POS0197 RESPONSIVENESS OF ULTRASOUND SYNOVITIS AND CLINICAL OUTCOMES IN PSORIATIC ARTHRITIS TREATED WITH SECUKINUMAB: DATA FROM THE ULTIMATE TRIAL

Abstract

Background: ULTIMATE (NCT02662985) is the first large, randomized, double‐blind, placebo‐controlled phase‐IIIb study in psoriatic arthritis (PsA) using global EULAR‐OMERACT synovitis score (GLOESS) as the primary endpoint which showed early and significant benefit of secukinumab vs. placebo on synovitis at Week 12. Here we report the responsiveness and discriminative validity of GLOESS compared to clinical outcomes on joints at Week 12 and report ultrasound and clinical efficacy data up to Week 24. Methods: This 52‐week study consists of 12‐week double‐blind placebo‐controlled period 1, 12‐week open‐label period 2 and 6‐month open‐label extension period 3. 1 Discriminative validity of GLOESS was analysed post‐hoc: within‐group responsiveness was assessed by comparing its standardised response mean (SRM) to that of core set of ACR response in the initial secukinumab group over 12 and 24 weeks. Mean change from baseline up to Week 12 of GLOESS was determined with mixed‐effect model repeated measures analysis (MMRM) and from Week 12‐24 as observed. Exploratory outcomes through Week 24 included ACR20/50/70 responses, HAQ‐DI, PASI75/90 responses and resolution of dactylitis. Results: Of 166 patients enrolled, a total of 155 patients (93%) completed 24 weeks of treatment (secukinumab, 95% (79); placebo, 92% (76)). Mean change from baseline to Week 24 in GLOESS was similar in the initial secukinumab and placebo‐secukinumab groups. A continued improvement in GLOESS was observed in the secukinumab group, with catch‐up improvement in the placebo group switched to secukinumab from Week 12 ( Figure ). Both SRM of GLOESS and ACR core components over 12 and 24 weeks were high ( Table ). Similar clinical response rates were reported for clinical joint count, skin, dactylitis and function at Week 24 in secukinumab and placebosecukinumab groups ( Table ). Conclusion: These analyses highlight the responsiveness and high discriminative validity of GLOESS in PsA, resembling that of key clinical PsA manifestations and physical function (Figure Presnted).