POS0234 SECUKINUMAB RETENTION AND SAFETY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: 2 YEAR INTERIM RESULTS OF THE OBSERVATIONAL SERENA STUDY
Authors: U. Kiltz, P. Sfikakis, N. Gullick, A. Theodoridou, J. Brandt-Juergens, E. Lespessailles, R. Rashkov, J. Fang, E. Pournara, B. Schulz, P. Jagiello, K. Gaffney
Journal: Annals of the Rheumatic Diseases (2021)

Background: SERENA is an ongoing, prospective, non-interventional study evaluating retention, effectiveness, safety/tolerability and quality of life in more than 2900 patients (pts) with moderate to severe plaque psoriasis, active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) treated with secukinumab (SEC) at 438 sites across Europe for a period of up to 5 years 1 . Objectives: We present interim results reporting SEC treatment retention and safety data through 2 years in the PsA and AS pts enrolled in the study. Methods: This interim analysis presents data from 534 PsA and 470 AS pts who were enrolled (target population fulfilling all eligibility criteria) in the study and were followed up for at least 2 years. Pts (aged ≥18 years) with active PsA or AS should have received at least 16 weeks SEC treatment before enrolment in the study 1 . Retention rate was defined as the percentage of pts who have not discontinued SEC treatment. A treatment break was defined as interruption of therapy for at least 3 months after last injection. Results: The mean treatment duration prior to enrolment in the study was 1.0 year and 0.91 year for PsA and AS, respectively. The retention rates for SEC after 1 year since enrolment and since initiation of treatment were: PsA, 85.2% [n=519, CI: 82.01–88.32] and 96.8% [n=528, CI: 95.18–98.38]; AS, 85.8% [n=452, CI: 82.52–89.17] and 94.2% [n=464, CI: 91.94–96.42], respectively. After 2 years since enrolment and since initiation of treatment, the retention rates were: PsA, 74.9% [n=498, CI: 70.99–78.81] and 87.0% [n=515, CI: 83.99–89.99]; AS, 78.9% [n=437, CI: 75.01–82.88] and 84.8% [n=454, CI: 81.39–88.21], respectively. Survival probabilities for individual indications are presented in Figure 1. At baseline, the majority of PsA (79.5%; n/N=423/532) pts were receiving SEC 300 mg, while 97.0% (n/N=456/470) of AS pts were receiving SEC 150 mg. The majority of pts continued their initial SEC dose; “no dose change” in SEC treatment was reported after 1 and 2 years in the study (Year 1: PsA, 93.4% [n=499] and AS, 92.6% [n=435]; Year 2: PsA, 89.7% [n=479] and AS, 87.9% [n=413]). SEC treatment break was recorded for 31 PsA pts [median (min, max) treatment break duration in days: 125.0 (61, 461)] and for 42 AS [118.0 (61, 813)] pts mainly due to adverse events reported in 58.1% (n=18) and 45.2% (n=19) of pts, respectively. The retreatment started with monthly dosing in most of the cases: PsA, 80.6% (n/N=25/31) and AS, 76.2% (n/N=32/42). No new or unexpected safety signals were reported (Table 1). Table 1. Safety profile of treatment-emergent adverse events within the study period AE summary, n (%) PsA N=575 AS N=499 Year 1 Year 2 Year 1 Year 2 Subject with any AE 239 (41.6) 289 (50.3) 203 (40.7) 247 (49.5) Subject with any serious AE 29 (5.0) 45 (7.8) 29 (5.8) 44 (8.8) Subject with AE leading to discontinuation 55 (9.6) 84 (14.6) 47 (9.4) 62 (12.4) Death 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.2) AEs of special interest, n (IR per 100 subject-years ) Serious infections and infestations 5 (0.96) 9 (0.95) 8 (1.78) 11 (1.33) Candida infections 1 (0.19) 2 (0.21) 2 (0.44) 2 (0.24) Malignancy 5 (0.96) 7 (0.74) N/R 3 (0.36) Major adverse cardiovascular events N/R 1 (0.11) 2 (0.44) 3 (0.36) Inflammatory bowel disease N/R N/R 1 (0.22) 1 (0.12) N, total number of patients in the safety set; n, number of patients with event; AE, adverse events; IR, incidence rate; N/R, not reported. Conclusion: Secukinumab retention rates in a real world setting after more than 2 years since initiation of treatment and after 2 years since enrolment in the study indicate high persistence rates. Safety data collected prospectively for up to 2 years confirm the favorable safety profile of secukinumab. References: [1]Kiltz, U et al. Adv Ther 2020; 37:2865–83. Disclosure of Interests: Uta Kiltz Consultant of: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Petros Sfikakis Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Nicola Gullick Speakers bureau: AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB., Consultant of: AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB., Grant/research support from: AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB., Athina Theodoridou Consultant of: UCB, Amgen, Novartis, Jan Brandt-Juergens Speakers bureau: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Consultant of: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Eric Lespessailles Speakers bureau: Amgen, Expanscience, Lilly and MSD, Consultant of: Amgen, Expanscience, Lilly and MSD, Grant/research support from: Abbvie, Amgen, Lilly, MSD and UCB, Rasho Rashkov Speakers bureau: AbbVie, Amgen, Pfizer, Novartis, MSD, UCB, Roche and Janssen, Consultant of: AbbVie, Amgen, Pfizer, Novartis, MSD, UCB, Roche and Janssen, Jenny Fang Employee of: Novartis, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Barbara Schulz Employee of: Novartis, Piotr Jagiello Employee of: Novartis, Karl Gaffney Speakers bureau: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Consultant of: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Grant/research support from: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB.