Late stage trial boost for Pfizer’s arthritis drug tasocitinib
pharmafile | November 8, 2010 | News story | | JAK inhibitors, Pfizer, arthritis, tasocitinib
Pfizer’s rheumatoid arthritis treatment tasocitinib has met its two of its three primary endpoints in a phase III trial.
Primary efficacy endpoints were ACR20 response rates, which showed a 20% improvement from baseline in the American College of Rheumatology scale, mean change in Health Assessment Questionnaire Disability Index and disease activity score 28-4(ESR) (DAS28) of less than 2.6 after three months of the trial.
The primary goal for the secondary endpoint was to improve patients’ ability to perform physical functions, to which the drug more than doubled what would be considered to be a minimal clinically important improvement.
On the third endpoint, which tasocitinib did not meet, the drug demonstrated a numerically higher measure of disease remission at three months than placebo, but that measure did not reach statistical significance.
Among patients treated with tasocitinib, there were statistically significant decreases in neutrophil count (type of white blood cell), statistically significant increases in LDL and HDL cholesterol, but there were no statistically significant changes in hemoglobin levels.
Roy Fleischmann, clinical professor in the department of internal medicine at the University of Texas Southwestern Medical Center in Dallas, said: “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.
“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 III ORAL trials of tasocitinib.”
Tasocitinib is being tested as a new series of oral JAK inhibitors that impacts the signaling of proteins that affects autoimmune diseases such as rheumatoid arthritis (RA).
The ORAL Solo trial was a six-month, double blind, placebo-controlled study of 611 randomised patients.
Tasocitinib was used on patients with moderately to severely active RA who had an inadequate response to at least one disease- modifying antirheumatic drug (DMARD) received tasocitinib 5 mg or 10 mg monotherapy or placebo twice a day.
Current treatments for RA include Abbott’s Humira, that is forecast to make $6 billion this year, and Pfizer’s Enbrel, that could see sales of more than $3.5 billion for 2010.
Ben Adams
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