Vedolizumab (VDZ) and corticosteroids have been found to be associated with an increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, the use of mesalazine does not appear to be associated with an increased risk of SARS-CoV-2 or severe COVID-19. These findings are based on the results of a study published in Gut.
Data on the impact of inflammatory bowel disease (IBD) medications on the risk of SARS-CoV-2 infection are currently limited. In addition, findings from previous studies on the impact of IBD medications on the clinical course of coronavirus disease 2019 (COVID-19) need to be validated in different study populations. Thus, a team of investigators conducted a retrospective national cohort study on 30,911 patients with IBD from the Veterans Affairs Healthcare System (VAHS) from January 20, 2020 to December 10, 2020. This study explores the risk of SARS-CoV-2 infection with all classes of IBD medications and the impact of these medications on disease course.
The primary outcome was time to SARS-CoV-2 infection. This was determined according to the results of PCR testing, performed in the VAHS. The secondary outcome was a combined outcome of hospitalizations related to COVID-19 infections or COVID-19 related mortality. The researchers defined the combined secondary outcome as death occurring within 90 days of documented infection.
Among the analytical cohort, the majority of the study participants were male (90.9%), most were white (78.6%), over half had ulcerative colitis (58.8%), and the median age was 65 (IQR, 50-73) years.
Over a median follow-up of approximately 10.7 months, 649 patients (2.1%) were diagnosed with SARS-CoV-2 infections and 149 (0.5%) met the criteria for the combined secondary outcome.
In adjusted mixed-effects Cox regression analysis, VDZ was significantly associated with infection compared with mesalazine alone (hazard ratio [HR], 1.70; 95% CI, 1.16 to 2.48; P =.006).
In competing risks regression analysis, patients on no IBD medications had increased risk of the combined secondary outcome relative to mesalazine alone (sub-HR, 1.64; 95% CI, 1.12 to 2.42; P =.01). However, no other IBD medication categories were significantly associated with this outcome compared with the mesalazine alone group (each P >.05).
The investigators noted that corticosteroid use was independently associated with both SARS-CoV-2 infection (HR, 1.60; 95% CI, 1.23 to 2.09; P =.001) and the combined secondary outcome (sub-HR, 1.90; 95% CI, 1.14 to 3.17; P =.01).
This study had multiple limitations, such as its retrospective nature and the fact that prescriptions filled outside the VA may be incomplete. Additionally, the large cohort assessed in the study consisted of patients who were mostly male and of older age compared with the average IBD population. Therefore, these findings may not be generalizable to younger IBD patients. Finally, medication exposure misclassification, particularly with corticosteroids, and bias estimates are possible.
According to the data, VDZ and corticosteroids were associated with an increased risk of SARS-CoV-2 infection. In addition, this is the first study to link VDZ with an increased risk of SARS-CoV-2 infection. However, VDZ was not associated with clinically severe COVID-19 outcomes such as hospitalization or death. Furthermore, contrary to previous research, mesalazine was not associated with an increased risk of SARS-CoV-2 infection or severe COVID-19.
According to the study authors, “this study reaffirms the recommendation that physicians should exercise caution to use corticosteroids for IBD during the SARS-CoV-2 pandemic.”
Disclosures: Multiple authors declared affiliations with the industry and this study was
funded by one source. Please refer to the original article for a full list of disclosures.
Khan N, Mahmud N, Trivedi C, Reinisch W, Lewis JD. Risk factors for SARS-CoV-2 infection and course of COVID-19 disease in patients with IBD in the Veterans Affair Healthcare System. Gut. Published online March 22, 2021. doi: 10.1136/gutjnl-2021-324356