Pfizer Inc. 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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