Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

Dig Liver Dis. 2023 Apr;55(4):442-453. doi: 10.1016/j.dld.2023.01.155.Epub 2023 Feb 13.


Fabio Salvatore Macaluso 1Claudio Papi 2Ambrogio Orlando 3Stefano Festa 2Daniela Pugliese 4Stefanos Bonovas 5Claudia Pansieri 5Daniele Piovani 5Gionata Fiorino 6Massimo Claudio Fantini 7Flavio Caprioli 8Marco Daperno 9Alessandro Armuzzi 10Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)Working panelReview panel


Lorenzo BertaniCristina BezzioGiorgia BodiniFabrizio BossaAndrea BudaEmma CalabreseFederica FurfaroSalvatore LeoneFilippo MocciaroSara OnaliLuca PastorelliEnrica PrevitaliMariabeatrice PrincipiSara RennaDavide Giuseppe RibaldoneAntonio RispoFernando RizzelloSimone SaibeniGianluca Matteo SampietroEdoardo SavarinoAnna TestaAngela VariolaAngelo ViscidoSandro ArdizzoneLivia BianconeMaria CappelloFabiana CastiglioneRachele CiccocioppoMichele ComberlatoFrancesco CostaRenata D'IncàSilvio DaneseAntonio Di SabatinoWalter FriesPaolo GionchettiGiovanni LatellaFrancesco MangusoMauro MastronardiGianmichele MeucciMonica MillaMaria Lia ScribanoMaurizio Vecchi


Author information

1IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy. Electronic address: fsmacaluso@gmail.com.

2IBD Unit, "San Filippo Neri" Hospital, Rome, Italy.

3IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy.

4CEMAD, IBD Unit, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.

5Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

6Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, Rome, Italy; Gastroenterology and Digestive Endoscopy, Vita-Salute San Raffaele University, Milan, Italy.

7Department of Medical Science and Public Health, University of Cagliari, University Hospital of Cagliari, Unit of Gastroenterology, Cagliari, Italy.

8Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy; Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico di Milano, Milan, Italy.

9Gastroenterology Unit, "Mauriziano" Hospital, Turin, Italy.

10Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. Electronic address: alessandro.armuzzi@hunimed.eu.


A cure for Crohn's disease (CD), a chronic inflammatory disease of the gastrointestinal tract of unknown etiology, is not available, so patients require lifelong management to keep inflammation under control. The therapeutic armamentarium has expanded with approval of several biological drugs, including infliximab, adalimumab, vedolizumab and ustekinumab - monoclonal antibodies that target different inflammatory pathways - and darvadstrocel, a suspension of expanded human allogeneic, adipose-derived, mesenchymal stromal cells for the treatment of refractory complex perianal fistula. Notwithstanding existing practice guidelines on medical therapy for CD, the Italian Group for the Study of Inflammatory Bowel Disease felt the need to issue new guidelines focused on the use of biologics for managing the intestinal manifestations of CD and based on the GRADE methodology. This document presents recommendations regarding six clinical settings, from the induction to the maintenance of clinical remission, and from optimization and de-escalation of treatments to dealing with perianal CD and post-operative recurrence. The 19 evidence-based statements are supported by information on the quality of the evidence, agreement rate among panel members, and panel comments mainly based on evidence from real world studies.


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