Efficacy of Canakinumab vs. triamcinolone acetonide according to multiple gouty arthritis‐related health outcomes measures

Summary 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 ( NSAID s) 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; PRO s 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 NSAID s and/or colchicine.