Von der Schuppenflechte zur Multiplen Sklerose – Die Fumarsäure auf dem Vormarsch der Basistherapie von chronisch progredienter Multipler Sklerose

Im Rahmen eines Selbstversuches wendete der Chemiker Schweckendiek 1959 ein Fumarsäure-Präparat zur Behandlung seiner Schuppenflechte an. 35 Jahre später wurde Fumarderm® zur Behandlung der Schuppenflechte zugelassen.

Man geht davon aus, das bei der MS, ebenfalls wie bei der Schuppenflechte, eine Autoimmunerkrankung zugrunde liegt.

Seit ca. 2006 erfolgen Untersuchungen zur Behandlung der MS mit Fumarsäure, wobei sich die Einnahme von 2 mal täglich 240 mg Fumarsäure als signifikant wirksam zeigte.

Das Präparat ist gut verträglich. Leichte Magen- und Darmnebenwirkungen bilden sich nach ca. 2 bis 3 Wochen zurück und führen nur bei ca. 3 % der Patienten zum Therapieabbruch. Das Medikament sollte langsam aufdosiert und der Patient dabei durch regelmäßige Blutbildkontrollen überwacht werden.

Mit einer Zulassung zur MS-Behandlung wird im Verlauf des Jahres 2013 gerechnet.

Genauere Einzelheiten sind im folgenden Artikel zitiert.

„Zitat“

 

Presseinformation

Wirksamer Schutz erkrankter Nerven – Fumarsäure hilft sicher bei Multipler Sklerose

Berlin/Amsterdam, 07. November 2011 – Der Wirkstoff Fumarsäure kann offenbar die Schubrate bei der Multiplen Sklerose (MS) annähernd halbieren und auch die MS-typischen Schädigungen des Gehirns deutlich reduzieren, so das Ergebnis einer Studie, die auf dem Fachkongress ECTRIMS in Amsterdam für großes Aufsehen sorgte. „Insbesondere die Kombination aus hoher Wirksamkeit und Sicherheit machen das Medikament zu einer interessanten Behandlungsoption“, kommentierte Studienleiter Professor Ralf Gold, Direktor der Neurologischen Universitätsklinik (St. Josef Hospital) in Bochum und Vorstandsmitglied der Deutschen Gesellschaft für Neurologie. Prof. Dr. Ralf Gold, Bochum © DGN 2010

Noch ist das erfolgreich getestete Fumarsäure-Präparat „BG-12“ nicht für die Behandlung der Multiplen Sklerose zugelassen, stellte Gold klar. Das Vorgängerprodukt Fumaderm® wird jedoch seit mehreren Jahren in einigen europäischen Ländern zur Behandlung der Schuppenflechte (Psoriasis) eingesetzt, was das Verfahren womöglich beschleunigen könnte. Dafür sprächen auch die überzeugenden Daten zur Verträglichkeit und Sicherheit von BG-12, die jetzt mit der DEFINE-Studie (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) vorgestellt werden konnten, so Gold.

In 28 Ländern hatten an dieser Studie 1234 Patienten mit schubförmiger MS und leichten bis mittelschweren Behinderungen im Alter zwischen 18 und 55 Jahren teilgenommen. Nach dem Losverfahren erhielten diese Freiwilligen entweder BG-12 oder ein Scheinmedikament. Nach zwei Jahren hatten Patienten, die BG-12 zweimal täglich einnahmen, 49 Prozent weniger Schübe erlitten, und bei dreimaliger Einnahme der Arznei 50 Prozent weniger als mit dem Scheinmedikament. Die Auswertung zeigte auch einen erheblichen Unterschied beim Anteil der Patienten, bei denen ein Schub beobachtet worden war: Unter BG-12 waren es neun Prozent gewesen, mit dem Scheinmedikament dagegen 15 Prozent.

Nebenwirkungen mild und vorübergehend

Zwar hatten etwa 95 Prozent der Teilnehmer Nebenwirkungen bemerkt, die waren jedoch mit der Studienarznei ähnlich häufig wie dem Scheinmedikament aufgetreten. Im gesamten Studienzeitraum war es weder zu medikamentenbezogenen Todesfällen oder Krebserkrankungen gekommen, noch wurden vermehrt Infektionen beobachtet, wie dies bei drei anderen neu entwickelten Wirkstoffen gegen MS der Fall war. Lediglich die vergleichsweise milden Nebenwirkungen Hautrötungen, Durchfall, Übelkeit und Magenschmerzen waren mit BG-12 häufiger aufgetreten als unter Placebo. Aber auch diese Beschwerden waren vorwiegend in den ersten 30 Behandlungstagen aufgetreten und dann zurückgegangen. Pressemitteilung der Deutschen Gesellschaft für Neurologie, 07. November 2011

„Daraus schließen wir, dass BG-12 eine therapeutische Option für Patienten mit schubförmiger MS sein könnte, mit ordentlicher Wirksamkeit, guter Verträglichkeit und einem exzellenten Sicherheitsprofil“, sagt Gold.

Der Wirkmechanismus der Arznei ist noch nicht vollständig aufgeklärt, jedoch scheint es nicht nur eine dämpfende Wirkung auf die überschießende Immunreaktion bei MS zu haben, sondern auch Nervenzellen zu schützen. Darauf deuten Ergebnisse der Magnetresonanztomographie (MRT) hin, die im Rahmen der DEFINE-Studie ebenfalls erhoben wurden und die einen starken Rückgang der MS-typischen Läsionen im Gehirn belegen. Die Zahl neuer Läsionen verringerte sich bei täglich zweimaliger Gabe von BG-12 um 85 Prozent, die Gesamtzahl sogenannter Gadolinium-verstärkter Läsionen um bis zu 90 Prozent.

