POS0234 SECUKINUMAB RETENTION AND SAFETY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: 2 YEAR INTERIM RESULTS OF THE OBSERVATIONAL SERENA STUDY

Abstract

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 years1.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 study1. 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 periodAE summary, n (%)PsA N=575AS N=499Year 1Year 2Year 1Year 2Subject with any AE239 (41.6)289 (50.3)203 (40.7)247 (49.5)Subject with any serious AE29 (5.0)45 (7.8)29 (5.8)44 (8.8)Subject with AE leading to discontinuation55 (9.6)84 (14.6)47 (9.4)62 (12.4)Death0 (0.0)0 (0.0)0 (0.0)1 (0.2)AEs of special interest, n (IR per 100 subject-years)Serious infections and infestations5 (0.96)9 (0.95)8 (1.78)11 (1.33)Candida infections1 (0.19)2 (0.21)2 (0.44)2 (0.24)Malignancy5 (0.96)7 (0.74)N/R3 (0.36)Major adverse cardiovascular eventsN/R1 (0.11)2 (0.44)3 (0.36)Inflammatory bowel diseaseN/RN/R1 (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.