Low discontinuation rates found for long-term use of tofacitinib monotherapy

Results presented at the EULAR Annual Congress showed most patients with rheumatoid arthritis treated with tofacitinib monotherapy had low rates of discontinuation due to lack of efficacy or adverse events during the course of 60 months.

“If a patient initially does well with tofacitinib 5 mg or 10 mg twice a day monotherapy and they do not have an adverse event, the chances of their continuing to do well over an extended period of time are good,” Roy Fleischmann, MD, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Metroplex Clinical Research Center told Healio.com Rheumatology of the study.

Researchers pooled data from two tofacitinib long-term extension studies in which patients with rheumatoid arthritis (RA) received tofacitinib 5 mg or 10 mg twice daily as monotherapy or with background conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Based on the average total daily dose of tofacitinib in the long-term extension studies, researchers assigned 1,750 patients to tofacitinib either 5 mg or 10 mg twice daily for this analysis and evaluated safety through 84 months and efficacy though 60 months.

Roy Fleischmann

Results showed 89% of patients stayed on herapy throughout the long-term extension study, with a mean treatment duration of 1,248 days for patients on 5 mg of tofacitinib monotherapy and a mean of 1,011 days for patients on 10 mg of tofacitinib monotherapy. Through 60 months, researchers noted stable efficacy responses for tofacitinib monotherapy. Overall, 66% of patients in the 5-mg group and 82% of patients in the 10-mg group stayed on initial dose throughout the long-term extension study, according to the results.

From baseline to 60 months, steroid use decreased from 56% of patients initially to 40% in the 5-mg group and from 41% to 35% in the 10-mg group. Researchers found low rates of discontinuation due to lack of efficacy and adverse events, and of serious infection and malignancy.

“Few patients lost efficacy. Few patients had an adverse event, which is not unexpected in terms of the adverse event because they had been on tofacitinib for 6 months or a year prior to that before entering the long-term extension,” Fleischmann said. “If they did not have an adverse event in the first 12 months, then the chances of having the event later on is small.” – by Kristine Houck, MA, ELS, and Casey Tingle

Reference:

Fleischmann R, et al. Abstract #THU0202. Presented at: EULAR Annual Congress; June 8-11, 2016; London.

Disclosure: Fleischmann reports he received a research grant and is a consultant for Pfizer.