AbbVie Reinforces Leadership in Dermatology With New Data Showcasing Research Advancements Across Growing Portfolio at the 27th European Academy of Dermatology and Venereology (EADV) Congress

- Twenty-four presentations of HUMIRA® (adalimumab) and pipeline data showcase the breadth and depth of robust dermatology portfolio

- Oral presentations include patient-reported outcomes data from a Phase 2b trial evaluating upadacitinib in atopic dermatitis and long-term safety and efficacy data evaluating HUMIRA in hidradenitis suppurativa

- Clinical and patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab in psoriasis to be presented

News provided by

AbbVie

Sep 04, 2018, 09:00 ET

NORTH CHICAGO, Ill., Sept. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new data across investigational medicines and HUMIRA^® (adalimumab) at the 27^th European Academy of Dermatology and Venereology (EADV) Congress, September 12-16, in Paris.

"While there have been significant advances in the treatment of serious dermatologic diseases in recent years, some patients still do not achieve their desired treatment goals and are in need of additional effective therapeutic options," said Marek Honczarenko M.D., P.h.D., vice president, global immunology development, AbbVie. "AbbVie's data at EADV reflect our unwavering commitment to addressing these ongoing therapeutic challenges for patients and our continued pursuit of innovative medicines that raise treatment expectations and improve upon the standard of care."

AbbVie will present data from three pivotal Phase 3 trials of risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in patients with moderate to severe psoriasis, including first presentation of the full data results from the IMMvent trial as well as patient-reported outcomes results from ultIMMa-1, ultIMMa-2 and IMMvent.

Additional patient-reported outcomes data from a Phase 2b trial evaluating upadacitinib, an investigational JAK1 inhibitor, in atopic dermatitis will be featured as an oral presentation on Thursday, September 13 at 3:20 p.m. CEST. In addition, efficacy and safety results at week 32 of the Phase 2b trial will be presented.

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

AbbVie will also share long-term efficacy and safety results evaluating HUMIRA in hidradenitis suppurativa (HS) during an oral presentation. Data reporting long-term inhibition of radiographic progression with HUMIRA in psoriatic arthritis will also be featured as an oral ePoster presentation, along with real-world long-term safety and effectiveness data that further support the real-world value of HUMIRA for the treatment of moderate to severe psoriasis.

HUMIRA is one of the most comprehensively-studied biologics available for immune-mediated diseases, and is supported by more than 20 years of clinical trial experience in immunology.¹

Key Abstracts of Interest

Risankizumab Abstracts

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
Efficacy and Safety of Risankizumab Compared with Placebo in Patients with Moderate-to-Severe Plaque Psoriasis: Integrated Analyses from Three Phase 3 Trials; ePoster #P1865
Efficacy of Risankizumab Compared with Placebo Across Subgroups in Patients with Moderate-to-Severe Plaque Psoriasis: Integrated Analyses from Three Phase 3 Trials; Oral ePoster #OP01.04; Oral ePoster presentations in Therapies; Thursday, September 13; 10:15-10:25 a.m. CEST
Incremental benefits on patient-reported outcomes for achieving PASI90 or PASI100 over PASI75 in patients with moderate to severe psoriasis; ePoster #P2002
Patient-Reported Outcomes from the IMMVent Trial: Comparison of Risankizumab with Adalimumab in Moderate to Severe Psoriasis Patients; ePoster #P1947
Risankizumab Significantly Improves Patient-Reported Outcomes in Moderate to Severe Psoriasis in Two Phase III ultIMMa Trials; ePoster #P1996

Upadacitinib Abstracts

Effects of Upadacitinib on Patient-Reported Itch, Skin Pain, and Impact on Sleep Due to Atopic Dermatitis: Results From the Phase 2b Randomized, Placebo-Controlled Trial in Moderate-to-Severe Atopic Dermatitis; Presentation #FC04.03; Free Communications in Therapy; Thursday, September 13; 3:20-3:30 p.m. CEST
Effects of Upadacitinib on Scratching and Activity During Sleep as Evaluated by Actigraphy in the Phase 2b Randomized, Placebo-Controlled Trial in Moderate-to-Severe Atopic Dermatitis; ePoster #P0235
Efficacy and Safety of Upadacitinib Treatment over 32 weeks for Patients with Atopic Dermatitis from a Phase 2b, Randomized, Placebo-Controlled Trial; ePoster #P0236

HUMIRA Abstracts
Psoriasis

Long-term Real-World Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from the Nine-Year Interim Analysis of the ESPRIT Registry; ePoster #P1942
Sustained Response to Adalimumab Over Multiple Years in Patients With Plaque Psoriasis: Analyses From the British Association of Dermatologists' Biological Interventions Register; ePoster #P2039

Hidradenitis suppurativa (HS)

Weekly Adalimumab in Patients with Moderate-to-Severe Hidradenitis Suppurativa Following Loss of Response, or Worsening or Absence of Improvement; Presentation #FC04.02; Free Communications in Therapy; Thursday, September 13; 3:10-3:20 p.m. CEST
Indirect economic burden associated with multiple and more complex surgical procedures for hidradenitis suppurativa; Presentation #FC05.04; Free Communications in Acne and Related Disorders; Saturday, September 15, 8:30-8:40 a.m. CEST

Psoriatic Arthritis

Long-term Inhibition of Radiographic Progression With Adalimumab in Patients With Moderate to Severe Psoriatic Arthritis With or Without Radiographic Damage at Baseline; Oral ePoster #OP01.02; Oral e-Poster Presentations in Therapies; Thursday, September 13; 9:55-10:05 a.m. CEST

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated disorders.^2,3 Phase 3 trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis and Crohn's disease are ongoing and it is also being investigated to treat ulcerative colitis, ankylosing spondylitis and atopic dermatitis.^4,5,6,7,8

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

About Risankizumab

Risankizumab is an investigational compound that selectively blocks IL-23 by binding to its p19 subunit.⁹IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.¹⁰Phase 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.^{3,11,12,13,14}

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

About HUMIRA in the European Union¹⁵

HUMIRA EU Therapeutic Indications

HUMIRA is approved for use in adults with moderate to severe active and progressive rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in adults and adolescents from 12 years of age with active moderate to severe hidradenitis suppurativa, and in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, chronic non-infectious anterior uveitis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indications.

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.

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

For more information about JAK inhibitors and AbbVie's research in atopic dermatitis, please read "What Makes the Immune System Compromise Your Health?" on www.abbvie.com.

For more information on IL-23 and AbbVie's psoriasis research, please read "Gone Rogue: What Happens When Cells Say the Wrong Thing" on www.abbvie.com.

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 or LinkedIn.

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.

¹ Burmester G.R., et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases Ann Rheum Dis. 2009;68:1863–1869.
² 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
³ Pipeline – Our Science | AbbVie. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on June 26, 2018.
⁴ A Study Comparing 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. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on June 26, 2018.
⁵ 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. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on June 26, 2018.
⁶ 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. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on June 26, 2018.
⁷ Phase 2b AD Dose Ranging Study (40wk) N=160Clinicaltrialsgov. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on June 26, 2018.
⁸ 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. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on June 26, 2018.
⁹ Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
¹⁰ Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
¹¹ A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on June 26, 2018.
¹² BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on June 26, 2018.
¹³ 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 on June 26, 2018.
¹⁴ A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on June 26, 2018.
¹⁵ 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 July 2018. Accessed July 31, 2018.