Abstract | INTRODUCTION: 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: TRIAL REGISTRATION: clinicaltrials.gov: NCT00798369.
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Authors | Naomi Schlesinger, Marc De Meulemeester, Andrey Pikhlak, A Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Alexander So |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 13
Issue 2
Pg. R53
(Mar 25 2011)
ISSN: 1478-6362 [Electronic] England |
PMID | 21439048
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- canakinumab
- Triamcinolone Acetonide
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents
(administration & dosage)
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Arthritis, Gouty
(complications, drug therapy)
- Dose-Response Relationship, Drug
- Humans
- Inflammation
(complications, drug therapy)
- Male
- Middle Aged
- Pain
(drug therapy, etiology)
- Quality of Life
- Single-Blind Method
- Triamcinolone Acetonide
(therapeutic use)
- Young Adult
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