{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T21:16:05Z","timestamp":1791234965955,"version":"4.1.0"},"reference-count":89,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2014,11,11]],"date-time":"2014-11-11T00:00:00Z","timestamp":1415664000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2015,3]]},"abstract":"<jats:p> Biological agents for inflammatory bowel diseases (IBD) targeting tumor necrosis factor (TNF) have changed the way to treat IBD refractory to standard medications and allowed us to reach new therapeutic goals such as mucosal healing and deep remission. A better understanding of the components of the pathological processes that are a hallmark of IBD has led to the development of a new family of biological agents in Crohn\u2019s disease and ulcerative colitis. Biosimilars, which are copy versions of currently licensed biological agents, will be soon available. The biosimilar of infliximab is as effective and as safe as its originator in rheumatologic conditions, while a new anti-TNF agent, namely golimumab, has been recently approved for refractory ulcerative colitis. Beyond TNF blockers, anti-adhesion molecules appear to be a potent drug class for IBD. Vedolizumab was recently approved for both Crohn\u2019s disease and ulcerative colitis. Numerous other compounds are in the pipeline. Ustekinumab looks very promising for Crohn\u2019s disease. Smad7 antisense oligonucleotide might enrich our armamentarium if preliminary data are confirmed in upcoming clinical trials. Herein, we review the efficacy and safety of new and emerging biological agents that are currently investigated in IBD clinical trials. <\/jats:p>","DOI":"10.1177\/1756283x14558193","type":"journal-article","created":{"date-parts":[[2014,11,13]],"date-time":"2014-11-13T01:16:18Z","timestamp":1415841378000},"page":"66-82","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":123,"title":["Current, new and future biological agents on the horizon for the treatment of inflammatory bowel diseases"],"prefix":"10.1177","volume":"8","author":[{"given":"Aurelien","family":"Amiot","sequence":"first","affiliation":[{"name":"Assistance Publique-H\u00f4pitaux de Paris, Paris Est Creteil University, Henri Mondor Hospital, Department of Gastroenterology and EA-EC2M3, Creteil, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy-Brabois, Universit\u00e9 de Lorraine, All\u00e9e du Morvan, 54511 Vandoeuvre-l\u00e8s-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2014,11,11]]},"reference":[{"key":"bibr1-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.2174\/1389450115666140915113503"},{"key":"bibr2-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.60"},{"key":"bibr3-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1586\/eci.12.82"},{"key":"bibr4-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.02.045"},{"key":"bibr5-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/41.10.1133"},{"key":"bibr6-1756283X14558193","doi-asserted-by":"crossref","unstructured":"Colombel J.F., Sandborn W.J., Rutgeerts P., Enns R., Hanauer S.B., Panaccione R. (2007) Adalimumab for maintenance of clinical response and remission in patients with Crohn\u2019s disease: the CHARM trial. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17241859 Gastroenterology 132: 52-65.","DOI":"10.1053\/j.gastro.2006.11.041"},{"key":"bibr7-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1104318"},{"key":"bibr8-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2013.06.007"},{"key":"bibr9-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-5173(03)00376-4"},{"key":"bibr10-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0060961"},{"key":"bibr11-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(13)60070-0"},{"key":"bibr12-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.392"},{"key":"bibr13-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-300904"},{"key":"bibr14-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(14)60530-8"},{"key":"bibr15-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.079137"},{"key":"bibr16-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(12)62179-9"},{"key":"bibr17-1756283X14558193","unstructured":"European Medicines Agency (2013) Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2013\/06\/WC500144124.pdf."},{"key":"bibr18-1756283X14558193","unstructured":"European Medicines Agency (2013) Inflectra \u2013 Summary of Opinion (Initial Authorisation). Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Summary_of_opinion_-_Initial_authorisation\/human\/002778\/WC500144831.pdf."},{"key":"bibr19-1756283X14558193","unstructured":"European Medicines Agency (2013) Refusal of the Marketing Authorisation for Xeljanz (Tofacitinib). Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Summary_of_opinion_-_Initial_authorisation\/human\/002542\/WC500146629.pdf."},{"key":"bibr20-1756283X14558193","unstructured":"European Medicines Agency (1995\u20132014) Clinical trials register. http:\/\/www.clinicaltrialsregister.eu (accessed June 2014)."},{"key":"bibr21-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.3109\/00365521.2013.845906"},{"key":"bibr22-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa042982"},{"key":"bibr23-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2008.06.007"},{"key":"bibr24-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.07.069"},{"key":"bibr25-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215734"},{"key":"bibr26-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020732"},{"key":"bibr27-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60140-9"},{"key":"bibr28-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)08512-4"},{"key":"bibr29-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.030"},{"key":"bibr30-1756283X14558193","unstructured":"ICH (2004) Comparability of biotechnological\/biological products subject to changes in their manufacturing process. