Abstract

BACKGROUND: Acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a major challenge in patients with Inflammatory Bowel Disease (IBD) as immunosuppression used to treat these patients may increase their risk for infection. This study examined the Covid-19 vaccination rates and the potential impact of IBD treatments on the SARS-CoV-2 infection rates after receiving full immunization against Covid-19. METHODS: We identified patients aged 18 to 90 who received the BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson) Covid-19 vaccines between January 20, 2020, and July 1, 2020, from 65 health organizations that are part of the TrinetX Research Network. The post-immunization Covid-19 infection rate was compared at 3 and 6 months between non-IBD versus IBD patients receiving treatment with biologic/small molecule (Certolizumab, Ustekinumab, Infliximab, Adalimumab, Vedolizumab, Tofacitinib), immunomodulators (Methotrexate, Azathioprine, Mercaptopurine, Mycophenolic acid, Mycophenolate mofetil), or other agents (Mesalamine, Sulfasalazine, Balsalazide, Budesonide). In order to control for potential confounders, propensity matched (PSM) was used to examine the cohorts. RESULTS: The total IBD cases identified was 140,493; of those, (n = 5,658) 4.02% were fully vaccinated (2 doses of Pfizer-BioNTech, 2 doses of Moderna, and 1 dose of Johnson & Johnson), and (n = 639) 0.45% were partially vaccinated (1 dose of Pfizer-BioNTech and 1 dose of Moderna). IBD cases on biologic/small molecule treatments (n = 1,315) were compared with the non-IBD population (n = 821,744), which created a well-matched PSM of (1,315/1,315). No significant difference was found for the Covid-19 infection rate at 3 months (36% vs 33.5%, P = 0.16) and at 6 months (37.0% vs 34.3%, P = 0.15). The IBD population that were on immunomodulators (n = 3,594) as part of their treatment were compared with the non-IBD population (n = 821,744), which created a well-matched PSM of (3,593/3,593). The Covid-19 infection rate at 3 months (33.8% vs. 37.2%, P = 0.03) and 6 months (35.1% vs. 38.7%, P = 0.002) showed a significant difference between these groups with higher rates in IBD patients. The authors examined other therapies among IBD cases (n = 1,199), which were compared with the non-IBD population of (n = 821,744); this created a well-matched PSM of (1,199/1,199). No significant difference was found for the Covid-19 infection rate at 3 months (36.7% vs. 35.7%, P = 0.61), and at 6 months (37.9% vs. 37.2%, P = 0.70). CONCLUSION: In a large nationwide database, the Covid-19 immunization rate among IBD patients was found to be suboptimal (4.02%). Only IBD patients on immunomodulators as a part of their treatment regimen were at an increased risk of Covid-19 infection post full vaccination at 3 and at 6 months. This may suggest that this population could benefit from an early booster against Covid-19.

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