Discontinuation Rates Low Among Patients Taking Xeljanz Monotherapy for RA

Patients treated with Xeljanz (tofacitinib; Pfizer) monotherapy for long-term treatment of rheumatoid arthritis (RA) had low rates of discontinuation due to lack of efficacy or adverse events, according to research presented at the EULAR 2016 Congress.

“Treatment options delivering sustained efficacy when given as monotherapy in RA are limited,” Roy Fleischmann, MD, of the Metroplex Clinical Research Center at the University of Texas Southwestern Medical Center in Dallas, TX, and colleagues wrote. “Tofacitinib is an oral [Janus kinase inhibitor (JAK)] inhibitor for the treatment of RA. Tofacitinib monotherapy demonstrated efficacy in adult patients with RA in two Phase 3 index studies.” 

The researchers pooled data from two long-term extension studies regarding the efficacy of tofacitinib. Study participants with rheumatoid arthritis received either 5 mg or 10 mg of tofacitinib as a monotherapy or as a combination therapy with disease-modifying antirheumatic drugs. The researchers evaluated drug safety through 84 months and drug efficacy through 60 months.

Study results showed that of the 1750 patients who started tofacitinib monotherapy, 1552 continued taking the drug throughout the study period. Additionally, the researchers noted that discontinuation rates due to lack of efficacy, adverse events, or serious infection were low. In total, 66% of participants in the 5 mg group and 82% in the 10 mg group stayed on the monotherapy throughout the duration of the study. 

For patients who continued the monotherapy, the mean treatment duration was 1248 days in the 5 mg group and 1011 days in the 10 mg group, according to the study results.

“In this analysis of patients receiving tofacitinib monotherapy in the long-term extension studies, nearly 90% of patients stayed on monotherapy, most did not have tofacitinib dose adjustments or add disease-modifying antirheumatic drugs and efficacy was sustained over 60 months, with low rates of discontinuation due to lack of efficacy or adverse events,” Fleishmann and colleagues said. “Safety was consistent with what has been reported previously.” 

This study was conducted with funding from Pfizer Inc.—David Costill