PMID- 38539103 OWN - NLM STAT- MEDLINE DCOM- 20240329 LR - 20240330 IS - 1471-230X (Electronic) IS - 1471-230X (Linking) VI - 24 IP - 1 DP - 2024 Mar 27 TI - Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials. PG - 121 LID - 10.1186/s12876-024-03163-5 [doi] LID - 121 AB - BACKGROUND: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited. AIM: Pooled analysis of randomised studies to compare efficacy and safety with IFX SC and VDZ in moderate-to-severe inflammatory bowel disease. METHODS: Parallel-group, randomised studies evaluating IFX SC and VDZ in patients with moderate-to-severe CD or UC were identified. Eligible studies reported >/= 1 prespecified outcome of interest at Week 6 (reflecting treatment during the induction phase) and/or at 1 year (Weeks 50-54; reflecting treatment during the maintenance phase). Prespecified efficacy and safety outcomes considered in this pooled analysis included the proportions of patients achieving disease-specific clinical responses, clinical remission, or discontinuing due to lack of efficacy, and the proportions of patients experiencing adverse events (AEs), serious AEs, infections, serious infections, or discontinuing due to AEs. Data from multiple studies or study arms were extracted and pooled using a random-effect model; comparative analyses were performed separately for patients with CD and UC. RESULTS: We identified three eligible CD trials and four eligible UC trials that assigned over 1200 participants per disease cohort to either IFX SC or VDZ. In patients with CD, intravenous induction therapy with IFX demonstrated better efficacy (non-overlapping 95% confidence intervals [CIs]) compared with VDZ; during the maintenance phase, IFX SC showed numerically better efficacy (overlapping 95% CIs) than VDZ. A lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In patients with UC, efficacy profiles were similar with IFX SC and VDZ during the induction and maintenance phases, and a lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In both cohorts, safety profiles for IFX SC and VDZ were generally comparable during 1 year. CONCLUSION: IFX SC demonstrated better efficacy than VDZ in patients with CD, and similar efficacy to VDZ in patients with UC; 1-year safety was comparable with IFX SC and VDZ. CI - (c) 2024. The Author(s). FAU - Peyrin-Biroulet, Laurent AU - Peyrin-Biroulet L AD - Department of Gastroenterology, Centre Hospitalier Regional Universitaire de Nancy, Nancy, France. FAU - Arkkila, Perttu AU - Arkkila P AD - Department of Gastroenterology, Helsinki University Hospital, Helsinki, Finland. FAU - Armuzzi, Alessandro AU - Armuzzi A AD - IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. FAU - Danese, Silvio AU - Danese S AD - Gastroenterology and Endoscopy, University Vita-Salute San Raffaele, Milan, Italy. FAU - Ferrante, Marc AU - Ferrante M AD - Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium. FAU - Jordi Guardiola AU - Jordi Guardiola AD - Department of Digestive Diseases, Bellvitge University Hospital, Bellvitge Biomedical Research Institute-IDIBELL, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain. FAU - Jahnsen, Jorgen AU - Jahnsen J AD - Institute of Clinical Medicine, University of Oslo, Oslo, Norway. FAU - Louis, Edouard AU - Louis E AD - Department of Gastroenterology, University Hospital CHU of Liege, Liege, Belgium. FAU - Lukas, Milan AU - Lukas M AD - Clinical and Research Center for Inflammatory Bowel Diseases, ISCARE Clinical Centre, Prague, Czech Republic. FAU - Reinisch, Walter AU - Reinisch W AD - Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. FAU - Roblin, Xavier AU - Roblin X AD - Department of Gastroenterology and Hepatology, University Hospital of Saint-Etienne, Saint-Etienne, France. FAU - Smith, Philip J AU - Smith PJ AD - Department of Gastroenterology, Royal Liverpool Hospital, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK. FAU - Kwon, Taek AU - Kwon T AD - Celltrion, Incheon, Republic of Korea. FAU - Kim, Jeeyoung AU - Kim J AD - Celltrion, Incheon, Republic of Korea. FAU - Yoon, Sangwook AU - Yoon S AD - Celltrion, Incheon, Republic of Korea. FAU - Kim, Dong-Hyeon AU - Kim DH AD - Celltrion, Incheon, Republic of Korea. FAU - Atreya, Raja AU - Atreya R AD - Medical Department 1, University Hospital Erlangen, Friedrich-Alexander-University of Erlangen-Nurnberg, Erlangen, Germany. raja.atreya@uk-erlangen.de. LA - eng PT - Journal Article DEP - 20240327 PL - England TA - BMC Gastroenterol JT - BMC gastroenterology JID - 100968547 RN - B72HH48FLU (Infliximab) RN - 9RV78Q2002 (vedolizumab) RN - 0 (Gastrointestinal Agents) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Adult