research Advancements Across Robust Portfolio at United European Gastroenterology (UEG) Week 2018

- Eleven presentations of HUMIRA® (adalimumab) and pipeline data showcase breadth and depth of robust gastroenterology portfolio

- First presentation of efficacy and safety results from the Phase 2b U-ACHIEVE study evaluating upadacitinib in ulcerative colitis to be presented during an oral presentation[1]

- Oral presentation of longer-term Phase 2 open-label extension study evaluates risankizumab in moderate to severe Crohn's disease[2]

- Additional analysis from the CALM study shows the impact of dose optimization based on a tight control approach with HUMIRA[3]

News provided by

AbbVie

Oct 16, 2018, 12:38 ET

NORTH CHICAGO, Ill., Oct. 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present new data across investigational medicines and HUMIRA^®(adalimumab) at United European Gastroenterology (UEG) Week 2018 from October 20-24 in Vienna. These include four oral presentations of new data evaluating upadacitinib in both Crohn's disease and ulcerative colitis and risankizumab in Crohn's disease, as well as two poster presentations of HUMIRA data in Crohn's disease.

"Inflammatory bowel diseases like Crohn's disease and ulcerative colitis can significantly impact the lives of patients," said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. "New AbbVie data presented across our robust gastroenterology portfolio at UEG Week is focused on our goal of advancing the quality of care for patients living with these conditions. We look forward to sharing new data with the gastroenterology community that further enhance our scientific understanding of how to achieve improvements in disease activity and shape the future of disease management."

The first presentation of efficacy and safety results from the Phase 2b U-ACHIEVE study evaluating upadacitinib, an investigational JAK1 inhibitor, in patients with moderately to severely active ulcerative colitis will be featured as an oral presentation on Tuesday, October 23 from 2:12 – 2:24 p.m. CEST.¹ Additional data on patient-reported outcomes and health-related quality of life measures from the U-ACHIEVE study will also be presented during the congress. Phase 3 trials for upadacitinib in ulcerative colitis have been initiated.

AbbVie will also present longer-term results (48 weeks) from an interim analysis of the Phase 2 open-label extension study evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in patients with moderate to severe Crohn's disease.² Risankizumab Phase 3 trials in Crohn's disease and Phase 2b/3 trials in ulcerative colitis are ongoing.

Risankizumab and upadacitinib are not approved by regulatory authorities and safety and efficacy have not been established.

HUMIRA data to be presented includes an analysis from the CALM study evaluating the impact of dose escalation and de-escalation on mucosal healing in Crohn's disease patients using a tight control approach.³

HUMIRA has been evaluated in more than 33,000 patients and has research spanning 20 years and more than 100 clinical trials.^4,5Since launching in 2003, HUMIRA has helped transform care for many patients who suffer from the significant and debilitating effects of immune-mediated diseases.

Abstracts of Interest

Upadacitinib Abstracts

Correlation of Biomarkers of Inflammation with Clinical and Endoscopic Endpoints in Patients with Moderate to Severe Crohn's Disease: Data from CELEST; IBD I; Presentation #P0340; Monday, October 22; 9:00 a.m. – 5:00 p.m. CEST
Exposure-Response Analyses of Upadacitinib (ABT-494) Efficacy in Subjects with Moderately to Severely Active Ulcerative Colitis – Analyses of a Phase 2 Dose Ranging Induction Study; IBD I; Presentation #P0347; Monday, October 22; 9:00 a.m. – 5:00 p.m. CEST
Improved Patient-Reported Outcomes with Upadacitinib as an Induction Therapy for Patients with Ulcerative Colitis: Data from U-ACHIEVE; IBD I; Presentation #P0336; Monday, October 22; 9:00 a.m. – 5:00 p.m. CEST
Induction Therapy of Upadacitinib is Associated with Improved Symptoms in Bowel Urgency and Abdominal Pain for Patients with Ulcerative Colitis: Data from U-ACHIEVE; Poster Champ Session: Lower Gastrointestinal Diseases; Presentation #P0348; Monday, October 22; 12:40 – 12:45 p.m. CEST
Efficacy and Safety of Upadacitinib as an Induction Therapy for Patients with Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b Study U-ACHIEVE IBD Clinical Trials I; Presentation #OP195; Tuesday, October 23; 2:12 – 2:24 p.m. CEST
Improvement in Patient-Reported Outcomes with Upadacitinib in Patients with Moderately to Severely Active Crohn's Disease: 52-Week Data from the CELEST Study; IBD on Fire; Presentation #OP236; Tuesday, October 23; 4:05 – 4:15 p.m. CEST
Correlation Between Clinical and Endoscopic Endpoints and Remission per Inflammatory Bowel Disease Questionnaire Score in Patients with Crohn's Disease: Data from CELEST; IBD Clinical Trials II; Presentation #OP304; Wednesday, October 24; 10:54 – 11:06 a.m. CEST

