Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry.

The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.

Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry.

BACKGROUND: Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases. OBJECTIVE: To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation. METHODS: This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included. RESULTS: Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1-74.9) at year 1, 60.5% (56.5-64.2%) at year 2, 55.6% (51.5-59.5%) at year 3, 50.6% (46.2-54.8%) at year 4, 45.1% (40.1-50.0%) at year 5, 44.2% (39.0-49.3) at year 6, and 39.5% (32.8-46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention. CONCLUSION: In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7. Key Points • Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. • This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7. • Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy.

Changes in the use patterns of bDMARDs in patients with rheumatic diseases over the past 13 years.

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.

Objectives and methodology of BIOBADASER phase iii. / Objetivos y metodología de la fase iii de BIOBADASER.

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 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. 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.

Use of benzodiazepines and antidepressants in patients who attend a Rheumatology clinic / Prevalencia de consumo de benzodiacepinas y antidepresivos en los pacientes que acuden por primera vez a la consulta de reumatología

ABSTRACT Introduction: During the last decades, benzodiazepines (BZD) and antidepressants (ADP) have been among the most prescribed therapies in all developed countries. They have side effects, and BZD carry a risk of abuse and dependence disorders. The purpose of this study was to evaluate the prevalence of BZD and ADP among patients who attend a Rheumatology clinic, as well as the indication for these drugs. Methods: The study included patients who were referred for the first time to the Rheumatology clinic. Demographical data, reason for referral, and final diagnosis were recorded. The indication for ADP and/or BZD was recorded, as well as the duration of treatment. Sample size was estimated for a 0.05% alpha risk. Univariate and multivariate analyses were performed in order to study the relationships with the demographical or clinical characteristics. Results: A total of 350 patients were included (women 77.1%, men 22.9%). Most of them (73.4%) had been referred for musculoskeletal pain. More than a third (36.6%) of patients were on BZD and/or ADP. The most frequent reasons for their prescription were anxiety, depression, and insomnia. The final diagnosis in the clinic was a non-inflammatory condition in 82%, and an inflammatory one in 18%. In the univariate analyses, the use of BZD/ADP was associated with female gender (p<.001), unemployment (p<.001) and non-inflammatory final diagnosis (p < .001). In the multivariate analyses, the use of BZD and/or ADP was associated with female sex (p = .002 [OR 3.4, 95% CI; 1.6-7.4]), and a non-inflammatory final diagnosis, specifically fibromyalgia (p = .007 [OR 16.1, 95% CI; 2.2-120.7]). Conclusion: Use of BZD and ADP is high and associated with non-inflammatory disease.

RESUMEN Introducción: Durante las últimas décadas, las benzodiacepinas (BZD) y los antidepresivos (ADP) han estado entre las terapias más prescritas en todos los países desarrollados. Estos fármacos tienen efectos secundarios y las BZD pueden ocasionar abuso y problemas de dependencia. El objetivo de este estudio fue evaluar la prevalencia de consumo de BZD y ADP entre los pacientes que acuden a una consulta de reumatología por primera vez, así como la indicación para ellos. Métodos: Se incluyeron pacientes remitidos por primera vez a la consulta de reumatología. Se registraron los datos demográficos, el motivo de la derivación y el diagnóstico final. Con respecto al tratamiento con ADP y/o BZD, se registraron su duración y la indicación de la prescripción. El tamaño de la muestra se estimó para un riesgo alfa de 0,05%. Se realizaron análisis univariantes y multivariantes para estudiar las asociaciones con características demográficas o clínicas. Resultados: Se incluyeron 350 pacientes (mujeres 77,1%, hombres 22,9%). La mayoría de ellos habían sido remitidos por dolor musculoesquelético (73,4%). Más de un tercio (36,6%) de los pacientes estaban en tratamiento con BZD y/o ADP. Las causas más frecuentes para su prescripción fueron ansiedad, depresión e insomnio. El diagnóstico final fue patología no inflamatoria en el 82% de los casos e inflamatoria en el 18% de estos. En el análisis univariante, el uso de BZD y/o ADP se asoció con el sexo femenino (p< 0,001), el desempleo (p< 0,001) y el diagnóstico de patología no inflamatoria (p< 0,001). En el análisis multivariante, el uso de BZD y/o ADP se asoció con el sexo femenino (p=0,002 [OR 3,4; IC 95% 1,6-7,4]) y el diagnóstico de patología no inflamatoria, específicamente con la fibromyalgia (p = 0,007 [OR 16,1; IC 95% 2,2-120,7]). Conclusión: El consumo de BZD y ADP es frecuente y está asociado con patología no inflamatoria.