How effective is tofacitinib in the treatment of rheumatoid arthritis (RA)?

Updated: Feb 07, 2020
  • Author: Howard R Smith, MD; Chief Editor: Herbert S Diamond, MD  more...
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Tofacitinib has been associated with reductions in signs and symptoms of RA and improvement in physical function. [107] Fleischmann et al demonstrated that ACR criteria for a 20% response were met in 59.8% of patients receiving monotherapy with tofacitinib 5 mg twice daily, compared with 26.7% of patients receiving placebo. [108] Health Assessment Questionnaire Disability Index (HAQ-DI) reduction was also greater in the tofacitinib group (−0.50 points) than in the placebo group (−0.19 points).

In another study, in which 717 patients who received stable MTX doses over 12 months were randomized to also receive 5 mg or 10 mg of tofacitinib orally twice daily, adalimumab 40 mg every 2 weeks, or placebo, ACR 20% response rates at 6 months were higher among patients receiving 5 mg or 10 mg of tofacitinib (51.5% and 52.6%, respectively) and among those receiving adalimumab (47.2%) than among those receiving placebo (28.3%). [109]

A once-daily 11-mg extended-release dosage form was approved by the FDA in February 2016 as an alternative to the 5-mg twice-daily regimen.

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