Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha

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; REsponses COVID-19 Vaccine IsRaeli

doi:10.1053/j.gastro.2021.10.029

Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha

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 ShacharShomron 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, REsponses COVID-19 Vaccine IsRaeli

Research output: Contribution to journal › Article › peer-review

71 Scopus citations

Abstract

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-TNF alpha levels and adverse events (AEs) were detected longitudinally. RESULTS: Overall, 258 subjects: 185 IBD (67 treated with antiTNF alpha, 118 non-anti-TNF alpha), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas similar to 7 regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNF alpha drug levels and vaccine responses did not affect anti-spike levels. Infection rate (similar to 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-TNF alpha, 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.

Original language	English
Pages (from-to)	454-467
Number of pages	14
Journal	Gastroenterology
Volume	162
Issue number	2
DOIs	https://doi.org/10.1053/j.gastro.2021.10.029
State	Published - 1 Feb 2022
Externally published	Yes

Keywords

COVID-19
Vaccine
mRNA-BNT162b2
Serologic Response

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10.1053/j.gastro.2021.10.029

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Edelman-Klapper, H., Zittan, E., Shitrit, A. B.-G., 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., ... IsRaeli, RE. COVID. V. (2022). Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha. Gastroenterology, 162(2), 454-467. https://doi.org/10.1053/j.gastro.2021.10.029

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title = "Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha",

abstract = "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-TNF alpha levels and adverse events (AEs) were detected longitudinally. RESULTS: Overall, 258 subjects: 185 IBD (67 treated with antiTNF alpha, 118 non-anti-TNF alpha), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas similar to 7 regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNF alpha drug levels and vaccine responses did not affect anti-spike levels. Infection rate (similar to 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-TNF alpha, 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.",

keywords = "COVID-19, Vaccine, mRNA-BNT162b2, Serologic Response",

author = "Hadar Edelman-Klapper and Eran Zittan and Shitrit, {Ariella Bar-Gil} and Rabinowitz, {Keren Masha} and Idan Goren and Irit Avni-Biron and Ollech, {Jacob E.} and Lev Lichtenstein and Hagar Banai-Eran and Henit Yanai and Yifat Snir and Pauker, {Maor H.} and Adi Friedenberg and Adva Levy-Barda and Arie Segal and Yelena Broitman and Eran Maoz and Baruch Ovadia and Golan, {Maya Aharoni} and Eyal Shachar and Shomron Ben-Horin and Tsachi-Tsadok Perets and {Ben Zvi}, Haim and Rami Eliakim and Revital Barkan and Sophy Goren and Michal Navon and Noy Krugliak and Michal Werbner and Joel Alter and Moshe Dessau and Meital Gal-Tanamy and Freund, {Natalia T.} and Dani Cohen and Iris Dotan and IsRaeli, {REsponses COVID-19 Vaccine}",

note = "Publisher Copyright: {\textcopyright} 2022 AGA Institute",

year = "2022",

month = feb,

day = "1",

doi = "10.1053/j.gastro.2021.10.029",

language = "אנגלית",

volume = "162",

pages = "454--467",

journal = "Gastroenterology",

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Edelman-Klapper, H, Zittan, E, Shitrit, AB-G, 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, 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, NT, Cohen, D, Dotan, I & IsRaeli, RECOVIDV 2022, 'Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha', Gastroenterology, vol. 162, no. 2, pp. 454-467. https://doi.org/10.1053/j.gastro.2021.10.029

TY - JOUR

T1 - Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha

AU - Edelman-Klapper, Hadar

AU - Zittan, Eran

AU - Shitrit, Ariella Bar-Gil

AU - Rabinowitz, Keren Masha

AU - Goren, Idan

AU - Avni-Biron, Irit

AU - Ollech, Jacob E.

AU - Lichtenstein, Lev

AU - Banai-Eran, Hagar

AU - Yanai, Henit

AU - Snir, Yifat

AU - Pauker, Maor H.

AU - Friedenberg, Adi

AU - Levy-Barda, Adva

AU - Segal, Arie

AU - Broitman, Yelena

AU - Maoz, Eran

AU - Ovadia, Baruch

AU - Golan, Maya Aharoni

AU - Shachar, Eyal

AU - Ben-Horin, Shomron

AU - Perets, Tsachi-Tsadok

AU - Ben Zvi, Haim

AU - Eliakim, Rami

AU - Barkan, Revital

AU - Goren, Sophy

AU - Navon, Michal

AU - Krugliak, Noy

AU - Werbner, Michal

AU - Alter, Joel

AU - Dessau, Moshe

AU - Gal-Tanamy, Meital

AU - Freund, Natalia T.

AU - Cohen, Dani

AU - Dotan, Iris

AU - IsRaeli, REsponses COVID-19 Vaccine

PY - 2022/2/1

Y1 - 2022/2/1

N2 - 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-TNF alpha levels and adverse events (AEs) were detected longitudinally. RESULTS: Overall, 258 subjects: 185 IBD (67 treated with antiTNF alpha, 118 non-anti-TNF alpha), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas similar to 7 regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNF alpha drug levels and vaccine responses did not affect anti-spike levels. Infection rate (similar to 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-TNF alpha, 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.

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-TNF alpha levels and adverse events (AEs) were detected longitudinally. RESULTS: Overall, 258 subjects: 185 IBD (67 treated with antiTNF alpha, 118 non-anti-TNF alpha), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas similar to 7 regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNF alpha treated compared with non-anti-TNF alpha treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNF alpha drug levels and vaccine responses did not affect anti-spike levels. Infection rate (similar to 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-TNF alpha, 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.

KW - COVID-19

KW - Vaccine

KW - mRNA-BNT162b2

KW - Serologic Response

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U2 - 10.1053/j.gastro.2021.10.029

DO - 10.1053/j.gastro.2021.10.029

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SN - 0016-5085

VL - 162

SP - 454

EP - 467

JO - Gastroenterology

JF - Gastroenterology

IS - 2

ER -

Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNF alpha

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