Efficacy and safety of tacrolimus (FK506) in treatment of RA

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J Rheumatol. 2004 Feb;31(2):243.

Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid

arthritis: a randomized, double blind, placebo controlled dose-finding

study.

Kondo H, Abe T, Hashimoto H, Uchida S, Irimajiri S, Hara M, Sugawara S.

Japanese Tacrolimus (FK506) RA Study Group, Kitasato University School

of Medicine, Kanagawa, Japan.

OBJECTIVE: To evaluate the efficacy and safety of tacrolimus (FK506) in

patients with active rheumatoid arthritis (RA) exhibiting resistance to

disease modifying antirheumatic drug (DMARD) therapy, and to determine

the optimal dosage. METHODS: A total of 212 patients with

DMARD-resistant RA were enrolled in this double blind, multicenter,

randomized, placebo controlled study and allocated to 3 groups. Patients

were administered tacrolimus at a dosage of 1.5 mg/day (68 patients) or

3 mg/day (70 patients), or placebo (74 patients), for 16 weeks. They

were allowed to continue taking prednisolone (</= 5 mg/day) and/or one

nonsteroidal antiinflammatory drug (NSAID) during the study. Clinical

assessment was based on the American College of Rheumatology (ACR) 20%

criteria. RESULTS: ACR 20% response rates were higher in both tacrolimus

groups (3 mg: 48.3%; 1.5 mg: 24.6%) than in the placebo group (14.1%),

with the rate in the 3 mg group significantly higher. There were no

significant differences between the tacrolimus groups and placebo group

in the incidence of adverse events. The main adverse events in the

tacrolimus groups, especially in the 3 mg group, were renal function

abnormalities and gastrointestinal symptoms. However, no significant

differences were observed among the 3 groups in the incidence of any

adverse event except decrease in serum Mg level.

CONCLUSION: Our findings demonstrate excellent dose-dependent efficacy

of tacrolimus in patients with DMARD-resistant RA and strongly suggest

the usefulness of tacrolimus for treatment of RA. The optimal dosage

appears to be 3 mg/day in terms of efficacy and safety.

PMID: 14760792

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