Vol.21 No.5

Original Article

Efficacy and safety of additional use of tacrolimus in patients with early rheumatoid arthritis with inadequate response to DMARDs?a multicenter, double-blind, parallel-group trial


Shinichi Kawai1 , Tsutomu Takeuchi2 , Kazuhiko Yamamoto3 , Yoshiya Tanaka4 , Nobuyuki Miyasaka5

  • Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan
  • Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
  • Tokyo University, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
  • University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
  • Tokyo Medicine and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan

17 November 2010


28 January 2011

Published online:

24 February 2011

Full Text

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In this trial, we investigated the safety and efficacy of tacrolimus used in addition to standard antirheumatic drugs in patients with rheumatoid arthritis. Tacrolimus 3 mg or placebo was orally administered once daily for 52 weeks in a double-blind manner to patients with early active rheumatoid arthritis receiving other disease-modifying antirheumatic drugs (DMARDs). A total of 123 patients were randomized to the tacrolimus group (61 patients) and to the placebo group (62 patients). In the tacrolimus group, 70.5% achieved a clinical response according to American College of Rheumatology (ACR) 20 criteria, whereas 45.2% in the placebo group did so (P = 0.005). The tacrolimus group also showed significant improvement in terms of the European League Against Rheumatism (EULAR) response criteria of ‘‘good or moderate’’ versus the placebo group (86.9 vs. 56.5%, respectively). Likewise, significantly more patients in the tacrolimus group versus the placebo group achieved remission of the Disease Activity Score in 28 joints (DAS28) (45 vs. 21%). The mean changes in the Total Sharp Score and erosion score were lower in the tacrolimus group, but the differences between the two groups were not significant. There was no significant difference between the two groups in the incidence of adverse events. Based on these results, we can conclude that the additional use of tacrolimus in patients with early rheumatoid arthritis with inadequate response to other DMARD treatments is useful, and this could become one of the treatment options for these rheumatoid arthritis patients.

Key words

DMARD - Randomized controlled trial - Rheumatoid arthritis - Tacrolimus