Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
The OPT clinical trial program is a global, comprehensive clinical development program that includes over 3,600 patients with moderate to severe chronic plaque psoriasis. Analysis of data from the OPT Pivotal 1 and OPT Pivotal 2 studies showed that tofacitinib 10mg and 5mg tablets twice daily met the co-primary efficacy endpoints of superiority over placebo at 16 weeks in the proportion of patients achieving a Physician’s Global Assessment (PGA) response of “clear” or “almost clear,” and the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75).
Currently the FDA is reviewing the supplemental New Drug Application (sNDA) for tofacitinib for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
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