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Xeljanz monotherapy may improve symptoms of RA

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Xeljanz prescribed alone may improve the symptoms of rheumatoid arthritis compared with methotrexate monotherapy, according to results from a phase 3 trial.

Researchers conducted a double-blind, parallel trial including three treatment groups of patients with rheumatoid arthritis (RA). Xeljanz (tofacitinib, Pfizer) at 5 mg twice daily was assigned to 373 patients, whereas 397 patients received 10 mg tofacitinib twice daily and 186 patients were assigned methotrexate titered from 10 mg to 20 mg per week.

Roy Fleischman

Patients were evaluated with the Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline and at follow-up. At 6 months, a greater number of patients achieved American College of Rheumatology (ACR) response criteria, had low disease activity and achieved remission in the tofacitinib groups compared patients who received placebo. However, some discordance was observed between some measures of low disease activity and remission and may have been greater with methotrexate compared with either dose of tofacitinib, according to the researchers.

Less improvement from baseline in patient-reported pain or Patient Global Assessment of disease, HAQ-DI, and swollen and tender joint counts was seen in patients who reached low disease activity or ACR50. Patient-reported outcomes were overall better among patients who received tofacitinib compared with those treated with methotrexate and were observed in ACR50 responders.

“A higher proportion of methotrexate-naïve patients receiving tofacitinib 5 or 10 mg BID achieved a clinical response compared with pts receiving methotrexate,” the researchers wrote. “While most patients achieve similar responses across different clinical measures, many may achieve a response in one measure but not the other. Variability of responses with clinical measures should be considered when setting treat-to-target goals in patients with RA.” – by Shirley Pulawski

Reference:

Fleischmann R, et al. Paper #THU0180. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosures: Fleischmann reports receiving grant/research support from Pfizer. He is also a consultant for Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.