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Available at: http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q5E\/Step4\/Q5E_Guideline.pdf"},{"key":"bibr31-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.01.012"},{"key":"bibr32-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1002\/art.34436"},{"key":"bibr33-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1002\/art.23383"},{"key":"bibr34-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051782"},{"key":"bibr35-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051847"},{"key":"bibr36-1756283X14558193","author":"Lautenschlager C.","year":"2013","journal-title":"Adv Drug Deliv Rev"},{"key":"bibr37-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/0092-8674(91)90393-D"},{"key":"bibr38-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60725-4"},{"key":"bibr39-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12639"},{"key":"bibr40-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2009.113"},{"key":"bibr41-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2012-303461"},{"key":"bibr42-1756283X14558193","first-page":"151","volume":"19","author":"Michelsen K.","year":"2013","journal-title":"Inflamm Bowel Dis"},{"key":"bibr43-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/mt.2011.290"},{"key":"bibr44-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1172\/JCI12821"},{"key":"bibr45-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.20148"},{"key":"bibr46-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60726-6"},{"key":"bibr47-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21896"},{"key":"bibr48-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203091"},{"key":"bibr49-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60995-2"},{"key":"bibr50-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-300049"},{"key":"bibr51-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2009.579"},{"key":"bibr52-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2013.53"},{"key":"bibr53-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.03.036"},{"key":"bibr54-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2011.68"},{"key":"bibr55-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S1873-9946(14)60636-X"},{"key":"bibr56-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2010.02.003"},{"key":"bibr57-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12477"},{"key":"bibr58-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050516"},{"key":"bibr59-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043335"},{"key":"bibr60-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2009.205443"},{"key":"bibr61-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.07.014"},{"key":"bibr62-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.05.048"},{"key":"bibr63-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.06.010"},{"key":"bibr64-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215739"},{"key":"bibr65-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1203572"},{"key":"bibr66-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1112168"},{"key":"bibr67-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.06.010"},{"key":"bibr68-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-12-200706190-00159"},{"key":"bibr69-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.10.032"},{"key":"bibr70-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S1873-9946(13)60012-4"},{"key":"bibr71-1756283X14558193","doi-asserted-by":"crossref","unstructured":"Schreiber S., Khaliq-Kareemi M., Lawrance I.C., Thomsen O.\u00d8., Hanauer S.B., McColm J. (2007) Maintenance therapy with certolizumab pegol for Crohn\u2019s disease. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17634459 N Engl J Med 357: 239\u2013250.","DOI":"10.1056\/NEJMoa062897"},{"key":"bibr72-1756283X14558193","doi-asserted-by":"crossref","unstructured":"Schreiber S., Rutgeerts P., Fedorak R.N., Khaliq-Kareemi M., Kamm M.A., Boivin M. (2005) A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn\u2019s disease. Gastroenterology http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=schreiber+2005+certolizumab 129: 807\u2013818.","DOI":"10.1053\/j.gastro.2005.06.064"},{"key":"bibr73-1756283X14558193","first-page":"CD008331","author":"Singh J.","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"bibr74-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.03.024"},{"key":"bibr75-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199710093371502"},{"key":"bibr76-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1186\/ar2740"},{"key":"bibr77-1756283X14558193","unstructured":"US Food and Drug Administration (2009) Natalizumab: Highlights of Prescribing Information. Available at: http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2008\/125104s106lbl.pdf"},{"key":"bibr78-1756283X14558193","unstructured":"US Food and Drug Administration (2012) Advisory Committee Meeting. Tofacitinib for the Treatment of Rheumatoid Arthritis. NDA 203214. Briefing Document. Available at: http:\/\/www.fda.gov\/downloads\/advisorycommittees\/committeesmeetingmaterials\/drugs\/arthritisadvisorycommittee\/ucm302960.pdf."},{"key":"bibr79-1756283X14558193","unstructured":"US Food and Drug Administration (2013) Draft Guidance on Biosimilar Product Development. Available at: http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/default.html."},{"key":"bibr80-1756283X14558193","unstructured":"US National Institutes of Health (2011) Clinicaltrials.Gov. http:\/\/www.clinicaltrials.gov (accessed June 2014)."},{"key":"bibr81-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051586"},{"key":"bibr82-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/j.expneurol.2014.04.002"},{"key":"bibr83-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60661-9"},{"key":"bibr84-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.1999.79.1.181"},{"key":"bibr85-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/ni.2366"},{"key":"bibr86-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2012-04-425744"},{"key":"bibr87-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1038\/nri3690"},{"key":"bibr88-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203090"},{"key":"bibr89-1756283X14558193","doi-asserted-by":"publisher","DOI":"10.1177\/0091270006298188"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X14558193","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1756283X14558193","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X14558193","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T16:44:02Z","timestamp":1740847442000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1756283X14558193"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,11,11]]},"references-count":89,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2015,3]]}},"alternative-id":["10.1177\/1756283X14558193"],"URL":"https:\/\/doi.org\/10.1177\/1756283x14558193","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,11,11]]}}}