The approval of adalimumab has been expanded to include the treatment of moderate to severe hidradenitis suppurativa.
Approval is based on the results of two phase III studies, PIONEER I and PIONEER II ; this is the first product approved for treating hidradenitis suppurativa, according to the manufacturer, AbbVie. AbbVie markets adalimumab as Humira.
The studies compared adalimumab to placebo in 633 adults with Hurley Stage II or III disease with at least three abscesses or inflammatory nodules. In both studies, more patients treated with adalimumab (40 mg a week) had a clinical response at week 12, based on the Hidradenitis Suppurativa Clinical Response (at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline): 42% vs. 26% in one study, and 59% vs. 28% in the second study, according to the updated prescribing information .
This is the ninth approved indication for adalimumab, a tumor necrosis factor blocker approved for treating rheumatoid arthritis in 2002. Other Food and Drug Administration–approved indications include psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
The prescribing information for adalimumab includes a boxed warning about the risk of serious infections and reports of malignancies in people treated with adalimumab and other TNF blockers; it is approved with a Medication Guide that explains the potential serious risks associated with treatment to patients.
Serious adverse events associated with adalimumab should be reported to the FDA MedWatch program.
