A new consensus report calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.
The nocebo effect, whereby a patient experiences a worsening of symptoms or poor outcomes because of negative beliefs about a given therapy rather than because of the therapy itself, has been the subject of increased discussion among biosimilar stakeholders. Recent months have seen the publication of a systematic review concluding that higher-than-expected discontinuation rates of biosimilars could be due to the effect, and another paper called for strategies to address the potential for the nocebo effect to impact patient outcomes. This week, a consensus report, published in Alimentary Pharmacology and Therapeutics, calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.
The consensus group, comprising 19 members from 5 European countries and including 7 gastroenterologists, 3 pharmacists, 2 oncologists, 2 rheumatologists, 2 methodologists, 1 dermatologist, 1 psychologist, and 1 nurse specialist in inflammatory bowel disease (IBD), sought to review the literature on the nocebo effect and its prevention and management in patients with IBD who receive biosimilars.
Three members of the group conducted a literature search up to July 2018, and 13 members of the group participated in a meeting during which they voted on their level of agreement with statements developed by 3 of the members.
The literature review revealed that the nocebo effect occurred in 12.8% of patients in 1 study of patients with immune-mediated inflammatory diseases, and that similar rates were observed in patients with IBD and those with rheumatic diseases. Predictors for the effect that emerged from the review included “learning by social observations,” “perceived dose,” “verbal suggestions of arousal and symptoms,” “type of clinical condition,” and “baseline symptom expectations.” An additional 4 patient factors that enhanced the risk of nocebo included learning by classical conditioning,” “likelihood suggestion,” “self‐awareness,” and “negative affect.” The authors add that only limited, indirect evidence exists to describe the impact of the nocebo effect, and interventional data on the prevention and management of the nocebo effect in biosimilar-treated patients with IBD do not exist.
The group reached a consensus on 11 statements, each of which gained 77% to 100% acceptance, all on the basis of very low-quality evidence:
Funding for the consensus group was provided by biosimilar developers Sandoz, Pfizer, Celltrion, Biogen, and Samsung Bioepis through unrestricted grants.
Pouillon L, Danese S, Hart A, et al. Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar-treated IBD patients [published online April 1, 2019]. Aliment Pharmacol Ther. doi: 10.1111/apt.15223.