The three-period randomized, double-blind, three-period, parallel group, placebo-controlled Phase III trial showed that tofacitinib, as a 5mg or 10mg pill taken twice daily, met its two primary efficacy endpoints.
The company said that safety profile of the drug in OPT Retreatment was consistent with previous studies and there were no new safety findings in the trial.
First primary endpoint in the trial evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to patients who were switched to placebo (withdrawal phase).
The trial’s second primary endpoint assessed patients who lost half of their original clinical response during the withdrawal phase, and measured the proportion of these patients who regained their original clinical response after restarting treatment with tofacitinib.
Innovaderm Research lead investigator Robert Bissonnette said, "The OPT Retreatment data showed that patients who stayed on therapy with tofacitinib maintained their rates of response and for those who stopped therapy, a proportion of patients were able to regain their original clinical response when retreated with tofacitinib."
Tofacitinib is part of a new class of medicines currently being developed for the treatment of moderate-to-severe plaque psoriasis.
The 56-week Phase III trial evaluated the efficacy and safety of the withdrawal and retreatment with tofacitinib 5mg and 10mg twice daily compared to placebo in 674 adult patients with moderate-to-severe chronic plaque psoriasis.
During the initial 24 weeks of treatment, which was the secondary endpoint, patients were treated with either tofacitinib at a dose of 5mg or 10mg twice daily in a blinded manner.
In this period 44% and 68% of patients who received tofacitinib 5mg and 10mg twice daily achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), respectively, and 42% and 63% of patients who received tofacitinib 5mg and 10mg twice daily achieved a PGA response of clear or almost clear skin, respectively.