Infammatory Bowel Diseases, 2022, XX, 1–5 https://doi.org/10.1093/ibd/izac228 Advance access publication 2 November 2022 Brief Report - Clinical Impact of Biologic Agents on the Immune Response Induced by the Additional Dose of SARS-CoV-2 Vaccine in Infammatory Bowel Disease Patients Laura Ramos, MD, *, Miriam Hernández-Porto, PhD, † Marta Carrillo-Palau, MD, PhD, * Inmaculada Alonso-Abreu, MD, PhD, * Cristina Reygosa, MD, * and Manuel Hernandez-Guerra, MD, PhD *,‡ From the * Gastroenterology and Hepatology Department, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife, Spain; † Microbiology Department, Hospital Universitario de Canarias, Tenerife, Spain; and ‡ Instituto Universitario de Tecnologías Biomédicas, Centro de Investigaciones Biomédicas de Canarias, Departamento de Medicina Interna, Psiquiatría y Dermatología, Universidad de La Laguna, Tenerife, Spain. Address correspondence to: Laura Ramos López, MD, Servicio de Aparato Digestivo, Hospital Universitario de Canarias, Ctra. Ofra s/n, 38280 La Laguna, Santa Cruz de Tenerife, Spain (laura7ramos@gmail.com). Lay Summary The immusne response to the vaccine against SARS-CoV-2 is altered in patients with inflammatory bowel disease using biological agents, and so we should ensure effective immunization in these patients by prioritizing those receiving anti-tumor necrosis factor agents in the indication of new doses or booster doses of the vaccine. Introduction The design of effective vaccines against severe acute respira- tory syndrome coronavirus 2 (SARS-CoV-2) prevents its se- vere forms and associated mortality. 1,2 During this pandemic, the increasing knowledge about immunization has allowed the adaptation of vaccination strategies, particularly in those patients considered to be immunocompromised. 3 At present, international experts recommend the vaccination of infam- matory bowel disease (IBD) patients at the earliest oppor- tunity possible, without delay due to immunosuppressive drugs, and according to national guidelines. 3 However, the most recent data suggest that the immunosuppressive drugs used in IBD alter the antibody response induced by SARS- CoV-2 vaccines (after a complete initial regimen) and are attenuated in recipients of infiximab associated or not with thiopurines. 4,5 Thus, in patients with IBD using biological agents, an additional dose of the vaccine for SARS-CoV-2 has been recommended to complete the initial regimen, although with scarce data about the effectiveness of this recommenda- tion. We sought to investigate the immune effect of the addi- tional dose of the SARS-CoV-2 vaccine in patients with IBD focusing on the type of biological agent received to assess the impact of vaccination recommendations in this population. Methods We performed a prospective unicenter study enrolling >18-year-old, nonpregnant IBD patients convoked for an additional dose of the COVID-19 vaccine (RNA vac- cine) to complete the initial vaccination regimen between October and December 2021. A total of 96 patients were included and divided into 2 medication groups; anti-tumor necrosis factor biologic agents (BIO antiTNF) (n = 50; infiximab and adalimumab) and non–anti-tumor necrosis factor biologic treatments (BIO NO antiTNF) (n = 46; vedolizumab and ustekinumab). None of the patients had evidence of SARS-CoV-2 infection before assessment. The immune response (humoral and cellular) before the ad- ditional dose of vaccine and the humoral response after this dose’s administration were evaluated in each patient. The vaccine-specifc humoral immune (immunoglobulin G [IgG] receptor binding domain [RBD] antibody) response was measured by chemiluminescent immunoassay from Abbott (ARCHITECT I 2000SR) using a reactive SARS- CoV-2 IgG II Quant, and values >7.1 BAU/mL (>50 AU/ mL) were considered positive. The SARS-CoV-2 spike protein–specifc T cell response was quantifed by a com- mercial, standardized interferon γ release assay using the EUROIMMUN SARS-CoV-2 interferon γ release assay stimulation tube set (product No. ET 2606-3003) and EUROIMMUN interferon γ enzyme-linked immuno- sorbent assay (product No. EQ 6841-960; PerkinElmer), and values >200 mIU/mL were interpreted as positive. An initial blood sample was collected on the same day of vaccination or at the day before the vaccination appoint- ment. We included a control group of IBD patients without biological treatment (NO BIO) (n = 20) who attended © The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com Received for publication: July 31, 2022. Editorial Decision: October 2, 2022 Downloaded from https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izac228/6793895 by guest on 04 November 2022