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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
  1. Katerina Chatzidionysiou1,
  2. Carl Turesson2,
  3. Annika Teleman3,
  4. Ann Knight4,
  5. Elisabet Lindqvist5,
  6. Per Larsson6,
  7. Lars Cöster7,
  8. Kristina Forslind8,9,
  9. Ronald van Vollenhoven1 and
  10. Mikael Heimbürger10
  1. 1Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institute, Stockholm, Sweden
  2. 2Rheumatology, Department of Clinical Sciences, Malmö, Lund University, Malmö, Sweden
  3. 3Capio Movement, Reumatologi, Halmstad, Sweden
  4. 4Rheumatology Department, Uppsala University, Uppsala, Sweden
  5. 5Rheumatology, Department Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden
  6. 6Rheumatology Department, Karolinska University Hospital, Stockholm, Sweden
  7. 7Rheumatology Department, University Hospital, Linköping, Sweden
  8. 8Section of Rheumatology, Department of Medicine, Helsingborg Hospital, Helsingborg, Sweden
  9. 9Rheumatology, Department of Clinical Sciences, Lund University, Helsingborg, Sweden
  10. 10AbbVie AB, Solna, Stockholm, Sweden
  1. Correspondence to Dr Katerina Chatzidionysiou; aikaterini.chatzidionysiou{at}


Objectives 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.

Trial registration number NCT00808509.

  • Anti-TNF
  • Rheumatoid Arthritis
  • Treatment

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