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A merged presentation of clinical and radiographic data using probability plots in a clinical trial, the JESMR study
  1. Hideto Kameda1,
  2. Katsuaki Kanbe2,
  3. Eri Sato3,
  4. Yukitaka Ueki4,
  5. Kazuyoshi Saito5,
  6. Shouhei Nagaoka6,
  7. Toshihiko Hidaka7,
  8. Tatsuya Atsumi8,
  9. Michishi Tsukano9,
  10. Tsuyoshi Kasama10,
  11. Shunichi Shiozawa11,
  12. Yoshiya Tanaka5,
  13. Hisashi Yamanaka3,
  14. Tsutomu Takeuchi1,12,
  15. on behalf of the Japan Biological Agent Integrated Consortium (JBASIC)
  1. 1Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan
  2. 2Department of Orthopedics, Medical Center East, Tokyo Women’ Medical University, Tokyo, Japan
  3. 3Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan
  4. 4Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Japan
  5. 5First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  6. 6Department of Rheumatology, Yokohama Minami Kyosai Hospital, Yokohama, Japan
  7. 7Institute of Rheumatology, Zenjinkai Shimin-No-Mori Hospital, Miyazaki, Japan
  8. 8Department of Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Japan
  9. 9Section of Orthopaedics and Rheumatology, Kumamoto Center for Arthritis and Rheumatology, Kumamoto, Japan
  10. 10Division of Rheumatology, Showa University School of Medicine, Tokyo, Japan
  11. 11Department of Medicine, Kyushu University Beppu Hospital, Beppu, Japan
  12. 12Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Kawagoe, Japan
  1. Correspondence to Dr Hideto Kameda, Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; kamehide{at}z6.keio.jp

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In terms of the relationship between synovial inflammation and radiographic changes, including both joint damage repair and progression,1 in rheumatoid arthritis (RA), pre-existing joint damage and persistent synovitis may promote joint destruction, while in the absence of synovitis, damaged joints may heal.2 ,3 Although presentation of radiographic results using cumulative probability plots has substantially improved understanding of clinical trial data,4 the effects of treatments on radiographic progression and improvement (regression) in individual RA patients has not yet been fully explained.

In the JESMR study,5 ,6 151 active RA patients unresponsive to treatment with methotrexate (MTX) were randomised into 1 of 2 treatment groups: etanercept (ETN) 50 mg/week with 6–8 mg/week of MTX (the E+M group), or ETN alone (the E group). Radiographs of the hands and feet before ETN (baseline) and during the first year of treatment were available from 53 (72%) and 68 (88%) patients in the E and E+M groups, respectively. Baseline characteristics of patients were comparable between those with and without available radiographic data in each treatment group (data not shown). However, most patients without data did not complete the study up to Week 52 as per protocol, chiefly due to lack of efficacy in the E group.6 The mean baseline total Sharp-van der Heijde score (TSS)7 was 114.5 in the E group and 113.1 in the E+M …

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