Canakinumab for the treatment of acute flares in difficult‐to‐treat gouty arthritis: Results of a multicenter, phase II, dose‐ranging study
- 8 June 2010
- journal article
- research article
- Published by Wiley in Arthritis & Rheumatism
- Vol. 62 (10), 3064-3076
- https://doi.org/10.1002/art.27600
Abstract
Objective To assess the efficacy and tolerability of canakinumab, a fully human anti–interleukin‐1β monoclonal antibody, for the treatment of acute gouty arthritis. Methods In this 8‐week, single‐blind, double‐dummy, dose‐ranging study, patients with acute gouty arthritis whose disease was refractory to or who had contraindications to nonsteroidal antiinflammatory drugs and/or colchicine were randomized to receive a single subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg; n = 143) or an intramuscular dose of triamcinolone acetonide (40 mg; n = 57). Patients assessed pain using a 100‐mm visual analog scale. Results Seventy‐two hours after treatment, a statistically significant dose response was observed for canakinumab. All canakinumab doses were associated with numerically less pain than triamcinolone acetonide; thus, a dose with equivalent efficacy to triamcinolone acetonide 72 hours after treatment could not be determined. The reduction from baseline in pain intensity with canakinumab 150 mg was greater than with triamcinolone acetonide 24, 48, and 72 hours after treatment (differences of −11.5 mm [P = 0.04], −18.2 mm [P = 0.002], and −19.2 mm [P < 0.001], respectively), and 4, 5, and 7 days after treatment (all P < 0.05). Canakinumab significantly reduced the risk of recurrent flares versus triamcinolone acetonide (P ≤ 0.01 for all doses) (relative risk reduction 94% for canakinumab 150 mg versus triamcinolone acetonide). The overall incidence of adverse events was similar for canakinumab (41%) and triamcinolone acetonide (42%); most were mild or moderate in severity. Conclusion Our findings indicate that canakinumab 150 mg provides rapid and sustained pain relief in patients with acute gouty arthritis, and significantly reduces the risk of recurrent flares compared with triamcinolone acetonide.This publication has 23 references indexed in Scilit:
- Use of Canakinumab in the Cryopyrin-Associated Periodic SyndromeNew England Journal of Medicine, 2009
- Developments in the scientific and clinical understanding of goutArthritis Research & Therapy, 2008
- Overview of the Management of Acute Gout and the Role of Adrenocorticotropic HormoneDrugs, 2008
- Primer: inflammasomes and interleukin 1β in inflammatory disordersNature Clinical Practice Rheumatology, 2008
- Colchicine for acute goutPublished by Wiley ,2006
- Neonatal-Onset Multisystem Inflammatory Disease Responsive to Interleukin-1β InhibitionNew England Journal of Medicine, 2006
- EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee For International Clinical Studies Including Therapeutics (ESCISIT)Annals Of The Rheumatic Diseases, 2006
- Gout-associated uric acid crystals activate the NALP3 inflammasomeNature, 2006
- Management of Acute and Chronic Gouty ArthritisDrugs, 2004
- The association between gout and nephrolithiasis: The National Health and Nutrition Examination Survey III, 1988-1994American Journal of Kidney Diseases, 2002