Experience with tofacitinib in the treatment of resistant rheumatoid arthritis

Abstract

The Russian Federation has not got sufficient experience with tofacitinib (TOFA) in patients with rheumatoid arthritis (RA) so far; in this connection, all follow-ups using this drug in real clinical practice are of particular interest. Objective: to evaluate the efficancy and safety of TOFA in an open-label noncomparative trial of RA patients who have failed to achieve low disease activity or remission in compliance with the EULAR criteria after standard disease-modifying therapy and who have been previously untreated with drugs from a group of biological agents. Subjects and methods. Five patients (4 women and 1 men, whose age was 45 to 58 years (mean age 53 years)) with a valid diagnosis of RA were followed up. All the patients had an advanced clinical stage of RA with erosive arthritis (X-ray Stage III), predominantly involving the minor hand joints. Seropositive and seronegative (for rheumatoid factor (RF)) RA was diagnosed in 4 and 1 patients, respectively. At the inclusion into the study, the patients received disease-modifying antirheumatic drugs. Due to the remaining disease activity, all the patients were given TOFA in a dose of 5 mg twice daily (10 mg/day); moreover, 4 patients received its monotherapy (1 because of intolerability and 3 because of noncompliance); 1 female patient took a combination of TOFA and methotrexate (MT) in a dose of 10 mg/week. Two patients continued to use methylprednisolone 4 mg/day (that had been long taken) in combination with TOFA. The duration of TOFA therapy was 3 months. Results. TOFA 10 mg/day showed high therapeutic efficacy and good tolerability. Three-month disease-modifying therapy with TOFA (4 patients) and its combination with MT (1 patient) resulted in a considerable reduction in DAS28 scores and a significant clinical improvement in ACR 20/50/70 responses. Positive clinical changes were associated with a reduction in the blood level of immune markers (C-reactive protein and RF) up to the seroconversion phenomenon in one female patient. Conclusion. The findings allow TOFA to be recommended for the treatment of RA in case of the inefficiency of standard disease-modifying agents or contraindications to their use.