Pfizer Inc. (NYSE:PFE) announced today detailed results from the
rial (OPT) Retreatment study (A3921111), a Phase 3 study investigating tofacitinib for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. This three-period study showed that tofacitinib, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The safety profile of tofacitinib in OPT Retreatment was consistent with previous studies and there were no new safety findings in this trial.
The first primary endpoint of OPT Retreatment 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 second primary endpoint examined 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. Throughout the study, the efficacy response was measured by the proportion of subjects achieving a Physician’s Global Assessment (PGA) response of “clear” or “almost clear” skin and the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis.
“Psoriasis is a chronic disease that affects approximately two-to-three percent of people worldwide, and there are times when patients with psoriasis may need to stop and restart therapy for medical or non-medical reasons, such as elective surgery or receipt of live immunizations,” said lead investigator Robert Bissonnette, M.D., Innovaderm Research, Montreal, QC, Canada. “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.”