Unmittelbar nach dem ECTRIMS-Kongress veröffentlichte die Herstellerfirma von BG-12 (Biogen Idec) auch die Daten der Studie CONFIRM (Comparator and an Oral Fumarate in RRMS), die der US-Neurologe Robert J. Fox, Direktor am Mellen Center für Multiple Sklerose der Cleveland Clinic in Ohio geleitet hat. BG-12 wurde dabei nicht mit einem Scheinmedikament verglichen, sondern mit dem Immunmodulator Glatirameracetat, einem Medikament das zur Behandlung der MS in Europa bereits seit 2001 zugelassen ist. Die Ergebnisse der 1430 Teilnehmer bestätigten laut Fox die Resultate der DEFINE-Studie: „Wir sahen eine robuste Verringerung der Schubrate und der Krankheitsaktivität. Es sieht so aus, als ob BG-12 eine nützliche First-Line-Therapie sein könnte.“

Tabletten statt Spritzen

Bei der Behandlung der Multiplen Sklerose haben sich zwar bestimmte Formen von Interferon ebenso wie Glatirameracetat bewährt, weil sie die Schubrate bei der relapsierend-remittierenden Form der Krankheit eindeutig reduzieren können. Allerdings müssen diese Substanzen regelmäßig gespritzt werden. Experten hoffen schon seit Jahren auf weniger belastende Medikamente, die in Form von Pillen geschluckt werden könnten. Mit dem Wirkstoff Fingolimod wurde im April 2011 erstmals eine Kapsel zum Einnehmen zugelassen, doch eignet sich diese Substanz nur für Patienten mit schweren Verlaufsformen der MS, erklärt Gold. „Deshalb wäre es ein erheblicher Fortschritt wenn die Wirksamkeit, Sicherheit und Verträglichkeit von BG-12 in weiteren Studien bestätigt würde und wir unseren Patienten eine Behandlung in Tablettenform anbieten könnten, ohne die einfachere Handhabung durch ein höheres Risiko erkaufen zu müssen.“

Fumarsäure ist eine natürliche organisch-chemische Substanz, die in größeren Mengen in Pflanzen, Pilzen und Flechten vorkommt. Namensgeber ist der Gewöhnlichen Erdrauch (Fumaria officinalis), der größere Mengen der Säure enthält.“ Weitere Anwendungsgebiete finden sich in der Lebensmittelindustrie, wo Fumarsäure als Säurungsmittel E 297 zugelassen ist. Auch in der Schweineaufzucht wird Fumarsäure als Futterzusatz für Ferkel genutzt um damit den pH-Wert im Darm aufrechtzuerhalten und E. coli-bedingten Infektionen vorzubeugen. Pressemitteilung der Deutschen Gesellschaft für Neurologie, 07. November 2011

Quellen

 Gold R et al. Clinical efficacy of BG-12, an oral therapy, in relapsing-remitting multiple sclerosis: Data from the phase III DEFINE trial

 Arnold D. et al. Efficacy on MRI endpoints of BG-12, an oral therapy, in relapsing-remitting multiple sclerosis: Data from the phase III DEFINE trial

 Selmaj K et al. Safety and tolerability of BG-12 in the phase III DEFINE trial in patients with relapsing-remitting multiple sclerosis

 Kappos L et al.BG-12 effects on patient-reported outcomes in relapsing-remitting multiple sclerosis: results from the DEFINE study

 (Vortrag und Poster, präsentiert am 21. Oktober 2011 auf dem Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), Amsterdam)

Fachlicher Kontakt bei Rückfragen Prof. Dr. med. Ralf Gold Direktor der Neurologischen Klinik an der Ruhr-Universität Bochum Gudrunstraße 56 44791 Bochum Tel.: +49 (0) 234 509-2410 Fax.: +49 (0) 234 509-2414 E-Mail: ralf.gold@rub.de

Die Deutsche Gesellschaft für Neurologie e.V. (DGN) sieht sich als neurologische Fachgesellschaft in der gesellschaftlichen Verantwortung, mit ihren mehr als 6500 Mitgliedern die neurologische Krankenversorgung in Deutschland zu verbessern. Dafür fördert die DGN Wissenschaft und Forschung sowie Lehre, Fort- und Weiterbildung in der Neurologie. Sie beteiligt sich an der gesundheitspolitischen Diskussion. Die DGN wurde im Jahr 1907 in Dresden gegründet. Sitz der Geschäftsstelle ist die Bundeshauptstadt Berlin. www.dgn.org

Geschäftsstelle Deutsche Gesellschaft für Neurologie 1. Vorsitzender: Prof. Dr. med. Wolfgang Oertel, Reinhardtstr. 14 2. Vorsitzender: Prof. Dr. med. Heinz Reichmann, 10117 Berlin 3. Vorsitzender: Prof. Dr. med. Martin Grond Tel: +49 (0)30- 531437-930 Geschäftsführer: Dr. rer. nat. Thomas Thiekötter Fax: +49 (0)30- 531437-939 E-Mail: info@dgn.org

 

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