Pfizer Says Endpoint Met in Tofacitinib OPT Study, Did Not Meet in Non-Inferiority Study
Pfizer Inc. (NYSE: PFE) announced today top-line results from two Phase 3 clinical trials of tofacitinib, a novel, oral Janus kinase (JAK) inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis: OPT Compare (A3921080) and OPT Retreatment (A3921111). These are the first two of five studies in the Phase 3 Oral Psoriasis Treatment (OPT) Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. Top-line results for the OPT Pivotal 1 and OPT Pivotal 2 trials (A3921078 and A3921079) are anticipated in the second quarter of 2014, and these four studies, in addition to a long-term extension study, will form the potential psoriasis submission package to regulatory authorities.
“We are excited to see progress in our development program in psoriasis,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “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 (BID) to high-dose ENBREL^® (etanercept) 50 mg twice-weekly (BIW), 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 dose-response relationship observed for tofacitinib in this trial is consistent with the findings from the Phase 2 trial. Additionally, 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. Additionally, among patients who lost an adequate response, many were able to recapture their response upon retreatment with tofacitinib. The results of OPT Retreatment will provide relevant information to physicians in clinical practice, as it is common for patients with psoriasis to stop and restart therapy.
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. Full analyses of the OPT Compare and OPT Retreatment data, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.
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