Does the Nocebo Effect Contribute to Treatment Failure of Biosimilars?
In a review article published in Rheumatology and Therapy, researchers explored the possibility that the nocebo effect may contribute to loss of efficacy and/or adverse outcomes following a nonmedical switch from an originator to a biosimilar in patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases.
The nocebo effect was defined as a negative outcome or failure of therapy resulting from a patient’s negative expectations toward a new therapy or a change in therapy.
The researchers reviewed data from randomized controlled trials and real-world evidence studies on nonmedical switching from originators infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira) to their respective biosimilars.
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“Currently, the question of whether all patients who develop an adverse event or lose efficacy after a switch to a biosimilar is due to a nocebo effect or differences between the originator and biosimilar cannot be answered owing to lack of well-designed, prospective and properly conducted, blinded clinical trials with appropriate control groups that could accurately investigate this question,” said the researchers. They called for more robust and well-designed nonmedical switching studies to evaluate the impact of the nocebo effect.
Data from several studies suggest that some patients who experience treatment failure or have an adverse event after a nonmedical switch to a biosimilar may regain treatment control after switching back to the originator biologic.
Cost was also identified as a motivator for nonmedical switching. However, initial cost savings could be offset by poorer outcomes, treatment discontinuation, and associated costs of care (eg, additional physician and hospital visits) of switching to a biosimilar.
Because patients’ negative expectations are the driver of the nocebo effect, the researchers suggested that better informed and standardized patient education could help minimize the misconceptions about therapy changes and biosimilars, thereby reducing the potential for the nocebo effect.
The researchers also recommended involving patients in the decision to switch, noting that in some countries and by some insurers, nonmedical switching is mandated as a treatment strategy in patients who are doing well on originator therapy. However, they recommend that switching not be mandated, as forced switching may exacerbate patients’ negative expectations, potentially leading to greater likelihood of the nocebo effect.
“With biosimilars continuing to enter the market, understanding the potential reasons leading to nonmedical switch failures will enable providers to take appropriate steps to lower or prevent them,” concluded the researchers. —Eileen Koutnik-Fotopoulos
Reference
Fleischmann R, Jairath V, Mysler E, Nicholls D, Declerck P. Nonmedical switching from originators to biosimilars: Does the nocebo effect explain treatment failures and adverse events in rheumatology and gastroenterology? Rheumatol Ther. 2020;7(1):35-64.
