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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

https://doi.org/10.1136/annrheumdis-2012-201804

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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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    Footnotes

    • Contributors HK, TT: conceived the study and prepared the manuscript; KK, ES, HY: scored the radiographs; KS, SN, TH, TA, MT, TK, SS, YT: collected data from patients.

    • Funding This study was supported by Advanced Clinical Research Organization (ACRO, Japan) and research grants from the Japanese Ministry of Health, Labor and Welfare.

    • Competing interests HK has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical Co. Ltd., Abbott, Eisai Pharma, and Bristol-Myers-Squibb. SN has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Abbott, Eisai, Chugai Pharma, and Bristol-Myers-Squibb, and a research grant from Pfizer. TH has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical Co. Ltd., Abbott, Eisai Pharma, Janssen Pharma, Chugai Pharma, Bristol-Myers-Squibb, Astellas Pharma, Astrazeneca, and Novartis. TA has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical Co. Ltd., Eisai Pharma, Chugai Pharma, Otsuka Pharma and Bristol-Myers-Squibb. TK has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Abbott, Eisai Pharma, Janssen Pharma, Chugai Pharma, and Bristol-Myers-Squibb, and research grants from Mitsubishi-Tanabe Pharma, Pfizer, Eisai Pharma, and Chugai Pharma. YT has received honoraria from Mitsubishi-Tanabe Pharma, Chugai Pharma, Eisai Pharma, Takeda Industrial Pharma, Astellas Pharma, Abbott Immunology Pharma, and received research grants from Mitsubishi-Tanabe Pharma, Takeda Industrial Pharma, Banyu Pharma, Chugai Pharma, Eisai Pharma, Astellas Pharma, and Abbott Immunology Pharma. HY has received lecture and/or consulting fees from Abbott, Eisai Co. Ltd., Takeda Pharmaceutical Co. Ltd, Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K., Hoffmann-La Roche, Chugai Pharmaceutical Co. Ltd., and research grants from Chugai Pharmaceutical Co. Ltd., Astellas Pharma Inc., Pfizer, Daiichi Sankyo Co. Ltd., Banyu Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Abbott Japan Co. Ltd., Eisai Co. Ltd., Santen Pharmaceutical Co. Ltd., Taishotoyama Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Kissei Pharmaceutical Co. Ltd., and Janssen Pharmaceutical K.K. TT has received honoraria from Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical Co. Ltd., Abbott, Eisai Pharma, Janssen Pharma, Chugai Pharma, Bristol-Myers-Squibb, and Novartis, and research grants from Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical Co. Ltd., Eisai Pharma, and Chugai Pharma.

    • Patient consent Obtained.

    • Ethics approval Institutional ethics committee of each participating institute.

    • Provenance and peer review Not commissioned; externally peer reviewed.