Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients
Summary Background The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes. Aim T...
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Veröffentlicht in: | Alimentary Pharmacology & Therapeutics (Suppl) 2019-05, Vol.49 (9), p.1181-1187 |
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creator | Pouillon, Lieven Danese, Silvio Hart, Ailsa Fiorino, Gionata Argollo, Marjorie Selmi, Carlo Carlo‐Stella, Carmelo Loeuille, Damien Costanzo, Antonio Lopez, Anthony Vegni, Elena Radice, Simona Gilardi, Daniela Socha, Marie Fazio, Maria González‐Lorenzo, Marien Bonovas, Stefanos Magro, Fernando Peyrin‐Biroulet, Laurent |
description | Summary
Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients. |
doi_str_mv | 10.1111/apt.15223 |
format | Article |
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Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients.</description><identifier>ISSN: 0269-2813</identifier><identifier>ISSN: 0953-0673</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.15223</identifier><identifier>PMID: 30932219</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Biosimilar Pharmaceuticals ; Biosimilar Pharmaceuticals - therapeutic use ; Chemical Sciences ; Consensus ; Disease management ; Europe ; Humans ; Inflammatory Bowel Diseases ; Inflammatory Bowel Diseases - drug therapy ; Italy ; Life Sciences ; Literature reviews ; Medical treatment ; Nocebo Effect ; Nocebos ; Patients ; Physics ; Physiological effects ; Placebo effect ; Practice Guidelines as Topic ; Risk factors ; Secondary Prevention ; Secondary Prevention - methods ; Secondary Prevention - standards ; Treatment Outcome</subject><ispartof>Alimentary Pharmacology & Therapeutics (Suppl), 2019-05, Vol.49 (9), p.1181-1187</ispartof><rights>2019 John Wiley & Sons Ltd</rights><rights>2019 John Wiley & Sons Ltd.</rights><rights>Copyright © 2019 John Wiley & Sons Ltd</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4533-7abebc627649716400417a1ec3530f9c4b82ef71aa84178d4d5c6f21e6c821863</citedby><cites>FETCH-LOGICAL-c4533-7abebc627649716400417a1ec3530f9c4b82ef71aa84178d4d5c6f21e6c821863</cites><orcidid>0000-0001-6102-6579 ; 0000-0003-2634-9668 ; 0000-0001-7341-1351 ; 0000-0003-2536-6618 ; 0000-0002-6745-2381 ; 0000-0001-8204-5701 ; 0000-0003-3144-0124 ; 0000-0002-9913-9090</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.15223$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.15223$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,309,310,314,776,780,785,786,881,1411,1427,23909,23910,25118,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30932219$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-lorraine.fr/hal-02923063$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Pouillon, Lieven</creatorcontrib><creatorcontrib>Danese, Silvio</creatorcontrib><creatorcontrib>Hart, Ailsa</creatorcontrib><creatorcontrib>Fiorino, Gionata</creatorcontrib><creatorcontrib>Argollo, Marjorie</creatorcontrib><creatorcontrib>Selmi, Carlo</creatorcontrib><creatorcontrib>Carlo‐Stella, Carmelo</creatorcontrib><creatorcontrib>Loeuille, Damien</creatorcontrib><creatorcontrib>Costanzo, Antonio</creatorcontrib><creatorcontrib>Lopez, Anthony</creatorcontrib><creatorcontrib>Vegni, Elena</creatorcontrib><creatorcontrib>Radice, Simona</creatorcontrib><creatorcontrib>Gilardi, Daniela</creatorcontrib><creatorcontrib>Socha, Marie</creatorcontrib><creatorcontrib>Fazio, Maria</creatorcontrib><creatorcontrib>González‐Lorenzo, Marien</creatorcontrib><creatorcontrib>Bonovas, Stefanos</creatorcontrib><creatorcontrib>Magro, Fernando</creatorcontrib><creatorcontrib>Peyrin‐Biroulet, Laurent</creatorcontrib><title>Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients</title><title>Alimentary Pharmacology & Therapeutics (Suppl)</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients.