title: A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission.
abstract: OBJECTIVE
  Treatment with tumour necrosis factor (TNF) blockers, once started as therapy for rheumatoid arthritis (RA), is usually continued indefinitely. The aim of this trial was to assess the possibility of discontinuing treatment with adalimumab (ADA) while maintaining remission in patients with RA with established disease in stable remission on combination therapy with ADA and methotrexate (MTX).
  
  
  METHODS
  In a randomised, controlled, open-label pilot study of patients with RA in stable remission treated with ADA+MTX, patients were randomised in a 1:1 ratio to continue with ADA plus MTX (arm AM) or MTX monotherapy (arm M) for 52 weeks. Flare was defined as Disease Activity Score (DAS28) ≥2.6 or a change in DAS28 (ΔDAS28) of >1.2 from baseline at any time. Patients in arm M with a flare restarted ADA. The primary end point was the proportion of patients in remission at week 28.
  
  
  RESULTS
  31 patients were enrolled in the study and randomised to arm AM (n=16) or arm M (n=15). At 28 weeks, 15/16 patients (94%) and 5/15 patients (33%) in arms AM and M, respectively, were in remission (p=0.001). During the first 28 weeks, 50% (8/16) in the AM arm and 80% (12/15) in the M arm had a flare (p=0.08). The number of patients in the AM and M arms with ≥1 ΔDAS28 >1.2 during the first 28 weeks was 1/16 (6%) and 8/15 (53%), respectively (p=0.005).
  
  
  CONCLUSIONS
  In this study, remission was rarely maintained in patients with long-standing disease who discontinued ADA. Discontinuation may be feasible in only a minority of patients with established RA in stable clinical remission.
  
  
  BACKGROUND
  NCT00808509.
authors.affiliation: Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID) , Karolinska Institute , Stockholm , Sweden.
authors.forename: Katerina
authors.initials: K
authors.lastname: Chatzidionysiou
authors.affiliation: Rheumatology, Department of Clinical Sciences , Malmö, Lund University , Malmö , Sweden.
authors.forename: Carl
authors.initials: C
authors.lastname: Turesson
authors.affiliation: Capio Movement, Reumatologi , Halmstad , Sweden.
authors.forename: Annika
authors.initials: A
authors.lastname: Teleman
authors.affiliation: Rheumatology Department , Uppsala University , Uppsala , Sweden.
authors.forename: Ann
authors.initials: A
authors.lastname: Knight
authors.affiliation: Rheumatology, Department Clinical Sciences Lund , Lund University , Skåne University Hospital , Lund , Sweden.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Lindqvist
authors.affiliation: Rheumatology Department , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Larsson
authors.affiliation: Rheumatology Department , University Hospital , Linköping , Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Cöster
authors.affiliation: Section of Rheumatology, Department of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Rheumatology, Department of Clinical Sciences, Lund University, Helsingborg, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Forslind
authors.affiliation: Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID) , Karolinska Institute , Stockholm , Sweden.
authors.forename: Ronald
authors.initials: R
authors.lastname: van Vollenhoven
authors.affiliation: AbbVie AB, Solna , Stockholm , Sweden.
authors.forename: Mikael
authors.initials: M
authors.lastname: Heimbürger
keywords: Anti-TNF; Rheumatoid Arthritis; Treatment
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