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 Tanaka1 , Shinichi Kawai2 , Tsutomu Takeuchi3 , Kazuhiko Yamamoto4 , Nobuyuki Miyasaka5
28 September 2012
11 December 2012
28 December 2012
PDF (member's only)
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.
DMARD, Rheumatoid arthritis, Tacrolimus