A randomised trial evaluating anakinra in early active rheumatoid arthritis

Ian C Scott, Fowzia Ibrahim, Gemma Simpson, Anna Kowalczyk, Beverley White-Alao, Andrew Hassell, Michael Plant, Selwyn Richards, David Walker, David L Scott

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33 Citations (Scopus)
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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.

Original languageEnglish
Pages (from-to)88-93
Number of pages6
JournalClinical and Experimental Rheumatology
Volume34
Issue number1
Publication statusPublished - 10 Feb 2016

Keywords

  • Adult
  • Aged
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Disability Evaluation
  • Disease Progression
  • Drug Therapy, Combination
  • England
  • Female
  • Humans
  • Interleukin 1 Receptor Antagonist Protein
  • Male
  • Methotrexate
  • Middle Aged
  • Quality of Life
  • Remission Induction
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

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