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Edelman-Klapper H, Zittan E, Bar-Gil Shitrit A, et al. Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated with Anti-TNFα. Gastroenterology. 2021;doi: 10.1053/j.gastro.2021.10.029.
Edelman-Klapper, H., Zittan, E., Bar-Gil Shitrit, A., Rabinowitz, K. M., Goren, I., Avni-Biron, I., Ollech, J. E., Lichtenstein, L., Banai-Eran, H., Yanai, H., Snir, Y., Pauker, M. H., Friedenberg, A., Levy-Barda, A., Segal, A., Broitman, Y., Maoz, E., Ovadia, B., Golan, M. A., Shachar, E., Ben-Horin, S., Perets, T. T., Ben Zvi, H., Eliakim, R., Barkan, R., Goren, S., Navon, M., Krugliak, N., Werbner, M., Alter, J., Dessau, M., Gal-Tanamy, M., Freund, N. T., Cohen, D., Dotan, I. (2021). Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated with Anti-TNFα. Gastroenterology, . https://doi.org/10.1053/j.gastro.2021.10.029
Edelman-Klapper, Hadar, et al. "Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated with Anti-TNFα." Gastroenterology vol. (2021). doi: https://doi.org/10.1053/j.gastro.2021.10.029
Edelman-Klapper H, Zittan E, Bar-Gil Shitrit A, Rabinowitz KM, Goren I, Avni-Biron I, Ollech JE, Lichtenstein L, Banai-Eran H, Yanai H, Snir Y, Pauker MH, Friedenberg A, Levy-Barda A, Segal A, Broitman Y, Maoz E, Ovadia B, Golan MA, Shachar E, Ben-Horin S, Perets TT, Ben Zvi H, Eliakim R, Barkan R, Goren S, Navon M, Krugliak N, Werbner M, Alter J, Dessau M, Gal-Tanamy M, Freund NT, Cohen D, Dotan I. Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated with Anti-TNFα. Gastroenterology. 2021 Oct 28; doi: 10.1053/j.gastro.2021.10.029. Epub 2021 Oct 28. PMID: 34717923; PMCID: PMC8552587.
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Gastroenterology. 2021 Oct 28; doi: 10.1053/j.gastro.2021.10.029. Epub 2021 Oct 28.

Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated with Anti-TNFα.

Gastroenterology

Hadar Edelman-Klapper, Eran Zittan, Ariella Bar-Gil Shitrit, Keren Masha Rabinowitz, Idan Goren, Irit Avni-Biron, Jacob E Ollech, Lev Lichtenstein, Hagar Banai-Eran, Henit Yanai, Yifat Snir, Maor H Pauker, Adi Friedenberg, Adva Levy-Barda, Arie Segal, Yelena Broitman, Eran Maoz, Baruch Ovadia, Maya Aharoni Golan, Eyal Shachar, Shomron Ben-Horin, Tsachi-Tsadok Perets, Haim Ben Zvi, Rami Eliakim, Revital Barkan, Sophy Goren, Michal Navon, Noy Krugliak, Michal Werbner, Joel Alter, Moshe Dessau, Meital Gal-Tanamy, Natalia T Freund, Dani Cohen, Iris Dotan,

Affiliations

  1. Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  2. The Abraham and Sonia Rochlin IBD Unit, Department of Gastroenterology, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine Technion-Israel Institute of Technology, Haifa, Israel.
  3. Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel; Faculty of Medicine, Hebrew University of Jerusalem, Israel.
  4. Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Felsenstein Medical Research Center, Sackler School of Medicine, Tel Aviv, Israel.
  5. Clalit Health Services, Petah Tikva, Israel.
  6. Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
  7. Biobank, Department of Pathology, Rabin Medical Center, Petah Tikva, Israel.
  8. The Institute of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva, Israel.
  9. Clalit Health Services, Tel Aviv, Israel.
  10. Department of Gastroenterology and Hepatology, Hillel Yaffe Medical Center, Hadera, Israel.
  11. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
  12. Gastroenterology Laboratory, Division of Gastroenterology, Rabin Medical Center, Israel; Adelson School of Medicine, Ariel University, Ariel, Israel.
  13. Microbiology Lab, Rabin Medical Center, Petah Tikva, Israel.
  14. School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  15. Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  16. Molecular Virology Lab, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel(20)The Laboratory of Structural Biology of Infectious Diseases, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
  17. Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: [email protected].

PMID: 34717923 PMCID: PMC8552587 DOI: 10.1053/j.gastro.2021.10.029

Abstract

BACKGROUND & AIM: Patients with inflammatory bowel diseases (IBD), specifically those treated with anti-tumor necrosis factor (TNF)α biologics, are at high risk for vaccine-preventable infections. Their ability to mount adequate vaccine responses is unclear. The aim of the study was to assess serologic responses to messenger RNA-Coronavirus Disease 2019 vaccine, and safety profile, in patients with IBD stratified according to therapy, compared with healthy controls (HCs).

METHODS: Prospective, controlled, multicenter Israeli study. Subjects enrolled received 2 BNT162b2 (Pfizer/BioNTech) doses. Anti-spike antibody levels and functional activity, anti-TNFα levels and adverse events (AEs) were detected longitudinally.

RESULTS: Overall, 258 subjects: 185 IBD (67 treated with anti-TNFα, 118 non-anti-TNFα), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas ∼7% of patients with IBD, regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNFα treated compared with non-anti-TNFα treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNFα treated compared with non-anti-TNFα treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNFα drug levels and vaccine responses did not affect anti-spike levels. Infection rate (∼2%) and AEs were comparable in all groups. IBD activity was unaffected by BNT162b2.

CONCLUSIONS: In this prospective study in patients with IBD stratified according to treatment, all patients mounted serologic response to 2 doses of BNT162b2; however, its magnitude was significantly lower in patients treated with anti-TNFα, regardless of administration timing and drug levels. Vaccine was safe. As vaccine serologic response longevity in this group may be limited, vaccine booster dose should be considered.

Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.

Keywords: COVID-19; Serologic Response; Vaccine; mRNA-BNT162b2

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