FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to Humira Prescribing Information
The FDA approved the inclusion of moderate to severe fingernail psoriasis data in AbbVie's Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Humira is the first biologic treatment with data on fingernail psoriasis in its US prescribing information.
Fingernail psoriasis, which the company says affects half of all psoriasis patients, 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.
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.
"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, PhD, 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."
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.