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

Abstract

BackgroundSERENA 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 with an expected duration of up to 5 years.1,2ObjectivesWe report long-term results (at least 3 years follow up) on secukinumab (SEC) retention, effectiveness and safety in pts with active PsA or AS from the SERENA study.MethodsThis analysis includes data of 524 PsA and 473 AS pts enrolled in the study and followed up for at least 3 years. Pts (aged ≥18 years) with active PsA or AS were required to have received at least 16 weeks of SEC treatment before enrolment in the study. Retention rate was defined as the percentage of pts who have not discontinued SEC treatment. Effectiveness assessments included swollen and tender joint counts (SJC and TJC) in pts with PsA, and BASDAI score in pts with AS. Safety assessments included the number of pts with any adverse events (AEs) and serious AEs, treatment-emergent AEs, AEs of special interest and their incidence rates.ResultsThe mean (SD) treatment duration prior to enrolment in the study for PsA and AS pts was 1.0 (0.5) years and 0.9 (0.5) years, while time since diagnosis was 8.7 (7.4) and 9.8 (9.5) years, respectively. Prior to SEC initiation, 67.4% of pts with PsA and 63.0% of pts with AS received a biologic therapy, with lack of efficacy reported as major reason for discontinuation (PsA: 89.5%; AS: 87.6%). SEC retention rates after at least 3 years since enrolment in the study were 67.3% for pts with PsA and 72.1% for pts with AS. Survival probabilities for individual indications are presented in Figure 1. Over 3 years of observation, SEC showed sustained effectiveness in pts with PsA [SJC, mean (SD): baseline, 3.2 (5.6); Year 3, 1.7 (2.7) and TJC: baseline, 6.4 (9.4); Year 3, 4.9 (6.4)] and AS [BASDAI, mean (SD): baseline, 3.2 (2.3); Year 3, 2.7 (2.2)]. No new or unexpected safety signals were reported; 11.0% of pts with PsA (N=574) and 12.9% of pts with AS (N=505) reported serious AEs (Table 1).Table 1.Overall safety profile within the study period (Safety set)Variable, n (%) unless otherwise specifiedPsA (N=574)AS (N=505)Pts with AE (≥1)327 (57.0)291 (57.6)Pts with SAE (≥1)63 (11.0)65 (12.9)AE leading to death3 (0.5)3 (0.6)AE leading to discontinuation119 (20.7)81 (16.0)Treatment emergent AE leading to discontinuation (in >1% pts in any group)n (%)IRn (%)IRGeneral disorders and administration site conditions74 (12.9)4.9050 (9.9)3.75Skin and subcutaneous tissue disorders13 (2.3)0.863 (0.6)0.22Musculoskeletal and connective tissue disorders26 (4.5)1.729 (1.8)0.67Infections and infestations2 (0.3)0.137 (1.4)0.52Gastrointestinal disorders2 (0.3)0.133 (0.6)0.22Neoplasms benign, malignant and unspecified (incl cysts and polyps)4 (0.7)0.263 (0.6)0.22Injury, poisoning and procedural complications002 (0.4)0.15Treatment emergent AE of special interest (PT)n (%)IRn (%)IRCandida infections2 (0.3)0.134 (0.8)0.30Malignancy8 (1.4)0.535 (1.0)0.37MACE3 (0.5)0.204 (0.8)0.30Injection site reaction002 (0.4)0.15Inflammatory bowel disease1 (0.2)0.072 (0.4)0.15Safety set consisted of pts who received at least one dose of SEC treatment after signing the informed consentAE, adverse event; AS, ankylosing spondylitis; IR, incidence rate; MACE, major adverse cardiac events; N, total number of pts; n, number of pts; PsA, psoriatic arthritis; pts, patients; PT, preferred term; SAE, serious adverse event; SEC, secukinumabConclusionAfter more than 3 years of observation in the SERENA study, SEC showed sustained retention rates, indicating high persistence in a real-world setting. Responses across effectiveness assessments in both PsA and AS cohorts were maintained or improved during the 3 years of follow up in the study. SEC showed a favourable safety profile, consistent with previous reports.