In First Phase 3 Trial, Tasocitinib (CP-690,550), an Oral JAK Inhibitor, Administered as Monotherapy, Reduces Signs and Symptoms of Active Rheumatoid Arthritis and Improves Ph...
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.
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,