Teduglutide, a novel mucosally active analog of glucagon‐like peptide‐2 (GLP‐2) for the treatment of moderate to severe Crohn's disease
Background: Teduglutide, an analog of glucagon‐like peptide‐2 (GLP‐2), is associated with trophic effects on gut mucosa. Its role in the treatment of active Crohn's disease (CD) was assessed in a pilot, randomized, placebo‐controlled, double‐blinded, dose‐ranging study. Methods: Subjects with m...
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| Veröffentlicht in: | Inflammatory bowel diseases 2010-06, Vol.16 (6), p.962-973 |
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| creator | Buchman, Alan L. Katz, Seymour Fang, John C. Bernstein, Charles N. Abou‐Assi, Souheil G. |
| description | Background:
Teduglutide, an analog of glucagon‐like peptide‐2 (GLP‐2), is associated with trophic effects on gut mucosa. Its role in the treatment of active Crohn's disease (CD) was assessed in a pilot, randomized, placebo‐controlled, double‐blinded, dose‐ranging study.
Methods:
Subjects with moderate‐to‐severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks. The primary outcome measure was the percentage of subjects in each group that responded to treatment, defined as a decrease in Crohn's Disease Activity Index (CDAI) score to 100 points. At week 8 there was an optional 12‐week open‐label period of treatment with teduglutide 0.10 mg/kg/d.
Results:
One hundred subjects were enrolled and 71 completed the study. The mean baseline CDAI score was 290.8 ± 57.6 and was similar across groups. There were numerically higher response and remission rates in all teduglutide‐treated groups as compared with placebo, although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group). Of subjects who had not achieved remission during the 8‐week placebo‐controlled phase in the higher‐dose group, 50% achieved remission during the more prolonged, open‐label treatment phase. Plasma citrulline was similar across groups at baseline, but increased substantially over time in all teduglutide groups when compared with placebo at week 8. Adverse events were not different between placebo and active treatment groups.
Conclusions:
Teduglutide is a novel and potentially effective therapy for inducing remission and mucosal healing in patients with active moderate‐to‐severe CD. Further clinical investigation of this growth factor is warranted. Inflamm Bowel Dis 2009 |
| doi_str_mv | 10.1002/ibd.21117 |
| format | Article |
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Teduglutide, an analog of glucagon‐like peptide‐2 (GLP‐2), is associated with trophic effects on gut mucosa. Its role in the treatment of active Crohn's disease (CD) was assessed in a pilot, randomized, placebo‐controlled, double‐blinded, dose‐ranging study.
Methods:
Subjects with moderate‐to‐severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks. The primary outcome measure was the percentage of subjects in each group that responded to treatment, defined as a decrease in Crohn's Disease Activity Index (CDAI) score to <150 or a decrease of > 100 points. At week 8 there was an optional 12‐week open‐label period of treatment with teduglutide 0.10 mg/kg/d.
Results:
One hundred subjects were enrolled and 71 completed the study. The mean baseline CDAI score was 290.8 ± 57.6 and was similar across groups. There were numerically higher response and remission rates in all teduglutide‐treated groups as compared with placebo, although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group). Of subjects who had not achieved remission during the 8‐week placebo‐controlled phase in the higher‐dose group, 50% achieved remission during the more prolonged, open‐label treatment phase. Plasma citrulline was similar across groups at baseline, but increased substantially over time in all teduglutide groups when compared with placebo at week 8. Adverse events were not different between placebo and active treatment groups.
