Tofacitinib treats symptoms and prevents structural damage in patients with rheumatoid arthritis (RA) who do not respond well to methotrexate (MTX), indicate phase III trial findings.
The planned interim results show significantly greater American College of Rheumatology (ACR)20 response rates after 6-month treatment in patients given the oral Janus kinase inhibitor at 5 mg and 10 mg twice daily doses than in those given placebo, at 51.5% and 61.8% versus 25.3%, respectively.
In addition, patients given tofacitinib 10 mg twice daily showed significantly less disease progression from baseline than placebo-treated patients at the 6- and 12-month check ups, as demonstrated on both the erosion and joint space narrowing scores of the van der Heijde modified total Sharp score.
This was accompanied by greater improvement in Health Assessment Questionnaire-Disability Index scores at 3 months for the 5 mg and 10 mg treatment groups compared with placebo-treated patients (-0.40 and -0.50 vs -0.15), as well as higher rates for remission, defined as a Disease Activity Score 28 below 2.6 (7.2 and 16.0 vs 1.6%).
Both tofacitinib doses also led to significantly less radiographic evidence of progression than placebo, the researchers report in Arthritis and Rheumatism.
"The results of this 12-month analysis from a 24-month Phase 3 study confirm findings seen previously in Phase 2 and Phase 3 studies in patients with active RA treated with tofacitinib and, for the first time, provide evidence of the potential to inhibit progression of structural damage," say Désirée van der Heijde (Leiden University Medical Center, the Netherlands) and co-authors.
The double-blind, parallel group trial included 797 RA patients with an inadequate response to MTX who were randomly assigned to receive tofacitinib 5 mg or 10 mg twice daily, or placebo. Patients who did not respond to placebo after 3 months were advanced blindly to tofacititib 5 mg or 10 mg twice daily; remaining patients were advanced to active drug at 6 months.
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