The efficacy and safety of tacrolimus for RA patients

Abstract

OBJECTIVE: Tacrolimus is an immunosuppressant with a calcineurin inhibitory effect. In Japan, administration of tacrolimus for the treatment of RA was approved in 2005. Our aim is to examine the efficacy and safety of tacrolimus for RA patients who have therapeutic difficulties with uncontrollable disease activity.
METHOD: 55 patients with RA who were resistant or intolerant to other disease-modifying antirhuematic drugs (DMARDs) were enrolled. They were administrated with tacrolimus (1-3 mg/day). We evaluated the effects of tacrolimus at 6, 12, 24 and 30 months by using DAS28 (CRP) and EULAR response criteria. We also examined whether MTX had influence on the efficacy of tacrolimus or not.
RESULT: The continuation rates at 6 months was 78%. 63.6% (21cases) of the patients achieved good or moderate responses at6monthes.Response rates seemed to be higher when they were treated in combination with MTX. After 6 months of treatment, 16 out of 43 cases achieved clinical remission. We didn’t see any serious adverse events.
CONCLUSION: Tacrolimus is safely and effectively used as a combination therapy with other DMARDs and prednisolone even for RA cases with high risk background when started with low dose and at an early stage of the disease. Blood concentration measurements and adjusting doses should be required for preventing severe adverse events.