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Randomized Controlled Trial
. 2011 Jul;70(7):1264-71.
doi: 10.1136/ard.2010.144063. Epub 2011 May 3.

Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study

Naomi Schlesinger  1 , Eduardo Mysler, Hsiao-Yi Lin, Marc De Meulemeester, Jozef Rovensky, Udayasankar Arulmani, Alison Balfour, Gerhard Krammer, Peter Sallstig, Alexander So
Affiliations
Randomized Controlled Trial

Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study

Naomi Schlesinger et al. Ann Rheum Dis. 2011 Jul.

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: Single canakinumab doses ≥50 mg or four 4-weekly doses provided superior prophylaxis against flares compared with daily colchicine 0.5 mg.

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Conflict of interest statement

Competing interests NS: grant, travel expenses and payment for advisory board membership from Novartis Pharma, payment for development of educational presentations from Takeda and payment for advisory board membership from Savient, URL Pharma and Enzyme Rx. H-YL, EM and JR report no conflicts of interest. MDeM: payment from Novartis for development of educational presentations. PS, UA, GK and AB are employees of Novartis and report having equity interests in Novartis. AS: payment from Novartis for board membership, consultancy and travel expenses.

Figures

Figure 1
Figure 1
Patient disposition. Patients were recruited from the following countries (number of centres): Argentina (1), Belgium (2), Columbia (5), Czech Republic (5), Germany (5), Guatemala (5), Hungary (4), Poland (2), Portugal (3), Russia (7), Singapore (1), Slovakia (6), South Africa (4), Spain (4), Taiwan (4), Turkey (8), UK (2) and USA (20).
Figure 2
Figure 2
Time to first acute gouty arthritis flare after randomisation (Kaplan–Meier estimate).
Figure 3
Figure 3
Median C reactive protein levels over time. CRP, C reactive protein; q4wk, every 4 weeks; ULN, upper limit of the normal range.
See this image and copyright information in PMC

References

    1. Kramer HM, Curhan G. The association between gout and nephrolithiasis: the National Health and Nutrition Examination Survey III, 1988-1994. Am J Kidney Dis 2002;40:37–42 - PubMed
    1. Mikuls TR, Farrar JT, Bilker WB, et al. Gout epidemiology: results from the UK General Practice Research Database, 1990-1999. Ann Rheum Dis 2005;64:267–72 - PMC - PubMed
    1. Schlesinger N. Diagnosis of gout. Minerva Med 2007;98:759–67 - PubMed
    1. Schlesinger N. Diagnosis of gout: clinical, laboratory, and radiologic findings. Am J Manag Care 2005;11(15 Suppl):S443–50; quiz S465–8 - PubMed
    1. Keenan RT, O'Brien WR, Lee KH, et al. Prevalence of contraindications and prescription of pharmacologic therapies for gout. Am J Med 2011;124:155–63 - PubMed

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