Effectiveness of SARS-CoV-2 Vaccination in a Veterans Affairs Cohort of Patients With Inflammatory Bowel Disease With Diverse Exposure to Immunosuppressive Medications

Abstract

Background and Aims Vaccination against SARS-CoV-2 has rapidly expanded, however clinical trials excluded patients taking immunosuppressive medications such as those with inflammatory bowel disease (IBD). Therefore, we explored real-world effectiveness of COVID-19 vaccination on subsequent infection in IBD patients with diverse exposure to immunosuppressive medications. Methods This was a retrospective cohort study of patients in the Veterans Health Administration with IBD diagnosed prior to 12/18/20, the start date of the VHA patient vaccination program. IBD medication exposures included 5-aminosalicylic acid, thiopurines, anti-tumor necrosis factor biologic agents, vedolizumab, ustekinumab, tofacitinib, methotrexate, and corticosteroid use. We used inverse probability weighting and Cox regression with vaccination status as a time-updating exposure, and computed vaccine effectiveness from incidence rates. Results The cohort comprised 14,697 patients, 7,321 of whom received at least one vaccine dose (45.2% Pfizer, 54.8% Moderna). The cohort had median age 68 years, was 92.2% male, 80.4% white, and 61.8% with ulcerative colitis. In follow-up data through April 20, 2021, unvaccinated individuals had the highest raw proportion of SARS-CoV-2 infection (197 [1.34%] versus 7 [0.11%] fully vaccinated). Full vaccination status, but not partial vaccination status, was associated with a 69% reduced hazard of infection relative to an unvaccinated status (hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.17-0.56, p<0.001), corresponding to an 80.4% effectiveness. Conclusion Full vaccination (>7 days after the 2 nd dose) against SARS-CoV-2 infection has an approximately 80.4% effectiveness in a broad IBD cohort with diverse exposure to immunosuppressive medications. These results may serve to increase patient and provider willingness to pursue vaccination in these settings.

COVID-19 vaccine safety and efficacy in patients with immune-mediated inflammatory disease: Review of available evidence

“…15 Although the prospective randomized studies for the currently available mRNA and adenovirus COVID-19 vaccines excluded patients on immunomodulatory medications, several groups have published case series of patients with IMID who have been vaccinated (Tables I and II). [16][17][18][19][20][21][22][23][24][25][26][27][28] These data suggest that patients receiving biologics for the treatment of inflammatory and autoimmune disease can safely receive, and are able to mount a detectable immune response to, the COVID-19 vaccines, with a few notable exceptions.…”

Efficacy and Effectiveness of SARS-CoV-2 vaccine: A systematic review and a meta-analysis.

“…The severity of COVID-19 one after the rst dose a heterogeneity of I 2= = 61%, OR of having severe COVID-19 one week after the rst dose was 0.21 (95% CI, 0.11-0.40). After omitting the study of Khan et al (37), the OR of having severe COVID-19 after the rst dose of vaccination among 79176 vaccinated and 78810 unvaccinated subjects in 6 studies was increased to 0.29 (0.19-0.46), I 2 was 25%. Only this study of Sadoff et al (32), did not show any protective effect of vaccination.…”

“…Pooled OR was 0.34 (95CI 0.26-0.44), however, the heterogeneity was statistically high 85%. After conducting a leave-oneout sensitivity analysis, the study of Khan et al (37), was omitted. The observed heterogeneity dropped to 0%, and the pooled effect was still signi cant OR= 0.46, (95% CI 0.35-0.61).…”

Challenges to Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Diseases

“…Clinical and laboratory outcomes were highly heterogeneous, reflecting the lack of consolidated data about the characteristics of the immune response in COVID-19 and anti-SARS-CoV-2 vaccination. Similar to studies investigating COVID-19 prevalence in patients with immune mediated-diseases [ 7 , 67 , 68 , 69 , 70 ], there was also broad variability in experimental methods, which ranged from web-based surveys [ 35 , 42 ] to clinician-supervised single- or multicentre studies [ 43 , 60 ] or registries [ 55 ]. Due to the recent onset of immunisation campaigns worldwide, only time-limited observations were available.…”

“…A total of 24 studies reporting on more than 11,000 patients with autoimmune/rheumatic diseases have been published so far. Beside one large study focused on elderly patients with inflammatory bowel diseases [ 55 ], most studies included heterogeneous patient groups with the majority of enrolled patients classified with chronic arthritides such as rheumatoid arthritis or psoriatic arthritis, in line with their relatively high prevalence in the general population ( Table 2 ). Most patients had an established diagnosis with relatively long follow-up data.…”