Molodecky NA, et al. Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time. Based on Systematic Review Gastroenterology. 2012;142(1):46-54.e42.

Google Scholar 

Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2018;390(10114):2769–78.

Article  Google Scholar 

Kaser A, Zeissig S, Blumberg RS. Inflammatory Bowel Disease. Annu Rev Immunol. 2010;28(1):573–621.

Article  CAS  PubMed Central  Google Scholar 

Murthy SK, et al. The 2023 Impact of Inflammatory Bowel Disease in Canada: Treatment Landscape. J Can Assoc Gastroenterol. 2023;6(Supplement_2):S97–110.

Article  PubMed Central  Google Scholar 

Hindryckx P, et al. The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? J Crohn’s Colitis. 2018;12(1):105–19.

Article  Google Scholar 

Rogler G. Where are we heading to in pharmacological IBD therapy? Pharmacol Res. 2015;100:220–7.

Article  CAS  Google Scholar 

Tang MT, et al. Review article: nonclinical and clinical pharmacology, pharmacokinetics and pharmacodynamics of etrolizumab, an anti-β7 integrin therapy for inflammatory bowel disease. Aliment Pharmacol Ther. 2018;47(11):1440–52.

Article  CAS  PubMed Central  Google Scholar 

Rubin DT, et al. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials. Lancet Gastroenterol Hepatol. 2022;7(1):17–27.

Article  CAS  Google Scholar 

Vermeire S, et al. Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study. Lancet Gastroenterol Hepatol. 2022;7(1):28–37.

Article  CAS  Google Scholar 

Peyrin-Biroulet L, et al. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022;7(2):128–40.

Article  CAS  Google Scholar 

Danese S, et al. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022;7(2):118–27.

Article  CAS  Google Scholar 

Shankar G, et al. Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations. AAPS J. 2014;16(4):658–73.

Article  CAS  PubMed Central  Google Scholar 

Mehta P, Manson JJ. What Is the Clinical Relevance of TNF Inhibitor Immunogenicity in the Management of Patients With Rheumatoid Arthritis? Front Immunol. 2020;11:589.

Article  CAS  PubMed Central  Google Scholar 

Vermeire S, et al. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014;384(9940):309–18.

Article  CAS  Google Scholar 

Wei X, et al. Assessment of Disease-Related Therapeutic Protein Drug-Drug Interaction for Etrolizumab in Patients With Moderately to Severely Active Ulcerative Colitis. J Clin Pharmacol. 2016;56(6):693–704.

Article  CAS  PubMed Central  Google Scholar 

Hässler S, et al. Clinicogenomic factors of biotherapy immunogenicity in autoimmune disease: A prospective multicohort study of the ABIRISK consortium. PLoS Med. 2020;17(10):e1003348.

Article  PubMed Central  Google Scholar 

Liu M, et al. Identification of HLA-DRB1 association to adalimumab immunogenicity. PLoS ONE. 2018;13(4):e0195325.

Article  PubMed Central  Google Scholar 

Sazonovs A, et al. HLA-DQA1*05 Carriage Associated With Development of Anti-Drug Antibodies to Infliximab and Adalimumab in Patients With Crohn’s Disease. Gastroenterology. 2020;158(1):189–99.

Article  CAS  Google Scholar 

Link J, et al. Human Leukocyte Antigen Genes and Interferon Beta Preparations Influence Risk of Developing Neutralizing Anti-Drug Antibodies in Multiple Sclerosis. PLoS ONE. 2014;9(3):e90479.

Article  PubMed Central  Google Scholar 

Hammer C, et al. Allelic variation in HLA-DRB1 is associated with development of antidrug antibodies in cancer patients treated with atezolizumab that are neutralizing in vitro. Clin Transl Sci. 2022;15(6):1393–9.

Article  CAS  PubMed Central  Google Scholar 

Saha A, McCarthy MI, Fischer SK, Sperinde G, Hammer C. HLA Class II Alleles are associated with Anti-Drug Antibodies in Ulcerative Colitis Patients Treated with Etrolizumab. medRxiv. 2025.

Moein A, Lu T, Jonsson S, et al. Population pharmacokinetic analysis of etrolizumab in patients with moderately-to-severely active ulcerative colitis. CPT Pharmacometrics Syst Pharmacol. 2022;11(9):1244–55.

Article  CAS  PubMed Central  Google Scholar 

Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format Guidance for Industry (Draft) [Internet]. 2022. Available from: https://www.fda.gov/media/155871/download. Accessed 2022

Cleynen I, et al. Inherited Determinants of Crohn’s Disease and Ulcerative Colitis Phenotypes: a genetic association study. Lancet. 2016;387(10014):156–67.

Article  PubMed Central  Google Scholar 

Aureli A, et al. HLA-DRB1*13:01 allele in the Genetic Susceptibility to Colorectal Carcinoma. Int J Cancer. 2015;136(10):2464–8.

Article  CAS  Google Scholar