CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

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BackgroundBetween 30%–40% of patients with rheumatoid arthritis (RA) discontinue at their first line biological therapy due to inadequate response or adverse events. There is currently a great controversy about using a second anti-TNF, after failure to the first one, or a therapeutic target change, due to the availability of a wide pharmacological arsenal for patients with RA.ObjectivesThe objective of this study is to determine the effectiveness and safety during one year of Certolizumab pegol (CZP) in patients with RA in second line (after failed to a previous antiTNF) and compare it with those who received this therapy as first line (bio-naïve).MethodsNational, observational, prospective, longitudinal and multicenter study in patients with RA who received CZP as the first line of biological treatment or failure to a previous anti-TNF for lack of efficacy, during one year of follow-up. Demographic and clinical variables were collected (gender, age, disease duration, TJC, SJC, ESR, CRP, DAS28, HAQ), at baseline visit, 3 and 12 months of treatment. As response variables, DAS28 remission, low disease activity by DAS28 (LDA) and EULAR response, were used. The Student t test and the Mann-Whitney U test were used for the statistical analysis and a survival analysis (Kaplan-Meier) was performedResultsA total of 360 patients were included, of which 272 (75.6%) were bio-naïve and 88 (24.4%) previous anti-TNF failure. Baseline characteristics of both groups are shown in table 1. Clinical variables of effectiveness at 3 and 12 months are summarised in table 2. Statistically significant differences in DAS28, HAQ and% patients with corticosteroids were observed in both groups at year of treatment comparing with baseline, even though bio-naïve group had a statistically lower DAS28 and a higher percentage response than the antiTNF failure group. According to Kaplan-Meier analysis, similar retention rates were observed independently if CZP were used as first (77.2%) or second line (73.9%). No differences were found in terms of safety at one year of treatment between both groups.ConclusionsThis study, derived from the experience of national clinical practice with CZP, demonstrates the effectiveness and safety of this drug in patients with RA regardless of its use in the first line or after failure to a previous antiTNF, with better response scores in bio-naïve patients. No differences were observed in the retention rate in both groups.Abstract THU0208 – Table 1Baseline characteristicsDisclosure of InterestNone declaredAbstract THU0208 – Table 2Effectiveness of CZP. Comparing at 12 months bionaïve and bioexperience groupsBaseline3 months12 months BionaïveBioexperience (after antiTNF failure)BionaïveBioexperience (after antiTNF failure)BionaïveBioexperience (after antiTNF failure)P HAQ, mean (SD)1.2 (±0.7)1.2 (±0.7)1.1 (±0.7)1.1 (±0.7)0.9 (±0.6)0.9 (±0.7)0.925DAS28, mean (SD)4.7 (±1.1)4.7 (±1.1)3.5 (±1.3)3.7 (±1.2)3.0 (±1.3)3.4 (±1.3)0.011Corticosteroids (yes),%72.863.661.856.843.845.50.780DAS28 remission,%--25.217.945.532.10.031D...

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