The better understanding of the safety of biologic DMARDs (bDMARDs), as well as the emergence of new bDMARDs against different therapeutic targets and biosimilars have likely influenced the use patterns of these compounds over time. The aim of this study is to assess changes in demographic characteristics, disease activity and treatment patterns in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who started a first- or second-line biologic between 2007 and mid-2020. Patients diagnosed with RA, PsA or AS included in the BIOBADASER registry from January 2007 to July 2020 were included. According to the start date of a first- or second-line biologic therapy, patients were stratified into four time periods: 2007–2009; 2010–2013; 2014–2017; 2018–2020 and analyzed cross-sectionally in each period. Demographic and clinical variables, as well as the type of biologic used, were assessed. Generalized linear models were applied to study the evolution of the variables of interest over time periods, the diagnosis, and the interactions between them. A total of 4543 patients initiated a first biologic during the entire time frame of the study. Over the four time periods, disease evolution at the time of biologic initiation (p < 0.001), disease activity (p < 0.001), retention rate (p < 0.001) and the use of tumor necrosis factor inhibitors as a first-line treatment (p < 0.001) showed a significant tendency to decrease. Conversely, comorbidities, as assessed by the Charlson index (p < 0.001), and the percentage of patients using bDMARDs in monotherapy (p < 0.001), and corticosteroids (p < 0.001) tended to increase over time. Over the entire period of the study's analysis, 3289 patients started a second biologic. The following trends were observed: decreased DAS28 at switching (p < 0.001), lower retention rates (p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p < 0.001). From 2007 until now rheumatic patients who started a biologic were older, exhibited less clinical activity, presented more comorbidities, and switched to a different biologic more frequently and earlier.

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Aim: To evaluate the persistence of the initial strategy of targeted therapy, with or without conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (combination and monotherapy strategies, respectively) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), under real-life conditions. Methods: This is a nested cohort study within BIOBADASER III, a prospective Spanish registry of patients with rheumatic diseases who are undergoing treatment with targeted therapy including biologics (b) and targeted synthetic (ts) DMARDs. The primary outcome was to determine the initial treatment strategy persistence; switching drugs within the same class, but maintaining the initial strategy (combination or monotherapy) was considered persistence. Bivariate comparisons and multivariate Cox proportional hazard models were used for the analyses.Results: A total of 2,589 patients were included in our study. In the multivariate model, compared to monotherapy, the combination therapy strategy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58, 95% confidence interval [CI] 1.00 to 2.50, p=0.049), PsA-Axial (HR 3.00, 95% CI 1.35 to 6.70, p=0.007), PsA-Peripheral (HR 2.58, 95% CI 1.51 to 4.39, p<0.001) and AS (HR 16.77, 95% CI 7.37 to 38.16, p<0.001). Overall, the combination strategy was associated with an increased incidence of any adverse event (incidence rate ratio [IRR] 1.13, 95% CI 1.05-1.21) but not of serious adverse events (1.02, 95% CI 0.84-1.24) compared to monotherapy,Conclusion: In this real-life study, compared to monotherapy, the strategy of combining a b/tsDMARD with a csDMARD at the start of treatment is associated with lower persistence and worse tolerability in RA, PsA and especially in AS, suggesting that combination therapy should be avoided in AS and possibly PsA patients and used cautiously in RA patients.