Discontinuing Methotrexate Does Not Worsen Rheumatoid Arthritis Outcomes

Clinician examining the hand of a patient with rheumatoid arthritis
Clinician examining the hand of a patient with rheumatoid arthritis
Researchers compared outcomes in patients with rheumatoid arthritis treated with tofacitinib in combination with persistent, discontinued, or interrupted oral methotrexate.

Patients with rheumatoid arthritis (RA) who initiate tofacitinib concurrently with oral methotrexate (MTX) may discontinue MTX and still achieve similar outcomes as those who continue MTX, albeit with reduced health care costs, according study results published in Clinical Therapeutics.

This retrospective claims analysis included 671 patients with RA who had at least one prescription claim for tofacitinib in the US between January 2013 and April 2017. Among these patients, 75.1% (n=504) continued MTX, 19.5% (n=131) discontinued MTX, and 5.4% (n=36) had their MTX use interrupted. All participants initiated dual tofacitinib and oral MTX (≥2 prescription claims for each) and had at least 12 months of continuous enrollment prior to and after initiation of treatment. The researchers examined tofacitinib treatment adherence, persistence, and effectiveness, as well as all-cause and RA-related health care costs. The impact of baseline variables on these outcomes was evaluated using generalized linear modeling.

The MTX-persistent and MTX-discontinued cohorts showed similar rates of 12-month persistence, adherence, and effectiveness with tofacitinib. Compared with the MTX-discontinued cohort, more individuals in the MTX-persistent cohort switched from tofacitinib to a new disease-modifying antirheumatic drug within 1 year of tofacitinib initiation. The MTX-persistent cohort also experienced higher 12-month RA-related health care costs than those in the MTX-discontinued cohort.

Limitations of the study included an inability to confirm whether tofacitinib was newly prescribed, a lack of information on RA-specific disease activity and reasons for MTX discontinuation, a large number of excluded participants, and a small sample size.

The study authors concluded, “[P]atients who initiate tofacitinib in combination with oral MTX are able to discontinue MTX without a negative impact on tofacitinib treatment persistence, adherence, or effectiveness, compared with those who persist with MTX. Patients who discontinue MTX may have lesser RA-related health care costs.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Cohen SB, Haraoui B, Curtis JR, et al. Impact of methotrexate discontinuation, interruption, or persistence in US patients with rheumatoid arthritis initiating tofacitinib + oral methotrexate combination. Published online June 3, 2022. Clin Ther. doi: 10.1016/j.clinthera.2022.05.002