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

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

Collaborators

Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Andrea Buda, Emma Calabrese, Federica Furfaro, Salvatore Leone, Filippo Mocciaro, Sara Onali, Luca Pastorelli, Enrica Previtali, Mariabeatrice Principi, Sara Renna, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Simone Saibeni, Gianluca Matteo Sampietro, Edoardo Savarino, Anna Testa, Angela Variola, Angelo Viscido, Sandro Ardizzone, Livia Biancone, Maria Cappello, Fabiana Castiglione, Rachele Ciccocioppo, Michele Comberlato, Francesco Costa, Renata D'Incà, Silvio Danese, Antonio Di Sabatino, Walter Fries, Paolo Gionchetti, Giovanni Latella, Francesco Manguso, Mauro Mastronardi, Gianmichele Meucci, Monica Milla, Maria Lia Scribano, Maurizio 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.

Abstract

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.