Xeljanz tofacitinib: Additional Phase III data

Additional data from the double-blind, international, Phase III OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079) trials in 1,859 patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy showed that 44% of patients receiving twice-daily 5 mg oral tofacitinib and 59.1% of patients receiving twice-daily 10 mg tofacitinib achieved a PGA response of “clear” or “almost clear” at week 16, a co-primary endpoint, vs. 10% of patients receiving placebo (p<0.0001 for both). Additionally, tofacitinib led to PASI 75 response rates at week 16, a co-primary endpoint, of 43.1% at the 5 mg dose and 59.4% at the 10 mg dose vs. 8.9% for placebo (p<0.0001 for both).

On secondary endpoints, tofacitinib led to PASI 90 response rates at week 16 of 22.2% at the 5 mg dose and 39.1% at the 10 mg dose vs. 3% for placebo (p<0.0001 for both). Low- and high-dose tofacitinib also significantly reduced mean DLQI scores from baseline to week 16 vs. placebo (7.1 and 8.9 points, respectively, vs. 2.4 points, p<0.0001 for both). Furthermore, tofacitinib reduced the mean percentage of psoriatic BSA from baseline to week 16 by 15.8% at the 5 mg dose and by 20.2% at the 10 mg dose vs. 1.6% for placebo (p<0.0001 for both). Data were presented at the American Academy of Dermatology meeting in San Francisco. ...