Literature DB >> 26535119

Biologics in inflammatory bowel disease: what are the data?

Justin Côté-Daigneault1, Mickael Bouin2, Raymond Lahaie2, Jean-Frédéric Colombel3, Pierre Poitras2.   

Abstract

BACKGROUND: Over the last decade, biologics have gained an important place for the treatment of moderate to severe inflammatory bowel disease (IBD), and many randomized control trials have evaluated their efficacy. AIM: The goal of this review is to analyze the results of these trials and to highlight the evidence and indications emerging from these studies for their implementation in the management of IBD patients.
METHODS: A PubMed search was realized to screen high-quality clinical trials studying biologic agents currently available in clinics for the treatment of IBD. Words used were: "infliximab," "adalimumab," "certolizumab," "golimumab," "natalizumab," "vedolizumab," "ustekinumab," "azathioprine," "methotrexate," "Crohn's disease," and "ulcerative colitis."
RESULTS: In Crohn's disease, studies supporting induction and maintenance therapies were documented for infliximab, adalimumab, certolizumab, natalizumab, vedolizumab, and ustekinumab. Infliximab, adalimumab, and certolizumab have evidences for fistulizing Crohn's disease and only infliximab and adalimumab have evidences for mucosal healing. In ulcerative colitis, studies supporting induction, maintenance, and mucosal healing were found with infliximab, adalimumab, golimumab, and vedolizumab. Only infliximab was associated with evidences for combination therapy with thiopurine and acute severe colitis in ulcerative colitis.
CONCLUSION: Management with biologics in IBD patients is well validated by high-quality clinical trials.

Entities:  

Keywords:  Crohn's disease; Inflammatory bowel disease; biologics; clinical trials; ulcerative colitis

Year:  2015        PMID: 26535119      PMCID: PMC4625751          DOI: 10.1177/2050640615590302

Source DB:  PubMed          Journal:  United European Gastroenterol J        ISSN: 2050-6406            Impact factor:   4.623


  37 in total

1.  Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.

Authors:  Walter Reinisch; William J Sandborn; Daniel W Hommes; Geert D'Haens; Stephen Hanauer; Stefan Schreiber; Remo Panaccione; Richard N Fedorak; Mary Beth Tighe; Bidan Huang; Wendy Kampman; Andreas Lazar; Roopal Thakkar
Journal:  Gut       Date:  2011-01-05       Impact factor: 23.059

2.  Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial.

Authors:  Jean-Frédéric Colombel; William J Sandborn; Paul Rutgeerts; Robert Enns; Stephen B Hanauer; Remo Panaccione; Stefan Schreiber; Dan Byczkowski; Ju Li; Jeffrey D Kent; Paul F Pollack
Journal:  Gastroenterology       Date:  2006-11-29       Impact factor: 22.682

3.  Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial.

Authors:  Stephen B Hanauer; Brian G Feagan; Gary R Lichtenstein; Lloyd F Mayer; S Schreiber; Jean Frederic Colombel; Daniel Rachmilewitz; Douglas C Wolf; Allan Olson; Weihang Bao; Paul Rutgeerts
Journal:  Lancet       Date:  2002-05-04       Impact factor: 79.321

4.  Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease.

Authors:  Mamoru Watanabe; Toshifumi Hibi; Kathleen G Lomax; Susan K Paulson; Jingdong Chao; M Shamsul Alam; Anne Camez
Journal:  J Crohns Colitis       Date:  2011-08-26       Impact factor: 9.071

5.  Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial.