</description><subject>Biosimilar Pharmaceuticals</subject><subject>Biosimilar Pharmaceuticals - therapeutic use</subject><subject>Chemical Sciences</subject><subject>Consensus</subject><subject>Disease management</subject><subject>Europe</subject><subject>Humans</subject><subject>Inflammatory Bowel Diseases</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Italy</subject><subject>Life Sciences</subject><subject>Literature reviews</subject><subject>Medical treatment</subject><subject>Nocebo Effect</subject><subject>Nocebos</subject><subject>Patients</subject><subject>Physics</subject><subject>Physiological effects</subject><subject>Placebo effect</subject><subject>Practice Guidelines as Topic</subject><subject>Risk factors</subject><subject>Secondary Prevention</subject><subject>Secondary Prevention - methods</subject><subject>Secondary Prevention - standards</subject><subject>Treatment Outcome</subject><issn>0269-2813</issn><issn>0953-0673</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10b1u1TAYBmALgeihMHADyBILHdL6J7ETttNToJWOBEOZLcf5Ql0ldrCdom6dOnONXAlOT38kJLxY-vL4dawXobeUHNK8jvSUDmnFGH-GVpSLqmCEi-doRZhoClZTvodexXhJCBGSsJdoj5OGM0abFbrdeBfBxTniAJMP6SM2g3XW6CEPjB9HcJ1ONivc-4DTBeApwBW4ZYa16_Conf4B2SXs-zvgvIHWY-h7MAlbh1vrox3toMOfm98pgE7Q4bPjEzzl6HwwvkYvej1EeHO_76Pvnz-db06L7dcvZ5v1tjBlxXkhdQutEUyKspFUlISUVGoKhlec9I0p25pBL6nWdf5Qd2VXGdEzCsLUjNaC76ODXe6FHtQU7KjDtfLaqtP1Vi0zwhrGieBXNNsPOzsF_3OGmNRoo4Fh0A78HBVjhEpKhFjo-3_opZ-Dyy9ZlJQNqUr5dLkJPsYA_eMfUKKWIlUuUt0Vme27-8S5HaF7lA_NZXC0A7_sANf_T1Lrb-e7yL9uzaf6</recordid><startdate>201905</startdate><enddate>201905</enddate><creator>Pouillon, Lieven</creator><creator>Danese, Silvio</creator><creator>Hart, Ailsa</creator><creator>Fiorino, Gionata</creator><creator>Argollo, Marjorie</creator><creator>Selmi, Carlo</creator><creator>Carlo‐Stella, Carmelo</creator><creator>Loeuille, Damien</creator><creator>Costanzo, Antonio</creator><creator>Lopez, Anthony</creator><creator>Vegni, Elena</creator><creator>Radice, Simona</creator><creator>Gilardi, Daniela</creator><creator>Socha, Marie</creator><creator>Fazio, Maria</creator><creator>González‐Lorenzo, Marien</creator><creator>Bonovas, Stefanos</creator><creator>Magro, Fernando</creator><creator>Peyrin‐Biroulet, Laurent</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0001-6102-6579</orcidid><orcidid>https://orcid.org/0000-0003-2634-9668</orcidid><orcidid>https://orcid.org/0000-0001-7341-1351</orcidid><orcidid>https://orcid.org/0000-0003-2536-6618</orcidid><orcidid>https://orcid.org/0000-0002-6745-2381</orcidid><orcidid>https://orcid.org/0000-0001-8204-5701</orcidid><orcidid>https://orcid.org/0000-0003-3144-0124</orcidid><orcidid>https://orcid.org/0000-0002-9913-9090</orcidid></search><sort><creationdate>201905</creationdate><title>Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients</title><author>Pouillon, Lieven ; Danese, Silvio ; Hart, Ailsa ; Fiorino, Gionata ; Argollo, Marjorie ; Selmi, Carlo ; Carlo‐Stella, Carmelo ; Loeuille, Damien ; Costanzo, Antonio ; Lopez, Anthony ; Vegni, Elena ; Radice, Simona ; Gilardi, Daniela ; Socha, Marie ; Fazio, Maria ; González‐Lorenzo, Marien ; Bonovas, Stefanos ; Magro, Fernando ; Peyrin‐Biroulet, Laurent</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4533-7abebc627649716400417a1ec3530f9c4b82ef71aa84178d4d5c6f21e6c821863</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Biosimilar Pharmaceuticals</topic><topic>Biosimilar Pharmaceuticals - therapeutic use</topic><topic>Chemical Sciences</topic><topic>Consensus</topic><topic>Disease management</topic><topic>Europe</topic><topic>Humans</topic><topic>Inflammatory