FDA Okays Fingernail Psoriasis Data for Humira Prescribing Information

The FDA recently expanded the indication of adalimumab (Humira) to include moderate-to-severe fingernail psoriasis prescribing information for patients with moderate-to-severe plaque psoriasis, according to a press release.

Humira is the only biologic drug in the United States that includes prescribing information about fingernail psoriasis.

Approximately half of all patients with psoriasis experience fingernail psoriasis, which is a form of plaque psoriasis. The condition is characterized by pitting, deformation, thickening, discoloration, pain, and separation of the nail from the nail bed, AbbVie reported.

Fingernail psoriasis can impact quality-of-life and cause patients to feel self-conscious about their condition. Unfortunately, this form of psoriasis is difficult to treat, but new results from a study indicate that fingernail psoriasis can be managed with Humira.

Newly included in Humira’s prescribing information are results from a phase 3 clinical trial of patients with fingernail psoriasis in patients with moderate-to-severe chronic plaque psoriasis. During the first 26 weeks of the study, patients were randomized to receive Humira 40-mg every other week starting 1 week after an initial 80-mg dose or placebo.

The investigators discovered that 48.9% of patients treated with Humira achieved a Physician's Global Assessment-fingernail-psoriasis score of clear or minimal, with at least 2-grade improvement in signs and symptoms, compared with 6.9% of placebo patients achieving the goal, according to the release.

There were no new safety concerns observed. Adverse events were consistent with Humira’s known safety profile, with relatively few patients reporting serious adverse events.

Humira first received FDA approval to treat adult patients with moderate-to-severe chronic plaque psoriasis in 2008. The new data are included as a third study in the plaque psoriasis clinical studies section of the drug’s label, according to the press release.

Humira has also been approved to treat patients with moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease, moderate-to-severe hidradenitis suppurativa, ulcerative colitis, moderate-to-severe plaque psoriasis, and non-infectious intermediate, posterior, and panuveitis.

The latest addition to prescribing information will provide guidance to physicians who are treating patients with fingernail 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," said John Medich, PhD, vice president, clinical development, Immunology at 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."