Pfizer Inc. has presented the detailed pooled results from two pivotal phase 3 studies from the oral treatment Psoriasis Trials (OPT) programme at the 73rd American Academy of Dermatology (AAD) Annual Meeting. These results, evaluating the efficacy and safety of tofacitinib citrate for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, have been selected for oral presentation during the Pearls from the Posters New and Noteworthy Research Finds [abstract 2020].
Additionally, an integrated analysis of safety data from the OPT global clinical development program for tofacitinib was presented during the Late-Breaking Research in Dermatology Forums
”We are excited about the data presented at AAD as it adds to the body of evidence for oral tofacitinib in patients with moderate to severe plaque psoriasis. Results from these studies, which are part of the phase 3 OPT clinical development program, supported Pfizer’s recent FDA filing seeking a psoriasis indication in the United States,” said Steve Romano, MD, senior vice president and Head, Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business.
The detailed, pooled analysis of 16 week data from the OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib 10 mg and 5 mg 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), two commonly used measures of efficacy in psoriasis. Both the tofacitinib 10 mg and 5 mg twice-daily doses showed statistically significant superiority over placebo for key secondary efficacy endpoints presented at AAD, including proportion of patients achieving =90% reduction in PASI (PASI90) relative to baseline at Week 16, percent change from baseline in Body Surface Area (BSA) at Week 16, change from baseline in Dermatology Life Quality Index (DLQI) at Week 16, and percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 in patients with nail psoriasis.
The safety profile of tofacitinib in the OPT Pivotal #1 and OPT Pivotal #2 studies was similar to previous Phase 3 studies, and no new safety signals were observed in the studies. Among the approximately 1,800 patients in the Week 0-16 study data, the most common adverse events (AEs) (=5% in any treatment group in the pooled data for OPT Pivotal #1 and OPT Pivotal #2) reported in both studies were nasopharyngitis, upper respiratory infection and headache. Rates of serious AEs were similar between active treatment and placebo arms.
Occurrences of serious infections were similar between active treatment groups and placebo (0.3% in tofacitinib 10 mg twice-daily dose, 0.4% in tofacitinib 5 mg twice-daily dose and 0.5% in placebo). Two deaths were reported in the tofacitinib 5 mg treatment group within the first 16 weeks, one each in OPT Pivotal #1 and OPT Pivotal #2. Neither of the deaths was considered by the investigators to be related to tofacitinib. There were no deaths reported in the tofacitinib 10 mg treatment group in either study. There was one death reported in the placebo group of OPT Pivotal #2.
“The robust data seen in the OPT Pivotal studies presented at this meeting provide important information on the profile of oral tofacitinib for moderate to severe psoriasis, and underscore that if approved, tofacitinib may offer a clinically meaningful option in oral therapy as the first potential treatment in a new class of medicines for this chronic condition,” said lead investigator Kim A. Papp, MD, PhD, FRCPC, Probity Medical Research.
Top-line results for the studies were previously announced in April 2014.
The integrated safety analysis summarizes safety information gathered from the tofacitinib psoriasis clinical development program and included one phase 2 trial, three 1-year phase 3 randomized controlled trials and an ongoing long-term extension study. The safety endpoints analyzed include: serious infections, herpes zoster, malignancy (excluding non-melanoma skin cancer [NMSC]), NMSC and major adverse cardiovascular events (MACE).
The phase 3 OPT clinical trial programme is a global, comprehensive clinical development program that includes over 3,600 patients in 36 countries, and is one of the largest global clinical trial programs in moderate to severe chronic plaque psoriasis to date. In addition to the OPT Pivotal #1 and OPT Pivotal #2 studies, the OPT Program includes the following Phase 3 studies of tofacitinib in adults with moderate to severe chronic plaque psoriasis:
OPT Compare (A3921080): A 12-week, phase 3 study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily to ENBREL (etanercept) 50 mg twice weekly as well as to placebo.
OPT Retreatment (A3921111): A Phase 3 study evaluating the efficacy and safety of the withdrawal from, and then the retreatment with, tofacitinib 5 mg and 10 mg twice daily compared to placebo.
OPT Extend (A3921061): An ongoing long-term extension study evaluating the safety and tolerability of tofacitinib. Patients who participated in the phase 2 or phase 3 studies had the option, if eligible, to enroll in this study.