{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T09:32:54Z","timestamp":1792056774218,"version":"4.4.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2022,5,17]],"date-time":"2022-05-17T00:00:00Z","timestamp":1652745600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.<\/jats:p>\n                  <jats:p>We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn\u2019s disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti\u2013tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izac092","type":"journal-article","created":{"date-parts":[[2022,5,17]],"date-time":"2022-05-17T11:36:57Z","timestamp":1652787417000},"page":"376-383","source":"Crossref","is-referenced-by-count":25,"title":["Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5767-5541","authenticated-orcid":false,"given":"Antonio","family":"Tursi","sequence":"first","affiliation":[{"name":"Territorial Gastroenterology Service, ASL BAT , Andria , Italy"},{"name":"Department of Medical and Surgical Sciences, Post-graduate School of Digestive Diseases, Catholic University , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giammarco","family":"Mocci","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cBrotzu\u201d Hospital , Cagliari , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo","family":"Allegretta","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cSanta Caterina Novella\u201d Hospital , Galatina (LE) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Aragona","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cGuglielmo da Saliceto\u201d Hospital , Piacenza , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Antonia","family":"Bianco","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cT. Maresca\u201d Hospital , Torre del Greco (NA) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaele","family":"Colucci","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy Unit, \u201cSan Matteo degli Infermi\u201d Hospital , Spoleto (PG) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Cuomo","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cUmberto I\u201d Hospital , Nocera Inferiore (SA) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Della Valle","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cOspedali Riuniti\u201d Hospital , Foggia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Ferronato","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy Unit , ULSS7 Pedemontana, Santorso (VI) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Forti","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy Unit, \u201cS. Maria Goretti\u201d Hospital , Latina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Gaiani","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma , Parma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"GianMarco","family":"Giorgetti","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy and Nutritional Unit, \u201cS. Eugenio\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Giovanna","family":"Graziani","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cS. Giovanni - Addolorata\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katia","family":"Lofano","sequence":"additional","affiliation":[{"name":"National Institute of Gastroenterology IRCCS Saverio de Bellis. Castellana Grotte , Bari , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Lorenzetti","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cNuovo Regina Margherita\u201d Territorial Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiziana","family":"Larussa","sequence":"additional","affiliation":[{"name":"Department of Health Science, University of Catanzaro , Catanzaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Penna","sequence":"additional","affiliation":[{"name":"Territorial Gastroenterology Service, ASL BA , Bari , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Pica","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, IBD Unit, \u201cS. Pertini\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Pranzo","sequence":"additional","affiliation":[{"name":"Ambulatory for IBD Treatment, \u201cValle D\u2019Itria\u201d Hospital , Martina Franca (TA) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Rodino\u2019","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cCiaccio-Pugliese\u201d Hospital , Catanzaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Scarcelli","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cSan Salvatore\u201d Hospital , Pesaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Costantino","family":"Zampaletta","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cBelcolle\u201d Hospital , Viterbo , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabrio","family":"Bassotti","sequence":"additional","affiliation":[{"name":"Gastroenterology & Hepatology Section, Department of Medicine & Surgery, University of Perugia , Perugia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia Immacolata","family":"Cazzato","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cSanta Caterina Novella\u201d Hospital , Galatina (LE) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Chiri","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cSanta Caterina Novella\u201d Hospital , Galatina (LE) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Clemente","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy and Nutritional Unit, \u201cS. Eugenio\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Cocco","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, IBD Unit, \u201cS. Pertini\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluigi","family":"de\u2019 Angelis","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma , Parma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Donnarumma","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cUmberto I\u201d Hospital , Nocera Inferiore (SA) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Faggiani","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cS. Camillo\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla","family":"Graziosi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cBelcolle\u201d