Humira adalimumab: Phase III data

Data from Period A of the double-blind, international Phase III PIONEER I trial in 307 patients with moderate to severe hidradenitis suppurativa showed that subcutaneous Humira given at 160 mg at week 0, 80 mg at week 2 and then 40 mg once weekly met the primary endpoint of a greater proportion of patients achieving an HiSCR at week 12, defined as a >=50% reduction from baseline in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count, vs. placebo (41.8% vs. 26%, p=0.003). Humira also significantly improved physical aspects of the Short Form 36-Item (SF-36) questionnaire vs. placebo, including the physical component summary score (4.2 vs. 1.5 points, p=0.005), role physical score (4.5 vs. 2.2 points, p=0.039), bodily pain score (4.9 vs. 2.4 points, p=0.018) and general health score (improvement of 3 points vs. reduction of 0.4 points, p<0.002).

Additionally, Humira significantly improved Dermatology Life Quality Index (DLQI) score (5.4 vs. 2.9 points, p<0.001) and reduced hidradenitis suppurativa-related skin pain at its worst (p=0.016) from baseline to week 12 vs. placebo. Data were presented at the European Society for Dermatological Research meeting in Copenhagen. The trial also includes a 24-week Period B, in which patients who received Humira in Period A are re-randomized to receive 40 mg Humira weekly, 40 mg Humira every 2 weeks or placebo. AbbVie plans to present data from the Phase III PIONEER II trial of Humira to treat moderate to severe hidradenitis suppurativa at an upcoming medical meeting, but did not disclose a timeline. Hidradenitis suppurativa is a chronic, inflammatory skin disease characterized by painful, recurrent abscesses and nodules. ...