Prevention of joint destruction by tacrolimus in patients with early rheumatoid arthritis: a post hoc analysis of a doub
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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 Yoshiya Tanaka • Shinichi Kawai • Tsutomu Takeuchi Kazuhiko Yamamoto • Nobuyuki Miyasaka
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Received: 28 September 2012 / Accepted: 11 December 2012 / Published online: 28 December 2012 Ó Japan College of Rheumatology 2012
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\0.5 in week 52. Patients with this factor were then investigated further. Results Univariate analysis showed that a baseline C-reactive protein (CRP) level of\1.5 mg/dL was the major determinant of DTSS \0.5 at week 52 in the tacrolimus group. Detailed analysis of patients with a baseline CRP of
Y. Tanaka (&) The First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan e-mail: [email protected] S. Kawai Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo, Japan T. Takeuchi Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan K. Yamamoto Department of Allergy and Rheumatology, University of Tokyo Graduate School of Medicine, Tokyo, Japan N. Miyasaka Department of Medicine and Rheumatology, Graduate School of Medical and Dental Science, Tokyo Medical and Dental University, Tokyo, Japan
\1.5 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 \1.5 mg/dL, and a poor response to oral DMARDs. Keywords
DMARD Rheumatoid arthritis Tacrolimus
Introduction Tacrolimus is a macrolide antibiotic that was first identified as a metabolic product of the actinomycete Streptomyces tsukubaensis. It is a calcineurin inhibitor that shows strong immunosuppressive activity by selectively blocking T-cell activation [1, 2]. Tacrolimus was initially used clinically in Japan in organ transplantation, after which its efficacy for myasthenia gravis, rheumatoid arthritis (RA), lupus nephritis, and ulcerative colitis was also demonstrated. In Japan, oral tacrolimus was approved for the treatment of RA in April 2005 (it is indic
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