Phase 3 Study of Tofacitinib for Adult Chronic Plaque Psoriasis Met Primary EndpointsMd Noman Siddique (Author) Published Date : Jun 17, 2014 09:48 ET
Biopharmaceutical company Pfizer (PFE) said a Phase 3 study of its tofacitinib treatment for adult patients with moderate-to-severe chronic plaque psoriasis showed the drug, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The first primary endpoint of 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, which was a 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, the company 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, said lead investigator Robert Bissonnette, of Innovaderm Research in Montreal. There was one cardiac-related death that occurred during the study at the 5 mg dose. However, in the opinion of the investigator, there was not a reasonable possibility that this death was related to tofacitinib, the company said. It intends to submit a supplemental New Drug Application to the U.S. Food and Drug Administration for the approval of tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015. PFE was down 0.2% at $29.60 in recent pre-market trading, in a 52-week range of $27.12 to $32.96.
Phase 3 Study of Tofacitinib for Adult Chronic Plaque Psoriasis Met Primary Endpoints