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.
RCT Entities:
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 RApatients 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 RApatients 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.
Authors: Kazuki Yoshida; Yoon-Kyoung Sung; Arthur Kavanaugh; Sang-Cheol Bae; Michael E Weinblatt; Mitsumasa Kishimoto; Kazuo Matsui; Shigeto Tohma; Daniel H Solomon Journal: Ann Rheum Dis Date: 2013-05-30 Impact factor: 19.103
Authors: Lise M Verhoef; Bart Jf van den Bemt; Aatke van der Maas; Johanna E Vriezekolk; Marlies E Hulscher; Frank Hj van den Hoogen; Wilco Ch Jacobs; Noortje van Herwaarden; Alfons A den Broeder Journal: Cochrane Database Syst Rev Date: 2019-05-24
Authors: Sine Schnoor Buhl; Casper Steenholdt; Jørn Brynskov; Ole Østergaard Thomsen; Klaus Bendtzen; Mark Andrew Ainsworth Journal: BMJ Open Date: 2014-12-18 Impact factor: 2.692
Authors: Christopher J Edwards; Bruno Fautrel; Hendrik Schulze-Koops; Tom W J Huizinga; Klaus Kruger Journal: Rheumatology (Oxford) Date: 2017-11-01 Impact factor: 7.580