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

Background: Power Doppler ultrasonography is a sensitive imaging tool to assess synovitis in psoriatic arthritis (PsA). 1,2 ULTIMATE ( NCT02662985 ) the first large, randomised, double-blind placebo-controlled phase IIIb study PsA, using ultrasound evaluate early response secukinumab on synovitis. The use of standardised and reliable global EULAR-OMERACT composite score at patient level (GLOESS) as primary endpoint showed significant benefit vs. placebo week 12. 3 Objectives: To investigate responsiveness discriminative validity GLOESS compared clinical outcomes joints 12 report efficacy data up 24. Methods: This 52-week with 12-week double-blind, period followed by open-label (OL) 6-month OL extension. All patients were switched (300 or 150 mg) Discriminative was analysed post-hoc: within-group assessed comparing its mean (SRM) that core set ACR initial group over 24 weeks. Mean change from baseline determined mixed-effect model repeated measures analysis (MMRM) 12-24 observed. included responses, HAQ-DI, PASI resolution dactylitis. These exploratory reported either according non-responder imputation (ACR response), observed (HAQ-DI, dactylitis). Results: Of 166 enrolled, total 155 (93%) completed weeks treatment (secukinumab, 79 95%; placebo, 76 92%). similar placebo-secukinumab groups. A continued improvement group, catch-up after switch active therapy (Figure 1). Both SRM components high (Table Similar rates for joint count, skin, dactylitis function switchers groups Conclusion: analyses highlight resembling key PsA manifestations physical function. References: [1]D’Agostino MA Coates LC. J Rheumatol. 2019;46:337–9. [2]Uson J, et al. Rheumatol Clin. 2018;14:27–35. [3]D’Agostino MA, Arthritis 2020;72 (suppl 10). Figure 1. through Week Table Responsiveness - Standardised (Initial Efficacy 0–12 (N = 83 0–24 Responders (% Secukinumab Placebo 12–24 1.05 1.06 ACR20 87 74 Tender count 1.03 1.35 ACR50 64 49 Swollen 0.91 1.18 ACR70 34 23 Patient assessment disease activity 1.37 1.55 HAQ-DI * 80 63 Physician 1.59 2.39 75 † 72 59 Pain 1.32 1.53 90 62 45 Resolution (LDI=0) 67 defined an least 0.35 points (change ≤ −0.35) N value are 36 33; respectively. calculated BSA ≥ %. BSA, Body Surface Area; LDI, Leeds Dactylitis Index Disclosure Interests: Maarten Boers Consultant of: BMS, Novartis, Pfizer, GSK, Philip G Conaghan Speakers bureau: AbbVie, AstraZeneca, Eli Lilly, Galapagos, Gilead, Novartis Georg Schett Celgene, Janssen, Roche UCB, Peter Mandl MSD, Grant/research support from: Esperanza Naredo Roche, Filip van den Bosch Merck, UCB Pharma, Ruben Burgos-Vargas: None declared, Anne-Marie Duggan Employee Punit Goyanka Corine Gaillez Shareholder Maria-Antonietta D’Agostino Sanofi, Lilly