FRI0114 Efficacy and retention rate of certolizumab pegol in rheumatoid arthritis: data from a large real-life multicentre retrospective cohort

Background Even though certolizumab pegol (CZP) has been licensed for the treatment of rheumatoid arthritis (RA) since longtime, observational data in a real-life setting are still lacking. Objectives To retrospectively evaluate the use of CZP in a multicentric observational cohort of Northern Italy (the LORHEN registry), calculating both clinical response and retention rate. To explore the effectiveness of CZP in childbearing age female. Methods Data were retrospectively extracted from the LORHEN registry which includes all RA patients treated with CZP as first or second-line biologic agent between December 2010 and April 2017. The 2 year clinical response was evaluated as EULAR response and proportion of patients achieving Disease Activity Score 28 (DAS28-ESR) remission. The 5 year retention rate was calculated by Kaplan-Meier method. Cox proportional hazard models were developed to examine potential predictors of CZP persistence, including sex, line of CZP treatment (naive vs switchers), childbearing age, and concomitant MTX as categorical variables, whereas age, disease duration, and baseline DAS28-ESR as continuous variables. Results The overall study population included 242 RA patients (78.9% female; mean [±standard deviation, SD] age 54.2±13.8 years; mean disease duration 10±13.1 years; baseline DAS28-ESR 4.58±1.39), who received CZP as first- (64%) or second-line (36%) biologic agent, as monotherapy (40.9%) or in combination with methotrexate (MTX, 59.1%). Two-year EULAR good +moderate response and remission rates were similar in first- and second-line patients (66% vs 60.7% [p=0.65] and 39.6% vs 32.1% [p=0.52], respectively). The overall 5 year retention rate was 42.5%, with no difference between first- and second-line therapy (43.5% vs 40.5%, respectively; p=0.98), but with a clear trend in favour of childbearing subpopulation versus older women (62.8% vs 32.3%, respectively; p=0.07). Concomitant MTX was a predictor of CZP persistence (Hazard Ratio [HR] 1.79, 95% confidence interval [95% CI] 1.08–2.95; p=0.02), whereas sex (HR 1.35, 95% CI 0.71–2.54, p=0.35), age (HR 1.01, 95% CI 0.99–1.03; p=0.14), mean disease duration (HR 0.99, 95% CI 0.97–1.02; p=0.87), and baseline DAS28-ESR (HR 1.15, 95% CI 0.96–1.38; p=0.12) were not associated with CZP retention rate. The most frequent reason for discontinuation was inefficacy (60%), whereas only 21% of patients stopped the drug because of adverse events. Conclusions In our real-life experience, CZP showed a very good clinical response, with more than one third of patients achieving 2 year clinical remission and more than 40% persisting on treatment after 5 years. Unexpectedly, no significant difference was found between first and second line of treatment. The use of CZP in childbearing women seems to be associated with a higher retention rate. Disclosure of Interest None declared