Humira (Adalimumab) Shows Promise in Patients With Inflammatory Skin Disease
Response rate is significantly greater versus placebo in phase II study (October 3)
Positive results have been reported from a post hoc analysis of a phase II study that evaluated Humira (adalimumab, AbbVie) in the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS) — a chronic inflammatory skin disease — after 16 weeks of therapy.
The new data, which analyze the reduction of the total abscess and inflammatory nodule (AN) count from baseline, were presented at the 22nd Congress of the European Academy of Dermatology and Venereology (EADV) in Istanbul, Turkey.
Humira (adalimumab) is not approved for the treatment of HS.
The analysis found that adalimumab induced a significant response rate in adult patients with moderate-to-severe HS at week 16 versus placebo for the two dosing regimens assessed.
The efficacy of adalimumab was re-evaluated in this analysis by using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure, which is an endpoint defined as at least a 50% reduction from baseline in the total AN count, with no increase in counts for abscesses and draining fistulas. Specifically, HiSCR response rates for HS patients given placebo, adalimumab 40 mg every other week, or adalimumab 40 mg weekly were 25.6% (11/43), 33.3% (15/45), and 54.5% (24/44), respectively.
HS is a chronic, often painful, immune-mediated disease characterized by inflamed areas, typically located around the armpits and groin. There is no approved treatment for HS, which is estimated to affect 1% of the general adult population.
Source: AbbVie; October 3, 2013.