Vol.20 No.4

Original Article

Clinical evaluation of tocilizumab for patients with active rheumatoid arthritis refractory to anti-TNF biologics: tocilizumab in combination with methotrexate

Authors

Yasuharu Nakashima1 , Masakazu Kondo2 , Hiroshi Harada3 , Takahiko Horiuchi4 , Takashi Ishinishi5 , Hiroshi Jojima6 , Koji Kuroda7 , Hisaaki Miyahara8 , Ryuji Nagamine9 , Hitoshi Nakashima10 , Takeshi Otsuka11 , Isao Saikawa5, Eisuke Shono5, Eiichi Suematsu5,Tomomi Tsuru5, Ken Wada5, Yukihide Iwamoto1

  • Department of Orthopaedic Surgery, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka Fukuoka, 812-8582, Japan
  • Kondo Clinic of Rheumatology and Orthopaedic Surgery, Fukuoka, Japan
  • Morooka Orthopedic Clinic, Fukuoka, Japan
  • Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
  • Fukuseikai Hospital, Fukuoka, Japan
  • Department of Orthopedic Surgery, School of Medicine, Fukuoka University, Fukuoka, Japan
  • Department of Orthopedic Surgery, School of Medicine, Fukuoka University, Fukuoka, Japan
  • Kuroda Orthopedic Hospital, Fukuoka, Japan
  • Department of Orthopedics, Clinical Research Institute, National Kyushu Medical Center, Fukuoka, Japan
  • Department of Orthopaedics Surgery, Sugioka Memorial Hospital, Fukuoka, Japan
  • Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
  • Munakata Medical Association Hospital, Fukuoka, Japan
  • Department of Orthopaedics Surgery, Fukuoka Municipal Hospital, Fukuoka, Japan
  • Shono Rheumatism Clinic, Fukuoka, Japan
  • Department of Internal Medicine and Rheumatology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
  • PS Clinic, Fukuoka, Japan
  • Wada Orthopaedic Clinic, Fukuoka, Japan
Received:

18 September 2009

Accepted:

8 February 2010

Published online:

18 May 2010

Full Text

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Abstract

We retrospectively observed the clinical efficacy and safety of tocilizumab (TCZ) in 74 patients with rheumatoid arthritis (RA) at 13 hospitals, without any restrictions on disease duration or stage, treatment history, and other influencing factors. TCZ was infused by the approved method, and disease activity was evaluated every 4 weeks until week 24 using a joint disease activity score (DAS28). Remission and treatment response were categorised using European League Against Rheumatism (EULAR) definitions. We also analysed the impact of previous treatment with other biologics and of concomitant methotrexate (MTX) therapy on the efficacy of TCZ. At week 24, the DAS28 had improved from 5.5 to 2.7 and the EULAR remission rate was 55.2%. Good and moderate responses according to the EULAR criteria were obtained in 61 and 36% of the patients, respectively. The biologic-naïve group had a significantly better DAS28 (2.1 vs. 2.8) and a significantly higher “good” response rate (86% vs. 54%) than the biologic-exposed group. Although the TCZ + MTX treatment group and the TCZ monotherapy group had a good response rate of 71 and 48%, respectively, the difference was not significant. Based on these results, we conclude that TCZ is able to significantly alleviate disease symptoms in a wide range of patients with RA in a normal clinical context.

Key words

DAS28-ESR - Rheumatoid arthritis - Tocilizumab