ABSTRACT
Introduction and objectives: This OBSErve Spain study, a part of the international OBSErve programme, evaluated belimumab real-world use and effectiveness following 6 months of treatment in patients with active systemic lupus erythematosus (SLE) in clinical practice in Spain. Materials and methods: In this retrospective, observational study (GSK Study 200883), eligible patients with SLE receiving intravenous belimumab (10mg/kg) had their disease activity (physician assessed), SELENA-SLEDAI scores, corticosteroid use, and healthcare resource utilisation (HCRU), assessed after 6 months of treatment versus index (belimumab initiation) or 6 months pre-index. Results: Overall, 64 patients initiated belimumab, mainly due to ineffectiveness of previous treatments (78.1%) and to reduce corticosteroid use (57.8%). Following 6 months of treatment, 73.4% of patients achieved ≥20% overall clinical improvement, while only 3.1% of patients worsened. Mean (standard deviation, SD) SELENA-SLEDAI score decreased from 10.1 (6.2) at index to 4.5 (3.7) 6 months post-index. HCRU decreased from 6 months pre-index to 6 months post-index, with fewer hospitalisations (10.9% vs 4.7% patients) and ER visits (23.4% vs 9.4% patients). Mean (SD) corticosteroid dose decreased from 14.5 (12.5)mg/day at index to 6.4 (5.1)mg/day 6 months post-index. Conclusions: Patients with SLE receiving belimumab for 6 months in real-world clinical practice in Spain experienced clinical improvements and a reduction in HCRU and corticosteroid dose.(AU)
Introducción y objetivos: El estudio OBSErve España, que forma parte del programa internacional OBSErve, evaluó el uso y la eficacia de belimumab en la práctica clínica real española tras seis meses de tratamiento en pacientes con lupus eritematoso sistémico (LES) activo. Materiales y métodos: En este estudio observacional y retrospectivo (GSK Study 200883) fue evaluada la respuesta clínica, la actividad de la enfermedad (puntuación SELENA-SLEDAI), el uso de corticosteroides y los recursos sanitarios utilizados de los pacientes con LES que recibieron belimumab intravenoso (10mg/kg), al inicio y tras seis meses de tratamiento. Resultados: En total 64 pacientes iniciaron belimumab, principalmente por ineficacia de los tratamientos previos (78,1%) y para reducir los corticoides (57,8%). Después de seis meses de tratamiento, 73,4% de los pacientes lograron una mejoría clínica general de ≥20%, mientras que solo 3,1% de los pacientes empeoró. La puntuación media (desviación estándar, DE) de SELENA-SLEDAI disminuyó de 10,1 (6,2) a 4,5 (3,7). Los recursos sanitarios utilizados disminuyeron con menos hospitalizaciones (10,9 vs. 4,7%) y visitas a urgencias (23,4 vs. 9,4%). La dosis media (DE) de corticosteroides disminuyó de 14,5 (12,5mg/día) a 6,4 (5,1mg/día). Conclusiones: Los pacientes con LES que recibieron belimumab durante seis meses en la práctica clínica real en España experimentaron mejoras clínicas y una reducción de la dosis de corticosteroides y recursos sanitarios utilizados.(AU)
Subject(s)
Humans , Male , Female , Lupus Erythematosus, Systemic/diagnosis , Lupus Erythematosus, Systemic/drug therapy , Adrenal Cortex Hormones/administration & dosage , Health Resources , Spain , Rheumatology , Rheumatic Diseases , Retrospective Studies , EffectivenessABSTRACT
INTRODUCTION AND OBJECTIVES: This OBSErve Spain study, a part of the international OBSErve programme, evaluated belimumab real-world use and effectiveness following 6 months of treatment in patients with active systemic lupus erythematosus (SLE) in clinical practice in Spain. MATERIALS AND METHODS: In this retrospective, observational study (GSK Study 200883), eligible patients with SLE receiving intravenous belimumab (10mg/kg) had their disease activity (physician assessed), SELENA-SLEDAI scores, corticosteroid use, and healthcare resource utilisation (HCRU), assessed after 6 months of treatment versus index (belimumab initiation) or 6 months pre-index. RESULTS: Overall, 64 patients initiated belimumab, mainly due to ineffectiveness of previous treatments (78.1%) and to reduce corticosteroid use (57.8%). Following 6 months of treatment, 73.4% of patients achieved ≥20% overall clinical improvement, while only 3.1% of patients worsened. Mean (standard deviation, SD) SELENA-SLEDAI score decreased from 10.1 (6.2) at index to 4.5 (3.7) 6 months post-index. HCRU decreased from 6 months pre-index to 6 months post-index, with fewer hospitalisations (10.9% vs 4.7% patients) and ER visits (23.4% vs 9.4% patients). Mean (SD) corticosteroid dose decreased from 14.5 (12.5)mg/day at index to 6.4 (5.1)mg/day 6 months post-index. CONCLUSIONS: Patients with SLE receiving belimumab for 6 months in real-world clinical practice in Spain experienced clinical improvements and a reduction in HCRU and corticosteroid dose.
