medwireNews: Patients with rheumatoid arthritis who are treated with the Janus kinase (JAK) inhibitor tofacitinib alongside methotrexate experience sustained efficacy for up to 2 years, suggest follow-up results from the phase III ORAL Scan study.
Previously reported findings from the 1-year interim analysis of this trial demonstrated significantly higher ACR20 response rates at 6 months with tofacitinib 5 or 10 mg twice daily versus placebo, say Carol Connell (Pfizer Inc, Groton, Connecticut, USA) and study co-authors.
The 2-year results, based on a total of 539 patients, demonstrate that clinical improvements – including ACR20, 50, and 70 responses as well as the proportion of patients achieving remission or low disease activity – were maintained from the 1- to the 2-year follow-up. For example, ACR20 response rates were 75.4% at 1 year and 73.5% at 2 years for patients given the 5 mg dose of tofacitinib, and 78.5% and 82.6%, respectively, for those given the 10 mg dose.
The researchers note in Arthritis & Rheumatology that structural damage was “limited” at both follow-up timepoints, and “[t]he safety profile and tolerability of tofacitinib through 24 months was consistent with published findings from the 12-month analysis and other Phase 3 clinical trials.”
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