Background/Purpose: Tacrolimus (TAC) is an immunosuppressant with a calcineurin inhibitory effect and has been shown to be beneficial in treating rheumatoid arthritis (RA). It`s well known that the effects of biologics for treating RA are better in patients receiving biologics with methotrexate (MTX) than those in patient receiving biologics alone. It`s therefore likely that MTX may enhance the effects of TAC for treating RA. To clarify the efficacy of combination therapy with TAC and MTX, we performed a retrospective cohort study of RA patients, who received TAC.
Method: We selected all RA patients treated with TAC from 2006 to 2010 in our hospital and corrected clinical data from their medical records. To compare improvement of disease activity score of 28 joints (DAS28) during 12 months between MTX+TAC group (patients treated with TAC and MTX) and TAC group (patients treated with TAC with or without Disease-modifying antirheumatic drugs), we adjusted DAS28 for sex, age, dosage of prednisolone, and analysed using multivariate analysis of variance (MANOVA).
Results: 142 patients were treated with TAC for RA between 2006 and 2010 (Figure 1). Thirty-six patients were discontinued due to the lack of efficacy within 12 months, and 22 patients were discontinued due to adverse events including infection (4 patients), renal dysfunction(5) or hyperglycemia (2). 53 patients (TAC+MTX group: 21 patients, TAC group: 32 patients) were continued to receive TAC therapy over 12 months. As shown in Table, TAC significantly improved DAS28 during 12 months. Adjusted DAS28 before TAC and after 12months were summarized in Figure 2. MANOVA showed that the improvement adjusted DAS28 in 12 months was significantly greater in TAC+MTX group than in TAC group (p=0.0017).
Conclusion: The results confirm that TAC has beneficial effects in treatment of RA. More importantly, the data demonstrate that combination therapy with TAC and MTX is more effective than TAC therapy.
Disclosure: K. Hoshi, None; S. Tanaka, None; T. Wada, None; J. Tanaka, None; T. Nagai, None; S. Hirohata, None.