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 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.
Authors
- Piotr Sobolewski (ORCID: https://orcid.org/0000-0003-4646-1702)
- Silvia Jesús (ORCID: https://orcid.org/0000-0002-1874-4628)
- John‐Ih Lee (ORCID: https://orcid.org/0000-0001-9622-0216)
- Pablo Mir (ORCID: https://orcid.org/0000-0003-1656-302X)
- Georg Comes (ORCID: https://orcid.org/0000-0002-4690-5425)
- Ewa Papuć (ORCID: https://orcid.org/0000-0002-8595-2857)
- Philipp Albrecht (ORCID: https://orcid.org/0000-0001-7987-658X)
- Małgorzata Tyślerowicz (ORCID: https://orcid.org/0000-0003-1928-1941)
- E. López Valdés (ORCID: https://orcid.org/0000-0002-7325-1578)
- Tristan Kölsche (ORCID: https://orcid.org/0009-0002-4075-669X)
- Pilar Sánchez Alonso (ORCID: https://orcid.org/0000-0003-0496-4707)
- Robin Jansen (ORCID: https://orcid.org/0009-0005-8492-7595)
- Marta Banach (ORCID: https://orcid.org/0000-0002-4656-3656)
- Stanisław Ochudlo
- Benjamin Waeschle
- Gabriel Salazar (ORCID: https://orcid.org/0000-0002-7958-6862)
- Holger Stark (ORCID: https://orcid.org/0000-0003-3336-1710)
- Elena Ojeda‐Lepe
- Sara Sánchez Valiente
Institutions
- Medical University of Lublin (PL)
- Jagiellonian University (PL)
- Jan Kochanowski University (PL)
- Instituto de Salud Carlos III (ES)
- Hospital Clínico San Carlos (ES)
- Düsseldorf University Hospital (DE)
- Hospital Universitario Puerta de Hierro Majadahonda (ES)
- Kliniken Maria Hilf (DE)
- Copernicus Memorial Hospital (PL)
- Centro de Investigación Biomédica en Red (ES)
- Poznańska Hodowla Roślin (Poland) (PL)
- Instituto de Biomedicina de Sevilla (ES)
- Hospital Clínico Universitario Lozano Blesa (ES)
- Hospital Universitario Virgen del Rocío (ES)
- Heinrich Heine University Düsseldorf (DE)
- Universidad de Sevilla (ES)
Publication Details
- Journal
- Toxins
- Published
- 2025-04-05
- DOI
- https://doi.org/10.3390/toxins17040180
- Primary Topic
- Botulinum Toxin and Related Neurological Disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00