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A randomised trial evaluating anakinra in early active rheumatoid arthritis

Lookup NU author(s): Dr David Walker


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ObjectiveThe 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.MethodsThe 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.Results154 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).ConclusionAnakinra (combined with methotrexate) is not effective in early, active RA. It provided no clinical benefits beyond methotrexate monotherapy.

Publication metadata

Author(s): Scott IC, Ibrahim F, Simpson G, Kowalczyk A, White-Alao B, Hassell A, Plant M, Richards S, Walker D, Scott DL

Publication type: Article

Publication status: Published

Journal: Clinical and Experimental Rheumatology

Year: 2016

Volume: 34

Issue: 1

Pages: 88-93

Online publication date: 10/02/2016

Acceptance date: 02/09/2015

ISSN (print): 0392-856X

ISSN (electronic): 1593-098X

Publisher: Pacini Editore SpA


PubMed id: 26842950


Funder referenceFunder name
Amgen Ltd.
National Institute for Health Research (NIHR)
19739Arthritis Research UK