Multiple sclerosis and related disorders · 2025
Recommendations for the use of off-label rituximab for the treatment of multiple sclerosis in low-resource settings.
СтатьяНазвание и аннотация: Перевод в очереди
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Rijke Nick, Yamout Bassem I, Saylor Deanna, Nonino Francesco, Filippini Graziella, Piggott Thomas, Laurson-Doube Joanna, Amato Laura, Banerjee Tapas K, Costello Kathleen, Giovane Cinzia Del, De Stefano Nicola, Abkari Najoua El, Giovannoni Gavin, Hartung Hans-Peter, Helme Anne, Mantel-Teeuwisse Aukje, Prato Chichiraldi Andrea, Ali Sahraian Mohammad, Suleman Fatima, Vecchi Simona, Zeineddine Maya, Viswanathan Shanthi, Schünemann Holger
Аннотация
BACKGROUND: Rituximab is a commonly used off-label disease-modifying treatment (DMT) for multiple sclerosis (MS). The MS International Federation (MSIF) articulated the need for evidence-based recommendations on the use of the medicine in 2021, with an assessment focused on low-resource settings where licensed alternatives may not be accessible.
OBJECTIVE: To provide recommendations intended to support people with MS (pwMS), clinicians, policymakers and other stakeholders to make decisions about the use and reimbursement of rituximab as a disease-modifying therapy for people with relapsing or progressive forms of MS and to improve health equity for pwMS.
METHODS: An international multidisciplinary guideline development panel, appointed by MSIF, developed evidence-based recommendations through the GRADE Evidence-to-Decision (EtD) Framework.
RESULTS: The panel developed seven conditional recommendations for use of rituximab in low-resource settings. Recommendations favoured the use of rituximab for people with relapsing forms of MS and with active progressive forms of MS, compared to no treatment and to several on-label DMTs. Recommendations were based on very low certainty of the evidence.
CONCLUSIONS: The available evidence, contextualised through the EtD Framework, provides a robust, transparent and viable case for health systems to provide and reimburse rituximab as a treatment for MS, particularly in low-resource settings.
OBJECTIVE: To provide recommendations intended to support people with MS (pwMS), clinicians, policymakers and other stakeholders to make decisions about the use and reimbursement of rituximab as a disease-modifying therapy for people with relapsing or progressive forms of MS and to improve health equity for pwMS.
METHODS: An international multidisciplinary guideline development panel, appointed by MSIF, developed evidence-based recommendations through the GRADE Evidence-to-Decision (EtD) Framework.
RESULTS: The panel developed seven conditional recommendations for use of rituximab in low-resource settings. Recommendations favoured the use of rituximab for people with relapsing forms of MS and with active progressive forms of MS, compared to no treatment and to several on-label DMTs. Recommendations were based on very low certainty of the evidence.
CONCLUSIONS: The available evidence, contextualised through the EtD Framework, provides a robust, transparent and viable case for health systems to provide and reimburse rituximab as a treatment for MS, particularly in low-resource settings.