AbbVie announces positive phase 3 results of Humira for hidradenitis suppurativa treatment
AbbVie has announced results from its PIONEER II study demonstrating the effectiveness of Humira in reducing symptoms of moderate-to-severe hidradenitis suppurativa.
The results of this study will contribute to worldwide regulatory filings to expand the use of Humira (adalimumab) for hidradenitis suppurativa (HS), according to a company press release.
In the phase 3, 36-week, multicenter, randomized, double-blind, two-period study, patients with moderate-to-severe HS were treated with adalimumab 40 mg weekly, beginning at week 4, after receiving adalimumab 160 mg at week 0 and adalimumab 80 mg at week 2.
Those taking adalimumab achieved a significantly greater response compared to those on placebo, according to the researchers (58.9% vs. 27.5%, respectively).
Response to treatment was defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count with no increase for either abscess or draining fistula count, according to the press release.
The PIONEER II study is the second registration study by AbbVie to evaluate the use of adalimumab in patients with moderate-to-severe HS.
More information on PIONEER I and PIONEER II can be found at www.clinicaltrials.gov (NCT01468207 and NCT01468233, respectively), according to the press release.