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Positive results in Phase III trial of Xeljanz (Pfizer) in patients with Rheumatoid Arthritis

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Last updated:26th Jan 2013
Published:26th Jan 2013
Source: Pharmawand

A Phase III clinical trial demonstrates that Xeljanz (tofacitinib), from Pfizer, improves disease activity and inhibits progression of joint damage in Rheumatoid Arthritis (RA) patients who did not respond to methotrexate (MTX). In this 24-month, double-blind, placebo-controlled study, 797 participants were randomized to receive 5mg of tofacitinib (n=321); 10 mg of tofacitinib (n=316) or placebo. Results from a 12-month interim analysis show that tofacitinib is effective in preserving joint structure in patients who had an inadequate response to MTX therapy.

The difference from placebo in mean change from baseline in the van der Heijde modified total Sharp score was statistically significant for tofacitinib at 10mg BID but not at 5mg BID at month six (co-primary endpoint) and month 12. Xeljanz was approved by the FDA for treating RA in November 2012. Results appear in Arthritis & Rheumatism. See: �Tofacitinib (CP-690,550) in Patients with Rheumatoid Arthritis on Methotrexate: 12-Month Data from a 24-Month Phase 3 Randomized Radiographic Study.� Desiree van der Heijde et al. Arthritis and Rheumatism; January 24, 2013 DOI: 10.1002/art.37816

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