POS1053 LONG-TERM RETENTION, EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: RESULTS FROM THE OBSERVATIONAL SERENA STUDY

Background SERENA is an ongoing, longitudinal, observational study of more than 2900 patients (pts) with moderate to severe psoriasis, active psoriatic arthritis (PsA), and ankylosing spondylitis (AS) conducted at 438 sites across Europe expected duration up 5 years. 1,2 Objectives We report long-term results (at least 3 years follow up) on secukinumab (SEC) retention, effectiveness safety in pts PsA or AS from the study. Methods This analysis includes data 524 473 enrolled followed for Pts (aged ≥18 years) were required have received 16 weeks SEC treatment before enrolment Retention rate was defined as percentage who not discontinued treatment. Effectiveness assessments included swollen tender joint counts (SJC TJC) PsA, BASDAI score AS. Safety number any adverse events (AEs) serious AEs, treatment-emergent AEs special interest their incidence rates. Results The mean (SD) prior 1.0 (0.5) 0.9 years, while time since diagnosis 8.7 (7.4) 9.8 (9.5) respectively. Prior initiation, 67.4% 63.0% a biologic therapy, lack efficacy reported major reason discontinuation (PsA: 89.5%; AS: 87.6%). retention rates after 67.3% 72.1% Survival probabilities individual indications are presented Figure 1. Over observation, showed sustained [SJC, (SD): baseline, 3.2 (5.6); Year 3, 1.7 (2.7) TJC: 6.4 (9.4); 4.9 (6.4)] [BASDAI, (2.3); 2.7 (2.2)]. No new unexpected signals reported; 11.0% (N=574) 12.9% (N=505) (Table 1). Table Overall profile within period (Safety set ) Variable, n (%) unless otherwise specified (N=574 (N=505 AE (≥1 327 (57.0) 291 (57.6) SAE 63 (11.0) 65 (12.9) leading death (0.6) 119 (20.7) 81 (16.0) Treatment emergent (in > 1% group (% IR General disorders administration site conditions 74 4.90 50 (9.9) 3.75 Skin subcutaneous tissue 13 (2.3) 0.86 0.22 Musculoskeletal connective 26 (4.5) 1.72 9 (1.8) 0.67 Infections infestations 2 (0.3) 0.13 7 (1.4) 0.52 Gastrointestinal Neoplasms benign, malignant unspecified (incl cysts polyps) 4 (0.7) 0.26 Injury, poisoning procedural complications 0 (0.4) 0.15 (PT Candida infections (0.8) 0.30 Malignancy 8 0.53 (1.0) 0.37 MACE 0.20 Injection reaction Inflammatory bowel disease 1 (0.2) 0.07 consisted one dose signing informed consent AE, event; AS, spondylitis; IR, rate; MACE, cardiac events; N, total pts; n, arthritis; pts, patients; PT, preferred term; SAE, SEC, Conclusion After observation study, rates, indicating high persistence real-world setting. Responses both cohorts maintained improved during favourable profile, consistent previous reports. References [1]Kiltz, U et al. Adv Ther 2020;37:2865–83 [2]Kiltz, Ann Rheum Dis 2021;80:337–38 Disclosure Interests Uta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche UCB, Grant/research support from: Petros Sfikakis Boehringer Ingelheim, Celgene, Eli-Lilly, Novartis Nicola Gullick Speakers bureau: Astra Zeneca, Izana, PELAGIA KATSIMPRI Genesis Pharma, Anastassios Kotrotsios: None declared, Jan Brandt-Juergens Roche, Sanofi-Aventis, BMS, Medac, Eric Lespessailles Expanscience, Lilly research grants Abbvie, MSD Maiden Eli-Lilly Karl Gaffney Daniel Peterlik Employee Barbara Schulz Effie Pournara Shareholder Piotr Jagiello