Risankizumab Abstract

Long-term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Interim Results of the Ongoing Phase 2 Open-Label Extension Study; IBD Clinical Trials II; Presentation #OP307; Wednesday, October 24; 11:30 – 11:42 a.m. CEST

HUMIRA Abstracts

Efficacy and Safety of Adalimumab in Chinese Patients with Moderately to Severely Active Crohn's Disease; IBD I; Presentation #P0335; Monday, October 22; 9:00 a.m. – 5:00 p.m. CEST
De-escalating Therapy in Patients with Crohn's Disease Receiving Adalimumab: A Subgroup Analysis of the CALM Study; IBD III; Presentation #P1614; Wednesday, October 24; 9:00 a.m. – 4:00 p.m. CEST

Upadacitinib and HUMIRA Abstract

Association between Proposed Definitions of Clinical Remission/Response and Well-Being of Patients with Crohn's Disease; Poster Champ Session: Lower Gastrointestinal Diseases; Presentation #P1563; Wednesday, October 24; 12:55 – 1:00 p.m. CEST

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an oral, small molecule JAK1-selective inhibitor being developed for immune-mediated diseases.⁶^,7 Phase 3 trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis and atopic dermatitis are ongoing and it is also being investigated to treat ankylosing spondylitis.^8-13

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

About Risankizumab

Risankizumab is an investigational compound that is designed to selectively block IL-23 by binding to its p19 subunit.¹⁴ IL-23, a key cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.¹⁵ Phase 3 trials of risankizumab in psoriasis and Crohn's disease are ongoing, and it is also being investigated to treat psoriatic arthritis and ulcerative colitis.^16-19

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.

About HUMIRA in the European Union²⁰

HUMIRA is approved for use in adults with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.

Important EU Safety Information²⁰

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; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, 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. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

Globally, prescribing information varies; refer to the individual country product label for complete information.

Full summary of product characteristics is available at: www.ema.europa.eu

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.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

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:

Sandborn, W.J., et al. Presentation #OP195. United European Gastroenterology Week 2018. October 2018.
Ferrante, M., et al. Presentation #OP307. United European Gastroenterology Week 2018. October 2018.
Bossuyt, P., et al. Poster #P1614. United European Gastroenterology Week 2018. October 2018.
European Medicines Agency. Assessment Report: HUMIRA. November 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000481/WC500221611.pdf. Accessed October 9, 2018.
AbbVie. Data on File. ABVRRTI62537.
Parmentier J, Voss J, Graff C et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatology. 2018;2(1).
Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at: https://www.abbvie.com/ourscience/pipeline.html. Accessed October 9, 2018.
A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed October 9, 2018.
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed October 9, 2018.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed October 9, 2018.
A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed October 9, 2018.
A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed October 9, 2018.
A Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects with Moderate to Severe Atopic Dermatitis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed October 9, 2018.
Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
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.
A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed October 9, 2018.
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed October 9, 2018.
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed October 9, 2018.
HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000481/WC500050870.pdf. Last updated August 2018. Accessed October 9, 2018.