Humira success in Phase III studies for Hidradenitis Suppurativa ("acne inversa")-AbbVie

AbbVie has announced results from a Phase III pivotal study demonstrating that Humira (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe Hidradenitis Suppurativa (HS), specifically the number of abscesses and inflammatory nodules. These data were presented at the 44th Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.

Results from the PIONEER I study show that moderate-to-severe HS patients treated with Humira 40 mg weekly achieved a significantly greater response versus those on placebo at week 12 (41.8% versus 26%, p = 0.003). Response was defined as an improvement of HS related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure. This is defined as at least 50% reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.

Results from a second Phase III clinical trial, PIONEER II, also evaluating the safety and efficacy of Humira in patients with moderate-to-severe HS, will be presented at an upcoming medical congress.