{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T00:02:26Z","timestamp":1764806546666,"version":"3.46.0"},"reference-count":15,"publisher":"Georg Thieme Verlag KG","issue":"12","license":[{"start":{"date-parts":[[2025,2,15]],"date-time":"2025-02-15T00:00:00Z","timestamp":1739577600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gesundheitswesen"],"published-print":{"date-parts":[[2025,12]]},"abstract":"Zusammenfassung<\/jats:title>\n Neu zugelassene Therapien haben meist noch unbekannte Nebenwirkungen, obwohl\n die klinischen Studien, die zur Zulassung f\u00fchrten, bereits Sicherheit und\n Wirksamkeit analysierten. Ein Grund daf\u00fcr ist, dass die Ein- und\n Ausschlusskriterien der Studien das meist heterogenere Patientenkollektiv in\n der klinischen Routineversorgung oft nicht komplett abbilden.<\/jats:p>\n In dieser Studie wurden die Auswirkungen der \u00dcbertragbarkeit von Phase-III\n Ein- und Ausschlusskriterien auf MS-Patienten in der klinischen Praxis\n analysiert, die mit DMDs behandelt werden. Dabei wurden die demografischen\n und klinischen Merkmale bei Therapiebeginn zwischen Patienten verglichen,\n die alle Kriterien erf\u00fcllt h\u00e4tten und solchen, die mindestens eines nicht\n erf\u00fcllt h\u00e4tten. Zudem wurden Unterschiede in der H\u00e4ufigkeit von\n (schwerwiegenden) unerw\u00fcnschten Ereignissen ((S)UEs) zwischen den beiden\n Gruppen untersucht.<\/jats:p>\n Datenbasis bildeten zwei nationale, prospektive, beobachtende, klinische,\n multizentrische Register, das REGIMS-Register und das MS-Register der DMSG.\n Folgende Ein- bzw. Ausschlusskriterien wurden angewandt: Alter, klinischer\n Verlauf der RRMS, Sch\u00fcbe, EDSS-Score, Medikationsgeschichte. F\u00fcr kategoriale\n Vergleiche wurde der Chi-Quadrat-Test durchgef\u00fchrt und f\u00fcr kontinuierliche\n Variablen der t-Test. Um den Unterschied in den Daten zur (S)UEs zu\n untersuchen, wurden logistische Regressionsmodelle berechnet. Ein p-Wert\n von<0,05 wurde als statistisch signifikant angesehen.<\/jats:p>\n 28% der Patienten des REGIMS-Registers und 5% der Patienten des MS-Registers\n haben die 4 vordefinierten Einschlusskriterien erf\u00fcllt und w\u00e4ren somit in\n eine Phase-III-Zulassungsstudie der entsprechenden Substanz aufgenommen\n worden.<\/jats:p>\n Unsere Ergebnisse zeigen eine deutliche Patientenselektion durch spezifische\n Einschlusskriterien in klinischen Studien von MS-Therapeutika, verglichen\n mit dem Patientenkollektiv, das nach Zulassung diese Therapie erh\u00e4lt. Diese\n Selektion geht allerdings nicht mit einem h\u00f6heren Risiko in Bezug auf SUEs\n f\u00fcr diejenigen Patienten einher, die nicht in die entsprechende klinische\n Phase-III-Studie eingeschlossen worden w\u00e4ren.<\/jats:p>","DOI":"10.1055\/a-2540-1749","type":"journal-article","created":{"date-parts":[[2025,2,15]],"date-time":"2025-02-15T18:31:56Z","timestamp":1739644316000},"page":"767-776","source":"Crossref","is-referenced-by-count":0,"title":["Generalisierbarkeit von Phase III Klinischen Studien am Beispiel\n Zweier Bundesweiter Multiple Sklerose Register"],"prefix":"10.1055","volume":"87","author":[{"given":"Kris Oliver","family":"Jalusic","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Epidemiologie und Sozialmedizin, Universit\u00e4t M\u00fcnster\n Medizinische Fakult\u00e4t M\u00fcnster, M\u00fcnster, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Ellenberger","sequence":"additional","affiliation":[{"name":"Deutsches MS Register, MS Forschungs- und Projektentwicklungs-gGmbH,\n Hannover, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Stahmann","sequence":"additional","affiliation":[{"name":"Deutsches MS Register, MS Forschungs- und Projektentwicklungs-gGmbH,\n Hannover, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Berger","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Epidemiologie und Sozialmedizin, Universit\u00e4t M\u00fcnster,\n M\u00fcnster, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2025,7,23]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1670","DOI":"10.1007\/s00415-021-10836-8","article-title":"Early and unrestricted access to high-efficacy disease-modifying therapies: a\n consensus to optimize benefits for people living with multiple sclerosis","volume":"269","author":"M Filippi","year":"2022","journal-title":"Journal of neurology"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"610","DOI":"10.2174\/187152712801661301","article-title":"Disease modifying drugs in multiple sclerosis: mechanisms of action and new\n drugs in the horizon","volume":"11","author":"M Marta","year":"2012","journal-title":"CNS & neurological disorders drug targets"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1038\/nrd.2017.107","article-title":"The multiple sclerosis market","volume":"16","author":"A Westad","year":"2017","journal-title":"Nature reviews. 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