AB0225 Clinical outcomes of treatment with golimumab in seropositive and seronegative rheumatoid arthritis patients in real-life settings. data from italian register gisea
Authors: F. Iannone, R. Caporali, V. Grosso, E.G. Favalli, A. Marchesoni, S. D’Angelo, G. Tramontano, P. Sarzi-Puttini, F. Atzeni, F. Conti, F. Miranda, R. Foti, G. Amato, A. Carletto, I. dal Forno, E. Gremese, A.L. Fedele, A. Cauli, D. Perra, R. Ramonda, M. Lorenzin, M. Sebastiani, G. Cassone, O. Epis, C. Casu, E. Fusaro, M. Priora, M. Govoni, F. Bergossi, F.P. Cantatore, F. D’Onofrio, L. Cantarini, S. Gentileschi, F. Salaffi, M. Di Carlo, G. Lapadula
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> There is evidence that autoimmunity, namely RF and ACPA antibodies, may influence disease activities and impact the clinical outcomes in RA. <h3>Objectives</h3> There is evidence that autoimmunity, namely RF and ACPA antibodies, may influence disease activities and impact the clinical outcomes in RA. <h3>Methods</h3> We analysed longitudinal data of consecutive RA patients from the Italian registry GISEA, starting a treatment with golimumab (GOL) and tested for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). Demographic and disease related characteristics were collected at baseline, 6 months, 12, and 24 months or at last observation visit. Primary endpoint was the persistence on GOL in RF/ACPA +ve and RF/ACPA patients. Secondary endpoint was the search of baseline predictors of drug survival and clinical outcomes n the two RA subsets. Drug survival was evaluated by Kaplan-Meier life table analysis. Estimates hazard ratios (HRs, 95% confidence intervals (CI)) of drug discontinuation or achievement of low-disease adjusted for patient's demographics, disease characteristics and prior biologic treatments were computed by Cox-regression stepwise backward models. <h3>Results</h3> 345 patients had data on RA and ACP testing and were included in this analysis. No significant difference in terms of age, BMI, disease activity, co-therapy with glucocorticoids or methotrexate (MTX) was detected between RF/ACPA+ve and RF/ACPA-ve patients, but the former had significantly higher disease duration (10.6±vs 8.2±6 years) and frequencies of comorbidities (60.6% vs 44.2%). The 2 years global drug retention was 64.5%, and it was almost identical in RF/ACPA+ve 64.2% and in RF/ACPA-ve 65% RA patients. Drug survival was not influenced by the gender or cause of discontinuation (adverse or inefficacy). To note, in 31% of the patients GOL was not associated to MTX. The only predictor of drug discontinuation was the lack of MTX at baseline (HR 1.62, 95 CI 1.07–2.46, p=0.02), and the GOL-naïve status (HR 0.62, 95 CI 0.39–0.99, p=0.04). At two years, 44.4% achieved the state of low-disease activity (DAS28 &lt;3.2) with no difference between RF/ACPA+ve (45.4%) and RF/ACPA-ve (42.0%) patients, and none baseline factor correlating with low disease activity. No safety issues were raised during the study. <h3>Conclusions</h3> In this study, we demonstrated that RF/ACPA positivity does not negatively impact on drug survival on golimumab. This may aid rheumatologists in their clinical decisions. <h3>Disclosure of Interest</h3> None declared