Dokument: "Studie zur Prävalenz von Antikörpern gegen Botulinumtoxin A und zum klinischen Verlauf bei mit Xeomin® behandelten Patienten mit fokaler Dystonie"
| Titel: | "Studie zur Prävalenz von Antikörpern gegen Botulinumtoxin A und zum klinischen Verlauf bei mit Xeomin® behandelten Patienten mit fokaler Dystonie" | |||||||
| Weiterer Titel: | "Study on the prevalence of antibodies against botulinum toxin A and the clinical course in patients with focal dystonia treated with Xeomin®" | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=65456 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20240409-114921-4 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Deutsch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Brauns, Raphaela Nausikaa [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. med. Albrecht, Philipp [Betreuer/Doktorvater] Prof. Dr. Germing, Ulrich [Betreuer/Doktorvater] | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibungen: | Abstract (deutsch)
In Deutschland sind 3 Botulinumneurotoxin-Typ A-Präparate zur Behandlung von fokalen Dystonien zugelassen, von denen zwei Präparate (aboBoNT/A=Dysport®; onaBoNT/A=Botox®) noch Komponenten des von den Clostridien botulinum gebildeten Gesamttoxinkomplexes über das reine Neurotoxin hinaus enthalten. Nur ein BoNT/A-Präparat ist hochgereinigt (inoBoNT/A=Xeomin®) und enthält keine Komplexproteine mehr. Da bei der Botulinumtoxin-Therapie körperfremdes Protein appliziert wird, ist die Entwicklung von neutralisierenden Antikörpern (NABs) eine klinisch relevante Komplikation in der Langzeitbehandlung. Seit der Zulassung von Xeomin® wird vermutet, dass Xeomin® auf Grund seines geringeren Proteingehaltes auch weniger antigen ist als die beiden anderen BoNT/A-Präparate. In der vorliegenden Arbeit werden zunächst 33 Patienten mit fokalen Dystonien, die ausschließlich mit Xeomin® behandelt wurden, hinsichtlich der klinischen Wirksamkeit der BoNT/A-Therapie befragt, vom Behandler diesbzgl. untersucht und auf das Vorliegen von NABs getestet. Ferner sollten diese Patienten den Verlauf des Schweregrades ihrer Erkrankung vor und nach dem Beginn der BoNT/A-Therapie zeichnen. Von besonderem Interesse war, ob Patienten eine initiale Verbesserung und danach eine sekundäre Verschlechterung (also ein sekundäres Therapieversagen (STF)) zeichneten. Danach wurden 34 Patienten mit einer zervikalen Dystonie (CD), die nur mit Xeomin® behandelt worden waren (XEO-Mono-Gruppe), mit 59 CD-Patienten verglichen, die zuvor unter einer aboBoNT/A- oder onaBoNT/A eine nahezu komplettes STF entwickelt hatten und dann auf incoBoNT/A umgestellt (Switch-Gruppe) und dann mindestens genauso lange mit incoBoNT/A behandelt worden waren wie die XEO-Mono-Gruppe). Die 33 Patienten mit einer fokalen Dystonie berichteten ein Langzeitergebnis mit einer im Mittel 70%igen Verbesserung. Kein Patient wies einen positiven NAB-Test auf, kein Patient zeichnete nach Beginn der inoBoNT/A-Therapie einen Verlauf mit sekundärer Verschlechterung (STF). Auch kein Patient der 34 Patienten mit CD in der XEO-Mono-Gruppe, die mit der Switch-Gruppe verglichen wurden, hatte einen positiven NAB-Test. Die Switch-Gruppe wies nach der Umstellung auf incoBoNT/A eine signifikante klinische Verbesserung des Langzeitergebnisses auf. Aber diese Verbesserung war signifikant geringer als die Verbesserung in der XEO-Mono-Gruppe. Damit werden in der vorliegenden Arbeit weitere Argumente dafür geliefert, dass incoBoNT/A geringer antigen ist als abo- oder onaBoNT/A. Daraus ergibt sich die klinische Empfehlung, Patienten mit fokalen Dystonien, die eine BoNT/A-Therapie benötigen, von vorneherein auf das geringer antigen wirkende incoBoNT/A-Präparat Xeomin® einzustellen.Summary (english) In Germany, three botulinum neurotoxin type A preparations are approved for the treatment of focal dystonia, of which two preparations (aboBoNT/A=Dysport; onaBoNT/A=Botox) still contain components of the total toxin complex formed by the Clostridia botulinum beyond the pure neurotoxin. Only one BoNT/A preparation is highly purified (incoBoNT/A=Xeomin) and no longer contains complex proteins. Since exogenous protein is applied during botulinum toxin therapy, the development of neutralizing antibodies (NABs) is a clinically relevant complication in long-term treatment. Since the approval of Xeomin, it has been suspected that Xeomin is less antigenic than the other two BoNT/A preparations due to its lower protein content. In the present study, 33 patients with focal dystonia who were treated exclusively with Xeomin, were first interviewed regarding the clinical efficacy of BoNT/A therapy, examined by the physician in this regard and tested for the presence of NABs. Furthermore, these patients were asked to plot the course of their disease severity before and after the start of BoNT/A therapy. Of particular interest was whether patients drew an initial improvement and then a secondary deterioration (i.e., secondary therapy failure (STF)). Subsequently, 34 patients with cervical dystonia (CD) who had been treated with Xeomin only (XEO mono group) were compared with 59 CD patients who had previously developed near-complete STF under aboBoNT/A or onaBoNT/A and then switched to incoBoNT/A (switch group) and then had been treated with incoBoNT/A for at least as long as the Xeo mono group. The 33 patients with focal dystonia reported a long-term outcome with a mean 70% improvement. No patient had a positive NAB test and no patient had a course of secondary deterioration (STF) after initiation of incoBoNT/A therapy. Also, none of the 34 patients with CD in XEO mono group compared to the Switch group had a positive NAB test. The Switch group showed significant clinical improvement in long-term outcome after switching to incoBoNT/A. But this improvement was significantly less than the improvement in the XEO mono group. Thus, the present work provides further arguments that incoBoNT/A is lower antigen than abo-or onaBoNT/A. This leads to the clinical recommendation that patients with focal dystonia who require BoNT/A therapy should be switched to the lower antigen incoBoNT/A preparation Xeomin from the outset. | |||||||
| Quelle: | Adler M, Keller JE, Sheridan RE (2001) Persistence of botulinum neurotoxin A demonstrated by sequential administration of serotypes A and E in rat EDL muscle. Toxicon 39:233–243
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| Lizenz: |  Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz | |||||||
| Bezug: | 23.06.2018-22.06.2023 | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 09.04.2024 | |||||||
| Dateien geändert am: | 09.04.2024 | |||||||
| Promotionsantrag am: | 19.07.2023 | |||||||
| Datum der Promotion: | 21.03.2024 |