Conclusions:
Teduglutide is a novel and potentially effective therapy for inducing remission and mucosal healing in patients with active moderate‐to‐severe CD. Further clinical investigation of this growth factor is warranted. Inflamm Bowel Dis 2009</description><identifier>ISSN: 1078-0998</identifier><identifier>EISSN: 1536-4844</identifier><identifier>DOI: 10.1002/ibd.21117</identifier><identifier>PMID: 19821509</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adolescent ; Adult ; citrullene ; Citrulline - blood ; Crohn Disease - drug therapy ; Crohn's disease ; Dose-Response Relationship, Drug ; Female ; Gastrointestinal Agents - therapeutic use ; Glucagon-Like Peptide 2 - adverse effects ; Glucagon-Like Peptide 2 - therapeutic use ; glucagon‐like peptide II ; Humans ; Male ; Middle Aged ; Peptides - adverse effects ; Peptides - therapeutic use ; teduglutide ; treatment ; Treatment Outcome ; Young Adult</subject><ispartof>Inflammatory bowel diseases, 2010-06, Vol.16 (6), p.962-973</ispartof><rights>Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4227-ebc5493de885ddbc729b28f3217b3a3aea509fa90f535ddff3d2f6fa5b42ba883</citedby><cites>FETCH-LOGICAL-c4227-ebc5493de885ddbc729b28f3217b3a3aea509fa90f535ddff3d2f6fa5b42ba883</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fibd.21117$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fibd.21117$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19821509$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buchman, Alan L.</creatorcontrib><creatorcontrib>Katz, Seymour</creatorcontrib><creatorcontrib>Fang, John C.</creatorcontrib><creatorcontrib>Bernstein, Charles N.</creatorcontrib><creatorcontrib>Abou‐Assi, Souheil G.</creatorcontrib><creatorcontrib>Teduglutide Study Group</creatorcontrib><title>Teduglutide, a novel mucosally active analog of glucagon‐like peptide‐2 (GLP‐2) for the treatment of moderate to severe Crohn's disease</title><title>Inflammatory bowel diseases</title><addtitle>Inflamm Bowel Dis</addtitle><description>Background:
Teduglutide, an analog of glucagon‐like peptide‐2 (GLP‐2), is associated with trophic effects on gut mucosa. Its role in the treatment of active Crohn's disease (CD) was assessed in a pilot, randomized, placebo‐controlled, double‐blinded, dose‐ranging study.
Methods:
Subjects with moderate‐to‐severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks. The primary outcome measure was the percentage of subjects in each group that responded to treatment, defined as a decrease in Crohn's Disease Activity Index (CDAI) score to <150 or a decrease of > 100 points. At week 8 there was an optional 12‐week open‐label period of treatment with teduglutide 0.10 mg/kg/d.
Results:
One hundred subjects were enrolled and 71 completed the study. The mean baseline CDAI score was 290.8 ± 57.6 and was similar across groups. There were numerically higher response and remission rates in all teduglutide‐treated groups as compared with placebo, although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group). Of subjects who had not achieved remission during the 8‐week placebo‐controlled phase in the higher‐dose group, 50% achieved remission during the more prolonged, open‐label treatment phase. Plasma citrulline was similar across groups at baseline, but increased substantially over time in all teduglutide groups when compared with placebo at week 8. Adverse events were not different between placebo and active treatment groups.
Conclusions:
Teduglutide is a novel and potentially effective therapy for inducing remission and mucosal healing in patients with active moderate‐to‐severe CD. Further clinical investigation of this growth factor is warranted. Inflamm Bowel Dis 2009</description><subject>Adolescent</subject><subject>Adult</subject><subject>citrullene</subject><subject>Citrulline - blood</subject><subject>Crohn Disease - drug therapy</subject><subject>Crohn's disease</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Glucagon-Like Peptide 2 - adverse effects</subject><subject>Glucagon-Like Peptide 2 - therapeutic use</subject><subject>glucagon‐like peptide II</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Peptides - adverse effects</subject><subject>Peptides - therapeutic use</subject><subject>teduglutide</subject><subject>treatment</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1078-0998</issn><issn>1536-4844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkclu2zAQhokiQbO0h75AwVtqoErELaKOqbMCBtpDehZG4tBRS4kOKTnwLS8QIM-YJwldG8gpKOYwC775B4OfkC8sP2Z5zk_a2hxzxljxgewzJU4zqaXcSXVe6CwvS71HDmL8k9AU5Ueyx0rNmcrLffJ0i2acu3FoDX6nQHu_REe7sfERnFtRaIZ2iRR6cH5OvaWJbWDu-5fHZ9f-RbrAxXo3tZx-u5r9WhcTan2gwx3SISAMHfbDerXzBgMMaeppxCUGpNPg7_qjSE0bESJ-IrsWXMTP23xIfl9e3E6vs9nPq5vp2SxrJOdFhnWjZCkMaq2MqZuClzXXVnBW1AIEIKTfLJS5VSIB1grD7akFVUteg9bikBxtdBfB348Yh6prY4POQY9-jFWhZDqgmPw_KYQSUhVFIicbsgk-xoC2WoS2g7CqWF6tbaqSTdU_mxL7das61h2aN3LrSwJONsBD63D1vlJ18-N8I_kKW9-gDA</recordid><startdate>201006</startdate><enddate>201006</enddate><creator>Buchman, Alan L.</creator><creator>Katz, Seymour</creator><creator>Fang, John C.</creator><creator>Bernstein, Charles N.</creator><creator>Abou‐Assi, Souheil G.