Discontinuation of adalimumab after achieving remission in patients with established rheumatoid arthritis: 1-year outcome of the HONOR study.

To investigate the possibility of discontinuing adalimumab (ADA) for 1 year without flaring (DAS28-erythrocyte sedimentation rate (ESR) ≥3.2), and to identify factors enabling established patients with rheumatoid arthritis (RA) to remain ADA-free.
Of 197 RA patients treated with ADA+methotrexate (MTX), 75 patients who met the ADA-free criteria (steroid-free and sustained DAS28-ESR remission for 6 months with stable MTX doses) were studied for 1 year.
The mean disease duration and DAS28-ESR score in 75 patients was 7.5 years and 5.1 at baseline, respectively. The proportion of patients who sustained DAS28-ESR <2.6 (48%) and DAS28-ESR <3.2 (62%) for 1 year were significantly lower in the ADA discontinuation group than in the ADA continuation group; however, in patients with deep remission (DAS28-ESR ≤1.98) identified by receiver operating characteristics analysis following logistic analysis, these rates increased to 68% and 79%, respectively, with no significant difference between both groups. Remarkably, ADA readministration to patients with flare was effective in returning DAS28-ESR to <3.2 within 6 months in 90% and 9 months in 100% patients; among the patients who sustained DAS28-ESR <3.2 during ADA discontinuation, 100% remained in structural remission and 94% in functional remission.
The possibility of remaining ADA-free for 1 year was demonstrated in established patients with RA with outcomes that ADA can be discontinued without flaring in 79% patients with deep remission, with similar rates in the ADA continuation group, and showed no functional or structural damage in patients with DAS28-ESR <3.2. ADA readministration to patients with flare during ADA discontinuation was effective.
AuthorsYoshiya Tanaka, Shintaro Hirata, Satoshi Kubo, Shunsuke Fukuyo, Kentaro Hanami, Norifumi Sawamukai, Kazuhisa Nakano, Shingo Nakayamada, Kunihiro Yamaoka, Fusae Sawamura, Kazuyoshi Saito
JournalAnnals of the rheumatic diseases (Ann Rheum Dis) Vol. 74 Issue 2 Pg. 389-95 (Feb 2015) ISSN: 1468-2060 [Electronic] England
PMID24288014 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightPublished by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • Adalimumab
  • Adalimumab
  • Antibodies, Monoclonal, Humanized (therapeutic use)
  • Antirheumatic Agents (therapeutic use)
  • Area Under Curve
  • Arthritis, Rheumatoid (drug therapy)
  • Female
  • Humans
  • Male
  • Middle Aged
  • ROC Curve
  • Remission Induction

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