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.
To describe disease-modifying antirheumatic drug (DMARD) patterns in routine clinical practice in adult rheumatoid arthritis (RA) patients and to ascertain the reasons for methotrexate (MTX) ...discontinuation.
A cross-sectional observational study was conducted from March to October 2014 at the Rheumatology Units of seven hospitals in Spain. In a single visit, the treating rheumatologist completed an online case report form. This report contained sociodemographic and RA variables. This study was conducted in accordance with Good Clinical Practice and local and national research legislations.
A total of 301 patients (71% women) with a mean age of 56.7±14.0 years and disease duration of 3.6±1.5 years were examined. The patients had RA with moderate disease activity, at least one poor prognostic factor, and comorbidities. The mean time between RA diagnosis and prescription of the first conventional synthetic DMARD (csDMARD) was 2.4±6.0 months. A total of 295 patients (98%) started the first csDMARD on monotherapy. MTX was the most-prescribed first-line drug (n=233, 79%). The mean treatment time of the first-line csDMARD was 27.0±19.4 months. Of these patients, 98% progressed to a second-line csDMARD; 118 patients were changed to another DMARD, mainly due to inefficacy (51, 37%), adverse events (AEs, 37, 27%), or intolerance (18, 13%). The use of MTX as second-line therapy reduced from 79% to 51%. At the time of the study, 200 patients (66%) received a csDMARD as monotherapy and 45 (15%) a combination of ≥2 csDMARDs. Fifty-five (18%) patients were being treated with a biological drug in monotherapy (16, 29%) or in a combination with a csDMARD (39, 71%), mainly MTX, 147 patients (57%) received steroids. Biological DMARD were prescribed as the second line for 42% of patients and 51% of patients received the third-line therapy or beyond. The rate of AEs that motivated a change in the csDMARD was 34%.
MTX was the most-used csDMARD as first and second-line therapy together with corticosteroids. The combination of two or more csDMARDs as first-line treatment was very infrequent. MTX toxicity and intolerance were higher and more significant than inefficacy but progressively decreased with use.
To describe the differential characteristics by gender and time since disease onset in patients diagnosed with ankylosing spondylitis (AS) attending the Spanish rheumatology clinics, including those ...on the "Spanish Registry of spondyloarthritis" (REGISPONSER), as well as the diagnostic and therapeutic implications that this entails.
This is a transversal and observational study of 1514 patients with AS selected from 2367 spondyloarthritis cases included in REGISPONSER. For each patient, the demographics, epidemiology, geriatric, clinical, laboratory, radiological, and therapeutic aspects were were evaluated and comprehensively recorded under the aegis of REGISPONSER, constituting the Minimum Basic identifying data for the disease. Physical function was assessed by Bath Ankylosing Spondylitis Functional Index (BASFI). Clinical activity was evaluated using erythrocyte sedimentation rate, C reactive protein and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Each patient underwent pelvic anteroposterior, anteroposterior and lateral lumbar spine as well as lateral cervical spine x rays; they were scored according to the Bath Ankylosing Spondylitis Spine Radiographic Index, which measures structural damage.
Of the 1514 patients screened, 1131 (74.7%) were men. We found significant differences in age at onset of symptoms as well as in the day of inclusion, between the two groups, being lower in men. We also obtained differences in the duration of the disease, which was lower in women. As for the existence of a history of AS among first-degree relatives, family forms were more common among women. The mean BASDAI score was also higher in women, regardless of time since onset of disease. In contrast, the improvement of pain with the use of NSAID's and radiological severity were higher in men, both reaching statistical significance.
Among the Spanish AS patients, there are some differences in the clinical manifestations, even when the time since onset of disease was controlled; we also found radiological differences by gender; men showing more structural damage, while women were more active. These data suggest that the phenotype of AS differs between genders. This can influence the subsequent diagnostic approach and therapeutic decisions.
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