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Objective Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Methodology Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase III began on 17 December 2015. Results During the first year, 35 centres participated. The number of patients included in this new phase in December 2016 was 2664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. Conclusions BIOBADASER phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores.

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 p p p p p p p p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p

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 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 Sanchez-Piedra: None declared, Eduardo Cuende: None declared, Raquel Martin-Domenech: None declared, Javier del Pino: None declared, Cristina Campos Fernandez: None declared, Javier Manero: None declared, Blanca Garcia-Magallon: None declared, Fernando Sanchez-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, Maria J. Arteaga Employee of: MSD, Luis Cea-Calvo Employee of: MSD, Juan J. Gomez-Reino: None declared

Isolated, space-occupying lesions in the brain encompass a wide differential diagnosis. Autoimmune diseases may be at the origin of these lesions and should be included in the diagnostic process. Isolated brain involvement by Sjogren's syndrome is very rare. We present the first case published in the literature confirmed with brain biopsy, secondary to a cerebellar pseudotumoral lesion due to localized lymphocytic vasculitis as the first manifestation of a Sjogren's Syndrome.

Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III).Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015.During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations.BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores.