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A randomised trial evaluating anakinra in early active rheumatoid arthritis


1, 2, 3, 4, 5, 6, 7, 8, 9, 10

 

  1. Department of Medical and Molecular Genetics, King’s College London, Guy’s Hospital, London; and Academic Department of Rheumatology, Centre for Molecular and Cellular Biology of Inflammation, King's College, London, UK. ian.scott@kcl.ac.uk
  2. Department of Rheumatology, Weston Education Centre, King’s College Hospital, London, UK.
  3. Department of Rheumatology, Weston Education Centre, King’s College Hospital, London, UK.
  4. Department of Rheumatology, Weston Education Centre, King’s College Hospital, London, UK.
  5. King's Clinical Trials Unit at KHP, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.
  6. Department of Rheumatology, Haywood Hospital, Stoke-on-Trent, Staffordshire, UK.
  7. Department of Rheumatology, James Cook University Hospital, Middlesbrough, UK.
  8. Department of Rheumatology, Poole Hospital, Poole, UK.
  9. Department of Rheumatology, Freeman Hospital, Newcastle upon Tyne, UK.
  10. Department of Rheumatology, Weston Education Centre, King’s College Hospital, London, UK.

CER8481
2016 Vol.34, N°1
PI 0088, PF 0093
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PMID: 26842950 [PubMed]

Received: 25/03/2015
Accepted : 02/09/2015
In Press: 02/02/2016
Published: 10/02/2016

Abstract

OBJECTIVES:
The effectiveness of anakinra (interleukin-1 receptor antagonist) in early rheumatoid arthritis (RA) is unknown. We evaluated the efficacy of anakinra (combined with methotrexate) in a randomised clinical trial of early active RA patients.
METHODS:
The Combination Anti-Rheumatic Drugs in Early RA-2 (CARDERA-2) trial was a randomised trial of early (duration <1 year) active RA. Patients were randomised to 12 months of: (1) methotrexate or (2) anakinra-methotrexate. Follow-up lasted 2 years. The primary outcome was erosive progression (changes from baseline in modified Larsen scores). Secondary outcomes were changes from baseline in disease activity score on a 28-joint count (DAS28), health assessment questionnaire (HAQ), and quality of life (EQ-5D) scores alongside ACR responder rates.
RESULTS:
154 patients received the allocated intervention (from 259 screened). Similar Larsen score progression was seen at 12 and 24 months in patients receiving anakinra-methotrexate (mean changes from baseline of 2.50 and 5.10, respectively) and methotrexate monotherapy (mean changes from baseline of 4.16 and 5.20, respectively). Lower improvements in DAS28 and HAQ scores were seen at all time-points in anakinra-methotrexate treated patients; these were significantly less at 24 months (DAS28 p=0.04; HAQ P=0.02). Significantly lower EQ-5D score increases were seen at 12 months with anakinra-methotrexate (p=0.03). Anakinra-methotrexate was associated with more serious adverse events compared with methotrexate monotherapy (11 vs. 6 patients), although this was not significant (p=0.59).
CONCLUSIONS:
Anakinra (combined with methotrexate) is not effective in early, active RA. It provided no clinical benefits beyond methotrexate monotherapy.

Rheumatology Article