Results for Humira in Chronic Skin Disease Trial
AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.
PIONEER I is a 36-week, multicenter, randomized, double-blind, two-period study in moderate-to-severe HS patients (n=307). In the first 12-week study period (Period A), patients were randomized to receive Humira 160mg at week 0, 80mg at week 2, and 40mg once weekly (n=153) starting at week 4, or placebo (n=154). Following Period A, patients were eligible to enroll in a 24-week treatment period (Period B). In Period B, patients originally randomized to Humira were re-randomized to receive Humira 40mg weekly, 40mg every other week, or placebo. Patients randomized to placebo were assigned to receive Humira weekly. The primary endpoint was the percentage of patients achieving a clinical response in improvement of HS severity at 12 weeks using the HiSCR measure.
Results from the PIONEER I study demonstrate that moderate-to-severe HS patients treated with Humira 40mg weekly achieved a significantly greater response vs. those on placebo at week 12 (41.8% vs. 26%, P=0.003). Response was defined as an improvement of HS related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure. This is defined as at least 50% reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.
Humira is already approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA), moderate to severe polyarticular juvenile idiopathic arthritis (JIA) psoriatic arthritis (PsA), ankylosing spondylitis, and moderate to severe Crohn's disease. It is also approved to induce remission in moderate to severe ulcerative colitis and to treat moderate to severe chronic plaque psoriasis.
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