FDA Adds Fingernail Psoriasis to Prescribing Information for AbbVie’s Humira Therapy

FDA Adds Fingernail Psoriasis to Prescribing Information for AbbVie’s Humira Therapy

The U.S. Food and Drug Administration (FDA) has approved the inclusion of fingernail psoriasis in prescribing information for Humira (adalimumab, AbbVie) a drug used by patients with moderate to severe chronic plaque psoriasis.

The decision is based on data from a multicenter, double-blind, randomized, parallel-arm, placebo-controlled Phase 3 clinical trial (NCT02016482) that evaluated the safety and efficacy of Humira for the treatment of nail psoriasis in patients with chronic plaque psoriasis.

In this clinical trial, 217 patients were randomized to 26 weeks of treatment either with Humira (40 mg every other week, starting one week after an initial 80 mg dose) or placebo.

The results showed that 48.9 percent 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. No safety issues were reported. Meanwhile, 56.9 percent of Humira-treated patients experienced adverse events, while 55.6 percent on placebo had some form of reaction.

Fingernail psoriasis affects half of all psoriasis patients. A form of chronic plaque psoriasis, it is characterized by pitting, deformation, thickening, discoloration, pain and separation of the nail from the nail bed. An estimated 10 to 78 percent of all patients with psoriasis have psoriatic nail disease, and 5 to 10 percent of patients have isolated nail psoriasis.

“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,”John Medich, PhD, AbbVie’s vice-president of clinical development, said in a press release. “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 FDA approved Humira in 2008 to treat adult patients with moderate to severe chronic plaque psoriasis who are ready for systemic therapy or phototherapy, and who are under the care of a physician who will make a decision if other systemic therapies are less suitable.

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