RESUMEN
OBJECTIVE: To analyze the long-term survival of subcutaneous biosimilar tumor necrosis factor inhibitors compared to the originator molecules in patients with rheumatic diseases, as well as the factors associated with drug discontinuation. METHODS: Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of patients with rheumatic disease receiving biologic and targeted disease-modifying antirheumatic drugs. Patients who started etanercept (ETN) or adalimumab (ADA) from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific causes (inefficacy or adverse events [AEs]) of discontinuation. RESULTS: A total of 4162 patients received 4723 treatment courses (2991 courses of ADA and 1732 courses of ETN), of which 722 (15.29%) were with originator molecules and 4001 (84.71%) were with biosimilars. The originators were more frequently discontinued than biosimilars (53.32% vs 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI 0.75-0.95). Female sex, obesity, and second or later treatment lines increased the risk of discontinuation, whereas disease duration and the use of concomitant methotrexate were associated with a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. CONCLUSION: No significant differences were found between treatments in long-term survival due to inefficacy or AEs.
Asunto(s)
Adalimumab , Antirreumáticos , Biosimilares Farmacéuticos , Etanercept , Sistema de Registros , Enfermedades Reumáticas , Humanos , Femenino , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/administración & dosificación , Masculino , Persona de Mediana Edad , Antirreumáticos/uso terapéutico , Antirreumáticos/administración & dosificación , Antirreumáticos/efectos adversos , Adalimumab/uso terapéutico , Adalimumab/administración & dosificación , Adalimumab/efectos adversos , Etanercept/uso terapéutico , Etanercept/administración & dosificación , Adulto , Anciano , Estudios Retrospectivos , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades Reumáticas/mortalidad , Estudios Prospectivos , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral/efectos adversos , Resultado del Tratamiento , Inyecciones Subcutáneas , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , España/epidemiologíaRESUMEN
OBJECTIVE: To analyse the effect of secukinumab on self-reported variables of patients diagnosed with psoriatic arthritis and/or ankylosing spondylitis in relation to their health status, pain, fatigue, sleep and quality of life. METHODS: A six-month, observational, longitudinal, prospective, multicentre study was conducted with 39 patients who initiated treatment with secukinumab as therapy for psoriatic arthritis and/or spondylitis. The main variables were changes in patient-reported measures and they were evaluated by means of the questionnaires: FACIT-fatigue, Insomnia Severity Index, EuroQol-3L-5D and PsAQoL. In addition, depending on the type of disease (peripheral psoriasis or spondyloarthritis) the DAS28 with ESR or the BASDAI were calculated, respectively. RESULTS: Levels of fatigue, moderate and severe insomnia significantly reduced after 6 months of treatment with secukinumab. At the same time, patient-reported quality of life increased significantly (Pâ¯=â¯.006). Data on pain and discomfort also show significant improvement after the treatment. CONCLUSIONS: Patients with psoriatic arthritis and/or ankylosing spondylitis who start treatment with secukinumab show improvement at 6 months in all effect sizes of the treatment, particularly in sleep, fatigue and quality of life. Furthermore, patient-reported outcome measures are of additional clinical value and allow more accurate and closer assessment of their real status of health and well-being.