Biological drugs have greatly improved the management of inflammatory diseases and the availability of biosimilar drugs over the last few years as well as reducing their costs. However, these are sometimes perceived as lower drugs with a consequent decrease in the feeling of effectiveness on the part of the patient. For this reason, some clinical recommendations have been published in Alimentary Pharmacology and Therapeutics regarding the prevention and management of the nocebo effect in patients with chronic inflammatory bowel disease (IBD) treated with biosimilar drugs.

The publication is the result of a group work, hosted by Humanitas last July, which saw the participation of 19 different specialists from 5 European countries. The multidisciplinary group, called “NOCE-BIO Consensus Group”, conducted a review of the scientific literature on the nocebo effect, with particular attention to information on its prevention and management in patients with IBD treated with biosimilars. The aim of the work was to draw up shared (consensual) recommendations based on scientific evidence.

The Consensus Group was also attended by specialists from Humanitas, such as Professor Silvio Danese, Head of the Centre for Chronic Inflammatory Bowel Diseases and coordinator of the Immuno-Center of Humanitas, Professor Carlo Selmi, Head of Rheumatology and Clinical Immunology, Professor Antonio Costanzo, Head of Dermatology, Professor Carmelo Carlo-Stella, Head of the Lymphoma, Myeloma and Experimental Therapies Section and Dr. Maria Fazio, Head of the Hospital Pharmacy Service.

What is the nocebo effect?

The nocebo effect is the negative effect of a medical treatment (pharmacological or not) and is induced by the expectations of patients and therefore is not related to the physiological action of the treatment. However, the nocebo effect can have a negative effect on the results of the treatment itself.

Nocebo effect is recognized as a clinical problem related to the use of biosimilars. Data on the transition from the original drug to the biosimilar in patients with immunomediated diseases, such as IBD, show a significant impact of the nocebo effect after the transition from the original drug to the biosimilar.

The work of the Consensus Group and its results

Following the review of the literature, a number of preliminary statements were made, which were then put to the vote at the Humanitas meeting. To be accepted, each statement must be voted on with a score of 4 (agree) or 5 (very agreeable), on a scale from 1 to 5 – by at least 75% of the participants.

At the end of the vote, consensus was reached for eleven statements, divided into three groups: general statements, prevention and management of the nosebleed effect, future scenarios.

The nocebo effect is certainly underestimated and is strongly influenced by patient factors and psychological mechanisms. Caution should therefore be exercised when assessing the side effects of treatment, as some may be related to the nocebo effect and all health care professionals who manage biosimilar drugs at various levels should be aware of this in order to adopt minimization strategies.

The relationship between the patient and the healthcare professional has been recognized as a key element in the acceptance of biosimilars. At the same time, insufficient knowledge of biosimilars by healthcare professionals and patients is clearly linked to an increase in the nocebo effect.

The need for research aimed at defining the extent of the problem on the one hand, and the existence of possible risk factors on the other, as well as measuring the impact of the nocebo effect on the response to biosimilar therapy is widely shared by the consensus group.