EFFECT OF SARS COV-2 VACCINE IN IBD PATIENTS ON BIOLOGIC THERAPY INCLUDING LIVER TRANSPLANT RECIPIENTS

ABSTRACT

Introduction Vaccination against SARS COV-2 represents currently the best option to reduce COVID-19 mortality and morbidity. Patients with inflammatory bowel diseases (IBD) including liver transplant recipients (LTR) are in higher risk for severe disease. Despite the proven effect of vaccines, the biologic agents (BA) and concomitant immunosuppression can reduce the development of adequate antibody-mediated immunity. The aim of our study was to evaluate the effect of vaccination in these specific groups of patients. Methods A total of 211 patients with IBD on BA was enrolled, including 11 LTR. Most of them were vaccinated with 2 doses of BNT162b2 (97.1%, n=205). Anti-COVID-19 IgG (anti-C19) levels were monitored before the 1st dose (D1) of the vaccine and at least 10 days after the 2nd dose (D2). Adverse events were monitored using a questionnaire after each dose. Results 90.3% of all IBD patients and 84.5% of LTR on BA were fully vaccinated, 24.6% presented positive levels of anti-C19 before D1 (>9.5kAU/l). The mean anti-C19 levels presented after D2 in vedolizumab-treated patients was higher comparing to anti-TNFa-treated patients (323.3 kAU/l vs. 248.3 kAU/l, p<0.05). The mean anti-C19 levels presented after D2 in intensified regimens of vedolizumab and anti-TNFa agents had no significant difference in the humoral response compared to standard regimens (vedolizumab, 315.8 kAU/l vs. 327.6 kAU/l;anti-TNFa 233.6 kAU/l vs. 263.4 kAU/l). Prednison-treated patients showed dose dependent negative trend of anti-C19 levels after D2 (1mg prednisone = -6.05 kAU/l, CI 95% [-11.58, -0.51], p<0.032). LTR with IBD on BA showed no significant difference in anti-C19 levels after D2 comparing to other IBD patients on BA (271.5 vs. 230.1). Positivity of anti-C19 (>9.5 kAU/l) before D1 is associated with higher antibody levels after D2 (p<0.001, beta=124.66, CI 95% [78.61, 170.70]). The age of the patients is inversely proportional with the anti-C19 levels after D2 and with the rate of adverse events (p=0.007, beta=-2.04, CI 95% [-3.52, -0.56];p=0.004, OR=0.95, CI 95% [0.91, 0.98]). Patients which presented adverse events after D1 showed higher incidence rate of adverse events after D2 (p<0.001, OR=15.14, CI 95% [5.68, 44.14]). Most common adverse events were arm pain (80.4%), fatigue (41.9%), headache (20.6%), swelling of the application site (20.1%), chills (15.0%), joint and muscle pain (15.0%), digestive problems (7.3%). Conclusion Anti-TNFa agents are associated with lower humoral response, early 3rd dose should be considered. Intensified regimens do not cause lower antibody response. LTR with IBD on BA showed no significant difference comparing standard IBD patients on BA. Higher doses of prednisone are associated with lower humoral response. Elderly IBD patients should be recommended for an early 3rd dose. (Figure Presented)