Humira adalimumab: Phase III data

Data from Period A of the double-blind, international Phase III PIONEER II trial in 326 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 (58.9% vs. 27.6%, p<0.001). Data were presented at the Congress of the European Academy of Dermatology and Venereology meeting in Amsterdam. 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.

In September, AbbVie reported data from Period A of the Phase III PIONEER I trial in the indication showing that Humira met the primary endpoint (see BioCentury, Sept. 29). AbbVie plans to submit worldwide regulatory applications seeking to expand Humira's label to include hidradenitis suppurativa, but did not disclose a timeline. Hidradenitis suppurativa is a chronic, inflammatory skin disease characterized by painful, recurrent abscesses and nodules. ...