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
Hauptverfasser: 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
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container_end_page 1187
container_issue 9
container_start_page 1181
container_title Alimentary Pharmacology & Therapeutics (Suppl)
container_volume 49
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
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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 &gt;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 &amp; Therapeutics (Suppl), 2019-05, Vol.49 (9), p.1181-1187</ispartof><rights>2019 John Wiley &amp; Sons Ltd</rights><rights>2019 John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2019 John Wiley &amp; 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 &amp; 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 &gt;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 ; 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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 &amp; 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 &gt;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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