MH - Humans MH - *Colitis, Ulcerative/drug therapy MH - Infliximab/adverse effects MH - *Crohn Disease/drug therapy MH - Gastrointestinal Agents/adverse effects MH - Remission Induction MH - Treatment Outcome MH - Randomized Controlled Trials as Topic MH - *Antibodies, Monoclonal, Humanized PMC - PMC10967176 OTO - NOTNLM OT - Biobetter OT - Bioinnovative OT - Inflammatory bowel disease OT - Subcutaneous infliximab OT - Tumour necrosis factor-alpha inhibitors OT - Vedolizumab COIS- Laurent Peyrin-Biroulet reports personal fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Enterome, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Hikma, InDex Pharmaceuticals, Inotrem, Janssen, Lilly, MSD, Mylan, Nestle, Norgine, OSE Immunotherapeutics, Oppilan Pharma, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Theravance, Tillots, and Vifor. Perttu Arkkila has been an advisory board member of Janssen. Alessandro Armuzzi reports grants from Biogen, MSD, Pfizer, and Takeda; and personal fees from AbbVie, Allergan, Amgen, Arena, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Novartis, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda, and TiGenix. Silvio Danese reports personal fees from AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., and Vifor. Marc Ferrante reports grants from Janssen, Pfizer, Takeda, and Viatris; personal fees from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Falk, Janssen, Lamepro, Medtronic, Regeneron, Samsung Bioepis, Sandoz, Thermo Fisher, Truvion Healthcare, and Viatris. Jordi Guardiola reports personal fees from AbbVie, Chiesi, Ferring, GE Healthcare, Janssen, Kern Pharma, MSD, Pfizer, Roche, and Takeda. Jorgen Jahnsen reports personal fees from AbbVie, Astro Pharma, Boehringer Ingelheim, BMS, Celltrion, Ferring, Gilead, Hikma, Janssen, Meda, MSD, NappPharma, Novartis, Orion Pharma, Pfizer, Pharmacosmos, Roche, Sandoz, Takeda, Tillotts, and Unimedic Pharma. Edouard Louis has received research grants from Janssen, Pfizer, and Takeda; received educational grants from AbbVie, Janssen, and Takeda; received speaker fees from AbbVie, Celgene, Falk, Ferring, Janssen, MSD, Pfizer, and Takeda; been an advisory board member for AbbVie, Arena, Eli Lilly, Celgene, Ferring, Galapagos, Gilead, Janssen, MSD, Pfizer, and Takeda; and been a consultant of AbbVie. Milan Lukas has received financial support for research and educational activities from Janssen, Pfizer, and Takeda; and has been an advisory board member for Egis, Janssen, and Takeda. Walter Reinisch reports grants from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk, Immundiagnostik, Janssen, MSD, Sandoz, and Takeda. Xavier Roblin reports personal fees from Amgen, Celltrion, Gilead, Janssen, MSD, Pfizer, Takeda, and Tillots; personal fees from Abbott Laboratories, AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Aptalis, Arena Pharmaceuticals, Astellas, AstraZeneca, Avaxia, Bioclinica, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, Chemocentryx, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernst & Young, Elan, Falk, Ferring, Galapagos, Gatehouse Bio Inc., Genentech, Gilead, Grunenthal, ICON, Immundiagnostik, InDex Pharmaceuticals, Inova, Intrinsic Imaging, J&J, Janssen, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pfizer, Pharmacosmos, Philip Morris Institute, PLS Education, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Roland Berger GmBH, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Shire, Sigmoid, Sublimity, Takeda, Therakos, Theravance, TiGenix, UCB, Vifor, Yakult, Zeeland, Zyngenia, and 4SC. Philip J Smith reports personal fees from AbbVie, Celltrion, Dr Falk, Galapagos, Janssen, Takeda, and Tillotts Pharma. Taek Kwon, Jeeyoung Kim, Dong-Hyeon Kim, and Sangwook Yoon are employees of Celltrion. Raja Atreya reports grants and personal fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Falk Foundation, Ferring, Fresenius Kabi, Galapagos, Gilead, GlaxoSmithKline, InDex Pharmaceuticals, Janssen-Cilag, Kliniksa Pharmaceuticals, Lilly, Merck Sharp & Dohme, Novartis, Pandion, Pfizer, Roche Pharma, Samsung Bioepis, Takeda Pharma, and Viatris. EDAT- 2024/03/28 06:45 MHDA- 2024/03/29 06:46 PMCR- 2024/03/27 CRDT- 2024/03/28 00:45 PHST- 2023/05/07 00:00 [received] PHST- 2024/02/07 00:00 [accepted] PHST- 2024/03/29 06:46 [medline] PHST- 2024/03/28 06:45 [pubmed] PHST- 2024/03/28 00:45 [entrez] PHST- 2024/03/27 00:00 [pmc-release] AID - 10.1186/s12876-024-03163-5 [pii] AID - 3163 [pii] AID - 10.1186/s12876-024-03163-5 [doi] PST - epublish SO - BMC Gastroenterol. 2024 Mar 27;24(1):121. doi: 10.1186/s12876-024-03163-5.