Bowel Diseases</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Italy</topic><topic>Life Sciences</topic><topic>Literature reviews</topic><topic>Medical treatment</topic><topic>Nocebo Effect</topic><topic>Nocebos</topic><topic>Patients</topic><topic>Physics</topic><topic>Physiological effects</topic><topic>Placebo effect</topic><topic>Practice Guidelines as Topic</topic><topic>Risk factors</topic><topic>Secondary Prevention</topic><topic>Secondary Prevention - methods</topic><topic>Secondary Prevention - standards</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pouillon, Lieven</creatorcontrib><creatorcontrib>Danese, Silvio</creatorcontrib><creatorcontrib>Hart, Ailsa</creatorcontrib><creatorcontrib>Fiorino, Gionata</creatorcontrib><creatorcontrib>Argollo, Marjorie</creatorcontrib><creatorcontrib>Selmi, Carlo</creatorcontrib><creatorcontrib>Carlo‐Stella, Carmelo</creatorcontrib><creatorcontrib>Loeuille, Damien</creatorcontrib><creatorcontrib>Costanzo, Antonio</creatorcontrib><creatorcontrib>Lopez, Anthony</creatorcontrib><creatorcontrib>Vegni, Elena</creatorcontrib><creatorcontrib>Radice, Simona</creatorcontrib><creatorcontrib>Gilardi, Daniela</creatorcontrib><creatorcontrib>Socha, Marie</creatorcontrib><creatorcontrib>Fazio, Maria</creatorcontrib><creatorcontrib>González‐Lorenzo, Marien</creatorcontrib><creatorcontrib>Bonovas, Stefanos</creatorcontrib><creatorcontrib>Magro, Fernando</creatorcontrib><creatorcontrib>Peyrin‐Biroulet, Laurent</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Alimentary Pharmacology & Therapeutics (Suppl)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pouillon, Lieven</au><au>Danese, Silvio</au><au>Hart, Ailsa</au><au>Fiorino, Gionata</au><au>Argollo, Marjorie</au><au>Selmi, Carlo</au><au>Carlo‐Stella, Carmelo</au><au>Loeuille, Damien</au><au>Costanzo, Antonio</au><au>Lopez, Anthony</au><au>Vegni, Elena</au><au>Radice, Simona</au><au>Gilardi, Daniela</au><au>Socha, Marie</au><au>Fazio, Maria</au><au>González‐Lorenzo, Marien</au><au>Bonovas, Stefanos</au><au>Magro, Fernando</au><au>Peyrin‐Biroulet, Laurent</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients</atitle><jtitle>Alimentary Pharmacology & Therapeutics (Suppl)</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2019-05</date><risdate>2019</risdate><volume>49</volume><issue>9</issue><spage>1181</spage><epage>1187</epage><pages>1181-1187</pages><issn>0269-2813</issn><issn>0953-0673</issn><eissn>1365-2036</eissn><abstract>Summary
Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30932219</pmid><doi>10.1111/apt.15223</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-6102-6579</orcidid><orcidid>https://orcid.org/0000-0003-2634-9668</orcidid><orcidid>https://orcid.org/0000-0001-7341-1351</orcidid><orcidid>https://orcid.org/0000-0003-2536-6618</orcidid><orcidid>https://orcid.org/0000-0002-6745-2381</orcidid><orcidid>https://orcid.org/0000-0001-8204-5701</orcidid><orcidid>https://orcid.org/0000-0003-3144-0124</orcidid><orcidid>https://orcid.org/0000-0002-9913-9090</orcidid></addata></record> |
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subjects | Biosimilar Pharmaceuticals Biosimilar Pharmaceuticals - therapeutic use Chemical Sciences Consensus Disease management Europe Humans Inflammatory Bowel Diseases Inflammatory Bowel Diseases - drug therapy Italy Life Sciences Literature reviews Medical treatment Nocebo Effect Nocebos Patients Physics Physiological effects Placebo effect Practice Guidelines as Topic Risk factors Secondary Prevention Secondary Prevention - methods Secondary Prevention - standards Treatment Outcome |
title | Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients |
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