Abstract
Nocebo effects encompass negative responses to inert interventions in the research setting and negative outcomes with active treatments in the clinical research or practice settings, including new or worsening symptoms and adverse events, stemming from patients’ negative expectations and not the pharmacologic action of the treatment itself. Numerous personality, psychosocial, neurobiological, and contextual/environmental factors contribute to the development of nocebo effects, which can impair quality of life and reduce adherence to treatment. Biologics are effective agents widely used in autoimmune disease, but their high cost may limit access for patients. Biosimilar products have gained regulatory approval based on quality, safety, and efficacy comparable to that of originator biologics in rigorous study programs. In this review, we identified gaps in patients’ and healthcare professionals’ awareness, understanding, and perceptions of biosimilars that may result in negative expectations and nocebo effects, and may diminish their acceptance and clinical benefits. We also examined features of nocebo effects with biosimilar treatment that inform research and clinical practices. Namely, when biosimilars are introduced to patients as possible treatment options, we recommend adoption of nocebo-reducing strategies to avoid negative expectations, including delivery of balanced information on risk–benefit profiles, framing information to focus on positive attributes, and promoting shared decision-making processes along with patient empowerment. Healthcare professionals confident in their knowledge of biosimilars and aware of bias-inducing factors may help reduce the risk of nocebo effects and improve patients’ adherence in proposing biosimilars as treatment for autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease.
Highlights
The concept of a nocebo, developed as the negative equivalent of a placebo, has started to draw considerable attention in the clinical research and practice settings (Kennedy, 1961; Pouillon et al, 2018)
A systematic literature review was not performed, a literature search of PubMed was conducted for articles on nocebo effects and biosimilar therapy published between January 2015 and July 2018
Communications were increased for patients who consented to switch from originator etanercept to biosimilar SB4, but not for patients who consented to switch from originator infliximab to biosimilar CT-P13
Summary
The concept of a nocebo, developed as the negative equivalent of a placebo, has started to draw considerable attention in the clinical research and practice settings (Kennedy, 1961; Pouillon et al, 2018). Nocebo effects include negative responses to inert interventions administered in laboratory or clinical research (e.g., patients in randomized clinical trials receiving placebo, not active medication, are known to discontinue treatment as a result of adverse events) (Barsky et al, 2002). Nocebo effects encompass negative responses, or underlie the absence of positive responses, to active interventions in clinical trials or practice that cannot be explained by the medication's pharmacologic properties (Colloca and Miller, 2011). In the switching study conducted by Tweehuysen et al, an enhanced communication strategy may have increased acceptance and persistence rates among patients with rheumatic disease after they transitioned from an originator biologic to a biosimilar (Tweehuysen et al, 2017). Patients in the enhanced communications group, who were less likely to discontinue after transitioning to biosimilar therapy, received treatment via individual subcutaneous administration, whereas those in the no-enhanced communications group, who were more likely to discontinue after transitioning, received treatment via intravenous infusion in a group setting
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