ABSTRACT
Resumen Introducción: Existe poca información local sobre el riesgo de infección grave por COVID-19 en pacientes con esclerosis múltiple (EM) que reciben tratamiento modificador de la enfermedad (DMT). El objetivo del estudio fue evaluar el impacto de la enfermedad por COVID-19 (gravedad y letalidad) en pacientes con EM que reciben DMT. Métodos: El estudio se realizó sobre una cohorte prospectiva de pacientes con EM. Se incluyeron 111 con EM y diagnóstico confirmado de COVID-19 tratados con DMT, seguidos hasta la resolución del COVID-19. Resultados: Un total de seis (5.4%; IC 95%: 2-11.4%) desarrollaron COVID-19 grave definido como requerimiento de internación en terapia intensiva o muerte, y tres fallecieron (tasa de letalidad cruda del 2.7%; IC 95%: 1.1-4.3%). La tasa de letalidad ajustada por edad fue del 1.5% (IC 95%: 0.6-2.4%). El factor que se asoció independientemente con COVID-19 grave fue la edad (OR 1.1; IC 1.0-1.3; p < 0.05) con una tendencia en la Escala del Estado de Incapacidad Ampliada (EDSS) ≥ 6(OR 6.2; IC 0.6-56.4; p = 0.10). Conclusión: La letalidad por COVID-19 en pacientes con EM es baja y la gravedad se asoció significativamente con la edad y mostró una tendencia con EDSS ≥ 6.
Abstract Introduction: There is limited local information on the risk of severe COVID-19 infection in patients with multiple sclerosis (MS) who are receiving disease-modifying treatments (DMT). The aim of the study was to assess the impact of COVID-19 disease (severity and lethality) in MS patients receiving DMT. Methods: The study was performed on a prospective cohort with EM. We included 111 patients with MS and a confirmed di agnosis of COVID-19 treated with DMT and followed up until the resolution of COVID-19. Results: A total of six patients (5.4%; 95% CI: 2-11.4%) developed severe COVID-19 defined as requiring hospitalization in intensive care unit or death and three died (crude case fatality rate of 2.7%; 95% CI: 1.1-4.3%). The age-adjusted case fatality rate was 1.5% (95% CI: 0.6-2.4%). The factor that was independently associated with severe COVID-19 was age (OR 1.1; CI 1.0-1.3; p < 0.05) with a trend in the Expanded Disability Status Scale (EDSS) ≥ 6 (OR 6.2; CI 0.6-56.4; p = 0.10). Conclusion: The lethality due to COVID-19 in MS patients is low, and severity was significantly associated with age and showed a trend with EDSS ≥ 6.
ABSTRACT
INTRODUCTION: There is limited local information on the risk of severe COVID-19 infection in patients with multiple sclerosis (MS) who are receiving disease-modifying treatments (DMT). The aim of the study was to assess the impact of COVID-19 disease (severity and lethality) in MS patients receiving DMT. METHODS: The study was performed on a prospective cohort with EM. We included 111 patients with MS and a confirmed diagnosis of COVID-19 treated with DMT and followed up until the resolution of COVID-19. RESULTS: A total of six patients (5.4%; 95% CI: 2-11.4%) developed severe COVID-19 defined as requiring hospitalization in intensive care unit or death and three died (crude case fatality rate of 2.7%; 95% CI: 1.1-4.3%). The age-adjusted case fatality rate was 1.5% (95% CI: 0.6-2.4%). The factor that was independently associated with severe COVID-19 was age (OR 1.1; CI 1.0-1.3; p < 0.05) with a trend in the Expanded Disability Status Scale (EDSS) = 6 (OR 6.2; CI 0.6-56.4; p = 0.10). CONCLUSION: The lethality due to COVID-19 in MS patients is low, and severity was significantly associated with age and showed a trend with EDSS = 6.
Introducción: Existe poca información local sobre el riesgo de infección grave por COVID-19 en pacientes con esclerosis múltiple (EM) que reciben tratamiento modificador de la enfermedad (DMT). El objetivo del estudio fue evaluar el impacto de la enfermedad por COVID-19 (gravedad y letalidad) en pacientes con EM que reciben DMT. Métodos: El estudio se realizó sobre una cohorte prospectiva de pacientes con EM. Se incluyeron 111 con EM y diagnóstico confirmado de COVID-19 tratados con DMT, seguidos hasta la resolución del COVID-19. Resultados: Un total de seis (5.4%; IC 95%: 2-11.4%) desarrollaron COVID-19 grave definido como requerimiento de internación en terapia intensiva o muerte, y tres fallecieron (tasa de letalidad cruda del 2.7%; IC 95%: 1.1-4.3%). La tasa de letalidad ajustada por edad fue del 1.5% (IC 95%: 0.6-2.4%). El factor que se asoció independientemente con COVID-19 grave fue la edad (OR 1.1; IC 1.0-1.3; p < 0.05) con una tendencia en la Escala del Estado de Incapacidad Ampliada (EDSS) = 6(OR 6.2; IC 0.6-56.4; p = 0.10). Conclusión: La letalidad por COVID-19 en pacientes con EM es baja y la gravedad se asoció significativamente con la edad y mostró una tendencia con EDSS = 6.
Subject(s)
COVID-19 , Multiple Sclerosis , Humans , Multiple Sclerosis/complications , Prospective Studies , Argentina/epidemiologyABSTRACT
BACKGROUND: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority. OBJECTIVES: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence. METHODS: Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States. RESULTS: All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns. CONCLUSION: Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.