title: Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study.
abstract: OBJECTIVE
  To evaluate the impact of discontinuation of adalimumab (ADA) for 1 year in Japanese patients with early rheumatoid arthritis (RA).
  
  
  METHODS
  This 52-week postmarketing study, HOPEFUL-2, enrolled patients who had completed HOPEFUL-1 for early RA, in which patients received either ADA + methotrexate (MTX) or MTX alone in a 26-week randomised phase, followed by ADA+MTX in a 26-week open-label phase.
  
  
  RESULTS
  A total of 220 patients (ADA discontinuation: 114 patients vs ADA continuation: 106 patients) were enrolled in this study. The proportion of patients with sustained low disease activity (LDA) in the ADA discontinuation group was significantly lower than that in the continuation group (80% (64/80 patients) vs 97% (71/73 patients); p=0.001); however, most patients sustained LDA in both groups. In patients with 28-joint disease activity score (DAS28)-C reactive protein ≤2.0 at week 52, the proportion of patients who achieved sustained LDA at week 104 was 93%, suggesting that DAS28 remission may be a predictor to indicate biological-free disease control in patients with early RA. The incidence of adverse events (AE) was significantly lower in the ADA discontinuation group than in the continuation group (34.2% (39/114 patients) vs 48.1% (51/106 patients); p=0.04), most notably for infection (14.9% vs 27.4%, p=0.031).
  
  
  CONCLUSIONS
  Although ADA discontinuation was associated with an increase in disease activity, a large proportion of patients maintained LDA with MTX monotherapy after ADA discontinuation. Since ADA discontinuation was associated with a lower AE incidence, physicians should weigh the risks and benefits of ADA discontinuation.
  
  
  BACKGROUND
  NCT01163292.
authors.affiliation: The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health, Japan , Kitakyushu , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.affiliation: Department of Orthopedic Surgery , Nagoya University Graduate School and School of Medicine , Nagoya , Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.affiliation: Tokyo Medical Dental University Graduate School , Tokyo , Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Miyasaka
authors.affiliation: AbbVie GK , Tokyo , Japan.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Kawana
authors.affiliation: AbbVie GK , Tokyo , Japan.
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Hiramatsu
authors.affiliation: Division of Rheumatology, Department of Internal Medicine , School of Medicine, Keio University , Tokyo , Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
keywords: Anti-TNF; Rheumatoid Arthritis; Treatment