Two doses of the mRNA COVID-19 vaccines, BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna), confer high serological responses with 100% seropositivity in patients with inflammatory bowel disease (IBD) on biological therapies, according to a study published in Gastroenterology.

Patients with IBD, such as Crohn disease (CD) and ulcerative colitis (UC), are at increased risk of severe COVID-19 due to treatment with immunosuppressive therapies. Vaccination against SARS-CoV-2 is encouraged for this population; however, previous studies have shown attenuation of anti-nucleocapsid responses to SARS-CoV-2 in IBD patients on infliximab and poor anti-spike antibody responses in transplant patients after the first dose of mRNA vaccines.

To address this concern, the investigators evaluated serological responses to COVID-19 vaccination with BNT162b2 and mRNA-1273 vaccines in IBD patients. All patients who self-reported at least 1 mRNA vaccination between December 14, 2020-February 12, 2021 from the ongoing Therapeutic Infusion (CiTI) study of IBD patients at the Icahn School of Medicine at Mount Sinai were included in the analysis.

Patients with IBD were compared to control groups without IBD, which included 14 completely vaccinated healthcare workers (HCW) and 29 vaccinated healthy volunteers (PICR cohort). Antibody testing results from 21 patients with positive SARS-CoV-2 were included for comparison in order to show relation to naturally-generated antibodies.


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A total of 48 IBD patients (n=23 with CD and n=25 with UC) were included in the study. Most patients (85.4%) were receiving treatment with biologics at the time of vaccination; 33.3% with tumor necrosis factor (TNF) antagonist monotherapy, 35.4% with vedolizumab monotherapy, 6.3% with vedolizumab + thiopurine, 8.3% with ustekinumab, and 1 patient with guselkumab for psoriasis. Three patients were receiving oral steroids and 5 patients were not receiving treatment at the time of vaccination.

Study participants received either the Pfizer-BioNTech COVID-19 vaccine (IBD n=23, HCW n=11, PICR n=20) or Moderna COVID-19 vaccine (IBD n=25, HCW n=3, PICR n=9). In the IBD group, 26 patients completed the 2-dose series while 22 patients completed 1 dose. All participants in both the HCW and the PICR control groups completed 2 doses.

Analysis showed that all IBD patients who completed 2 doses of either mRNA vaccine (n=26) had positive anti-receptor binding domain (RBD) tests; 22 of the 26 patients achieved levels that would qualify for convalescent plasma donation. Additionally, compared with the HCW and PICR cohorts, similar titers of anti-S IgG levels were found in IBD patients at all timepoints.

Of those 26 fully-vaccinated patients, 8 were on anti-TNF monotherapy, 12 were on vedolizumab monotherapy, 2 were on ustekinumab and 4 were not receiving treatment. “Analyses of the effects of anti-TNF and vedolizumab monotherapy on serological response in these patients revealed that anti-TNFs were associated with lower anti-RBD total Ig only (P =.0299), and vedolizumab was associated with lower anti-RBD total Ig (P =.0069), anti-RBD IgG (P =.045), and anti-S IgG (P =.0043) than in HCW controls,” the authors reported.

The investigators concluded that serological responses with 100% seropositivity occurred in IBD patients on biological therapies following 2 doses of the Pfizer-BioNTech and Moderna vaccines. Additionally, they suggested that further investigation is warranted to evaluate the effect of anti-TNF and vedolizumab monotherapy on anti-RBD total Ig, anti-RBD IgG, and anti-S IgG levels.

“This is the first data of serological responses to COVID-19 vaccines in IBD patients with detailed analysis of antibodies to both nucleocapsid and RBD/spike proteins,” the authors stated. “Larger studies with more detailed measurements including cell-mediated responses, particularly between dose 1 and 2, will be required to assess immune responses and the effects of medications. In the meantime, our results support the consensus recommendation for IBD patients to receive COVID-19 vaccines when available.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Wong S-Y, Dixon R, Pazos VM, Gnjatic S, Colombel J-F, Cadwell K, ICARUS-IBD Working Group. Serological response to mRNA COVID-19 vaccines in IBD patients receiving biological therapies. [published online April 20, 2021.] Gastroenterology. doi: 10.1053/j.gastro.2021.04.025