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Verfasst von:Gomez-Mancilla, Baltazar [VerfasserIn]   i
 Meriggioli, Matthew N. [VerfasserIn]   i
 Genge, Angela [VerfasserIn]   i
 Roubenoff, Ronenn [VerfasserIn]   i
 Espié, Pascal [VerfasserIn]   i
 Dupuy, Cyrielle [VerfasserIn]   i
 Hartmann, Nicole [VerfasserIn]   i
 Pezous, Nicole [VerfasserIn]   i
 Kinhikar, Arvind [VerfasserIn]   i
 Tichy, Mia [VerfasserIn]   i
 Dionne, Annie [VerfasserIn]   i
 Vissing, John [VerfasserIn]   i
 Andersen, Henning [VerfasserIn]   i
 Schoser, Benedikt [VerfasserIn]   i
 Meisel, Andreas [VerfasserIn]   i
 Devlikamova, Farida [VerfasserIn]   i
 Poverennova, Irina [VerfasserIn]   i
 Stuchevskaya, Fatima [VerfasserIn]   i
 Lin, Thy-Sheng [VerfasserIn]   i
 Rush, James S. [VerfasserIn]   i
 Gergely, Peter [VerfasserIn]   i
Titel:Efficacy and safety of iscalimab, a novel anti-CD40 monoclonal antibody, in moderate-to-severe myasthenia gravis
Titelzusatz:A phase 2 randomized study
Mitwirkende:Jordan, Berit   i
Verf.angabe:Baltazar GomezMancilla, Matthew N. Meriggioli, Angela Genge, Ronenn Roubenoff, Pascal Espié, Cyrielle Dupuy, Nicole Hartmann, Nicole Pezous, Arvind Kinhikar, Mia Tichy, Annie Dionne, John Vissing, Henning Andersen, Benedikt Schoser, Andreas Meisel, Berit Jordan, Farida Devlikamova, Irina Poverennova, Fatima Stuchevskaya, Thy-Sheng Lin, James S. Rush, Peter Gergely
E-Jahr:2023
Jahr:20 November 2023
Umfang:9 S.
Illustrationen:Diagramm
Fussnoten:Gesehen am 08.07.2024
Titel Quelle:Enthalten in: Journal of clinical neuroscience
Ort Quelle:Burlington, Mass. : Harcourt, 1994
Jahr Quelle:2024
Band/Heft Quelle:119(2024), Seite 76-84
ISSN Quelle:1532-2653
Abstract:Background - Increased morbidity in many patients with myasthenia gravis (MG) on long-term immunosuppression highlights the need for improved treatments. The aim of this study is to investigate the safety and efficacy of iscalimab (CFZ533), a fully human anti-CD40 monoclonal antibody, in patients with moderate-to-severe MG receiving standard-of-care (SoC) therapies. - Methods - In this double-blind, placebo-controlled phase 2 study, symptomatic patients (n = 44) despite SoC were randomized 1:1 to receive intravenous iscalimab (10 mg/kg; n = 22) or placebo (n = 22) every 4 weeks for 6 doses in total. Patients were followed up for 6 months after the last dose. The total duration of the study was 52 weeks. - Results - In total, 34 of 44 patients (77.3 %) completed the study. The primary endpoint, Quantitative MG score, did not change significantly between baseline and week 25 for iscalimab (median [90 % CI], −4.07 [−5.67, −2.47]) versus placebo (−2.93 [−4.53, −1.33]); however, non-thymectomized patients (n = 29) showed more favorable results (iscalimab, −4.35 [−6.07, −2.64] vs placebo, −2.26 [−4.16, −0.36]). A statistically significant difference between iscalimab and placebo groups was observed in MG Composite score (adjusted mean change: −4.19 [−6.67, −1.72]; p = 0.007) at week 13, and MG-Activities of Daily Living score (−1.93 [−3.24, −0.62]; p = 0.018) at week 21. Adverse events were comparable between the iscalimab (91 %) and placebo (96 %) groups. - Conclusion - Iscalimab showed favorable safety and improvements compared with placebo in non-thymectomized patients with moderate-to-severe MG. It did not show any protective effect in patients with moderate-to-severe MG.
DOI:doi:10.1016/j.jocn.2023
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1016/j.jocn.2023.11.013
 Volltext: https://www.sciencedirect.com/science/article/pii/S0967586823003430
 Resolving-System: https://doi.org/10.1016/j.jocn.2023.11.013
 DOI: https://doi.org/10.1016/j.jocn.2023
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Anti-CD40 monoclonal antibody clinical trial
 Efficacy
 Iscalimab
 Myasthenia gravis
 Safety
K10plus-PPN:1885180012
Verknüpfungen:→ Zeitschrift

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