Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study.
Abstract | OBJECTIVE: 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:
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Authors | Alexander So, Marc De Meulemeester, Andrey Pikhlak, A Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Naomi Schlesinger |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 62
Issue 10
Pg. 3064-76
(Oct 2010)
ISSN: 1529-0131 [Electronic] United States |
PMID | 20533546
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Gout Suppressants
- Interleukin-1beta
- canakinumab
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Topics |
- Adolescent
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Arthritis, Gouty
(drug therapy)
- Dose-Response Relationship, Drug
- Female
- Gout Suppressants
(administration & dosage)
- Humans
- Injections, Intramuscular
- Injections, Subcutaneous
- Interleukin-1beta
(antagonists & inhibitors)
- Male
- Middle Aged
- Pain
(drug therapy)
- Young Adult
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