Document Detail

Discontinuation of adalimumab treatment in rheumatoid arthritis patients after achieving low disease activity.
MedLine Citation:
PMID:  22270346     Owner:  NLM     Status:  MEDLINE    
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.
Masayoshi Harigai; Tsutomu Takeuchi; Yoshiya Tanaka; Tsukasa Matsubara; Hisashi Yamanaka; Nobuyuki Miyasaka
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-01-20
Journal Detail:
Title:  Modern rheumatology / the Japan Rheumatism Association     Volume:  22     ISSN:  1439-7609     ISO Abbreviation:  Mod Rheumatol     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-15     Completed Date:  2013-05-07     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  100959226     Medline TA:  Mod Rheumatol     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  814-22     Citation Subset:  IM    
Department of Pharmacovigilance, Tokyo Medical and Dental University, Yushima, Bunkyo-ku, Tokyo, Japan.
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MeSH Terms
Antibodies, Monoclonal, Humanized / therapeutic use*
Antirheumatic Agents / therapeutic use*
Arthritis, Rheumatoid / drug therapy*
Double-Blind Method
Middle Aged
Prospective Studies
Remission Induction
Severity of Illness Index
Treatment Outcome
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Antirheumatic Agents; FYS6T7F842/adalimumab
Erratum In:
Mod Rheumatol. 2012 Nov;22(6):823

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