New results from a phase-3 study demonstrating the effect of Humira (adalimumab, AbbVie) in treating moderate-to-severe hidradenitis suppurativa (HS) may lead to worldwide regulatory filings for expanded use of the drug.
Humira is approved in the United States for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate-to-severe chronic psoriasis and juvenile idiopathic arthritis.
Researchers conducting the Pioneer II study found that at 12 weeks, patients with HS who were treated with weekly adalimumab doses of 40 mg — beginning at week four after initial doses of 160 mg and 80 mg at week two — achieved a statistically significant greater response compared with patients on placebo (specifically, 58.9 versus 27.6 percent), according to a news release.
Response was evaluated at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure, which is defined as at least 50 percent reduction from baseline in total abscess and inflammatory nodule count with no increase for either abscess or draining fistula count.
Those were the results of Period A of the 36-week, two-period study. In Period B, patients originally randomized to Humira were re-randomized to receive it at 40 mg weekly, 40 mg every other week or placebo. Patients randomized to placebo in Period A remained on placebo in Period B. AbbVie has not released the results for Period B.
“Results from the Pioneer trials support the potential for adalimumab to be an important new treatment option for patients with HS,” study investigator Gregor Jemec, M.D., professor of dermatology at University of Copenhagen Roskilde Hospital, stated in the news release.
The results were presented as a late-breaking abstract at the 23rd Congress of the European Academy of Dermatology and Venereology held recently in Amsterdam.