Vol.23 No.6

Original Article

Prevention of joint destruction by tacrolimus in patients with early rheumatoid arthritis: a post hoc analysis of a double-blind, randomized, placebo-controlled study

Authors

Yoshiya Tanaka1 , Shinichi Kawai2 , Tsutomu Takeuchi3 , Kazuhiko Yamamoto4 , Nobuyuki Miyasaka5

  • The First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
  • Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo, Japan
  • Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
  • Department of Allergy and Rheumatology, University of Tokyo Graduate School of Medicine, Tokyo, Japan
  • Department of Medicine and Rheumatology, Graduate School of Medical and Dental Science, Tokyo Medical and Dental University, Tokyo, Japan
Received:

28 September 2012

Accepted:

11 December 2012

Published online:

28 December 2012

Full Text

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Abstract

Objectives A multicenter, randomized, double-blind, placebo-controlled study of the oral calcineurin inhibitor tacrolimus was performed in patients with early rheumatoid arthritis who had responded poorly to disease-modifying antirheumatic drugs (DMARDs), and factors related to suppression of joint destruction were investigated.
Methods The change in the total Sharp score (DTSS) was assessed by univariate analysis in patients with X-ray films to identify the main determinant of a DTSS of%ABST%.5 in week 52. Patients with this factor were then investigated further.
Results Univariate analysis showed that a baseline C-reactive protein (CRP) level of.5 mg/dL was the major determinant of DTSS %ABST%.5 at week 52 in the tacrolimus group. Detailed analysis of patients with a baseline CRP of .5 mg/dL revealed no significant differences in background factors between the two groups. In week 52, DTSS was significantly smaller in the tacrolimus group than in the placebo group (2.67 ± 5.40 vs. 8.05 ± 10.32, respectively, p = 0.017). Both groups had a similar incidence of adverse reactions.
Conclusions Adding tacrolimus to DMARDs significantly suppressed disease activity and joint destruction in patients with early rheumatoid arthritis, a disease duration B3 years, a CRP.5 mg/dL, and a poor response to oral DMARDs.

Key words

DMARD, Rheumatoid arthritis, Tacrolimus