Authors:  David Laharie; Arnaud Bourreille; Julien Branche; Matthieu Allez; Yoram Bouhnik; Jerome Filippi; Frank Zerbib; Guillaume Savoye; Maria Nachury; Jacques Moreau; Jean-Charles Delchier; Jacques Cosnes; Elena Ricart; Olivier Dewit; Antonio Lopez-Sanroman; Jean-Louis Dupas; Franck Carbonnel; Gilles Bommelaer; Benoit Coffin; Xavier Roblin; Gert Van Assche; Maria Esteve; Martti Färkkilä; Javier P Gisbert; Philippe Marteau; Stephane Nahon; Martine de Vos; Denis Franchimont; Jean-Yves Mary; Jean-Frederic Colombel; Marc Lémann
Journal:  Lancet       Date:  2012-10-10       Impact factor: 79.321

6.  Ustekinumab induction and maintenance therapy in refractory Crohn's disease.

Authors:  William J Sandborn; Christopher Gasink; Long-Long Gao; Marion A Blank; Jewel Johanns; Cynthia Guzzo; Bruce E Sands; Stephen B Hanauer; Stephan Targan; Paul Rutgeerts; Subrata Ghosh; Willem J S de Villiers; Remo Panaccione; Gordon Greenberg; Stefan Schreiber; Simon Lichtiger; Brian G Feagan
Journal:  N Engl J Med       Date:  2012-10-18       Impact factor: 91.245

7.  Vedolizumab as induction and maintenance therapy for ulcerative colitis.

Authors:  Brian G Feagan; Paul Rutgeerts; Bruce E Sands; Stephen Hanauer; Jean-Frédéric Colombel; William J Sandborn; Gert Van Assche; Jeffrey Axler; Hyo-Jong Kim; Silvio Danese; Irving Fox; Catherine Milch; Serap Sankoh; Tim Wyant; Jing Xu; Asit Parikh
Journal:  N Engl J Med       Date:  2013-08-22       Impact factor: 91.245

8.  Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis.

Authors:  Remo Panaccione; Subrata Ghosh; Stephen Middleton; Juan R Márquez; Boyd B Scott; Laurence Flint; Hubert J F van Hoogstraten; Annie C Chen; Hanzhe Zheng; Silvio Danese; Paul Rutgeerts
Journal:  Gastroenterology       Date:  2014-02       Impact factor: 22.682

9.  Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.

Authors:  William J Sandborn; Brian G Feagan; Colleen Marano; Hongyan Zhang; Richard Strauss; Jewel Johanns; Omoniyi J Adedokun; Cynthia Guzzo; Jean-Frederic Colombel; Walter Reinisch; Peter R Gibson; Judith Collins; Gunnar Järnerot; Toshifumi Hibi; Paul Rutgeerts
Journal:  Gastroenterology       Date:  2013-06-02       Impact factor: 22.682

10.  Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial.

Authors:  Stephen B Hanauer; William J Sandborn; Paul Rutgeerts; Richard N Fedorak; Milan Lukas; Donald MacIntosh; Remo Panaccione; Douglas Wolf; Paul Pollack
Journal:  Gastroenterology       Date:  2006-02       Impact factor: 22.682

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  32 in total

Review 1.  Ustekinumab in Crohn's disease: evidence to date and place in therapy.

Authors:  Tal Engel; Uri Kopylov
Journal:  Ther Adv Chronic Dis       Date:  2016-07-06       Impact factor: 5.091

2.  A SPECIAL MEETING REVIEW EDITION: CCFA/Advances in Inflammatory Bowel Diseases 2015: Highlights in Ulcerative Colitis and Crohn's Disease: A Review of Selected Presentations From the CCFA/Advances in Inflammatory Bowel Diseases 2015 Clinical and Research Conference • December 10-12, 2015 • Orlando, FloridaSpecial Reporting on:• New and Future Adhesion Molecule-Based Therapies in IBD• Efficacy and Safety of Vedolizumab for Inflammatory Bowel Disease in Clinical Practice• A Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Ustekinumab, a Human IL-12/23p40 Monoclonal Antibody, in Moderate-Severe Crohn's Disease Refractory to Anti-TNFα: UNITI-1• Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease• Does Vedolizumab Affect Postoperative Outcomes in Patients Undergoing Abdominal Operations for Inflammatory Bowel Disease?PLUS Meeting Abstract Summaries With Expert Commentary by: Gary R. Lichtenstein, MDProfessor of MedicineDirector, Center for Inflammatory Bowel DiseaseUniversity of Pennsylvania Health SystemHospital of the University of PennsylvaniaPhiladelphia, Pennsylvania.

