The nocebo effect: a clinical challenge in the era of biosimilars

ABSTRACT

Introduction: The nocebo effect is defined as a negative effect of a pharmacological or non-pharmacological medical treatment that is induced by patients’ expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect is an important clinical challenge in the current era of biosimilars.

Areas covered: This review aims to answer five key questions about the nocebo effect, namely to reveal its definition, pathophysiology, clinical relevance, contributing factors, and management.

Expert commentary: The nocebo effect lowers patients’ quality of life and negatively affects treatment adherence rates in biosimilar-treated patients. It may negatively impact on the cost-savings of biosimilars. Health-care providers in charge of biosimilar-treated patients need to be aware of the nocebo effect and adopt strategies to minimize it. They have to be well-informed and confident about the existing evidence about biosimilars. A good patient–physician relationship will improve patients’ acceptance of biosimilars, and limits the risk of inappropriate negative bias and the nocebo effect.

KEYWORDS:

• Biosimilars
• nocebo effect
• switching
• inflammatory bowel disease
• biologicals

Declaration of interest

L Pouillon received travel fees from Ferring and Takeda. S Danese has served as a speaker, a consultant and an advisory board member for Abbvie, Allergan, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Takeda, Mundipharma, Pfizer, Sandoz, Tigenix, UCB Pharma and Vifor. L Peyrin-Biroulet has received consulting fees from Abbvie, Amgen, Biogaran, Biogen, Boerhinger-Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Ferring, Forward Pharma, Genentech, H.A.C. Pharma, Hospira, Index Pharmaceuticals, Janssen, Lycera, Merck, Lilly, Mitsubishi, Norgine, Pfizer, Pharmacosmos, Pilège, Samsung Bioepis, Sandoz, Takeda, Tillots, and Vifor. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.