A randomised phase I study of etrolizumab (rhuMAb β7) in moderate to severe ulcerative colitis
Objective Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and...
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| Published in | Gut Vol. 62; no. 8; pp. 1122 - 1130 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BMJ Publishing Group Ltd and British Society of Gastroenterology
01.08.2013
BMJ Publishing Group LTD BMJ Group |
| Series | Original article |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0017-5749 1468-3288 1468-3288 |
| DOI | 10.1136/gutjnl-2011-301769 |
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| Abstract | Objective Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC. Design In the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD). Results In the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively. Conclusion Etrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted. |
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| AbstractList | Objective Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC. Design In the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD). Results In the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively. Conclusion Etrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted. Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC. In the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD). In the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively. Etrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted. ObjectiveEtrolizumab (rhuMAb beta 7, anti- beta 7, PRO145223) is a humanised monoclonal antibody targeting the beta 7 subunit of the heterodimeric integrins alpha 4 beta 7 and alpha E beta 7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC.DesignIn the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10mg/kg intravenous, 3.0mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5mg/kg SC (n=4), 1.5mg/kg SC (n=5), 3.0mg/kg SC (n=4), 4.0mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD).ResultsIn the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of beta 7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively.ConclusionEtrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted. Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC.OBJECTIVEEtrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC.In the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD).DESIGNIn the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD).In the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively.RESULTSIn the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively.Etrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted.CONCLUSIONEtrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted. |
| Author | Egen, Jackson Sturm, Andreas Williams, Marna Danilenko, Dimitri Rutgeerts, Paul J Visich, Jennifer Luca, Diana Keir, Mary Tang, Meina Wei, Xiaohui Schreiber, Stefan Mansfield, John C Bressler, Brian O'Byrne, Sharon Baumgart, Daniel C Hommes, Daan W Fedorak, Richard N |
| AuthorAffiliation | 6 Christian Albrechts University, Kiel, Germany 7 University of Newcastle upon Tyne, Newcastle upon Tyne, UK 2 University of Alberta, Edmonton, Alberta, Canada 4 U Charité Medical School, Humboldt-University of Berlin, Berlin, Germany 1 Department of Medicine, Division of Gastroenterology, University of Leuven, Leuven, Belgium 3 Center for Inflammatory Bowel Diseases, University of California Los Angeles, Los Angeles, California, USA 8 Genentech Research & Early Development, South San Francisco, California, USA 5 University of British Columbia, Vancouver, British Columbia, Canada |
| AuthorAffiliation_xml | – name: 8 Genentech Research & Early Development, South San Francisco, California, USA – name: 4 U Charité Medical School, Humboldt-University of Berlin, Berlin, Germany – name: 1 Department of Medicine, Division of Gastroenterology, University of Leuven, Leuven, Belgium – name: 7 University of Newcastle upon Tyne, Newcastle upon Tyne, UK – name: 3 Center for Inflammatory Bowel Diseases, University of California Los Angeles, Los Angeles, California, USA – name: 2 University of Alberta, Edmonton, Alberta, Canada – name: 5 University of British Columbia, Vancouver, British Columbia, Canada – name: 6 Christian Albrechts University, Kiel, Germany |
