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.
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.
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