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Xeljanz, Methotrexate Combination More Effective for RA Treatment Than Methotrexate Alone

October 21, 2016

Adding tofacitinib to methotrexate produced greater clinical response versus adding placebo in patients with rheumatoid arthritis regardless of the background methotrexate dose, according to a study in the online Clinical Rheumatology.

“Tofacitinib plus methotrexate generally showed greater clinical and radiographic efficacy than placebo plus methotrexate in methotrexate-inadequate responder patients with rheumatoid arthritis,” researchers wrote. “The findings reported here suggest that in this population, the effect of tofacitinib is irrespective of background methotrexate dose, and that concomitant high-dose methotrexate may not be needed for tofacitinib efficacy.”

Current guidelines for rheumatoid arthritis treatment recommend starting with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. For patients with inadequate response, options include adding targeted synthetic small-molecule DMARDs such as tofacitinib. Previous studies have demonstrated the efficacy of tofacitinib, an oral Janus kinase inhibitor, at twice-daily doses of 5 mg and 10 mg alone or in combination with DMARDs, according to the study background.


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To investigate whether the methotrexate dose influences tofacitinib efficacy, researchers conducted a post-hoc analysis of the 2-year ORAL Scan phase 3 trial that involved 797 patients with rheumatoid arthritis who had inadequate response to methotrexate alone. Patients received tofacitinib 5 mg or 10 mg twice daily or placebo with background methotrexate categorized as low dose (12.5 mg or less per week), moderate dose (between 12.6 and 17.5 mg per week), or high dose (more than 17.5 mg per week).

At 3 and 6 months, patients taking either tofacitinib dose showed greater improvements compared with placebo on criteria of the American College of Rheumatology (ACR20) across all 3 methotrexate dose groups, researchers reported. At 3 months, regardless of methotrexate group, improvements in Clinical Disease Activity Index and Health Assessment Questionnaire-Disability Index scores were significantly improved for both tofacitinib doses compared with placebo—and those improvements were maintained at 6 months.

Also at 6 months, tofacitinib at either dose across methotrexate groups showed improvements in Disease Activity Score in 28 joints–4(erythrocyte sedimentation rate) and less structural progression compared with placebo, according to the study.—Jolynn Tumolo



Fleischmann R, Mease P, Schwartzman S, et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group [published online October 12, 2016]. Clin Rheumatol. doi:10.1007/s10067-016-3436-1.

Walsh N. RA: Background dose doesn’t matter with JAK inhibitor. MedPage Today. October 17, 2016.

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