Tofacitinib (Xeljanz) Slows RA Joint Damage
Disease progression reduced in patients unresponsive to methotrexate (Jan. 24)
According to data from a recent phase III trial, tofacitinib (Xeljanz, Pfizer) has the potential to improve disease activity and to inhibit the progression of joint damage in patients with rheumatoid arthritis (RA) who do not respond to methotrexate (MTX). The new findings were published in Arthritis & Rheumatism.
RA is a chronic autoimmune disease that causes inflammation, pain, and swelling of the joints. Over time, the disorder may destroy joints, impair daily function, and lead to significant disability. According to the American College of Rheumatology (ACR), RA affects 1.3 million people in the U.S.
Tofacitinib inhibits Janus kinase (JAK) enzymes in white blood cells, which help to regulate the immune system.
In the new 24-month, double-blind, placebo-controlled study, 797 patients with RA were randomly assigned to receive 5 mg of tofacitinib twice daily (n = 321); 10 mg of tofacitinib twice daily (n = 316); placebo to tofacitinib 5 mg twice daily (n = 81); or placebo to tofacitinib 10 mg twice daily (n = 79). The patients’ mean age was 53 years; 85% were female; and 56% were Caucasian. The mean duration of the patients’ RA was 9 years. Those who did not respond to placebo were advanced to tofacitinib at 3 months, and the remaining placebo participants were advanced at 6 months.
The results from a planned 12-month interim analysis showed that tofacitinib was effective in preserving joint structure in patients with moderate to severe RA who had shown an inadequate response to MTX therapy. The difference from placebo in the mean change from baseline in the van der Heijde modified total Sharp score was statistically significant for tofacitinib 10 mg twice daily but not for tofacitinib 5 mg twice daily at month 6 (a co-primary endpoint) and at month 12.
Patients treated with either tofacitinib 5 mg or 10 mg twice daily showed less progression of joint erosion and joint-space narrowing (JSN) compared with placebo at 6 and 12 months. The change in the JSN score was statistically significant at month 12 for the tofacitinib groups versus the placebo groups. In addition, the proportion of patients with no radiographic progression in the tofacitinib groups was significantly greater compared with that of the placebo groups.
Xeljanz (tofacitinib) 5 mg twice daily is approved for RA patients who are unresponsive to or intolerant of MTX.
Source: Wiley; January 24, 2013.