AB0933 Survival at 6 and 12 months of ustekinumab in patients with psoriatic arthritis in conditions of clinical practice
Authors: L. Perez Albaladejo, I. Notario Ferreira, I. Añón Oñate, M. Á. Ferrer González, M.J. Soto Pino, S. Quirosa Flores, A. García Sánchez, M.C. Ramírez Barberena, M. Ramírez de la Torre, J.M. Andreu Ubero, R. Cáliz Cáliz
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Introduction</h3> Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with skin psoriasis. Ustekinumab is a monoclonal antibody which inhibits IL12/23 and has proven efficacy and safety in the treatment of patients with PsA. <h3>Objectives</h3> To determine the survival rate and the reasons for Ustekinumab discontinuation in a patient cohort with PsA in conditions of clinical practice. <h3>Methods</h3> Descriptive, prospective, longitudinal and open study including 66 patients diagnosed with PsA and treated with Ustekinumab at dosis according to the data sheet (45 mg in the 0, 4 and every 12 weeks), except for 3 patients who were administered a 90 mg dose with the aforementioned regimen. The patients were monitored at 6 and 12 months. The following variables were collected: age, sex, years of evolution, previous treatment with Synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or biologic DMARD. All the adverse events (AE) which caused the discontinuation of the drug in patients who had received at least one dose of Ustekinumab were also collected. The Kaplan-Meier method was used to analyse the survival rate. The survival rate in naïve patients with biologic DMARD was compared with those who had received at least one biologic DMARD treatment before; and patients treated with Ustekinumab in monotherapy with those who were in a combined therapy with DMARDs. The Log-Rank Test was used for the comparative analysis of both subgroups <h3>Results</h3> Out of the 66 patients of our cohort, 34 (51.5%) were women, whose mean age was 47.2±11.3 years. 49 presented only peripheral affectation (74.2%), mainly in polyarticular form, and 10 had mixed affectation. The rest presented axial affectation exclusively. Our patients had been suffering from this disease for an average of 6±7.7 years, and had received an average of 1.26±1.45 previous biologic DMARD. 51.5% were receiving Ustekinumab in a combined therapy with DMARD (most of them Methotrexate) and 48.5% were in monotherapy. The survival rates at 6 and 12 months were 85% and 74.6% respectively. Comparing the subgroups, the naïve patients with biologic DMARDs presented higher survival rates at 6 (91.6% vs 80.7%) and at 12 months (85.1% vs 66.7%), a statistically significant difference with the group that received previous biologic DMARD (p=0.036). The patients in combined therapy with DMARDs presented higher rates of survival than the patients in monotherapy with Ustekinumab (90% vs 80%; 78% vs 71.1% at 6 and 12 months respectively), although the differences were not statistically significant. The main reason for discontinuation was the decrease of efficacy (14 patients; 21.2%), mostly in patients who had received previous treatment with biologic DMARD. 5 patients (7.6%) did not continue due to AE (2 due to relapsing herpes zoster; 1 patient deceased, with a personal history of neoplasms and a previous treatment with anti-TNF; and 2 had reactions at the injection site). <h3>Conclusions</h3> Ustekinumab is a safe drug, presenting high rates of drug retention, especially in patients who have not received any previous biologic therapy. <h3>Disclosure of Interest</h3> None declared