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Multicenter Study
. 2023 Feb;55(2):154-159.
doi: 10.1016/j.dld.2022.08.027. Epub 2022 Aug 29.

Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Fabio Salvatore Macaluso  1 , Mariabeatrice Principi  2 , Federica Facciotti  3 , Antonella Contaldo  4 , Alessia Todeschini  2 , Simone Saibeni  5 , Cristina Bezzio  5 , Fabiana Castiglione  6 , Olga Maria Nardone  6 , Rocco Spagnuolo  7 , Massimo Claudio Fantini  8 , Gaia Riguccio  9 , Flavio Caprioli  10 , Chiara Viganò  11 , Carla Felice  12 , Gionata Fiorino  13 , Carmen Correale  14 , Giorgia Bodini  15 , Monica Milla  16 , Giulia Scardino  17 , Marta Vernero  18 , Federico Desideri  19 , Mariella Mannino  20 , Giuseppe Rizzo  20 , Ambrogio Orlando  20 ; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
Collaborators, Affiliations
Multicenter Study

Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Fabio Salvatore Macaluso et al. Dig Liver Dis. 2023 Feb.

Abstract

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy.

Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) METHODS: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs).

Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p<0.001). HCs had higher antibody concentrations (median OD 8.72 [IQR 5.2-14-2]) compared to the whole cohort of IBD patients (median OD 1.54 [IQR 0.8-3.6]; p<0.001) and the subgroup of IBD patients (n=280) without any treatment or on aminosalicylates only (median OD 1.72 [IQR 1.0-4.1]; p<0.001).

Conclusions: Although most IBD patients showed seropositivity after COVID-19 vaccines, the magnitude of the humoral response was significantly lower than in HCs. Differently from other studies, these findings seem to be mostly unrelated to the use of immune-modifying treatments (ClinicalTrials.govID:NCT04769258).

Keywords: Biologics; SARS-CoV-2; Vaccines.

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Conflict of interest statement

Conflict of interest FSM served as an advisory board member and/or received lecture grants from AbbVie, Biogen, Galapagos, Janssen, MSD, Pfizer, Samsung Bioepis, Takeda Pharmaceuticals. MP served as an advisory board member and/or received lecture grants from MSD, Takeda, Janssen, Pfizer, Abbvie. SS received lecture fees from or served as a consultant and advisory board member for AbbVie, Arena, Gilead, Janssen Pharmaceuticals and Takeda. CB received lecture fees from Takeda, MSD, AbbVie and Janssen. FC received lecture fees from or served as a consultant or advisory board member for Abbvie, Janssen, Pfizer, Takeda Pharmaceuticals. OMN received lecture fees from Ferring, Fresenius Kabi, and Janssen. MCF received consultancy fees from Roche, Takeda, Jannsen-Cilag, Pfizer, Sandoz, Biogen, Galapagos and research economic support from Abbvie. GF served as a consultant and advisory board member for Janssen, Takeda, Pfizer, Amgen, Celltrion, Sandoz, Samsung Bioepis, Ferring, Vifor, Galapagos. FC served as consultant to Abbvie, MSD, Takeda, Janssen, Roche, Celgene, Bristol Myers Squibb, Galapagos, Gilead, Pfizer, Mundipharma, Galapagos, Biogen, received lecture fees from Abbvie, Ferring, Takeda, Allergy Therapeutics, Janssen, Pfizer, Biogen, and unrestricted research grants from Giuliani, Sofar, MSD, Takeda, Abbvie .AO served as an advisory board member for AbbVie, Galapagos, MSD, Janssen, Pfizer, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals. All other authors: nothing to disclose.

Figures

Fig 1
Fig. 1
Seropositivity rates (A) and anti-SARS-CoV-2 IgG levels (B) among healthy controls (HCs) and IBD patients (IBD).
Fig 2
Fig. 2
Seropositivity rates (A) and anti-SARS-CoV-2 IgG levels (B) among healthy controls (HCs), IBD patients who were on no treatment or on monotherapy with 5-ASA (IBD NO IM) and IBD patients receiving immune-modifying drugs (IBD IM).
Fig 3
Fig. 3
Seropositivity rates (A) and anti-SARS-CoV-2 IgG levels (B) among IBD patients who were on no treatment or monotherapy with 5-ASA (No TR/5-ASA), thiopurines, anti-TNFs, Vedolizumab (VDZ), and Ustekinumab (UST).
See this image and copyright information in PMC

Comment in

References

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