Hospital , Viterbo , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Le Grazie","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma , Parma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Luzza","sequence":"additional","affiliation":[{"name":"Department of Health Science, University of Catanzaro , Catanzaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Costantino","family":"Meucci","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cT. Maresca\u201d Hospital , Torre del Greco (NA) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Monterubbianesi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cS. Camillo\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiano","family":"Pagnini","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cS. Giovanni - Addolorata\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizia","family":"Perazzo","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cSanta Caterina Novella\u201d Hospital , Galatina (LE) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcello","family":"Picchio","sequence":"additional","affiliation":[{"name":"Division of General Surgery, \u201cP. Colombo\u201d Hospital , ASL Roma 6, Velletri (Roma) , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodolfo","family":"Sacco","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cOspedali Riuniti\u201d Hospital , Foggia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladislava","family":"Sebkova","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cCiaccio-Pugliese\u201d Hospital , Catanzaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariaelena","family":"Serio","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cCiaccio-Pugliese\u201d Hospital , Catanzaro , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Napolitano","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Pugliese","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franco","family":"Scaldaferri","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"},{"name":"Catholic University, School of Medicine , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Schiavoni","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Turchini","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1572-0118","authenticated-orcid":false,"given":"Alessandro","family":"Armuzzi","sequence":"additional","affiliation":[{"name":"IBD Center, IRCCS Humanitas Research Hospital , Rozzano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Elisei","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cS. Camillo\u201d Hospital , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Maconi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, \u201cL. Sacco\u201d University Hospital , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Papa","sequence":"additional","affiliation":[{"name":"Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario \u201cA. Gemelli\u201d IRCCS Foundation , Rome , Italy"},{"name":"Catholic University, School of Medicine , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,5,17]]},"reference":[{"key":"2024012517160296200_CIT0001","doi-asserted-by":"crossref","first-page":"2769","DOI":"10.1016\/S0140-6736(17)32448-0","article-title":"Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies.","volume":"390","author":"Ng","year":"2017","journal-title":"Lancet."},{"key":"2024012517160296200_CIT0002","doi-asserted-by":"crossref","first-page":"s1","DOI":"10.1136\/gutjnl-2019-318484","article-title":"British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults.","volume":"68","author":"Lamb","year":"2019","journal-title":"Gut."},{"key":"2024012517160296200_CIT0003","doi-asserted-by":"crossref","first-page":"1291","DOI":"10.1111\/apt.14030","article-title":"Systematic review with meta-analysis: comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn\u2019s disease and ulcerative colitis controlled trials.","volume":"45","author":"Cholapranee","year":"2017","journal-title":"Aliment Pharmacol Ther."},{"key":"2024012517160296200_CIT0004","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1053\/j.gastro.2005.11.030","article-title":"Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn\u2019s disease: the CLASSIC-I trial.","volume":"130","author":"Hanauer","year":"2006","journal-title":"Gastroenterology."},{"key":"2024012517160296200_CIT0005","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1053\/j.gastro.2006.11.041","article-title":"Adalimumab for maintenance of clinical response and remission in patients with Crohn\u2019s disease: the CHARM trial.","volume":"132","author":"Colombel","year":"2007","journal-title":"Gastroenterology."},{"key":"2024012517160296200_CIT0006","doi-asserted-by":"crossref","first-page":"1771","DOI":"10.1038\/ajg.2014.242","article-title":"Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3.","volume":"109","author":"Colombel","year":"2014","journal-title":"Am J Gastroenterol."},{"key":"2024012517160296200_CIT0007","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1136\/gut.2010.221127","article-title":"Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.","volume":"60","author":"Reinisch","year":"2011","journal-title":"Gut."},{"key":"2024012517160296200_CIT0008","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1097\/MEG.0000000000002087","article-title":"Long-term real-life efficacy and safety of infliximab and adalimumab in the treatment of inflammatory bowel diseases outpatients.","volume":"33","author":"Tursi","year":"2021","journal-title":"Eur J Gastroenterol Hepatol."},{"key":"2024012517160296200_CIT0009","doi-asserted-by":"crossref","first-page":"73","DOI":"10.2147\/CEOR.S15988","article-title":"The economic burden of TNF\u03b1 inhibitors and other biologic treatments in Norway.","volume":"3","author":"Norum","year":"2011","journal-title":"Clinicoecon Outcomes Res."},{"key":"2024012517160296200_CIT0010","first-page":"24","article-title":"Innovation and competition: will biosimilars succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. 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