AB0433 Tnf-inhibitors and anti-b- cell treatment in patients with rheumatoid arthritis. real-world data from the russian north-western biological treatment cohort
Authors: E. Vasilenko, R.R. Samigullina, V.I. Mazurov, E.A. Trofimov, I.Z. Gaydukova
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Biologics are drugs that improved the status of rheumatoid arthritis (RA). At the same time real-world data (RWD) from large cohorts can give some additional information about efficacy and safety of the biological agents. <h3>Objectives</h3> The aim of the study was to analyse the efficacy and safety of biological treatment in large prospective cohort during 102 weeks of treatment. <h3>Methods</h3> The data from 1 400 patients on biological treatment from North-Western State Medical University Biological Treatment Cohort Study (St. Petersburg, Russia) were analysed. In final analysis data from 758 patients with RA/EULAR 2010 criteria), were included. Following drugs were used: adalimumab (n=22), certolizumab pegol (n=62), etanercept (n=64), golimumab (n=21) and infliximab (n=69), rituximab (n=520)). The disease activity index (DAS28) and high-sensitive C-reactive protein (C-RP) were evaluated as markers of RA activity. Side effects were registered during the study. <h3>Results</h3> RA activity, demographic characteristics, and concomitant treatment (including methotrexate, glucocorticoids, NSAIDs, analgesics) at baseline were similar in all the treatment groups (p≥0.05 for all the parameters). The faster response was found in golimumab and certolizumab pegol patients (p and lt; 0.01 for difference of DAS28 in golimumab, certolizumab pegol treatment and other treatment groups at week 6), figure 1. After week 12 the similar efficacy of all the TNFa-blockers (figure 1). RA activity, demographic characteristics, and concomitant treatment (including methotrexate, glucocorticoids, NSAIDs, analgesics) at baseline were similar in all the treatment groups (p≥0.05 for all the parameters). The faster response was found in golimumab and certolizumab pegol patients (p&lt;0.01 for difference of DAS28 in golimumab, certolizumab pegol treatment and other treatment groups at week 6), figure 1. After week 12 the similar efficacy of all the TNFa-blockers (figure 1).C-RP levels were similar in all the treatment groups in all time-points (p≥0.05). DAS28 (mean ±SD) in RA patients, treated with rituximab, at baseline, and at weeks 24, 54, and 102 was 6.6±2.4, 3.7±1.7, 3.62±2.1 and 3.2±2.05, respectively; p≥0.05 for the differences with all another treatment groups at the same time-points. The most frequent side-effects were opportunistic infections, OR=1.8 [95% CI 1.4–2.1]. Risk of infections was higher in patients, receiving monoclonal antibodies to TNFα, as compared to other TNFα inhibitors (p&lt;0.01 for differences between infliximab/adalimumab/golimumab and etanercept, and p&lt;0.05 for differences between infliximab/adalimumab/golimumab and certolizumab pegol). The risk of cancer in RA patients on biological treatment and in total Russian population (including lymphomas and skin cancer) was comparable: for all the tumours OR=0.98 [95% CI 0.76–1.26], for lymphomas OR=1.23 [95% CI 0.92–1.41], for skin cancer OR=1.11 [0.88–0.36]. <h3>Conclusions</h3> According to the RWD from the North-Western Biological Treatment Cohort, the efficacy of all the TNFα-inhibitors and rituximab in RA treatment after week 12 is the same. Infections, but not tumours, are the most frequent side-effects of biological treatment in RA patients. <h3>Disclosure of Interest</h3> None declared