FONT-SIZE Plus   Neg

Pfizer Reports Top-line Results From Tofacitinib Phase 3 Trials - Quick Facts

Pfizer Inc. (PFE) announced top-line results from two Phase 3 clinical trials of tofacitinib, an oral Janus kinase inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis: OPT Compare and OPT Retreatment. Pfizer said no new safety signals for tofacitinib were observed in these studies, and the efficacy and safety profile of tofacitinib in psoriasis remains consistent with that seen in the Phase 2 clinical trial.

Steven Romano, SVP, and the head of the Medicines Development Group for Pfizer Specialty Care, said, "The OPT Compare and OPT Retreatment studies provide information that is consistent with our expectations based on the Phase 2 data in psoriasis. We look forward to the results of our remaining Phase 3 trials in order to fully evaluate tofacitinib in psoriasis and how it may fit into clinical practice for patients and physicians."

OPT Compare is a 12-week, non-inferiority study comparing the efficacy and safety of tofacitinib 5 and 10 mg twice-daily to high-dose ENBREL 50 mg twice-weekly, the approved starting dose for ENBREL for the first twelve weeks, and placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. Top-line results from the OPT Compare study showed that tofacitinib met the primary endpoint of non-inferiority to high-dose ENBREL at the 10 mg BID dose. Tofacitinib did not meet the non-inferiority criteria to high-dose ENBREL at the 5 mg BID dose. The company said the dose-response relationship observed for tofacitinib in this trial is consistent with the findings from the Phase 2 trial. The rates of important safety events were similar across the active treatment arms.

OPT Retreatment is a 56-week study comparing the efficacy and safety of withdrawal and retreatment with tofacitinib 5 and 10 mg BID to placebo for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. The OPT Retreatment study met its primary efficacy endpoints at the 5 and 10 mg BID doses by demonstrating that a greater proportion of patients continuing tofacitinib treatment maintained their response during the treatment withdrawal phase compared to patients who switched to placebo. Among patients who lost an adequate response, many were able to recapture their response upon retreatment with tofacitinib.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator. Reynolds American Inc. (RAI) on Friday confirmed that British American Tobacco plc (BATS.L, BTI) has offered to buy the remaining 57.8 percent stake that it does not own in the US tobacco company for $47 billion. Reynolds said its board of directors will evaluate the offer, and respond accordingly to BAT, which currently owns 42.2 percent stake in Reynolds. The proposal represents an enterprise va
comments powered by Disqus
Follow RTT