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3. Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn's Disease Who Failed Biologic Therapies: A National Cohort Study

Author

Liefferinckx, Claire, Verstockt, Bram, Gils, Ann, Noman, Maja, Van Kemseke, Catherine, Macken, Elisabeth, De Vos, Martine, Van Moerkercke, Wouter, Rahier, Jean-François, Bossuyt, Peter, Dutré, Joris, Humblet, Evelien, Staessen, Dirk, Peeters, Harald, Van Hootegem, Philippe, Louis, Edouard, Franchimont, Denis, Baert, Filip, Vermeire, Séverine, Belgian Inflammatory Bowel Disease Research and Development Group (BIRD group), Belgian Inflammatory Bowel Disease Research and Development Group [BIRD group], UCL - (MGD) Service de gastro-entérologie, and UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie

Subjects
Crohn’s disease, Male, Disease, Body Mass Index, Cohort Studies, 0302 clinical medicine, Belgium, Crohn Disease, Medicine, Gastro-entérologie, 030212 general & internal medicine, Child, Crohn's disease, Remission Induction, Gastroenterology, General Medicine, Middle Aged, Arthralgia, Biological Therapy, 030211 gastroenterology & hepatology, Female, Ustekinumab, medicine.drug, Cohort study, Adult, medicine.medical_specialty, Adolescent, effectiveness, ustekinumab, Vedolizumab, 03 medical and health sciences, Clinical, Young Adult, real-life cohort, Gastrointestinal Agents, Internal medicine, Humans, Adverse effect, Glucocorticoids, Aged, Retrospective Studies, Ankylosing spondylitis, business.industry, Tumor Necrosis Factor-alpha, medicine.disease, Clinical effectiveness, Concomitant, Human medicine, business
Abstract

Background: Ustekinumab [UST] was recently approved in Europe for the treatment of moderate to severe Crohn's disease [CD]. Long-term real-world data are currently scarce for CD patients previously exposed to several biologics. Methods: This is an observational, national, retrospective multicentre study. Patients received intravenous UST ~6 mg/kg at baseline, with 90 mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at Weeks 8, 16, and 52. Results: Data from 152 patients were analysed. All patients were exposed to at least one anti-TNFα agent, with 69.7% were exposed to even two anti-TNFα and vedolizumab. After 1 year, 42.1% and 25.7% of patients had experienced clinical response and clinical remission, respectively, and 38.8% and 24.3% had achieved steroid-free clinical response and remission, respectively; 38.8% of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at 1 year, and low body mass index [BMI] at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia was reported by 17.9% of patients at Week 8 and 13.5% of patients at Week 52. No impact of UST on arthralgia was observed in patients with concomitant ankylosing spondylitis [n = 17]. Others adverse events were reported in 7.2% of patients. Conclusions: This real-world cohort study confirms the effectiveness of UST in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with respect to adverse events. Podcast: This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2019

4. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study.

Author

Moens, Annick, van der Woude, Janneke CJ, Julsgaard, Mette, Humblet, Evelien, Sheridan, Juliette, Baumgart, Daniel, Gilletta De Saint-Joseph, Cyrielle, Nancey, Stéphane, Rahier, Jean François, Bossuyt, Peter, Cremer, Anneline, Dewit, Sophie, Eriksson, C, Hoentjen, Frank, Krause, Thomas, Louis, Edouard, Macken, Elisabeth, Milenkovic, Zoran, Nijs, Jochen, Posen, Annelies, Van Hootegem, Anneleen, Van Moerkercke, W., Vermeire, Séverine, Bar-Gil Shitrit, Ariella, Ferrante, Marc, Moens, Annick, van der Woude, Janneke CJ, Julsgaard, Mette, Humblet, Evelien, Sheridan, Juliette, Baumgart, Daniel, Gilletta De Saint-Joseph, Cyrielle, Nancey, Stéphane, Rahier, Jean François, Bossuyt, Peter, Cremer, Anneline, Dewit, Sophie, Eriksson, C, Hoentjen, Frank, Krause, Thomas, Louis, Edouard, Macken, Elisabeth, Milenkovic, Zoran, Nijs, Jochen, Posen, Annelies, Van Hootegem, Anneleen, Van Moerkercke, W., Vermeire, Séverine, Bar-Gil Shitrit, Ariella, and Ferrante, Marc

Abstract

Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain disease remission. Data on outcome of vedolizumab-exposed pregnancies (VDZE) are sparse., info:eu-repo/semantics/published