| Author_xml | – sequence: 1 givenname: Paul J surname: Rutgeerts fullname: Rutgeerts, Paul J email: paul.rutgeerts@uz.kuleuven.ac.be organization: Department of Medicine, Division of Gastroenterology, University of Leuven, Leuven, Belgium – sequence: 2 givenname: Richard N surname: Fedorak fullname: Fedorak, Richard N email: paul.rutgeerts@uz.kuleuven.ac.be organization: University of Alberta, Edmonton, Alberta, Canada – sequence: 3 givenname: Daan W surname: Hommes fullname: Hommes, Daan W email: paul.rutgeerts@uz.kuleuven.ac.be organization: Center for Inflammatory Bowel Diseases, University of California Los Angeles, Los Angeles, California, USA – sequence: 4 givenname: Andreas surname: Sturm fullname: Sturm, Andreas email: paul.rutgeerts@uz.kuleuven.ac.be organization: U Charité Medical School, Humboldt-University of Berlin, Berlin, Germany – sequence: 5 givenname: Daniel C surname: Baumgart fullname: Baumgart, Daniel C email: paul.rutgeerts@uz.kuleuven.ac.be organization: U Charité Medical School, Humboldt-University of Berlin, Berlin, Germany – sequence: 6 givenname: Brian surname: Bressler fullname: Bressler, Brian email: paul.rutgeerts@uz.kuleuven.ac.be organization: University of British Columbia, Vancouver, British Columbia, Canada – sequence: 7 givenname: Stefan surname: Schreiber fullname: Schreiber, Stefan email: paul.rutgeerts@uz.kuleuven.ac.be organization: Christian Albrechts University, Kiel, Germany – sequence: 8 givenname: John C surname: Mansfield fullname: Mansfield, John C email: paul.rutgeerts@uz.kuleuven.ac.be organization: University of Newcastle upon Tyne, Newcastle upon Tyne, UK – sequence: 9 givenname: Marna surname: Williams fullname: Williams, Marna email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 10 givenname: Meina surname: Tang fullname: Tang, Meina email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 11 givenname: Jennifer surname: Visich fullname: Visich, Jennifer email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 12 givenname: Xiaohui surname: Wei fullname: Wei, Xiaohui email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 13 givenname: Mary surname: Keir fullname: Keir, Mary email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 14 givenname: Diana surname: Luca fullname: Luca, Diana email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 15 givenname: Dimitri surname: Danilenko fullname: Danilenko, Dimitri email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 16 givenname: Jackson surname: Egen fullname: Egen, Jackson email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA – sequence: 17 givenname: Sharon surname: O'Byrne fullname: O'Byrne, Sharon email: paul.rutgeerts@uz.kuleuven.ac.be organization: Genentech Research & Early Development, South San Francisco, California, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22717454$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2013 |
| Copyright_xml | – notice: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions – notice: Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions – notice: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2013 |
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| DOI | 10.1136/gutjnl-2011-301769 |
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| Keywords | IBD basic research cell cycle rhuMAb β7 signal transduction IBD clinical IBD models drug development Etrolizumab apoptosis Crohn's disease IBD autoimmune disease antibody targeted therapy integrins dendritic cells genetics arthritis safety inflammatory bowel disorders pharmacokinetics cytokines ulcerative colitis immunology IBD–genetics |
| Language | English |
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| Snippet | Objective Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7,... Etrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are... ObjectiveEtrolizumab (rhuMAb beta 7, anti- beta 7, PRO145223) is a humanised monoclonal antibody targeting the beta 7 subunit of the heterodimeric integrins... |
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| SubjectTerms | Adolescent Adult Aged Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - blood Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized antibody targeted therapy Apoptosis arthritis autoimmune disease Cell adhesion & migration cell cycle Chronic illnesses Colitis, Ulcerative - blood Colitis, Ulcerative - drug therapy Crohn's disease cytokines Dendritic cells Dose-Response Relationship, Drug Double-Blind Method drug development Etrolizumab Female Gastrointestinal Agents - administration & dosage Gastrointestinal Agents - adverse effects Gastrointestinal Agents - blood Gastrointestinal Agents - therapeutic use genetics Headache Humans IBD IBD basic research IBD clinical IBD models IBD–genetics Immunoglobulins immunology Inflammation Inflammatory Bowel Disease inflammatory bowel disorders Infusions, Intravenous Injection Injections, Subcutaneous Integrins Intravenous administration Lymphocytes Male Middle Aged Migration Monoclonal antibodies Pharmacokinetics Remission Retention rhuMAb β7 safety Severity of Illness Index signal transduction Studies Treatment Outcome Ulcerative colitis Wound healing Young Adult |
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| Title | A randomised phase I study of etrolizumab (rhuMAb β7) in moderate to severe ulcerative colitis |
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