Authors: 
Journal:  Gastroenterol Hepatol (N Y)       Date:  2016-02

3.  Vitamin D deficiency in patients with either rheumatic diseases or inflammatory bowel diseases on biologic therapy.

Authors:  Vincenzo Bruzzese; Angelo Zullo; Andrea Picchianti Diamanti; Lorenzo Ridola; Roberto Lorenzetti; Cinzia Marrese; Palma Scolieri; Vincenzo De Francesco; Cesare Hassan; Alberto Migliore; Bruno Laganà
Journal:  Intern Emerg Med       Date:  2016-03-03       Impact factor: 3.397

4.  Relapse From Deep Remission After Therapeutic De-escalation in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.

Authors:  Bing Zhang; Alakh Gulati; Omeed Alipour; Ling Shao
Journal:  J Crohns Colitis       Date:  2020-10-05       Impact factor: 9.071

5.  Cost of Illness in Inflammatory Bowel Disease.

Authors:  Nagesh Kamat; C Ganesh Pai; M Surulivel Rajan; Asha Kamath
Journal:  Dig Dis Sci       Date:  2017-08-01       Impact factor: 3.199

Review 6.  Biosimilars in rheumatic diseases: structural and functional variability that may impact clinical and regulatory decisions.

Authors:  Amit Lakhanpal; Ernest Brahn
Journal:  Clin Rheumatol       Date:  2016-10-06       Impact factor: 2.980

7.  LINGO3 regulates mucosal tissue regeneration and promotes TFF2 dependent recovery from colitis.

Authors:  Kelly M Zullo; Bonnie Douglas; Nicole M Maloney; Yingbiao Ji; Yun Wei; Karl Herbine; Rachel Cohen; Christopher Pastore; Zvi Cramer; Xin Wang; Wenjie Wei; Ma Somsouk; Li Yin Hung; Christopher Lengner; Michael H Kohanski; Noam A Cohen; De'Broski R Herbert
Journal:  Scand J Gastroenterol       Date:  2021-05-03       Impact factor: 2.423

8.  Cost-effectiveness of biological treatment sequences for fistulising Crohn's disease across Europe.

Authors:  Petra Baji; László Gulácsi; Valentin Brodszky; Zsuzsanna Végh; Silvio Danese; Peter M Irving; Laurent Peyrin-Biroulet; Stefan Schreiber; Fanni Rencz; Péter L Lakatos; Márta Péntek
Journal:  United European Gastroenterol J       Date:  2017-05-08       Impact factor: 4.623

9.  Biopsy-derived Intestinal Epithelial Cell Cultures for Pathway-based Stratification of Patients With Inflammatory Bowel Disease.

Authors:  Wiebe Vanhove; Kris Nys; Ingrid Arijs; Isabelle Cleynen; Manuel Noben; Sebastiaan De Schepper; Gert Van Assche; Marc Ferrante; Séverine Vermeire
Journal:  J Crohns Colitis       Date:  2018-01-24       Impact factor: 9.071

Review 10.  Assessment of Vedolizumab Disease-Drug-Drug Interaction Potential in Patients With Inflammatory Bowel Diseases.

Authors:  Wan Sun; Richard A Lirio; Jennifer Schneider; Jiri Aubrecht; Harisha Kadali; Mike Baratta; Parul Gulati; Ajit Suri; Tiffany Lin; Raghavan Vasudevan; Maria Rosario
Journal:  Clin Pharmacol Drug Dev       Date:  2020-12-16
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