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| Verfasst von: | Gomez-Mancilla, Baltazar [VerfasserIn]  |
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| | Meriggioli, Matthew N. [VerfasserIn] |
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| | Genge, Angela [VerfasserIn] |
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| | Roubenoff, Ronenn [VerfasserIn] |
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| | Espié, Pascal [VerfasserIn] |
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| | Dupuy, Cyrielle [VerfasserIn] |
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| | Hartmann, Nicole [VerfasserIn] |
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| | Pezous, Nicole [VerfasserIn] |
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| | Kinhikar, Arvind [VerfasserIn] |
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| | Tichy, Mia [VerfasserIn] |
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| | Dionne, Annie [VerfasserIn] |
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| | Vissing, John [VerfasserIn] |
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| | Andersen, Henning [VerfasserIn] |
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| | Schoser, Benedikt [VerfasserIn] |
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| | Meisel, Andreas [VerfasserIn] |
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| | Devlikamova, Farida [VerfasserIn] |
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| | Poverennova, Irina [VerfasserIn] |
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| | Stuchevskaya, Fatima [VerfasserIn] |
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| | Lin, Thy-Sheng [VerfasserIn] |
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| | Rush, James S. [VerfasserIn] |
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| | Gergely, Peter [VerfasserIn] |
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| Titel: | Efficacy and safety of iscalimab, a novel anti-CD40 monoclonal antibody, in moderate-to-severe myasthenia gravis |
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| Titelzusatz: | A phase 2 randomized study |
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| Mitwirkende: | Jordan, Berit |
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| 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 |
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| E-Jahr: | 2023 |
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| Jahr: | 20 November 2023 |
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| Umfang: | 9 S. |
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| Illustrationen: | Diagramm |
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| Fussnoten: | Gesehen am 08.07.2024 |
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| Titel Quelle: | Enthalten in: Journal of clinical neuroscience |
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| Ort Quelle: | Burlington, Mass. : Harcourt, 1994 |
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| Jahr Quelle: | 2024 |
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| Band/Heft Quelle: | 119(2024), Seite 76-84 |
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| ISSN Quelle: | 1532-2653 |
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| 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. |
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| DOI: | doi:10.1016/j.jocn.2023 |
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| 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 |
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| | Volltext: https://www.sciencedirect.com/science/article/pii/S0967586823003430 |
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| | Resolving-System: https://doi.org/10.1016/j.jocn.2023.11.013 |
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| | DOI: https://doi.org/10.1016/j.jocn.2023 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | Anti-CD40 monoclonal antibody clinical trial |
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| | Efficacy |
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| | Iscalimab |
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| | Myasthenia gravis |
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| | Safety |
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| K10plus-PPN: | 1885180012 |
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| Verknüpfungen: | → Zeitschrift |
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Efficacy and safety of iscalimab, a novel anti-CD40 monoclonal antibody, in moderate-to-severe myasthenia gravis / Gomez-Mancilla, Baltazar [VerfasserIn]; 20 November 2023 (Online-Ressource)
