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Biosimilars und der Nocebo-Effekt

Biosimilars and the nocebo effect

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Zusammenfassung

In Deutschland sind seit vielen Jahren Biosimilars zugelassen, seit wenigen Jahren auch in der Rheumatologie. Zwar haben die Biosimilars, die wie die Referenzbiologika biotechnologisch hergestellten Produkte sind, inzwischen in einigen Regionen schon erheblich Marktanteile erreicht, es gibt aber bei Patienten und Ärzten immer noch viele Zweifler, die einen Qualitätsverlust befürchten – auch, wenn es dafür keinen Anhalt gibt. Ein Teil dieses Problems ist durch den Nocebo-Effekt zu erklären, der aber auch darüber hinaus eine erhebliche medizinische Bedeutung hat. Dieser Effekt wird in diesem Artikel beschrieben und erläutert. Psychosoziale und kontextbezogene Faktoren wie die Beziehung zwischen Patient und Arzt, frühere Behandlungserfahrungen und Behandlungserwartungen können die Wirksamkeit einer therapeutischen Intervention entweder verbessern oder beeinträchtigen. Diese Phänomene werden üblicherweise als Placebo- und Nocebo-Effekte bezeichnet. Da Placebo- und Nocebo-Effekte die Symptomentwicklung, die Häufigkeit unerwünschter Ereignisse und die Wirksamkeit der Behandlung beeinflussen können, ist es entscheidend, diese Effekte zu kennen und Strategien zur Prävention zu entwickeln, um die Behandlungsergebnisse zu optimieren. Während experimentelle Studien in den letzten Jahren wesentliche Fortschritte bei der Aufklärung der psychosozialen und neurobiologischen Mechanismen von Placebo-Effekten erzielt haben, sind die detaillierten Mechanismen von Nocebo-Effekten noch weitgehend unerforscht. Ein besseres Verständnis dieser Mechanismen verspricht die Entwicklung benutzerfreundlicher Strategien für die klinische Versorgung zur Verbesserung der Behandlungsergebnisse und der Patientenzufriedenheit.

Abstract

Biosimilars have been approved for use in Germany for many years and in the meantime also in rheumatology but only a few years ago. Biosimilars, which are biotechnologically manufactured products the same as reference biologicals, have actually now achieved a substantial proportion of the market in some regions but there are still doubters among patients and physicians who fear a loss of quality even if there is no evidence for this. A part of this problem can be explained by the nocebo effect but which furthermore also has a substantial medical importance. This effect is described and explained in this article. Psychosocial and context-related factors, such as the relationship between patient and physician, previous experience with treatment and treatment expectations can either improve or impair the efficacy of treatment interventions. These phenomena are commonly known as placebo and nocebo effects. As placebo and nocebo effects can influence the development of symptoms, the frequency of undesired events and the efficacy of treatment, it is decisive to know these effects and to develop strategies for prevention in order to optimize the treatment results. Although in recent years experimental studies have achieved substantial progress in the clarification of the psychosocial and neurobiological mechanisms of placebo effects, detailed mechanisms of nocebo effects are still widely unexplored. An improved understanding of these mechanisms promises the development of user-friendly strategies for the clinical care to improve treatment results and patient satisfaction.

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  1. Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Claudiusstr. 45, 44649, Herne, Deutschland

    J. Braun, S. Tsiami, B. Buehring, D. Kiefer, I. Andreica, X. Baraliakos &  U. Kiltz

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J. Braun hat Honorare für Vorträge, Advisory boards, bezahlte Beratungen und finanzielle Unterstützung für Studien von Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis und UCB erhalten. U. Kiltz hat Honorare für Vorträge, Advisory boards, bezahlte Beratungen und finanzielle Unterstützung für Studien von AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche und UCB sowie Forschungsunterstützung (unrestricted grant) von Abbvie, Biogen, Novartis und Pfizer erhalten. X. Baraliakos hat Beraterhonorare, Forschungsunterstützung und Bildungszuschüsse von AbbVie, BMS, Celgene, Chugai, Galapagos, Janssen, Lilly, MSD, Novartis, Mylan, Pfizer, Sandoz und UCB erhalten. B. Buehring hat Honorare für Vorträge, Advisory boards, bezahlte Beratungen von GE/Lunar, Kinemed, Janssen, UCB, Lilly, AbbVie und Gilead erhalten. I. Andreica hat Berater- und/oder Referentenhonorare von den Firmen AbbVie, Chugai, Eli Lilly, MSD, Novartis und Pfizer erhalten. D. Kiefer hat Honorare für Vorträge und advisory boards von Abbvie, Chugai/Roche, Janssen, Merck, Novartis, Sandoz und UCB erhalten. S. Tsiami gibt an, dass kein Interessenkonflikt besteht.

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Braun, J., Tsiami, S., Buehring, B. et al. Biosimilars und der Nocebo-Effekt. Z Rheumatol 79, 267–275 (2020). https://doi.org/10.1007/s00393-019-00729-7

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