Vol.21 No.1

Original Article

Humanized anti-interleukin-6-receptor antibody (tocilizumab) monotherapy is more effective in slowing radiographic progression in patients with rheumatoid arthritis at high baseline risk for structural damage evaluated with levels of biomarkers, radiography, and BMI: data from the SAMURAI study

Authors

Jun Hashimoto1 , Patrick Garnero2 , De´sire´e van der Heijde3 , Nobuyuki Miyasaka4 , Kazuhiko Yamamoto5 , Shinichi Kawai6 , Tsutomu Takeuchi7 , Hideki Yoshikawa1 , Norihiro Nishimoto8,9

  • Osaka University Graduate School of Medicine
  • INSERM Research Unit
  • University Hospital Maastricht, Maastricht
  • Tokyo Medical and Dental University
  • The University of Tokyo
  • Toho University
  • Keio University
  • Wakayama Medical University
  • Laboratory of Immune Regulation, Wakayama Medical University, 105 Saito Bio Innovation Center
Received:

3 March 2010

Accepted:

31 May 2010

Published online:

24 June 2010

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Abstract

Our aim was to assess the ability of tocilizumab monotherapy to reduce progressive structural joint damage in rheumatoid arthritis patients at high risk of progression. This study was a subanalysis from a prospective 1-year, multicenter, X-ray-reader-blinded, randomized controlled trial of tocilizumab [Study of Active Controlled Monotherapy Used for Rheumatoid Arthritis, an IL-6 Inhibitor (SAMURAI) trial]. All patients were categorized into two or three groups according to four independent predictive markers for progressive joint damage [urinary C-terminal crosslinking telopeptide (uCTX-II), urinary pyridinoline/deoxypyridinoline (uPYD/DPD) ratio, body mass index (BMI), and joint-space narrowing (JSN) score at baseline]. One-year progression of joint destruction was assessed in high-risk versus low-risk groups receiving tocilizumab monotherapy and compared with patients receiving conventional disease-modifying antirheumatic drugs (DMARDs) (n = 157 and 145, respectively). In patients at high risk of progression of erosion as estimated by high uCTX-II, uPYD/DPD, or low BMI, and at high risk of progression of JSN as estimated by low BMI or high JSN score, the 52-week changes in radiological erosion and JSN, respectively, were significantly less in patients treated with tocilizumab monotherapy compared with those receiving DMARDs for each type of risk factor. In patients at low risk, those receiving tocilizumab also progressed less than those on DMARDs, although the difference did not reach statistical significance. Tocilizumab monotherapy is more effective in reducing radiological progression in patients presenting with risk factors for rapid progression than in low-risk patients. Patients at high risk for progression may benefit more from tocilizumab treatment.

Key words

CTX-II - PYD/DPD - Rheumatoid arthritis - Interleukin-6 - Tocilizumab - Joint destruction