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A randomised trial evaluating anakinra in early active rheumatoid arthritis.
- Source :
-
Clinical and experimental rheumatology [Clin Exp Rheumatol] 2016 Jan-Feb; Vol. 34 (1), pp. 88-93. Date of Electronic Publication: 2016 Feb 02. - Publication Year :
- 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.<br />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.<br />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).<br />Conclusions: Anakinra (combined with methotrexate) is not effective in early, active RA. It provided no clinical benefits beyond methotrexate monotherapy.
- Subjects :
- Adult
Aged
Antirheumatic Agents adverse effects
Arthritis, Rheumatoid diagnosis
Arthritis, Rheumatoid immunology
Disability Evaluation
Disease Progression
Drug Therapy, Combination
England
Female
Humans
Interleukin 1 Receptor Antagonist Protein adverse effects
Male
Methotrexate therapeutic use
Middle Aged
Quality of Life
Remission Induction
Severity of Illness Index
Surveys and Questionnaires
Time Factors
Treatment Outcome
Antirheumatic Agents therapeutic use
Arthritis, Rheumatoid drug therapy
Interleukin 1 Receptor Antagonist Protein therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0392-856X
- Volume :
- 34
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Clinical and experimental rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 26842950