Protocol and Demographics of the RELY-CD Study: Assessing Long-Term Clinical Response to Botulinum Neurotoxin in Cervical Dystonia

The RELY-CD study investigated the long-term clinical response to botulinum neurotoxin type A in cervical dystonia within a multicenter, real-world setting. This retrospective study focused on patients treated with complex-free (incobotulinumtoxinA) and complex-containing (onabotulinumtoxinA and abo...

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Detalles Bibliográficos
Autores: Waeschle, Benjamin, Lee, John-Ih, Kölsche, Tristan, Jansen, Robin, Banach, Marta, Ochudlo, Stanislaw, Tyślerowicz, Małgorzata, Sobolewski, Piotr, Sánchez Valiente, Sara, López-Valdés, Eva, Mir, Pablo, Jesús, Silvia, Ojeda, Elena, Papuć, Ewa, Sánchez Alonso, Pilar, Salazar, Gabriel, Comes, Georg, Stark, Holger, Albrecht, Philipp
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/391163
Acceso en línea:http://hdl.handle.net/10261/391163
https://api.elsevier.com/content/abstract/scopus_id/105003873926
Access Level:acceso abierto
Palabra clave:AbobotulinumtoxinA
Botulinum toxin
Cervical dystonia
Immunogenicity
IncobotulinumtoxinA
Long-term treatment
OnabotulinumtoxinA
Real-world evidence
Descripción
Sumario:The RELY-CD study investigated the long-term clinical response to botulinum neurotoxin type A in cervical dystonia within a multicenter, real-world setting. This retrospective study focused on patients treated with complex-free (incobotulinumtoxinA) and complex-containing (onabotulinumtoxinA and abobotulinumtoxinA) BoNT/A formulations over an up to 10-year period. The novel dose-effect parameter "DEff" was introduced to quantify the relationship between dose adjustments and clinical outcomes, enabling the identification of partial treatment failures. The primary endpoint was a comparison of a clinically meaningful worsening in DEff in treatment year 7 compared to year 2 between complex-free and complex-containing botulinum neurotoxin type A. The RELY-CD study provides unique insights into long-term treatment patterns, clinical resistance phenomena, and the implications of formulation differences on treatment outcomes, addressing a critical gap in the literature on real-world botulinum neurotoxin type A application. The study methodology, including the definition and calculation of the novel DEff, as well as clinical baseline characteristics, are presented.

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