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Tofacitinib plus methotrexate sustain improvements for 2 years in RA
A twice daily 5-mg or 10-mg dose of tofacitinib plus methotrexate was associated with improved clinical and radiographic responses between 1 and 2 years among patients with rheumatoid arthritis, with no new safety signals, according to findings published in Arthritis & Rheumatology.
Désirée van der Heijde , MD, PhD, of Leiden University Medical Center in the Netherlands, and colleagues evaluated tofacitinib (Xeljanz, Pfizer) in a cohort of 779 patients in the phase 3, 24-month placebo-controlled ORAL Scan trial.
The researchers randomly assigned patients to receive 5-mg or 10-mg tofacitinib twice daily, or placebo that ultimately transitioned to 5-mg or 10-mg tofacitinib. The transition from placebo to active therapy occurred at month 3 in nonresponders and month 6 in the remaining patients. Van der Heijde and colleagues evaluated tofacitinib efficacy, including structural progression.
The 24-month treatment completion rate was 67.6%. Results showed that a number of parameters were maintained between 12 and 24 months of treatment, including ACR20/50/70 responses; the number of patients reaching DAS28-4(ESR)-defined remission or low disease activity (LDA); Clinical Disease Activity Index; Simplified Disease Activity Index and Boolean remission; and Health Assessment Questionnaire Disability Index.
The rates of these outcomes were comparable between the two tofacitinib doses, according to the results. While the 10-mg dose yielded a numerical trend toward higher response rates than the 5-mg dose, the researchers noted that the current data set was insufficiently powered to draw this conclusion.
The 10-mg dose was associated with “modestly higher months in LDA and remission, with numerically higher proportions of patients achieving 12 months’ uninterrupted LDA,” the researchers wrote.
Other findings showed limited structural damage at either 12 or 24 months. Additionally, there were 11 fatalities during the study, six of which were considered to be associated with study drug administration.
Safety data showed that discontinuation due to treatment-emergent adverse events between 0 and 24 months ranged between 11.1% and 17.1%. Pneumonia occurred in 2.2% of patients in the tofacitinib 5-mg dose, while herpes zoster and urinary tract infections each occurred in 1.3% of patients receiving the 10-mg dose. Twelve opportunistic infections occurred, all among women in Asia. Safety events were similar between doses.
“This 24-month [randomized controlled trial] in methotrexate-[inadequate response] patients with RA receiving tofacitinib 5 or 10 mg [twice daily] plus methotrexate demonstrated maintenance of efficacy with tofacitinib in those patients with initial responses, including limited structural damage, through 24 months,” van der Heijde and colleagues wrote. – by Rob Volansky
Disclosure: D. van der Heijde has received consultancy fees, speaking fees, and/or honoraria of less than $10,000 from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer Inc., Regeneron, Roche, Sanofi, Takeda, and UCB. The study was sponsored by Pfizer, Inc.