</creator><general>Wiley Subscription Services, Inc., A Wiley Company</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>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>201006</creationdate><title>Teduglutide, a novel mucosally active analog of glucagon‐like peptide‐2 (GLP‐2) for the treatment of moderate to severe Crohn's disease</title><author>Buchman, Alan L. ; Katz, Seymour ; Fang, John C. ; Bernstein, Charles N. ; Abou‐Assi, Souheil G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4227-ebc5493de885ddbc729b28f3217b3a3aea509fa90f535ddff3d2f6fa5b42ba883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>citrullene</topic><topic>Citrulline - blood</topic><topic>Crohn Disease - drug therapy</topic><topic>Crohn's disease</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Glucagon-Like Peptide 2 - adverse effects</topic><topic>Glucagon-Like Peptide 2 - therapeutic use</topic><topic>glucagon‐like peptide II</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Peptides - adverse effects</topic><topic>Peptides - therapeutic use</topic><topic>teduglutide</topic><topic>treatment</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buchman, Alan L.</creatorcontrib><creatorcontrib>Katz, Seymour</creatorcontrib><creatorcontrib>Fang, John C.</creatorcontrib><creatorcontrib>Bernstein, Charles N.</creatorcontrib><creatorcontrib>Abou‐Assi, Souheil G.</creatorcontrib><creatorcontrib>Teduglutide Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Inflammatory bowel diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Buchman, Alan L.</au><au>Katz, Seymour</au><au>Fang, John C.</au><au>Bernstein, Charles N.</au><au>Abou‐Assi, Souheil G.</au><aucorp>Teduglutide Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Teduglutide, a novel mucosally active analog of glucagon‐like peptide‐2 (GLP‐2) for the treatment of moderate to severe Crohn's disease</atitle><jtitle>Inflammatory bowel diseases</jtitle><addtitle>Inflamm Bowel Dis</addtitle><date>2010-06</date><risdate>2010</risdate><volume>16</volume><issue>6</issue><spage>962</spage><epage>973</epage><pages>962-973</pages><issn>1078-0998</issn><eissn>1536-4844</eissn><abstract>Background:
Teduglutide, an analog of glucagon‐like peptide‐2 (GLP‐2), is associated with trophic effects on gut mucosa. Its role in the treatment of active Crohn's disease (CD) was assessed in a pilot, randomized, placebo‐controlled, double‐blinded, dose‐ranging study.
Methods:
Subjects with moderate‐to‐severe CD were randomized 1:1:1:1 to placebo or 1 of 3 doses of teduglutide (0.05, 0.10, or 0.20 mg/kg daily) delivered as a daily subcutaneous injection for 8 weeks. The primary outcome measure was the percentage of subjects in each group that responded to treatment, defined as a decrease in Crohn's Disease Activity Index (CDAI) score to <150 or a decrease of > 100 points. At week 8 there was an optional 12‐week open‐label period of treatment with teduglutide 0.10 mg/kg/d.
Results:
One hundred subjects were enrolled and 71 completed the study. The mean baseline CDAI score was 290.8 ± 57.6 and was similar across groups. There were numerically higher response and remission rates in all teduglutide‐treated groups as compared with placebo, although the percentage of subjects who achieved a clinical response or remission was more substantial, and seen as early as week 2 of treatment in the highest dose (0.2 mg/kg/d) group (44% response and 32% remission versus 32% response and 20% remission in the placebo group). Of subjects who had not achieved remission during the 8‐week placebo‐controlled phase in the higher‐dose group, 50% achieved remission during the more prolonged, open‐label treatment phase. Plasma citrulline was similar across groups at baseline, but increased substantially over time in all teduglutide groups when compared with placebo at week 8. Adverse events were not different between placebo and active treatment groups.
Conclusions:
Teduglutide is a novel and potentially effective therapy for inducing remission and mucosal healing in patients with active moderate‐to‐severe CD. Further clinical investigation of this growth factor is warranted. Inflamm Bowel Dis 2009</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>19821509</pmid><doi>10.1002/ibd.21117</doi><tpages>12</tpages></addata></record> |
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| ispartof | Inflammatory bowel diseases, 2010-06, Vol.16 (6), p.962-973 |
| issn | 1078-0998 1536-4844 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adolescent Adult citrullene Citrulline - blood Crohn Disease - drug therapy Crohn's disease Dose-Response Relationship, Drug Female Gastrointestinal Agents - therapeutic use Glucagon-Like Peptide 2 - adverse effects Glucagon-Like Peptide 2 - therapeutic use glucagon‐like peptide II Humans Male Middle Aged Peptides - adverse effects Peptides - therapeutic use teduglutide treatment Treatment Outcome Young Adult |
| title | Teduglutide, a novel mucosally active analog of glucagon‐like peptide‐2 (GLP‐2) for the treatment of moderate to severe Crohn's disease |
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