Clinical utility of ustekinumab in Crohn's disease.
Identifieur interne : 000803 ( Main/Exploration ); précédent : 000802; suivant : 000804Clinical utility of ustekinumab in Crohn's disease.
Auteurs : Paulo Gustavo Kotze [Canada, Brésil] ; Christopher Ma [Canada] ; Abdulelah Almutairdi [Canada, Arabie saoudite] ; Remo Panaccione [Canada]Source :
- Journal of inflammation research [ 1178-7031 ] ; 2018.
Abstract
The introduction of anti-tumor necrosis factor (TNF) therapy marked an important milestone in the management of moderate-to-severe Crohn's disease (CD). However, there remains a pressing demand for alternative therapeutic options for patients with primary nonresponse, secondary loss of response, or intolerable side effects to conventional treatment and TNF antagonists. Ustekinumab (UST) is a fully human IgG1κ monoclonal antibody that inhibits the p40 subunit shared by the proinflammatory cytokines, the interleukin (IL)-12 and -23. This blockade leads to dampening of the inflammatory cascade and differentiation of inflammatory T cells. The clinical development program for UST in CD includes dose finding Phase II (Crohn's Evaluation of Response to Ustekinumab Anti-Interleukin-12/23 for Induction [CERTIFI]) and the pivotal Phase III (UNITI) trials that demonstrated both the clinical efficacy and safety in anti-TNF-naive and anti-TNF-exposed patients. Real-world evidence has further defined the role of UST in CD management. In this review, we discuss the mechanism of action of UST, describe the results of the randomized controlled trials with this agent, and review the real-world efficacy and safety data from observational cohorts. Finally, we identify areas of future research in the IL-12/23 inflammatory pathway and discuss the positioning of this novel therapeutic option in CD treatment algorithms.
DOI: 10.2147/JIR.S157358
PubMed: 29445293
PubMed Central: PMC5810512
Affiliations:
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Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba</wicri:regionArea><wicri:noRegion>Curitiba</wicri:noRegion></affiliation></author><author><name sortKey="Ma, Christopher" sort="Ma, Christopher" uniqKey="Ma C" first="Christopher" last="Ma">Christopher Ma</name><affiliation wicri:level="4"><nlm:affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Almutairdi, Abdulelah" sort="Almutairdi, Abdulelah" uniqKey="Almutairdi A" first="Abdulelah" last="Almutairdi">Abdulelah Almutairdi</name><affiliation wicri:level="4"><nlm:affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.</nlm:affiliation><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh</wicri:regionArea><wicri:noRegion>Riyadh</wicri:noRegion></affiliation></author><author><name sortKey="Panaccione, Remo" sort="Panaccione, Remo" uniqKey="Panaccione R" first="Remo" last="Panaccione">Remo Panaccione</name><affiliation wicri:level="4"><nlm:affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author></analytic><series><title level="j">Journal of inflammation research</title><idno type="ISSN">1178-7031</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The introduction of anti-tumor necrosis factor (TNF) therapy marked an important milestone in the management of moderate-to-severe Crohn's disease (CD). However, there remains a pressing demand for alternative therapeutic options for patients with primary nonresponse, secondary loss of response, or intolerable side effects to conventional treatment and TNF antagonists. Ustekinumab (UST) is a fully human IgG1κ monoclonal antibody that inhibits the p40 subunit shared by the proinflammatory cytokines, the interleukin (IL)-12 and -23. This blockade leads to dampening of the inflammatory cascade and differentiation of inflammatory T cells. The clinical development program for UST in CD includes dose finding Phase II (Crohn's Evaluation of Response to Ustekinumab Anti-Interleukin-12/23 for Induction [CERTIFI]) and the pivotal Phase III (UNITI) trials that demonstrated both the clinical efficacy and safety in anti-TNF-naive and anti-TNF-exposed patients. Real-world evidence has further defined the role of UST in CD management. In this review, we discuss the mechanism of action of UST, describe the results of the randomized controlled trials with this agent, and review the real-world efficacy and safety data from observational cohorts. Finally, we identify areas of future research in the IL-12/23 inflammatory pathway and discuss the positioning of this novel therapeutic option in CD treatment algorithms.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">29445293</PMID><DateRevised><Year>2020</Year><Month>10</Month><Day>01</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1178-7031</ISSN><JournalIssue CitedMedium="Print"><Volume>11</Volume><PubDate><Year>2018</Year></PubDate></JournalIssue><Title>Journal of inflammation research</Title><ISOAbbreviation>J Inflamm Res</ISOAbbreviation></Journal><ArticleTitle>Clinical utility of ustekinumab in Crohn's disease.