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Anti-TNF-Biosimilars bei chronisch entzündlichen Darmerkrankungen

Was können Rheumatologen daraus lernen?

Anti-TNF biosimilars in chronic inflammatory bowel disease

What can rheumatologists learn from it?

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Zusammenfassung

Hintergrund

Der Patentablauf für Anti-TNF (Tumornekrosefaktor) bindende Antikörper erlaubt die Zulassung von Biosimilars.

Zielsetzung

Es erfolgen eine Zusammenfassung und Diskussion spezifischer Aspekte in der Therapie chronisch entzündlicher Darmerkrankungen mit Anti-TNF-Biosimilars.

Material und Methode

Ein Review und eine Kommentierung der vorhandenen Literatur wurden durchgeführt.

Ergebnisse

Die Therapie der chronisch entzündlichen Darmerkrankungen mit Anti-TNF neutralisierenden Proteinen weicht von der Anwendung bei rheumatischen Erkrankungen ab. Insbesondere die Medikamente Infliximab, Adalimumab und Golimumab haben in der Behandlung der chronisch entzündlichen Darmerkrankungen (CED) einen hohen Stellenwert als Erstlinientherapie. Die Etablierung von Biosimilars für Infliximab erfolgte vorwiegend an Indikationen aus dem rheumatologischen Formenkreis, da die hier verwendeten Aktivitätsindizes stabilere statistische Signale ergeben.

Schlussfolgerungen

Die Verwendung neuer Versionen für TNF bindende Antikörper bei Patienten mit chronisch entzündlichen Darmerkrankungen ist durch Extrapolation möglich. An die sich daraus ergebende kompetitive Situation ist die Hoffnung geknüpft, dass Wissenslücken zum „besten Einsatz“ von TNF-Antikörpern bei Morbus Crohn und Colitis ulcerosa (Einsatzzeitpunkt, Dosis) geschlossen werden.

Abstract

Background

The expiry of the patent for tumor necrosis factor (TNF)-binding antibodies allowed the approval of biosimilars.

Objectives

Assessment and discussion of specific aspects of anti-TNF biosimilars in the therapy of inflammatory bowel diseases.

Methods

Review and discussion of currently available literature.

Results

The use of TNF-binding antibodies differs between the therapy of rheumatoid disorders and inflammatory bowel diseases. Clinical proof of efficacy for biosimilars for infliximab has been achieved in rheumatoid diseases because activity indices are more stable than in inflammatory bowel diseases and require extrapolation. The TNF-binding antibodies, in particular infliximab, adalimumab and golimumab play a central role in the first-line therapy of inflammatory bowel diseases.

Conclusion

The use of TNF-binding biosimilars for patients suffering from inflammatory bowel diseases is possible through extrapolation. Competition should not only drive a price reduction but also a better clinical profiling of anti-TNF therapy for patients with inflammatory bowel diseases. Missing information for “best use” include optimal strategies for dosing and timing for introduction during the course of Crohn’s disease and ulcerative colitis.

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Einhaltung ethischer Richtlinien

Interessenkonflikt. S. Schreiber hat Vortrags- und/oder Beratungshonorare erhalten von AbbVie, Amgen, Boehringer-Ingelheim, Celltrion, Hospira, Janssen Cilag, Mundipharma, MSD und Takeda.

Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren.

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  1. Klinik für Innere Medizin I, Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr.12, 24105, Kiel, Deutschland

    S. Schreiber

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Schreiber, S. Anti-TNF-Biosimilars bei chronisch entzündlichen Darmerkrankungen. Z Rheumatol 74, 689–694 (2015). https://doi.org/10.1007/s00393-014-1488-7

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