AB0772 SAFETY AND SURVIVAL ANALYSIS OF SECUKINUMAB TREATMENT IN A COHORT OF RHEUMATIC PATIENTS NAÏVE TO BIOLOGICAL THERAPY

Abstract

BackgroundSecukinumab is a fully human monoclonal antibody that selectively binds to IL-17A and inhibits the interaction with the IL-17 receptor. IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA).ObjectivesTo describe the safety and survival profile of treatment with Secukinumab in a cohort of patients (pac) with PsA, AS and non-radiographic SpA naïve to biological therapy.MethodsDescriptive observational study. Patients: Cohort of patients with PsA, AS and non-radiographic SpA from the Rheumatology Service of the H.U.V. del Rocío of Seville who undergo treatment with Secukinumab 150mg sc/m as the first line of biological treatment. Main variable: Secukinumab suspension due to adverse event (AE) (mild: requires suspension, serious: hospital admission or death), inefficacy (primary or secondary failure), decision of the pac, clinical remission or other reasons.Secondary variables: age, sex, type of disease (PsA, AS or non-radiographic SpA), clinical manifestations (axial, peripheral affectation and both) other clinical manifestations (cutaneous affectation, enthesis and/or dactylitis). Time from diagnosis to start of biological therapy (months) and exposure time to Secukinumab (months). Concomitant treatment with DMARDs. Statistical analysis: The statistical package SPSS v21 was used. Qualitative variables were analyzed using the Chi2 and Fisher tests, as required. It was considered statistically significant, p values ​​<0.05. Survival analysis was performed using Kaplan-Meier survival curves, compared using the Log-Rank test.Results171 patients who underwent treatment with Secukinumab during their disease were analyzed. A total of 61 patients naïve to biological therapy were included. The baseline characteristics of the sample are shown in Table 1. The patients received treatment with Secukinumab for a median of 35m (SD +/- 17.5m). The drug was suspended in 27 patients; In 19 patients (70%) due to inefficiency (11 due to primary failure and 8 due to secondary failure); in 5 patients due to mild AD (1 patient with mucocutaneous candidiasis); 3 patients due to loss of follow-up and 1 patient for their own decision. There were no serious AEs. The average exposure time of the drug was 32.7 months. Drug survival was 85%, 76%, 68%, and 56%, at 6 months, 1, 2, and 3 years, respectively, with an overall survival of 69%.Table 1.Basal featuresGender, men36 (59%)Age, years (average, SD)47,8 (+/- 13,3)Disease:-Psoriatic arthritis36 (59%)-Ankylosing spondylitis22 (36%)-Non-radiographic axial spondyloarthritis3 (5%)Disease time of evolution, years (average, SD)12,6 (+/- 8)Time from diagnosis to start of biological therapy with Secukinumab, years (median)6Clinical manifestations (%):-Axial involvement32 (52%)-Peripherical involvement43 (70%)-Axial and peripherical involvement.31 (50,8%)Other manifestations:-Enthesis18 (29%)-Dactylitis17 (27%)Concomitant treatment with DMARDs after 6 months of treatment with Secukinumab (n, %):-Methotrexate19 (31%)-Leflunomide7 (11,5%)-Sulfasalazine6 (9,8%)There was no association between the different diagnoses and drug suspension, both variables were independent (p=0.702) with a 5% significance level. There was also no evidence of a significative relationship between the type of involvement (axial/peripheral/both), and the suspension of treatment (p=0.743).ConclusionThe suspension of the drug due to AEs was small in our sample (8,2%) and the AEs detected were mild (including a mucocutaneous candidiasis). No serious AEs were observed. We found an overall drug survival of 70% in our study. These data are consistent with those published in the different clinical trials of the drug (FUTURE I, II and V, MEASURE I, II and III, PREVENT...). Therefore, we can conclude that Secukinumab constitutes a drug with a good security profile.Disclosure of InterestsNone declared