BACKGROUND AND AIMS: Anti-tumor necrosis factor-α inhibitors (anti-TNFs) are the established treatment for perianal Crohn's disease (pCD), but relapse and non-response are common. Data on second- and third-line biologics are limited. We present the first direct comparison of second- and third-line biologics in pCD patients with active perianal disease previously treated with first-line anti-TNFs. METHODS: A multicenter retrospective cohort study included adult patients with pCD who failed first-line anti-TNF. The primary outcome was clinical perianal response, with secondary outcomes of radiological response (magnetic resonance imaging or transrectal ultrasound) and healing, and clinical remission. Propensity score matching (PSM) was used to adjust for baseline differences. RESULTS: A total of 486 pCD patients from 23 IBD centers were included, with 333/486 (68.5%) and 216/263 (82.1%) matched by PSM in the second and third-line treatment groups, respectively. In the second-line group, 62/78 (79.5%) of ustekinumab (UST)-treated patients achieved clinical perianal response, compared to 46/78 (58.9%) with vedolizumab (VDZ) (OR 4.47, 95% CI, 1.94-10.28, P < .001) and 38/78 (48.7%) with anti-TNFs (OR 5.29, 95% CI, 2.39-11.71, P < .001). In the third-line group, 38/49 (77.6%) of UST-treated patients achieved clinical perianal response, compared to 29/49 (59.2%) with VDZ (OR 9.96, 95% CI, 2.6-38.4, P < .001) and 27/49 (55.1%) with anti-TNFs (OR 12.03, 95% CI, 2.99-48.47, P < .001). UST-treated patients also had higher radiological response rates than VDZ (OR 3.28, 95% CI, 1.07-10.07, P = .038). CONCLUSION: In pCD patients failing anti-TNFs as first-line treatment, ustekinumab may be more effective than vedolizumab or another anti-TNF as second or third-line therapy.

2nd Department of Internal Medicine Gastroenterology and Geriatrics University Hospital Olomouc Faculty of Medicine and Dentistry Palacky University Olomouc Olomouc Czech Republic

CEMAD IBD UNIT Unità Operativa Complessa di Medicina Interna e Gastroenterologia Dipartimento di Scienze Mediche e Chirurgiche Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy

Center for Gastroenterology Department of Internal Medicine University of Szeged Szeged Hungary

Centre for Genomic and Experimental Medicine Institute of Genetics and Cancer University of Edinburgh Edinburgh United Kingdom

Clinical and Research Center for Inflammatory Bowel Disease ISCARE and 1st Faculty of Medicine Charles University Prague Czech Republic

Clinical Pharmacology Unit São João University Hospital Center Porto Portugal

Department of Gastroenterology and Hepatology Ghent University Hospital Ghent Belgium

Department of Gastroenterology Dietetics and Internal Diseases Poznan University of Medical Sciences Poznan Poland

Department of Gastroenterology Hepatology and Clinical Oncology Centre of Postgraduate Medical Education Warsaw Poland

Department of Gastroenterology Hepatology and Nutrition University Hospital Zagreb Zagreb Croatia

Department of Gastroenterology Hospital de Bellvitge L'Hospitalet Spain

Department of Gastroenterology Lyon Sud Hospital Hospices Civils de Lyon and INSERM U1111 University Claude Bernard Lyon 1 Lyon France

Department of Gastroenterology Sheba Medical Center Tel Hashomer Ramat Gan Israel

Department of Gastroenterology Venizeleio General Hospital Heraklion Greece

Department of IBD and Wolfson Unit for Endoscopy St Mark's National Bowel Hospital London United Kingdom

Department of Internal Medicine B Sheba Medical Center Tel Hashomer Ramat Gan Israel

Department of Oncological Gastroenterology The Maria Sklodowska Curie National Research Institute of Oncology Warsaw Poland

Digestive Diseases Centre Hospital AGEL Vitkovice Ostrava Czech Republic

Dipartimento Universitario di Medicina e Chirurgia Traslazionale Università Cattolica del Sacro Cuore Rome Italy

Division of Gastroenterology Department of Medicine University of Alberta Edmonton Alberta Canada

Edinburgh IBD Unit Western General Hospital Edinburgh United Kingdom

Gastroenterology and Endoscopy Unit Santa Maria delle Grazie Hospital Pozzuoli Naples Italy

Gastroenterology Department Colentina Clinical Hospital Carol Davila University of Medicine and Pharmacy Bucharest Romania

Gastroenterology Department Hospital Clínico Universitario de Santiago de Compostela Santiago Spain

Gastroenterology Department University Hospital Carol Davila University of Medicine and Pharmacy Bucharest Romania

Gastroenterology Unit Azienda Ospedale Università di Padova Padua Italy

Inflammatory Bowel Disease Unit Department of Gastroenterology and Hepatology Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain

School of Medicine University of Zagreb Zagreb Croatia

Service de Gastrologie Entérologie Hépatologie CHU de Saint Etienne Saint Etienne France

University Hospital São João Porto Portugal

UOS Gastroenterologia Ospedale Isola Tiberina Gemelli Isola 00186 Rome Italy

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