Trial reportAnnals of the rheumatic diseases2011
Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study.
Trial report in Annals of the rheumatic diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00927810 (A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab), which is not on this map. Cited by 83 papers, 14 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
Who cites it
83 citing papers in PubMed, 14 syntheses or guidelines pooled it, 237 citations in OpenAlex.
- Korean guidelines for the management of gout.The Korean journal of internal medicine · 2023Guideline
- Interleukin-1β inhibitors for the management of acute gout flares: a systematic literature review.Arthritis research & therapy · 2023Pooled it
- Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated Disorders.Frontiers in immunology · 2022Pooled it
- Colchicine for acute gout.The Cochrane database of systematic reviews · 2021Pooled it
- A systematic review of the infectious complications of colchicine and the use of colchicine to treat infections.Seminars in arthritis and rheumatism · 2021Pooled it
- Effect of canakinumab on clinical and biochemical parameters in acute gouty arthritis: a meta-analysis.Inflammopharmacology · 2021Pooled it
- [Results of the systematic literature search as basis for the "Evidence-based treatment recommendations for familial Mediterranean fever patients with insufficient response or intolerability to colchicine" of the Society for Pediatric and Adolescent Rheumatology and the German Society for Rheumatology].Zeitschrift fur Rheumatologie · 2020Pooled it
- 2020 American College of Rheumatology Guideline for the Management of Gout.Arthritis care & research · 2020Guideline
- Adverse events during oral colchicine use: a systematic review and meta-analysis of randomised controlled trials.Arthritis research & therapy · 2020Pooled it
- Interleukin-1 blockade treatment decreasing cardiovascular risk.Clinical cardiology · 2019Pooled it
- [Full version of the S2e guidelines on gouty arthritis : Evidence-based guidelines of the German Society of Rheumatology (DGRh)].Zeitschrift fur Rheumatologie · 2016Guideline
- Colchicine for prevention of cardiovascular events.The Cochrane database of systematic reviews · 2016Pooled it
- Outcome measures in acute gout: a systematic literature review.The Journal of rheumatology · 2014Pooled it
- 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis.Arthritis care & research · 2012Guideline
- Trial
- Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Firsekibart in Gout: A Phase Ib/II Clinical Trial.International journal of rheumatic diseases · 2026Trial
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1β Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study.Advances in therapy · 2025Trial
- Prognostic factors associated with early gout flare recurrence in patients initiating urate-lowering therapy during an acute gout flare.Clinical rheumatology · 2019Trial
- Comparison of an interactive voice response system and smartphone application in the identification of gout flares.Arthritis research & therapy · 2019Trial
- Trial
23 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study assessed the efficacy and safety of canakinumab, a fully human anti-interleukin 1β monoclonal antibody, for prophylaxis against acute gouty arthritis flares in patients initiating urate-lowering treatment.
methodsIn this double-blind, double-dummy, dose-ranging study, 432 patients with gouty arthritis initiating allopurinol treatment were randomised 1:1:1:1:1:1:2 to receive: a single dose of canakinumab, 25, 50, 100, 200, or 300 mg subcutaneously; 4×4-weekly doses of canakinumab (50+50+25+25 mg subcutaneously); or daily colchicine 0.5 mg orally for 16 weeks. Patients recorded details of flares in diaries. The study aimed to determine the canakinumab dose having equivalent efficacy to colchicine 0.5 mg at 16 weeks.
resultsA dose-response for canakinumab was not apparent with any of the four predefined dose-response models. The estimated canakinumab dose with equivalent efficacy to colchicine was below the range of doses tested. At 16 weeks, there was a 62% to 72% reduction in the mean number of flares per patient for canakinumab doses ≥50 mg versus colchicine based on a negative binomial model (rate ratio: 0.28-0.38, p≤0.0083), and the percentage of patients experiencing ≥1 flare was significantly lower for all canakinumab doses (15% to 27%) versus colchicine (44%, p<0.05). There was a 64% to 72% reduction in the risk of experiencing ≥1 flare for canakinumab doses ≥50 mg versus colchicine at 16 weeks (hazard ratio (HR): 0.28-0.36, p≤0.05). The incidence of adverse events was similar across treatment groups.
conclusionsSingle canakinumab doses ≥50 mg or four 4-weekly doses provided superior prophylaxis against flares compared with daily colchicine 0.5 mg.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.