PMID- 34717923
OWN - NLM
STAT- MEDLINE
DCOM- 20220131
LR  - 20230207
IS  - 1528-0012 (Electronic)
IS  - 0016-5085 (Print)
IS  - 0016-5085 (Linking)
VI  - 162
IP  - 2
DP  - 2022 Feb
TI  - Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory 
      Bowel Diseases Treated With Anti-TNFalpha.
PG  - 454-467
LID - S0016-5085(21)03701-X [pii]
LID - 10.1053/j.gastro.2021.10.029 [doi]
AB  - BACKGROUND & AIM: Patients with inflammatory bowel diseases (IBD), specifically 
      those treated with anti-tumor necrosis factor (TNF)alpha 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-TNFalpha levels and adverse events (AEs) were detected 
      longitudinally. RESULTS: Overall, 258 subjects: 185 IBD (67 treated with 
      anti-TNFalpha, 118 non-anti-TNFalpha), and 73 HCs. After the first vaccine dose, all HCs 
      were seropositive, whereas  approximately 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-TNFalpha treated compared 
      with non-anti-TNFalpha treated patients, and HCs (both P < .001). Neutralizing and 
      inhibitory functions were both lower in anti-TNFalpha treated compared with 
      non-anti-TNFalpha treated patients, and HCs (P < .03; P < .0001, respectively). 
      Anti-TNFalpha drug levels and vaccine responses did not affect anti-spike levels. 
      Infection rate ( approximately 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-TNFalpha, 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.
CI  - Copyright (c) 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.
FAU - Edelman-Klapper, Hadar
AU  - Edelman-Klapper H
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Zittan, Eran
AU  - Zittan E
AD  - 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.
FAU - Bar-Gil Shitrit, Ariella
AU  - Bar-Gil Shitrit A
AD  - Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel; 
      Faculty of Medicine, Hebrew University of Jerusalem, Israel.
FAU - Rabinowitz, Keren Masha
AU  - Rabinowitz KM
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; 
      Felsenstein Medical Research Center, Sackler School of Medicine, Tel Aviv, 
      Israel.
FAU - Goren, Idan
AU  - Goren I
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Avni-Biron, Irit
AU  - Avni-Biron I
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Ollech, Jacob E
AU  - Ollech JE
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Lichtenstein, Lev
AU  - Lichtenstein L
AD  - Clalit Health Services, Petah Tikva, Israel.
FAU - Banai-Eran, Hagar
AU  - Banai-Eran H
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Yanai, Henit
AU  - Yanai H
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Snir, Yifat
AU  - Snir Y
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Pauker, Maor H
AU  - Pauker MH
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Friedenberg, Adi
AU  - Friedenberg A
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
FAU - Levy-Barda, Adva
AU  - Levy-Barda A
AD  - Biobank, Department of Pathology, Rabin Medical Center, Petah Tikva, Israel.
FAU - Segal, Arie
AU  - Segal A
AD  - The Institute of Gastroenterology and Hepatology, Soroka University Medical 
      Center, Beer-Sheva, Israel.
FAU - Broitman, Yelena
AU  - Broitman Y
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Maoz, Eran
AU  - Maoz E
AD  - Clalit Health Services, Tel Aviv, Israel.
FAU - Ovadia, Baruch
AU  - Ovadia B
AD  - Department of Gastroenterology and Hepatology, Hillel Yaffe Medical Center, 
      Hadera, Israel.
FAU - Golan, Maya Aharoni
AU  - Golan MA
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Shachar, Eyal
AU  - Shachar E
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of 
      Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
FAU - Ben-Horin, Shomron
AU  - Ben-Horin S
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of 
      Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
FAU - Perets, Tsachi-Tsadok
AU  - Perets TT
AD  - Gastroenterology Laboratory, Division of Gastroenterology, Rabin Medical Center, 
      Israel; Adelson School of Medicine, Ariel University, Ariel, Israel.
FAU - Ben Zvi, Haim
AU  - Ben Zvi H
AD  - Microbiology Lab, Rabin Medical Center, Petah Tikva, Israel.
FAU - Eliakim, Rami
AU  - Eliakim R
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of 
      Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
FAU - Barkan, Revital
AU  - Barkan R
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
FAU - Goren, Sophy
AU  - Goren S
AD  - School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel 
      Aviv, Israel.
FAU - Navon, Michal
AU  - Navon M
AD  - Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, 
      Tel Aviv University, Tel Aviv, Israel.
FAU - Krugliak, Noy
AU  - Krugliak N
AD  - Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, 
      Tel Aviv University, Tel Aviv, Israel.
FAU - Werbner, Michal
AU  - Werbner M
AD  - Molecular Virology Lab, The Azrieli Faculty of Medicine, Bar-Ilan University, 
      Safed, Israel.
FAU - Alter, Joel
AU  - Alter J
AD  - The Laboratory of Structural Biology of Infectious Diseases, The Azrieli Faculty 
      of Medicine, Bar-Ilan University, Safed, Israel.
FAU - Dessau, Moshe
AU  - Dessau M
AD  - The Laboratory of Structural Biology of Infectious Diseases, The Azrieli Faculty 
      of Medicine, Bar-Ilan University, Safed, Israel.
FAU - Gal-Tanamy, Meital
AU  - Gal-Tanamy M
AD  - Molecular Virology Lab, The Azrieli Faculty of Medicine, Bar-Ilan University, 
      Safed, Israel.
FAU - Freund, Natalia T
AU  - Freund NT
AD  - Department of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, 
      Tel Aviv University, Tel Aviv, Israel.
FAU - Cohen, Dani
AU  - Cohen D
AD  - School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel 
      Aviv, Israel.
FAU - Dotan, Iris
AU  - Dotan I
AD  - Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler 
      Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: 
      irisdo@clalit.org.il.
CN  - REsponses to COVid-19 vaccinE IsRaeli IBD group (RECOVER)
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20211028
PL  - United States
TA  - Gastroenterology
JT  - Gastroenterology
JID - 0374630
RN  - 0 (Antibodies, Viral)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - N38TVC63NU (BNT162 Vaccine)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral/blood/immunology
MH  - BNT162 Vaccine/*immunology
MH  - COVID-19/*prevention & control
MH  - Case-Control Studies
MH  - Female
MH  - Humans
MH  - Immunogenicity, Vaccine/*drug effects
MH  - Inflammatory Bowel Diseases/drug therapy/*immunology
MH  - Israel
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - SARS-CoV-2/immunology
MH  - Tumor Necrosis Factor Inhibitors/*immunology
PMC - PMC8552587
OTO - NOTNLM
OT  - COVID-19
OT  - Serologic Response
OT  - Vaccine
OT  - mRNA-BNT162b2
EDAT- 2021/11/01 06:00
MHDA- 2022/02/01 06:00
PMCR- 2021/10/28
CRDT- 2021/10/31 20:45
PHST- 2021/08/07 00:00 [received]
PHST- 2021/09/26 00:00 [revised]
PHST- 2021/10/15 00:00 [accepted]
PHST- 2021/11/01 06:00 [pubmed]
PHST- 2022/02/01 06:00 [medline]
PHST- 2021/10/31 20:45 [entrez]
PHST- 2021/10/28 00:00 [pmc-release]
AID - S0016-5085(21)03701-X [pii]
AID - 10.1053/j.gastro.2021.10.029 [doi]
PST - ppublish
SO  - Gastroenterology. 2022 Feb;162(2):454-467. doi: 10.1053/j.gastro.2021.10.029. 
      Epub 2021 Oct 28.