The US Food and Drug Administration (FDA) has approved the addition of moderate to severe fingernail psoriasis data to the adalimumab (Humira, AbbVie) prescribing information for patients with moderate to severe chronic plaque psoriasis, according to a company news release.
Adalimumab is now the "first-and-only biologic treatment with data on fingernail psoriasis in its US prescribing information," the company explains in the news release.
"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...it is our hope that the fingernail psoriasis data will support healthcare providers treating this difficult condition," John Medich, PhD, vice president, clinical development, immunology, AbbVie, said in the news release.
Adalimumab is a tumor necrosis factor blocker that is currently approved for use in certain patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, ulcerative colitis, plaque psoriasis, and noninfectious intermediate, posterior, and panuveitis.
In 2008, the FDA approved adalimumab for adults with moderate to severe chronic plaque psoriasis who are ready to undergo systemic therapy or phototherapy and who are being cared for by a physician who will determine whether or not other systemic therapies are less appropriate.
The decision follows consideration of data from a phase 3 multicenter, double-blind, randomized, parallel-arm, placebo-controlled clinical trial that evaluated the safety and efficacy of adalimumab in patients with moderate to severe chronic plaque psoriasis and moderate to severe fingernail psoriasis.
The researchers randomly assigned 217 patients to receive adalimumab 40 mg every other week (n = 109) beginning 1 week after an initial 80-mg dose or matching placebo (n = 108) during the first 26 weeks.
At 26 weeks, 48.9% of adults who received adalimumab achieved a Physician's Global Assessment fingernail-psoriasis score of 0 (clear) or 1 (minimal) with a 2-grade or more improvement from baseline compared with 6.9% of patients who received placebo (P < 0.001).
Through 26 weeks, no new safety signals were observed for adalimumab. Adverse events were observed in 56.9% of patients in the adalimumab group compared with 55.6% of patients in the placebo group. Serious adverse events were observed in 7.3% of patients in the adalimumab group compared with 4.6% of those in the placebo group, including serious infections in 3.7% and 1.9% of patients in the adalimumab and placebo groups, respectively. The difference between the groups was not statistically significant.
The data for fingernail psoriasis are included as a third psoriasis study (Study Ps-III) in the plaque psoriasis clinical studies section (14.8) of the product label.
Half of all patients with psoriasis develop fingernail psoriasis – a form of chronic plaque psoriasis in which patients develop pitting, deformation, thickening, discoloration, pain, and separation of the nail from the nail bed. Patients with nail psoriasis can experience social stigmatization and decreased quality of life.
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Cite this: Fingernail Psoriasis Data Added to Humira Prescribing Info - Medscape - Mar 30, 2017.