FDA approves adding fingernail psoriasis data to Humira prescribing information

The FDA has approved including moderate-to-severe fingernail psoriasis data in the Humira prescribing information for patients with moderate-to-severe plaque psoriasis, AbbVie has reported.

Humira (adalimumab, AbbVie) is the first biologic treatment with data on fingernail psoriasis in its U.S. prescribing information, according to a news release from AbbVie.

“Fingernail psoriasis is often difficult to treat, and we are pleased the FDA recognized the importance of these data so that more health care providers can make informed medical decisions when prescribing treatments for those living with psoriasis,” John Medich, PhD, vice president, clinical development, immunology, AbbVie, stated in the release. “It is our hope that the fingernail psoriasis data will support health care providers in treating this difficult condition.”

Researchers conducted a phase 3, multicenter, double-blind, study to measure safety and efficacy of adalimumab in 217 patients with moderate-to severe-fingernail psoriasis and moderate-to-severe chronic plaque psoriasis. The patients were randomized to receive adalimumab 40 mg every other week starting 1 week after an initial 80 mg dose or matching placebo for the first 26 weeks. Primary endpoint of Physician’s Global Assessment-fingernail psoriasis of 0 (clear) or 1 minimal) was met by 48.9% of adults treated with adalimumab compared with 6.9% of patients treated with placebo (P < .001), according to the release.

AbbVie reported there were no new safety signals for adalimumab observed in the study. Adverse events were reported by 56.9% of patients treated with adalimumab and 55.6% of patients treated with placebo through 26 weeks. Serious adverse events were reported by 7.3% of patients treated with adalimumab and 4.6% of those treated with placebo, with the difference between the groups not statistically significant, according to the release.

Reference: www.abbvie.com