Published
2020

5. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study

Author

Moens, Annick, primary, van der Woude, C. Janneke, additional, Julsgaard, Mette, additional, Humblet, Evelien, additional, Sheridan, Juliette, additional, Baumgart, Daniel C., additional, Gilletta De Saint-Joseph, Cyrielle, additional, Nancey, Stéphane, additional, Rahier, Jean-François, additional, Bossuyt, Peter, additional, Cremer, Anneline, additional, Dewit, Sophie, additional, Eriksson, Carl, additional, Hoentjen, Frank, additional, Krause, Thomas, additional, Louis, Edouard, additional, Macken, Elisabeth, additional, Milenkovic, Zoran, additional, Nijs, Jochen, additional, Posen, Annelies, additional, Van Hootegem, Anneleen, additional, Van Moerkercke, Wouter, additional, Vermeire, Séverine, additional, Bar-Gil Shitrit, Ariella, additional, and Ferrante, Marc, additional

Published
2019
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6. Su1846 – Outcomes of Pregnancy in IBD Patietns Treated with Vedolizumab, Anti-TNF Or Conventional Therapy

Author

Moens, Annick, primary, Van Der Woude, Christien Janneke, additional, Julsgaard, Mette, additional, Sebastian, Shaji, additional, Arebi, Naila, additional, Alzinaty, Mohannad, additional, Humblet, Evelien, additional, Kok, Klaartje, additional, Sheridan, Juliette, additional, Gilletta, Cyrielle, additional, Nancey, Stephane, additional, Rahier, Jean-Francois, additional, Bossuyt, Peter, additional, Cremer, Anneline, additional, Dewit, Sophie, additional, Eriksson, Carl, additional, Hoentjen, Frank, additional, Krause, Thomas, additional, Louis, Edouard, additional, Macken, Elisabeth, additional, Milenkovic, Zoran, additional, Nijs, Jochen, additional, Posen, Annelies, additional, Van Hootegem, Anneleen, additional, Van Moerkercke, Wouter, additional, Vermeire, Severine, additional, Shitrit, Ariella Bar-Gil, additional, and Ferrante, Marc, additional

Published
2019
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7. Mo1910 – Long-Term Clinical Efficacy of Ustekinumab in Refractory Crohn’s Disease: A Multi-Centre Belgian Cohort Study

Author

Liefferinckx, Claire, primary, Verstockt, Bram, additional, Gils, Ann, additional, Noman, Maja, additional, Van Kemseke, Catherine, additional, Macken, Elisabeth, additional, De Vos, Martine, additional, Van Moerkercke, Wouter, additional, Rahier, Jean-Francois, additional, Bossuyt, Peter, additional, Dutré, Joris, additional, Humblet, Evelien, additional, Staessen, Dirk, additional, Peeters, Harald, additional, Van Hootegem, Philippe, additional, Louis, Edouard, additional, Franchimont, Denis, additional, Baert, Filip J., additional, and Vermeire, Severine, additional

Published
2019
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8. Mo1865 - Ustekinumab Induces Clinical and Biological Remission in Biologic Refractory Crohn's Disease Patients: A Real World Belgian Cohort Study

Author

Liefferinckx, Claire, primary, Verstockt, Bram, additional, Gils, Ann, additional, Noman, Maja, additional, Van Kemseke, Catherine, additional, Elisabeth, Macken, additional, De Vos, Martine, additional, Van Moerkercke, Wouter, additional, Rahier, Jean-Francois, additional, Bossuyt, Peter, additional, Dutré, Joris, additional, Humblet, Evelien, additional, Staessen, Dirk, additional, Peeters, Harald, additional, Van Hootegem, Philippe, additional, Louis, Edouard, additional, Franchimont, Denis, additional, Baert, Filip J., additional, and Vermeire, Severine, additional

Published
2018
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9. Sa1697 - Outcome of Pregnancies in Vedolizumab Treated Female IBD Patients

Author

Moens, Annick, primary, van Hoeve, Karen, additional, Humblet, Evelien, additional, Rahier, Jean-Francois, additional, Bossuyt, Peter, additional, Dewit, Sophie, additional, Franchimont, Denis, additional, Elisabeth, Macken, additional, Nijs, Jochen, additional, Posen, Annelies, additional, Van Hootegem, Anneleen, additional, Van Moerkercke, Wouter, additional, Vermeire, Severine, additional, and Ferrante, Marc, additional

