NEW YORK, Nov. 7, 2010 /PRNewswire-FirstCall/ — Pfizer Inc.
(NYSE:
PFE) today announced results of ORAL Solo (1045), a Phase 3
study that showed tasocitinib (CP-690,550), an investigational,
novel, oral JAK inhibitor, administered as monotherapy met two
primary endpoints, demonstrating a statistically significant
reduction in signs and symptoms of moderately to severely active
rheumatoid arthritis (RA) and improvement in physical function as
measured by ACR20 response rates and mean change in HAQ-DI,
respectively, versus placebo at three months. For a third primary
endpoint, the rate of DAS28-4(ESR) <2.6, a measure of disease
remission, treatment with tasocitinib resulted in a numerically
greater, but not statistically significant difference from placebo
at three months.
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In ORAL Solo, a similar frequency of adverse events was seen
across all treatment groups. Serious adverse events were reported
in 4.1 percent of patients. Additionally, decreases in neutrophil
count and hemoglobin and an increase in cholesterol occurred by
month three. These changes tended to stabilize thereafter. No new
safety signals were detected.
“We are encouraged by the statistically significant and
clinically meaningful improvements we observed in a proportion of
patients treated with tasocitinib monotherapy in ORAL Solo,” said
Roy Fleischmann, MD, Clinical Professor in the Department of
Internal Medicine at the University of Texas Southwestern Medical
Center in Dallas. “Further research into additional treatment
options for patients with moderately to severely active RA is
important, and we look forward to seeing the results of the
additional Phase 3 ORAL trials of tasocitinib.”
ORAL Sequel (1024), an open label, follow-up Phase 2/3
study,
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