Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study
Open Access
- 3 May 2011
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 70 (7), 1264-1271
- https://doi.org/10.1136/ard.2010.144063
Abstract
This 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. In 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. A 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. Single canakinumab doses ≥50 mg or four 4-weekly doses provided superior prophylaxis against flares compared with daily colchicine 0.5 mg.Keywords
This publication has 32 references indexed in Scilit:
- Prevalence of Contraindications and Prescription of Pharmacologic Therapies for GoutAmerican Journal Of Medicine, 2011
- The pathogenesis of bone erosions in gouty arthritisAnnals Of The Rheumatic Diseases, 2010
- Diagnosing and Treating Gout: A Review to Aid Primary Care PhysiciansPostgraduate Medicine, 2010
- Gout – what are the treatment options?Expert Opinion on Pharmacotherapy, 2009
- Quality of Life and Disability in Patients with Treatment-Failure GoutThe Journal of Rheumatology, 2009
- Perceptions of disease and health-related quality of life among patients with goutRheumatology, 2008
- Diagnosis of gout.2007
- Diagnosis of gout: clinical, laboratory, and radiologic findings.2005
- Gout epidemiology: results from the UK General Practice Research Database, 1990-1999Annals Of The Rheumatic Diseases, 2005
- The association between gout and nephrolithiasis: The National Health and Nutrition Examination Survey III, 1988-1994American Journal of Kidney Diseases, 2002