Published
2018
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10. Tu1895 TOFACITINIB INDUCES CLINICAL AND ENDOSCOPIC REMISSION IN BIOLOGIC REFRACTORY ULCERATIVE COLITIS PATIENTS: A REAL-WORLD BELGIUM COHORT STUDY

Author

Cremer, Anneline, Lobaton, Triana, Vieujean, Sophie, Bossuyt, Peter, Rahier, Jean-Francois, Baert, Filip J., Dewit, Olivier, Macken, Elisabeth, Somers, Michaël, Vijverman, Anne, Van Hootegem, Philippe, Mana, Fazia, Willandt, Barbara, Caenepeel, Philip, Humblet, Evelien, D'Heygere, François, Verreth, Annelies, El Nawar, Abdo, Coenegrachts, Jean-Louis, Dewit, Sophie, De Coninck, Steven, Schoofs, Nele, Delen, Stefan, Dutré, Joris, Thienpont, Clara, Branden, Stijn Vanden, Staessen, Dirk, and Franchimont, Denis

Published
2020
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11. Outcome of Pregnancies in Female Patients With Inflammatory Bowel Diseases Treated With Vedolizumab.

Author

Moens, Annick, Hoeve, Karen van, Humblet, Evelien, Rahier, Jean-François, Bossuyt, Peter, Dewit, Sophie, Franchimont, Denis, Macken, Elisabeth, Nijs, Jochen, Posen, Annelies, Strubbe, Beatrijs, Hootegem, Anneleen Van, Moerkercke, Wouter Van, Vermeire, Séverine, Ferrante, Marc, and (BIRD), Belgian IBD Research and Development group

Abstract

Background and Aims Vedolizumab is an IgG1 anti-α4β7 integrin antibody approved for the treatment of inflammatory bowel diseases [IBD], but without clear safety data during conception, pregnancy and nursing. Animal studies showed that mucosal vascular addressin cell adhesion molecule 1 [MAdCAM-1] is expressed by maternal vessels in the placenta and recruits α4β7-expressing cells that are considered important for maternal/fetal tolerance. Blocking this interaction by vedolizumab might affect this process. We aimed to evaluate pregnancy outcomes in vedolizumab-treated female IBD patients. Methods We conducted a retrospective, multicentre Belgian observational study. Details on disease activity, prenatal complications, delivery and neonatal outcome were collected through a case report form. Results Twenty-four pregnancies were reported. Five women had active disease at conception and one patient flared during pregnancy. There were 23 live births. Complications were observed in 25% of pregnancies [premature rupture of membranes, pre-eclampsia, miscarriage, elective termination and stillbirth] and in 35% of infants [prematurity, intra-uterine growth retardation, small for gestational age and congenital malformations including hip dysplasia, pulmonary valve stenosis and Hirschprung's disease]. Vedolizumab was continued throughout pregnancy in two females and stopped in the 1st and 2nd trimester in five and 16 patients, respectively. For live born children, the median [interquartile range] gestational age, weight and Apgar score 5 min after birth were 39 [37–39.6] weeks, 3270 [3080–3585] grams and 10 [9–10], respectively. Conclusions Although several complications were observed, both in mothers and in newborns, no firm conclusions can be drawn. Awaiting prospective and controlled registries, vigilance and strict follow-up of pregnant patients treated with vedolizumab seems mandatory. [ABSTRACT FROM AUTHOR]

Published
2019
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12. Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial

Author

Van Assche, Gert, primary, Vermeire, Séverine, additional, Ballet, Vera, additional, Gabriels, Frederik, additional, Noman, Maja, additional, D'Haens, Geert, additional, Claessens, Christophe, additional, Humblet, Evelien, additional, Vande Casteele, Niels, additional, Gils, Ann, additional, and Rutgeerts, Paul, additional

Published
2011
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13. W1305 Efficacy and Safety Profile of Certolizumab Pegol: Results From the Compas Programme in Belgium

Author

Vermeire, Severine, primary, Van den Broeck, Karolien, additional, Noman, Maja, additional, Van de Mierop, Frank J., additional, Mana, Fazia, additional, Baert, Filip J., additional, Louis, Edouard, additional, Caenepeel, Philip, additional, Humblet, Evelien H., additional, Claessens, Christophe, additional, D'Haens, Geert R., additional, Holvoet, Joannes, additional, Moreels, Tom G., additional, Peeters, Harald, additional, Potvin, Philippe M., additional, Van Assche, Gert A., additional, Rutgeerts, Paul J., additional, and Franchimont, Denis, additional

Published
2010
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