Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study.

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Serval ID
serval:BIB_503F5423086E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study.
Journal
Arthritis Research and Therapy
Author(s)
Schlesinger N., De Meulemeester M., Pikhlak A., Yücel A.E., Richard D., Murphy V., Arulmani U., Sallstig P., So A.
ISSN
1478-6362 (Electronic)
ISSN-L
1478-6354
Publication state
Published
Issued date
2011
Volume
13
Number
2
Pages
R53
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Abstract
INTRODUCTION: We report the impact of canakinumab, a fully human anti-interleukin-1β monoclonal antibody, on inflammation and health-related quality of life (HRQoL) in patients with difficult-to-treat Gouty Arthritis.
METHODS: In this eight-week, single-blind, double-dummy, dose-ranging study, patients with acute Gouty Arthritis flares who were unresponsive or intolerant to--or had contraindications for--non-steroidal anti-inflammatory 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 Likert scale, physicians assessed clinical signs of joint inflammation, and HRQoL was measured using the 36-item Short-Form Health Survey (SF-36) (acute version).
RESULTS: At baseline, 98% of patients were suffering from moderate-to-extreme pain. The percentage of patients with no or mild pain was numerically greater in most canakinumab groups compared with triamcinolone acetonide from 24 to 72 hours post-dose; the difference was statistically significant for canakinumab 150 mg at these time points (P < 0.05). Treatment with canakinumab 150 mg was associated with statistically significant lower Likert scores for tenderness (odds ratio (OR), 3.2; 95% confidence interval (CI), 1.27 to 7.89; P = 0.014) and swelling (OR, 2.7; 95% CI, 1.09 to 6.50, P = 0.032) at 72 hours compared with triamcinolone acetonide. Median C-reactive protein and serum amyloid A levels were normalized by seven days post-dose in most canakinumab groups, but remained elevated in the triamcinolone acetonide group. Improvements in physical health were observed at seven days post-dose in all treatment groups; increases in scores were highest for canakinumab 150 mg. In this group, the mean SF-36 physical component summary score increased by 12.0 points from baseline to 48.3 at seven days post-dose. SF-36 scores for physical functioning and bodily pain for the canakinumab 150 mg group approached those for the US general population by seven days post-dose and reached norm values by eight weeks post-dose.
CONCLUSIONS: Canakinumab 150 mg provided significantly greater and more rapid reduction in pain and signs and symptoms of inflammation compared with triamcinolone acetonide 40 mg. Improvements in HRQoL were seen in both treatment groups with a faster onset with canakinumab 150 mg compared with triamcinolone acetonide 40 mg.
TRIAL REGISTRATION: clinicaltrials.gov: NCT00798369.
Keywords
Adolescent, Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents/administration & dosage, Antibodies, Monoclonal/administration & dosage, Arthritis, Gouty/complications, Arthritis, Gouty/drug therapy, Dose-Response Relationship, Drug, Humans, Inflammation/complications, Inflammation/drug therapy, Male, Middle Aged, Pain/drug therapy, Pain/etiology, Quality of Life, Single-Blind Method, Triamcinolone Acetonide/therapeutic use, Young Adult
Pubmed
Web of science
Open Access
Yes
Create date
05/10/2011 11:03
Last modification date
20/08/2019 14:06
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