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The Clinical Implications of Nocebo Effects for Biosimilar Therapy

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 pha...

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Detalles Bibliográficos
Autores principales: Colloca, Luana, Panaccione, Remo, Murphy, T. Kevin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6895996/
https://www.ncbi.nlm.nih.gov/pubmed/31849647
http://dx.doi.org/10.3389/fphar.2019.01372
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author Colloca, Luana
Panaccione, Remo
Murphy, T. Kevin
author_facet Colloca, Luana
Panaccione, Remo
Murphy, T. Kevin
author_sort Colloca, Luana
collection PubMed
description 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.
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spelling pubmed-68959962019-12-17 The Clinical Implications of Nocebo Effects for Biosimilar Therapy Colloca, Luana Panaccione, Remo Murphy, T. Kevin Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2019-11-29 /pmc/articles/PMC6895996/ /pubmed/31849647 http://dx.doi.org/10.3389/fphar.2019.01372 Text en Copyright © 2019 Colloca, Panaccione and Murphy http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Colloca, Luana
Panaccione, Remo
Murphy, T. Kevin
The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title_full The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title_fullStr The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title_full_unstemmed The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title_short The Clinical Implications of Nocebo Effects for Biosimilar Therapy
title_sort clinical implications of nocebo effects for biosimilar therapy
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6895996/
https://www.ncbi.nlm.nih.gov/pubmed/31849647
http://dx.doi.org/10.3389/fphar.2019.01372
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