Safety, tolerability through 24 months was consistent with 12-month tofacitinib analysis
MONDAY, Feb. 4, 2019 (HealthDay News) — The clinical benefits of tofacitinib in combination with methotrexate are sustained over two years among patients with rheumatoid arthritis (RA), according to a study published online Jan. 22 in Arthritis & Rheumatology.
Désirée van der Heijde, M.D., Ph.D., from the Leiden University Medical Center in the Netherlands, and colleagues conducted a phase 3, 24-month, placebo-controlled trial to evaluate the efficacy of tofacitinib (including structural progression) and safety in 797 patients with active RA who had an inadequate methotrexate response (MTX-IR). Participants were randomly assigned to tofacitinib (5 or 10 mg twice daily [BID]) or placebo advancing to tofacitinib (5 or 10 mg) at month 3 for nonresponders or month 6 for the remaining patients.
Among the 539 patients who completed 24 months of treatment, the researchers found that improvements were maintained in American College of Rheumatology 20/50/70 responses, proportions of patients achieving Disease Activity Score in 28 joints-defined remission or low disease activity, the Clinical Disease Activity Index, Simplified Disease Activity Index and Boolean remission, and Health Assessment Questionnaire Disability Index through months 12 to 24. Improvements were similar between tofacitinib doses. For both tofacitinib doses, safety events were similar in type and frequency, and they were consistent with those previously reported.
“In conclusion, this 24-month randomized controlled trial in MTX-IR patients with RA receiving tofacitinib 5 or 10 mg BID plus MTX demonstrated maintenance of efficacy with tofacitinib in those patients with initial responses, including limited structural damage, through 24 months,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, which manufactures tofacitinib and funded the study.
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