SAT0158 FACTORS ASSOCIATED TO PERSISTENCE OF TREATMENT WITH GOLIMUMAB IN THE BIOBADASER REGISTRY, WITH UP TO 6 YEARS OF FOLLOW-UP

Background Survival, or persistence in treatment with a biological drug can be considered an indirect measure of efficacy, safety and tolerability Objectives We assessed the probability of persistence (survival) of treatment with golimumab in patients with rheumatic diseases and the factors associated to persistence with up to 6 years of follow-up. Methods BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. A data-base analysis was done in December 2018 on all the patients aged 18 years or more who had initiated golimumab for one of the approved indications (rheumatoid arthritis [RA], axial spondyloarthritis [SpA] or psoriatic arthritis [PsA]). The probability of persistence was calculated with a Kaplan-Meier test. Factors related to persistence were analyzed with a Cox-regression model. Results 581 patients were included (165 [28.4%] RA, 249 [42.9%] axial SpA and 167 [28.7%] PsA), mean age 51 [12] years, 53% women). Median duration of disease at the onset of golimumab was 8.0 (3.0-14.7) years. Golimumab was prescribed as first biological drug in 37.9% of the patients, as second in 32.1% and as third or further in 30.0%. Concomitant medications at golimumab initiation included steroids (28.2%), methotrexate (MTX) (35.5%), sulphasalazine (7.2%) and leflunomide (13.9%). The probability of persistence of treatment with golimumab since treatment initiation was 74.3% at year 1 (95% CI 70.3 – 77.8), 63.5% at year 2 (59.0 – 67.6), 60.5% at year 3 (55.9 – 65.8), 54.5% (49.1 – 59.7) at year 4 and 5, and 52.1% (44.9 – 57.7) at year 6. Persistence was higher when golimumab was used as first biological agent (p log-rank <0.001) and for the treatment of axial SpA or PsA compared to RA (p log-rank <0.001). As first biological drug the probability of persistence was 82.8% (year 1) and 66.5% at year 4. At year 5, survival rates (all lines of therapy) were 59.7%, 63.4% and 37.3% for axial SpA, PsA and RA respectively. Cox-regression analysis (table) showed that the probability of persistence in treatment with golimumab therapy was higher in first vs second or third biological line patients (Hazard Ratio [HR] for discontinuation: 1.78 for second and 2.41 for third or further line versus first line), in SpA and PsA patients (HR discontinuation of RA patients: 1.94 versus PsA), and lower in women (HR: 1.62), in those needing steroids (HR: 1.47) or DMARDs different to MTX (HR: 2.17). Patients treated with MTX had higher but non-significant persistence rate (HR discontinuation 0.79, table). Conclusion The probability of persistence (survival) on therapy with golimumab was high up to 6 years of follow-up and was higher in patients treated with golimumab as first biological drug or for PsA and SpA, and lower in those needing steroids, DMARDs different to MTX and in women. Acknowledgement This study was funded by Merck Sharp & Dohme of Spain. Disclosure of Interests Manuel Pombo: None declared, Carlos Sánchez-Piedra: None declared, Eduardo Cuende: None declared, Raquel Martín-Domenech: None declared, Javier del Pino: None declared, Cristina Campos Fernández: None declared, Javier Manero: None declared, Blanca Garcia-Magallon: None declared, Fernando Sánchez-Alonso: None declared, Federico Diaz-Gonzalez Grant/research support from: MSD, Abbvie, Roche, Novartis, Consultant for: Lilly, Novartis, Pfizer, Amgen, Biogen, Celgene, Speakers bureau: MSD, Lilly, Janssen, BMS, Roche, María J. Arteaga Employee of: MSD, Luis Cea-Calvo Employee of: MSD, Juan J. Gómez-Reino: None declared