Effect of methotrexate plus tofacitinib in Rheumatoid Arthritis

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Effect of methotrexate plus tofacitinib in Rheumatoid Arthritis

Tofacitinib belongs to the class of janus kinase inhibitor used for rheumatoid arthritis (RA) treatment. Fleischmann R, et al., conducted a post hoc analysis to estimate the effect of methotrexate (MTX) on the efficacy of tofacitinib in RA patients.

This ORAL Scan (NCT00847613) was a 2-year, randomized, phase 3 trial investigating tofacitinib in MTX-inadequate responder (IR) RA patients. A total of 797 patients were included in this analysis with tofacitinib 5 mg BID (N=321), tofacitinib 10 mg BID (N=316), or placebo (N=160).

The patients were given tofacitinib 5 mg or 10 mg twice daily (BID), or placebo, with low (≤12.5 mg/week), moderate (>12.5 to <17.5 mg/week), or high (≥17.5mg/week) firm background MTX.

At months 3 and 6, the efficacy endpoints encompassed American College of Rheumatology (ACR) 20/50/70 response rates and mean change from baseline in Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints (DAS28)–4 (erythrocyte sedimentation rate [ESR]), Health Assessment Questionnaire-Disability Index (HAQ-DI), and altered Total Sharp score.

Low MTX doses were given to 242 patients, moderate MTX doses to 333 patients and high MTX doses to 222 patients. Across all MTX doses, ACR20/50/70 response rates were greater for both tofacitinib doses vs placebo at months 3 and 6. The mean changes from baseline in CDAI and HAQ-DI were notably greater for both tofacitinib doses vs placebo, irrespective of MTX category at month 3. Stability was observed in improvements at month 6.

Across MTX doses at month 6, both the tofacitinib doses revealed improvements in DAS28–4(ESR) and less structural progression vs placebo. Hence, regardless of MTX dose, tofacitinib plus MTX portrayed greater clinical and radiographic efficacy than placebo in MTX-IR patients with RA.


Clinical Rheumatology

Link to the source:


The original title of the article:

Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group


R Fleischmann et al.

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