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

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Tác giả: Philipp Albrecht, Marta Banach, Georg Comes, Robin Jansen, Silvia Jesús, Tristan Kölsche, John-Ih Lee, Eva López-Valdés, Pablo Mir, Stanislaw Ochudlo, Elena Ojeda-Lepe, Ewa Papuć, Gabriel Salazar, Pilar Sánchez Alonso, Sara Sánchez Valiente, Piotr Sobolewski, Holger Stark, Małgorzata Tyślerowicz, Benjamin Waeschle

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: Switzerland : Toxins , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 743962

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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