THE PLACE OF TOFACITINIB IN THE TREATMENT STRATEGY OF RHEUMATOID ARTHRITIS

Objective: to determine the efficiency and safety of therapy with tofacitinib (TOFA) in combination with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) after insufficient previous therapy in real clinical practice.

Subjects and methods. The investigation enrolled a total of 33 patients with RA who met the 1987 American College of Rheumatology (ACR) and/or the 2010 ACR/European League Against Rheumatism (EULAR) criteria. All the patients received TOFA 5–10 mg administered orally twice daily in combination with MTX; 30 patients took TOFA 10 mg/day and 3 patients had TOFA 20 mg/day. Every 6 weeks, the patients were examined by a rheumatologist and laboratory-instrumental tests. RA activity changes were assessed with DAS28-CRP, SDAI, and CDAI.

Results and discussion. Results were assessed at weeks 12, 54, and 114. A significant decrease in DAS28-CRP, SDAI, and CDAI values was noted just at 12-week follow-up; at week 54, the mean values of these indices were 3.7±1.0, 14.9±8.8, and 13.4±9.0, respectively. There was a substantial decline in the levels of rheumatoid factor in 27% of the patients; while one third of them had a 60% decrease in its level and four patients achieved a negative seroconversion. Neither serious adverse events (AEs) no AEs that had not previously been described in the literature were observed during the follow-up study. Nine non-serious AEs were recorded in 8 (25.0%) patients.

Conclusion. The investigation shows that TOFA makes it possible to control the activity of the inflammatory process and, with its sufficient safety and generally good tolerance, to achieve low RA activity in 49% of cases, including patients with multidrug resistance. The high efficacy of TOFA and, in particular, its combination with MTX used in patients with refractory RA give grounds for wider use of this drug, as confirmed by our investigation.

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