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Objectives: To evaluate how disease-modifying antirheumatic drugs (DMARDs) affects efficacy of tofacitinib (TOFA) therapy in patients with rheumatoid arthritis (RA).
Methods: We analyzed the history of 107 patients (mean age 51,4±12,1 yrs) with RA according to the 2010 ACR/EULAR criteria, from 11 regions Russian Federation, including patients who were treated at the V.A. Nasonova Research Institute of Rheumatology. These patients were non-responders to DMARDs, previously biologic therapy and were treated with TOFA in combination with DMARDs or without. 107 patients (77 woman (72%),tested positive for ACCP (76.5%)/RF (87.3%), the median disease duration was 7,5±6,6 years; the mean DAS28 score was 5,8±1,0, mean SDAI and CDAI score was 35,6±13,4 and 32,1±12,4 respectively) received TOFA for 12 months. TOFA therapy was started in all patients in dose 5 mg BID per os with escalation to 10 mg BID in 17,6% pts.
Results: The use of TOFA was accompanied by a decrease in the disease activity after 6 and 12 months of therapy. All patients were divided into 3 groups, depending on DMARDs therapy: TOFA+ methotrexate (MTX), TOFA+ another DMARDs (leflunomide, hydroxychloroquine, azathioprine), mono-therapy of TOFA. The dynamic of the disease activity in 3 groups is presenting on the table below:
A Outcome of contributory AEs/SAE at close of follow-up. B SAEs classified as ‘expected’. DLT: dose limiting toxicity; N+V: nausea, vomiting.
| Parameters | Weeks | TOFA+MTX
| TOFA+ another DMARDs (n=20) | TOFA monotherepy (n=18) |
|---|---|---|---|---|
| DAS28 (ESR) | baseline | 5,9 ±1,0 | 5,6±1,1 | 6,0±0,8 |
| 6 months | 3,5±1,2* | 4,1±1,1* | 4,2±1,6* | |
| 12 months | 3,3±1,0* | 3,5±1,3* | 3,8±1,2* | |
| SDAI | baseline | 36,2±14,2 | 32,6±9,5 | 35,3± 10,3 |
| 6 months | 14,4± 10,7* | 16,7± 10,2* | 27,3±19,1* | |
| 12 months | 9,5±8,0* | 12,9± 8,6* | 15,3±10,2* | |
| CDAI | baseline | 32,4±12,1 | 29,7±8,9 | 33,2±9,8 |
| 6 months | 13,3±10,2* | 15,6±9,8* | 22,4±16,8* | |
| 12 months | 8,7±7,6* | 12,6±8,2* | 14,4±9,6* |
*p<0,05
Patients who received TOFA with MTX had lower disease activity during the therapy. Patients on mono-therapy of TOFA had higher disease activity according to DAS28, SDAI, CDAI.
Conclusion: Tofacitinib is effective ts-DMARDs for active rheumatoid arthritis on the Russian population. It shows better efficacy in combination with methotrexate, than in combination with another DMARDs (leflunomide and other) or in mono-therapy.
Disclosure of Interests: None declared