AbbVie Presents Initial Data from Pivotal Phase-3 Trial Evaluating the Efficacy and Safety of HUMIRA® (adalimumab) for Moderate to Severe Fingernail Psoriasis in Adult Patients at Psoriasis 2016 Congress

- Data from Phase 3 randomized, placebo controlled trial demonstrates that 46.6 percent of adult patients with moderate to severe psoriasis treated with HUMIRA® achieved at least a 75 percent improvement in their moderate to severe fingernail psoriasis

- Fingernail psoriasis occurs in up to 55 percent of people living with psoriasis and up to 70 percent of people living with psoriatic arthritis(1)

News provided by

AbbVie

Jul 07, 2016, 03:00 ET

PARIS, July 7, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today will present findings of a Phase 3 study of patients with moderate to severe psoriasis demonstrating that nearly half of adult patients treated with HUMIRA® (adalimumab) achieved at least a 75 percent improvement in their moderate to severe fingernail psoriasis compared to patients receiving placebo. The study will be presented at Psoriasis 2016 - 5th Congress of the Psoriasis International Network taking place July 7 - 9 in Paris, alongside additional abstracts.

Fingernail psoriasis occurs in up to 55 percent of people living with psoriasis and up to 70 percent of people living with psoriatic arthritis.¹ It is associated with pitting, deformation, thickening, discoloration and separation of the nail from the nail bed.²

"Fingernail psoriasis is a very challenging condition that is often unaddressed due to the lack of treatment options," said Kim Papp, M.D., Ph.D., study investigator, founder and president, Probity Medical Research, Waterloo, Ontario. "The results presented today are encouraging for patients living with this unmet need."

In this study, HUMIRA treated patients met primary endpoints at week 26:³

46.6 percent achieved at least a 75 percent improvement in modified Nail Psoriasis Severity Index (mNAPSI) versus 3.4 percent for placebo (p<0.001)
48.9 percent achieved Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a 2-point improvement from baseline versus 6.9 percent for placebo (p<0.001)

"This research reinforces our commitment to identifying solutions for serious unmet medical needs in dermatology," said John Medich, Ph.D., vice president, clinical development, immunology, AbbVie. "Our data at Psoriasis 2016 demonstrates AbbVie's continued commitment to HUMIRA and expands on the extensive research conducted over more than 18 years to support patients with serious immune-mediated diseases."

About the Phase 3 Fingernail Psoriasis Study³This Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study evaluated the safety and efficacy of HUMIRA in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis. During the first 26-weeks (Period A), enrolled patients (n=217) were randomized to receive HUMIRA 40mg every other week (n=109) following an initial 80mg dose or matching placebo (n=108). After week 16 in Period A, if psoriasis-affected body surface area increased by ≥25 percent from baseline, patients could transition to receive open label HUMIRA for 26 weeks (Period B). HUMIRA-treated patients met primary endpoints at week 26: 46.6 percent achieved at least a 75 percent improvement in modified Nail Psoriasis Severity Index (mNAPSI) versus 3.4 percent for placebo (p<0.001) and 48.9 percent achieved Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a 2-point improvement from baseline versus 6.9 percent for placebo (p<0.001).

Period A analysis identified no new safety signals with HUMIRA every other week dosing through 26 weeks. Adverse events (AEs) were reported by 56.9 percent of HUMIRA-treated patients and 55.6 percent of placebo-treated patients. Serious AEs were reported by 7.3 percent and 4.6 percent, respectively, including serious infections in 3.7 percent of those treated with HUMIRA compared to 1.9 percent on placebo.

More information on the pivotal Phase 3 study is available at www.clinicaltrials.gov (NCT02016482).

Additional AbbVie data presentations at Psoriasis 2016 include:

Psychometric Evaluation of The Self-Assessment of Psoriasis Symptoms (Saps)-Clinical Trial and the Saps-Real World Patient Reported Outcomes; Armstrong A, et al.; P032; Oral Presentation; Saturday, July 9; 15:00; ROOM 252 AB
Baseline Demographics and Disease Characteristics of Long-Term Responders to Adalimumab in REVEAL; Yamauchi P, et al.; P148; E-Poster
Safety of Adalimumab in Pediatric Patients with Psoriasis, Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, and Crohn's Disease; Seyger M, et al.; P039; E-Poster
Impact of a Patient Support Program on Adherence and Healthcare Costs in Patients with Psoriasis and Psoriatic Arthritis; Strober B, et al.; P121; E-Poster

About Fingernail Psoriasis
Psoriasis is a chronic immune disease that most commonly appears on the scalp, knees, elbows, and lower back, though it can appear anywhere on the skin⁴, and may also affect the fingernails.² Fingernail psoriasis is associated with pitting, deformation, thickening, discoloration and separation of the nail from the nail bed.² Fingernail psoriasis is frequently overlooked and management of the condition remains difficult.^2,5

About HUMIRA
Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries, and is currently being used to treat more than 989,000 patients worldwide across 14 globally approved indications.^6-8

About HUMIRA in the European Union

HUMIRA EU Therapeutic Indications⁷HUMIRA is approved for use in adults with moderate to severe active 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, active moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.

Important EU Safety Information⁷HUMIRA 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.
(See SmPC for full details)

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

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be 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 2015 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:

Oram Y. Treatment of Nail Psoriasis: Common Concepts and New Trends. Dermatol Res Pract. 2013. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3666424/#B1. Accessed May 20, 2016.
Treating specific locations: Hands, Feet and Nails. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails. Accessed May 20, 2016.
Adalimumab for Nail Psoriasis: Efficacy and Safety from the First 26 Weeks of a Phase-3, Randomized, Placebo-Controlled Trial. P131. Psoriasis 2016 - 5th Congress of the Psoriasis International Network, Paris, France, 2016.
About Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis. Accessed May 20, 2016.
Rigopoulos D. (2014). Nail Psoriasis From A to Z. DOI: 10.1007/978-3-319-08810-5. Accessed May 20, 2016. Available at: http://link.springer.com/book/10.1007/978-3-319-08810-5.
AbbVie Data on File.
HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated Jun 24, 2016. Accessed Jul 1, 2016.
Pharmaceutical and Medical Devices Agency (PMDA). New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed May 20, 2016.