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Pfizer Inc. (NYSE:PFE) announced today detailed results from OPT Compare (A3921080), a Phase 3 study of tofacitinib, the first in a new class of treatment, oral Janus kinase (JAK) inhibitors, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis. Top-line results from OPT Compare were previously announced in October 2013. This is the first of five studies from the Phase 3 Oral treatment Psoriasis Trial (OPT) Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. The results of OPT Compare showed that in a step-down procedure design, tofacitinib 10 mg twice daily (BID) was non-inferior to high-dose ENBREL
® (etanercept) 50 mg twice weekly (BIW), and tofacitinib 5 mg twice daily did not meet the non-inferiority criteria compared to high-dose ENBREL. No new safety signals for tofacitinib were observed in the OPT Compare study. Detailed results of this study are being presented as an oral presentation during the Latest in Dermatology Research Symposium at the 72nd American Academy of Dermatology (AAD) Annual Meeting held in Denver, at 9:45 a.m. MDT today.
“We are pleased to present the detailed results of OPT Compare, the first Phase 3 trial showing non-inferiority of an oral small molecule, tofacitinib, versus an injected biologic agent, ENBREL, in psoriasis. The results demonstrated that tofacitinib 10 mg twice daily had similar efficacy to high-dose ENBREL 50 mg twice weekly,” said lead author Hervé Bachelez, M.D., Ph.D., Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, APHP Hôpital Saint-Louis, Paris, France.
OPT Compare is a 12-week, non-inferiority study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg BID to high-dose ENBREL 50 mg BIW, the approved starting dose for ENBREL for the first 12 weeks, and placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. The results of the study showed that tofacitinib 10 mg BID was non-inferior to high-dose ENBREL 50 mg BIW as measured by Psoriasis Area and Severity Index (PASI) 75 response and Physician’s Global Assessment (PGA) response. The proportion of patients that achieved a PASI75 response at week 12 was: tofacitinib 10 mg BID: 63.6 percent; ENBREL 50 mg BIW: 58.8 percent; tofacitinib 5 mg BID: 39.5 percent; placebo: 5.6 percent. The proportion of patients that achieved “clear” or “almost clear” in PGA at week 12 were: tofacitinib 10 mg BID: 68.2 percent; ENBREL 50 mg BIW: 66.3 percent; tofacitinib 5 mg BID: 47.1 percent; placebo: 15.0 percent. Tofacitinib 5 mg BID did not meet the non-inferiority criterion of 15 percent difference compared to high-dose ENBREL as measured by PASI75.