AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Humira is now the first-and-only biologic treatment with data on fingernail psoriasis in its U.S. prescribing information.
Fingernail psoriasis affects half of all psoriasis patients. It is a form of chronic plaque psoriasis characterized by pitting, deformation, thickening, discoloration, pain and separation of the nail from the nail bed. Nail psoriasis can also contribute to social stigmatization and impact quality of life.
"Fingernail psoriasis is often difficult to treat, and we are pleased the FDA recognized the importance of these data so that more healthcare providers can make informed medical decisions when prescribing treatments for those living with psoriasis," said John Medich, Ph.D., vice president, clinical development, Immunology, AbbVie. "AbbVie's nearly 20 years of research in immunology provides us with in-depth knowledge of challenging diseases and allows us to identify ways to address them - it is our hope that the fingernail psoriasis data will support healthcare providers treating this difficult condition."
The Phase 3 study was dedicated to evaluating fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. The study demonstrated nearly half of adult patients treated with Humira achieved an assessment of clear or minimal with at least a two-grade improvement from baseline in signs and symptoms of fingernail psoriasis compared to 6.9 percent of placebo patients (p<0.001). No new safety signals for Humira were observed in the study.
In 2008, Humira was FDA approved to treat adults with moderate to severe chronic plaque psoriasis who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. These fingernail psoriasis data are included as a third psoriasis study (Study Ps-III) in the plaque psoriasis clinical studies section (14.8) of the Humira label.
About the Phase 3 Fingernail Psoriasis Study
This Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study (NCT02016482) 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, enrolled patients (n=217) were randomized to receive Humira 40mg every other week (n=109) starting one week after an initial 80mg dose or matching placebo (n=108). The primary endpoint was met, with 48.9 percent of Humira-treated patients achieving a Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a two-grade improvement from baseline at week 26 versus 6.9 percent for placebo patients (p<0.001).
Through 26 weeks, there were no new safety signals with Humira 40mg every other week. 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 receiving placebo. The difference between these two groups was not statistically significant.
About Humira in the U.S.
Uses
Humira is a prescription medicine used:
- To reduce the signs and symptoms of:
Moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.
Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Humira can be used alone, with methotrexate, or with certain other medicines.
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