P640 Serologic response and safety after third dose of the COVID-19 BNT162b2 vaccine in patients with Inflammatory Bowel Diseases. (30th January 2023)

• Record Type: Journal Article
• Authors: Edelman-Klapper, H; Rabinowitz, K M; Zittan, E; Bar-Gil Shitrit, A; Goren, I; Avni-Biron, I; Ollech, J E; Lichtenstein, L; Banai-Eran, H; Yanai, H; Snir, Y; Pauker, M H; Friedenberg, A; Levy-Barda, A; Segal, A; Broitman, Y; Maoz, E; Ovadia, B; Aharoni Golan, M; Shachar, E; Ben-Horin, S; Mor, M; Ben Zvi, H; Perets, T T; Eliakim, R; Barkan, R; Navon, M; Gal-Tanamy, M; Freund, N T; Goren, S; Cohen, D; Dotan, I;
• Is Part Of: Journal of Crohn's and colitis. Volume 17(2023)Supplement 1
• Page Start: i772
• Page End: i773
• Publication Date: 2023-01-30
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjac190.0770
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Vaccines are pivotal for control of the ongoing coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBD) treated with anti-tumor necrosis factor (TNF)-α have lower serologic response after two COVID-19 vaccine doses. Data regarding a 3 rd vaccine are scarce. Methods: Aim: To assess immune responses to, and safety of COVID-19 vaccines in patients with IBD, stratified according to therapy, and compared to healthy controls (HC). Subjects were recruited before the 1 st vaccine (BNT162b2, Pfizer) and prospectively evaluated after the 2 nd and 3 rd vaccine doses. Evaluation included: disease activity, anti-spike (S) and nucleocapsid (N), anti-TNFα drug levels and adverse events (AE) Results: Of 198 subjects having the 3 rd vaccine dose, 125 had IBD: average age: 39.1±14.8 years; 40.8% females; 82- Crohn's disease (CD), 33 ulcerative colitis (UC), 6 pouch, 3 IBD-U. There were 73 HC: average age 39.4±12.5 years, 69.9% females. Among patients with IBD: 51 and 74 (40.8%, 59.2%)) were treated or not with anti-TNFα, respectively. A month after the 3 rd vaccine dose IBD activity was comparable in all patients regardless of treatment, and no increase in C-reactive protein or white blood cells was observed. Higher but not significant AE rate was registered in all subjects after the 3 rd compared to 2 nd vaccine dose (81% vs. 76%, respectively). AE rate in IBD and HC was comparable. No serious AE detected. There was a significant increase in anti-S levels one month after compared to pre 3 rd vaccine dose in all participants. Furthermore, increase was 2-3 folds higher than that observed one month after the 2 nd dose. Importantly, patients treated with anti-TNFα compared to non-anti-TNFα treated had significantly lower responses: 9219 (6347-13390) vs 16955 (13721-20951) (GMC (95%CI)), p<0.05. Serologic response did not correlate with anti-TNFα drug levels, antibodies or interval between drug and vaccine administration. During extended follow-up post 3 rd dose, we found that lower serologic response predicts infection over time. Conclusion: This prospective study shows that a 3 rd dose of BNT162b2 vaccine is effective and safe in patients with IBD. Furthermore, patients treated with anti-TNFα had significantly lower serologic responses compared to anti-TNFα untreated ones. Lack of correlation between anti-TNFα drug levels and immune responses suggests there is no need to modify vaccination timing relatively to anti-TNFα administration. The significantly steeper increase in anti-S levels between 2 nd and 3 rd doses, suggests the 3 rd dose is crucial in anti-TNFα treated patients, specifically due to the fact that higher serologic response predicts better defense from infection.