</ArticleTitle><Pagination><MedlinePgn>35-47</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.2147/JIR.S157358</ELocationID><Abstract><AbstractText>The introduction of anti-tumor necrosis factor (TNF) therapy marked an important milestone in the management of moderate-to-severe Crohn's disease (CD). However, there remains a pressing demand for alternative therapeutic options for patients with primary nonresponse, secondary loss of response, or intolerable side effects to conventional treatment and TNF antagonists. Ustekinumab (UST) is a fully human IgG1κ monoclonal antibody that inhibits the p40 subunit shared by the proinflammatory cytokines, the interleukin (IL)-12 and -23. This blockade leads to dampening of the inflammatory cascade and differentiation of inflammatory T cells. The clinical development program for UST in CD includes dose finding Phase II (Crohn's Evaluation of Response to Ustekinumab Anti-Interleukin-12/23 for Induction [CERTIFI]) and the pivotal Phase III (UNITI) trials that demonstrated both the clinical efficacy and safety in anti-TNF-naive and anti-TNF-exposed patients. Real-world evidence has further defined the role of UST in CD management. In this review, we discuss the mechanism of action of UST, describe the results of the randomized controlled trials with this agent, and review the real-world efficacy and safety data from observational cohorts. Finally, we identify areas of future research in the IL-12/23 inflammatory pathway and discuss the positioning of this novel therapeutic option in CD treatment algorithms.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kotze</LastName><ForeName>Paulo Gustavo</ForeName><Initials>PG</Initials><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ma</LastName><ForeName>Christopher</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Almutairdi</LastName><ForeName>Abdulelah</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Panaccione</LastName><ForeName>Remo</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2018</Year><Month>02</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>New Zealand</Country><MedlineTA>J Inflamm Res</MedlineTA><NlmUniqueID>101512684</NlmUniqueID><ISSNLinking>1178-7031</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Crohn’s disease</Keyword><Keyword MajorTopicYN="N">interleukin</Keyword><Keyword MajorTopicYN="N">ustekinumab</Keyword></KeywordList><CoiStatement>Disclosure CM is supported in part by the Canadian Institutes of Health Research and the Canadian Association of Gastroenterology. PGK has received consulting fees from AbbVie, Takeda, and Pfizer and speaker’s bureau fees from AbbVie, Takeda, Ferring, Pfizer, UCB, and Janssen. RP has received scientific advisory board fees from Abbott/AbbVie, Amgen, Janssen, Merck, Pfizer, Prometheus Laboratories, Salix Pharma, Shire, Takeda, and Warner Chilcott, consulting fees from Abbott/AbbVie, Amgen, Aptalis, Astra Zeneca, Baxter, BMS, Centocor, Elan/Biogen, Eisai, Ferring, GSK, Janssen, Merck, Millennium, Pfizer, Proctor & Gamble, Prometheus Therapeutics and Diagnostics, Schering-Plough, Shire, Takeda, UCB Pharma, and Warner Chilcott, research grants from Abbott/AbbVie, Amgen, Aptalis, Astra Zeneca, Baxter, BMS, Centocor, Eisai, Elan/Biogen, Ferring, GSK, Janssen, Merck, Millennium, Pfizer, Proctor & Gamble, Prometheus, Shire, Schering-Plough, Takeda, UCB Pharma, and Warner Chilcott, and speaker’s bureau fees from Abbott/AbbVie, Amgen, Aptalis, Astra Zeneca, Baxter, BMS, Centocor, Eisai, Elan/Biogen, Ferring, GSK, Janssen, Merck, Millennium, Pfizer, Proctor & Gamble, Prometheus, Schering-Plough, Shire, Takeda, UCB Pharma, and Warner Chilcott. The authors report no other conflicts of interest in this work.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2018</Year><Month>2</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2018</Year><Month>2</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>2</Month><Day>16</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">29445293</ArticleId><ArticleId IdType="doi">10.2147/JIR.S157358</ArticleId><ArticleId IdType="pii">jir-11-035</ArticleId><ArticleId IdType="pmc">PMC5810512</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Ann N Y Acad Sci. 2010 Jan;1183:211-21</Citation><ArticleIdList><ArticleId IdType="pubmed">20146717</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2002 May 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(5):833-839</Citation><ArticleIdList><ArticleId IdType="pubmed">28328624</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Arabie saoudite</li><li>Brésil</li><li>Canada</li></country><region><li>Alberta</li></region><settlement><li>Calgary</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><country name="Canada"><region name="Alberta"><name sortKey="Kotze, Paulo Gustavo" sort="Kotze, Paulo Gustavo" uniqKey="Kotze P" first="Paulo Gustavo" last="Kotze">Paulo Gustavo Kotze</name></region><name sortKey="Almutairdi, Abdulelah" sort="Almutairdi, Abdulelah" uniqKey="Almutairdi A" first="Abdulelah" last="Almutairdi">Abdulelah Almutairdi</name><name sortKey="Ma, Christopher" sort="Ma, Christopher" uniqKey="Ma C" first="Christopher" last="Ma">Christopher Ma</name><name sortKey="Panaccione, Remo" sort="Panaccione, Remo" uniqKey="Panaccione R" first="Remo" last="Panaccione">Remo Panaccione</name></country><country name="Brésil"><noRegion><name sortKey="Kotze, Paulo Gustavo" sort="Kotze, Paulo Gustavo" uniqKey="Kotze P" first="Paulo Gustavo" last="Kotze">Paulo Gustavo Kotze</name></noRegion></country><country name="Arabie saoudite"><noRegion><name sortKey="Almutairdi, Abdulelah" sort="Almutairdi, Abdulelah" uniqKey="Almutairdi A" first="Abdulelah" last="Almutairdi">Abdulelah Almutairdi</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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