OP0226 TOWARDS DEVELOPMENT OF AN ULTRASOUND ENTHESITIS SCORE IN PSORIATIC ARTHRITIS: 24-WEEK RESULTS FROM THE PHASE III RANDOMISED ULTIMATE STUDY

Background: Enthesitis is a key clinical domain and imaging hallmark of psoriatic arthritis (PsA). Ultrasound (US) highly sensitive tool for detecting synovitis enthesitis in PsA. The Outcome Measures Rheumatology Initiative (OMERACT) has developed an US definition scoring system studies. 1 ULTIMATE study ( NCT02662985 ) the first large double-blind (DB), placebo-controlled phase IIIb designed to demonstrate rapid significant benefit subcutaneous secukinumab vs. placebo on detected patients with 2 Objectives: To report response over 24 weeks using two novel composite scores. Methods: This was 52-week consisting 12-week DB, open-label (OL) 6-month extension period. Inclusion criteria required ≥1 as per SPARCC index, but not US-assessed enthesitis. Patients were randomised (1:1) either weekly (300 or 150 mg according severity skin psoriasis) followed by 4-weekly dosing thereafter. All switched OL (placebo-secukinumab) at Week 12. Throughout study, assessed US. Six anatomical sites bilaterally US: insertions lateral epicondyle tendons, quadriceps, patellar ligaments (distal proximal insertions), Achilles tendons plantar fascia. Two exploratory global OMERACT-US scores tested: Definition combining power Doppler (PD; 0–3) Grey Scale (0–1) inflammation rating PD only (0–3) across six sites. Data analysed mixed-effect model repeated measures (MMRM) up 12 observed from 24. comparison score within treatment groups tested paired between unpaired t-tests. Results: Of 166 enrolled, 93% completed (secukinumab, 95%; placebo-secukinumab, 92%). average count baseline 4. Since presence mandatory inclusion criterion, higher proportion met Global (81% 33%) (Table). Mean reduction index 3 each initial placebo-secukinumab groups. Resolution (SPARCC) 46% 54% A comparable decrease (Definition 2) (Figure). Table 1. Distribution OMERACT Secukinumab Placebo Def >0 N= 73 34 61 20 Anatomical sites, % tendon 49 45 Lateral 21 46 Patellar ligament distal insertion 8 29 4 10 18 Plantar fascia 36 0 28 Quadriceps 55 40 Proportion irrespective site left right side. N, total number Conclusion: consistent shown through switcher While demonstrated responsiveness these scores, further work test PsA cohorts both References: [1]Balint PV, et al. Ann Rheum Dis . 2018;77:1730-5. [2]D’Agostino MA, Arthritis Rheumatol 2020;72(suppl 10). Disclosure Interests: Maria-Antonietta D’Agostino Speakers bureau: Sanofi, Novartis, BMS, Janssen, Celgene, AbbVie, UCB pharma Eli Lilly, Consultant of: Philip G Conaghan AstraZeneca, Galapagos, Gilead, Novartis Pfizer, Corine Gaillez Shareholder Employee Maarten Boers GSK, Esperanza Naredo Roche, UCB, Janssen Grant/research support from: Philippe Carron MSD, Gilead MSD Petra Hanova: None declared, Tomás Cazenave: Catherine Bakewell Sanofi Genzyme, consulting honoraria Anne-Marie Duggan Punit Goyanka Georg Schett Roche