Xeljanz tofacitinib: Phase III data

Top-line data from the double-blind, international Phase III OPT Retreatment (A3921111) trial in 674 patients with moderate to severe chronic plaque psoriasis showed that twice-daily 5 and 10 mg tofacitinib each met the co-primary endpoints of a greater proportion of patients maintaining a PASI 75 response and a PGA of "clear" or "almost clear" compared to patients who switched to placebo in period B of the trial. The trial also met the co-primary endpoints of the proportion of placebo-treated patients who regained a PASI 75 response and a PGA of "clear" or "almost clear" upon retreatment with tofacitinib in period C of the trial after having lost adequate responses during period B. Pfizer said there was no predefined threshold to meet the period C endpoint, but declined to disclose how the endpoint was specifically met.

During period A of the trial, patients received twice-daily 5 or 10 mg tofacitinib in a blinded manner for 24 weeks. To qualify for period B, patients had to achieve both a PASI 75 response and a PGA of "clear" or "almost clear." In period B (withdrawal), patients were randomized to either continue tofacitinib or switch to placebo for 16 weeks or until they lost 50% of their original PASI response to treatment from period A. In period C (retreatment), all patients resumed their original tofacitinib dose until week 56. No new safety signals for tofacitinib were reported. ...