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dc.contributor.authorColloca, L.
dc.contributor.authorPanaccione, R.
dc.contributor.authorMurphy, T.K.
dc.date.accessioned2019-12-25T18:07:11Z
dc.date.available2019-12-25T18:07:11Z
dc.date.issued2019
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85076570813&doi=10.3389%2ffphar.2019.01372&partnerID=40&md5=801ccdf2e1119706f501c8542a032576
dc.identifier.urihttp://hdl.handle.net/10713/11547
dc.description.abstractNocebo 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. Copyright 2019 Colloca, Panaccione and Murphy.en_US
dc.description.sponsorshipThis work was funded by Pfizer Inc.en_US
dc.description.urihttps://doi.org/10.3389/fphar.2019.01372en_US
dc.language.isoen_USen_US
dc.publisherFrontiers Media S.A.en_US
dc.relation.ispartofFrontiers in Pharmacology
dc.subjectBiosimilaren_US
dc.subjectNocebo effecten_US
dc.subjectPatient's expectanciesen_US
dc.subjectPatient–clinician communicationen_US
dc.subjectPlacebo effecten_US
dc.titleThe clinical implications of nocebo effects for biosimilar therapyen_US
dc.typeArticleen_US
dc.identifier.doi10.3389/fphar.2019.01372


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