AbbVie's Humira hits main goal of Phase III trial for Hidradenitis suppurativa

AbbVie on Thursday said that Humira (adalimumab) achieved the primary endpoint of a significantly higher percentage of patients who experienced a clinical response in improvement of Hidradenitis suppurativa (HS) severity at week 12 versus placebo in a late-stage trial. The results were presented at the European Society for Dermatological Research (ESDR) annual meeting.

In the first part of the PIONEER I study, 307 patients with moderate-to-severe HS were randomised to receive Humira, given at a dose of 160 milligrams at week zero, 80 milligrams at week two and 40 milligrams once weekly starting at week four, or placebo. In the second part of the trial, after 12 weeks, patients initially randomised to receive Humira were re-randomised to receive the drug at a dose of 40 milligrams either weekly or biweekly, or placebo, for 24 weeks. Meanwhile, patients randomised to placebo in part one were assigned to receive Humira weekly.

Results for part one of trial demonstrated that 41.8 percent of patients in the Humira arm exhibited a clinical response, defined as an improvement of HS-related abscesses and inflammatory nodules at 12 weeks using the HS Clinical Response measure, versus 26 percent of placebo-treated patients. AbbVie noted that the measure is defined as an at least 50 percent reduction versus baseline in the total abscess and inflammatory nodule count without an increase in either the abscess or draining fistula count. The company added that the most common adverse events observed in Humira-treated subjects were exacerbation of HS, nasopharyngitis and headache, while serious adverse events were noted in 2 percent of patients in the Humira arm and 3.3 percent of placebo-treated patients.

John Medich, AbbVie's vice president of clinical development, immunology, commented "we are encouraged by the results...and look forward to sharing results from our second Phase III trial, PIONEER II." AbbVie stated that results from PIONEER II will be presented at an upcoming medical conference. The company added that there is currently no cure for HS and there are no approved medications for the disease.

Humira has been cleared for several inflammatory indications, including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis and moderate-to-severe Crohn's disease. The therapy generated $3.3 billion in revenue for the second quarter of 2014.

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