| Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. | |
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MedLine Citation:
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PMID: 20533546 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Alexander So; Marc De Meulemeester; Andrey Pikhlak; A Eftal Yücel; Dominik Richard; Valda Murphy; Udayasankar Arulmani; Peter Sallstig; Naomi Schlesinger |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Arthritis and rheumatism Volume: 62 ISSN: 1529-0131 ISO Abbreviation: Arthritis Rheum. Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-10-08 Completed Date: 2010-11-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370605 Medline TA: Arthritis Rheum Country: United States |
Other Details:
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Languages: eng Pagination: 3064-76 Citation Subset: AIM; IM |
Affiliation:
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University Hospital of Lausanne, Lausanne, Switzerland. AlexanderKai-Lik.So@chuv.ch |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00798369 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Antibodies, Monoclonal / administration & dosage* 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 |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 0/Gout Suppressants; 0/Interleukin-1beta; 0/canakinumab |
| Comments/Corrections | |
Comment In:
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Arthritis Rheum. 2010 Oct;62(10):2845-9
[PMID:
20597109
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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