Vol.22 No.6

Original Article

Discontinuation of adalimumab treatment in rheumatoid arthritis patients after achieving low disease activity

Authors

Masayoshi Harigai1,2 , Tsutomu Takeuchi3 , Yoshiya Tanaka4 , Tsukasa Matsubara5 , Hisashi Yamanaka6 , Nobuyuki Miyasaka2,7

  • Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
  • Department of Medicine and Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
  • Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Faculty of Medicine, Keio University, Tokyo, Japan
  • The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  • Matsubara Mayflower Hospital, Hyogo, Japan
  • Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
  • Global Center of Excellence Program, International Research Center for Molecular Science in Tooth and Bone Diseases, Tokyo, Japan
Received:

22 September 2011

Accepted:

22 December 2011

Published online:

20 January 2012

Full Text

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Abstract

Objective We implemented a retrospective study to explore discontinuation of therapy with adalimumab (ADA) without exacerbation in rheumatoid arthritis (RA) patients who had achieved low disease activity (LDA) with the biological agent.
Methods We enrolled 46 RA patients who had completed open extension of a double-blind, placebo-controlled trial of ADA monotherapy in Japan and who had LDA (DAS28-CRP <2.7) at the last administration of ADA in the extension trials; this date was defined as week 0 in the present study. Treatment of RA was at the discretion of the attending physician after week 0. The primary endpoint of this study was the percentage of patients who maintained discontinuation of biological agents and LDA for 52 weeks.
Results Twenty-four of the enrolled patients continued ADA while the rest discontinued ADA after the administration of the drug at week 0. Fourteen of the 22 patients did not restart biological agents, and 4 (18.2%) of these maintained LDA through week 52. All 4 of these patients had received ADA monotherapy before week 0.
Conclusion Some RA patients who have achieved LDA with ADA monotherapy can discontinue the biologic without incurring increased disease activity. A prospective randomized study is required to confirm the results of our study.

Key words

Adalimumab - Biological disease-modifying antirheumatic drug - Low disease activity - Rheumatoid arthritis