AbbVie announced that the Food and Drug Administration (FDA) has approved the addition of moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. This labeling update makes Humira the first biologic drug with the inclusion of fingernail psoriasis data in its prescribing information.
The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study. For the first 26 weeks, 217 patients were randomized to Humira 40mg every other week, 1 week after an initial 80mg dose or matching placebo.
The primary endpoint was met where 48.9% of Humira-treated patients achieved a Physician’s Global Assessment fingernail psoriasis of 0 (clear) or 1 (minimal) with ≥2 grade improvement from baseline at Week 26 vs. 6.9% for placebo patients (P<0.001). No new safety signals were observed with Humira 40mg every other week during the 26-week duration.
Adverse events were reported in 56.9% of Humira-treated patients and 55.6% of placebo-treated patients.
Humira, a tumor necrosis factor (TNF) blocker, is currently approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, ulcerative colitis, plaque psoriasis, and non-infectious intermediate, posterior, and panuveitis.
Humira is available as 10mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL single-dose prefilled syringes and single-dose prefilled pens.
For more information call (800) 633-9110 or visit Humira.com.