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Positive Phase III Results Reported for Humira (Adalimumab) in Treatment of Inflammatory Skin Disease
Data from a phase III pivotal study have shown that Humira (adalimumab, Abbvie) is effective in reducing common clinical signs and symptoms — specifically, the number of abscesses and inflammatory nodules — in patients with moderate-to-severe hidradenitis suppurativa (HS). The new findings were presented at the 44th Annual European Society for Dermatological Research (ESDR) meeting in Copenhagen, Denmark.
The PIONEER I trial was a 36-week, randomized, double-blind, two-period study in 307 patients with moderate-to-severe HS. In the first 12-week study period (Period A), the patients were randomly assigned to receive adalimumab 160 mg at week 0, 80 mg at week 2, and 40 mg once weekly (n = 153) starting at week 4 or placebo (n = 154). The primary endpoint was the percentage of patients achieving a clinical response in improvement of HS severity at 12 weeks.
After Period A, the patients were eligible to enroll in a 24-week treatment phase (Period B). In this phase, patients originally assigned to adalimumab were re-randomized to receive adalimumab 40 mg weekly, 40 mg every other week, or placebo. The patients who had been given placebo were assigned to receive adalimumab weekly.
In period A, patients with moderate-to-severe HS treated with adalimumab 40 mg weekly achieved a significantly greater response compared with those given placebo at week 12 (41.8% versus 26%, respectively; P = 0.003). A response was defined as an improvement in HS-related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure.
Results from Period B have not been reported.
The most common adverse events associated with adalimumab compared with placebo included exacerbations of HS (9.2% vs. 13.2%, respectively), nasopharyngitis (5.9% vs. 10.5%) and headache (9.2% vs. 9.9%). Serious AEs were observed in 2% of adalimumab-treated patients and in 3.3% of those given placebo.
Hidradenitis suppurativa (HS) — sometimes called “acne inversa” by dermatologists — is a chronic, often-painful, immune-mediated disease characterized by inflamed areas typically located around the armpits and groin. These affected areas often include lesions, nodules, boils, and abscesses, which usually occur where many oil and sweat glands are located, as well as under the breasts, on the buttocks, and in the inner thighs, where skin rubs together. The reason why patients develop HS is unclear; however, an abnormal response in the body’s immune system may play a role.
It has been estimated that HS occurs in 1% of the general adult population. However, the disease can be challenging to diagnose, and many patients experience lengthy delays in diagnosis and treatment. There is no cure for HS, and no medications have been approved for treatment of the disease.
Source: Abbvie; September 11, 2014.