Treatment responses to tofacitinib with additional therapies in patients with rheumatoid arthritis.

This study assessed the responses of patients with rheumatoid arthritis (RA) to tofacitinib (Xeljanz), tofacitinib with methotrexate (MTX; Otrexup), and adalimumab (Humira) with MTX. The data showed that some patients did not require combined therapy to achieve higher responses, however, overall, greater responses were achieved with tofacitinib and MTX compared to tofacitinib alone.

RA is a chronic, inflammatory disease that causes joint destruction and impacts the function and quality of life of patients. If treatment responses with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) like MTX are inadequate, then additional therapy with a biological DMARD (bDMARD) or a targeted synthetic DMARD (tsDMARD) is recommended. However, patients with inadequate responses to previous treatments with DMARDs can have poorer responses to further therapy.

Tofacitinib is a Janus kinase (JAK) inhibitor that was investigated in a phase III/IV study alone, and in combination with MTX or adalimumab (ADA). Results suggested that tofacitinib with MTX was more effective than tofacitinib alone, but further assessments of patient responses from the study are needed.

This analysis included 1146 patients with RA. Group 1 included 384 patients who were given 5 mg of tofacitinib, twice daily. Group 2 included 376 patients who received 5 mg of tofacitinib, twice daily with MTX. Group 3 included 386 patients who were given 40 mg of ADA every other week and MTX. Clinical disease activity, functional responses, and C-reactive protein (CRP; an inflammation marker) levels were assessed for 12 months.

At 12 months, patients with better responses to treatment showed similar average changes in clinical disease activity and functional outcomes. Patients with lower response levels that received tofacitinib alone, did not respond as well as those given combined therapies. Patients treated with tofacitinib and MTX, that achieved remission at 6 months and 12 months, had higher reductions in CRP levels compared to patients that did not.

The study suggested that some patients achieved clinical and functional responses after receiving tofacitinib with or without additional therapy. However, patients with poorer responses did better when they received combination therapies.

Additional factors that may have affected responses were not considered and a single study was used for this analysis. Further studies are needed. This study received funding from Pfizer, the manufacturer of tofacitinib.