title: Efficacy of Canakinumab vs. triamcinolone acetonide according to multiple gouty arthritis-related health outcomes measures.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA, USA; Veterans Affairs San Diego Healthcare System, San Diego, CA, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Hirsch
authors.forename: A
authors.initials: A
authors.lastname: Gnanasakthy
authors.forename: R
authors.initials: R
authors.lastname: Lale
authors.forename: K
authors.initials: K
authors.lastname: Choi
authors.forename: A J
authors.initials: AJ
authors.lastname: Sarkin
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015210:Arthritis, Gouty / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D053583:Interleukin-1beta / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D012189:Retrospective Studies; D014222:Triamcinolone Acetonide / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D053583:Interleukin-1beta; C541220:canakinumab; D014222:Triamcinolone Acetonide