Abstract | AIM:
Canakinumab (CAN), a selective, fully human, anti-IL-1β monoclonal antibody, has demonstrated long-term benefits in gouty arthritis (GA) patients, who have contraindications for, or are unresponsive or intolerant of, non-steroidal anti-inflammatory drugs ( NSAIDs) or colchicine (two trials:β-RELIEVED [n = 228]; β-RELIEVED II [n = 226]). The trials collected different responses, including patient-reported outcomes (PRO). A composite response end-point (CRE) was used to interpret each patient's overall response to treatment. METHODS: Data from β-RELIEVED trials were pooled for this retrospective analysis. The CRE representing overall change in GA-related health outcomes, from baseline to 12 weeks, included clinical markers; PROs from the Gout Impact Scale (GIS); and the SF-36 bodily pain scale. Response to each variable (i.e. markedly important difference) was determined a priori. Variable values [1 (responder) or 0 (non-responder)] were summed to create a CRE score for each patient. RESULTS: For eight of 12 variables measured, the percentage of CAN responders was significantly greater than for TA (p < 0.05). On average, patients receiving CAN met a higher percentage of response criteria (65%) than patients receiving triamcinolone acetonide (TA) (49%), p < 0.001. Mean CRE scores were significantly higher for CAN vs. TA (mean [SD]; 4.7 [2.7] vs. 3.7 [2.4], p < 0.001). Treatment differences remained even after serially removing individual responder variables and domains from the composite end-point, indicating that the differences between CAN and TA were robust. CONCLUSION: CAN was superior to TA across multiple health-outcome variables comprising clinical markers and PRO over 12 weeks in patients contraindicated, intolerant or unresponsive to NSAIDs and/or colchicine.
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Authors | J D Hirsch, A Gnanasakthy, R Lale, K Choi, A J Sarkin |
Journal | International journal of clinical practice
(Int J Clin Pract)
Vol. 68
Issue 12
Pg. 1503-7
(Dec 2014)
ISSN: 1742-1241 [Electronic] India |
PMID | 25298264
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2014 John Wiley & Sons Ltd. |
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Interleukin-1beta
- canakinumab
- Triamcinolone Acetonide
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Topics |
- Adult
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(pharmacology, therapeutic use)
- Antibodies, Monoclonal
(pharmacology, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Arthritis, Gouty
(drug therapy, mortality)
- Female
- Humans
- Interleukin-1beta
(pharmacology, therapeutic use)
- Male
- Middle Aged
- Patient Outcome Assessment
- Retrospective Studies
- Triamcinolone Acetonide
(pharmacology, therapeutic use)
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