Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNFα

Abstract

BACKGROUND & AIM: Patients with inflammatory bowel diseases (IBD), specifically those treated with anti-tumor necrosis factor (TNF)a biologics, are at high risk for vaccine-preventable infections. Their ability to mount adequate vaccine responses is unclear. The aim of the study was to assess serologic responses to messenger RNA-Coronavirus Disease 2019 vaccine, and safety profile, in patients with IBD stratified according to therapy, compared with healthy controls (HCs). METHODS: Prospective, controlled, multicenter Israeli study. Subjects enrolled received 2 BNT162b2 (Pfizer/BioNTech) doses. Anti-Gastroenterology 2021;-:1-14 CLINICAL ATspike antibody levels and functional activity, anti-TNFa levels and adverse events (AEs) were detected longitudinally. RE-SULTS: Overall, 258 subjects: 185 IBD (67 treated with anti-TNFa, 118 non-anti-TNFa), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas w7% of patients with IBD, regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNFa treated compared with non-anti-TNFa treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNFa treated compared with non-anti-TNFa treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNFa drug levels and vaccine responses did not affect anti-spike levels. Infection rate (w2%) and AEs were comparable in all groups. IBD activity was unaffected by BNT162b2. CONCLUSIONS: In this prospective study in patients with IBD stratified according to treatment, all patients mounted serologic response to 2 doses of BNT162b2; however, its magnitude was significantly lower in patients treated with anti-TNFa, regardless of administration timing and drug levels. Vaccine was safe. As vaccine serologic response longevity in this group may be limited, vaccine booster dose should be considered.

Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease

“…This study aimed at reporting the experience on the acceptance and safety of vaccines against COVID-19 in IBD patients. Interestingly, it was highlighted that the occurrence of AEs after vaccination against COVID-19 in Greek IBD patients was similar to that reported in other ethnic IBD and non-IBD populations [7][8][9][10][11][12]. No severe disease relapse or serious AEs including hospitalizations for any reason, severe allergic reactions, thromboembolic events or myopericarditis were recorded.…”

“…This was somehow confirmed by a recent study that showed no difference on steroid use 30 days after vaccination between vaccinated and unvaccinated IBD patients [8]. No difference in clinical disease activity scores was also found in another cohort between anti-TNFa and non-anti-TNFa users after either vaccine dose irrespective of disease activity at vaccination (one third of each group reported not being in remission at vaccine administration [9]. Interestingly, in our cohort 6.4% and 8.4% of the patients reported novel gastrointestinal symptoms (predominantly diarrhea and abdominal pain) after D1 and D2 respectively.…”

“…In an attempt to find a possible correlation between the use of biologic agents and occurrence of AEs, we have proceeded to a sub-analysis according to treatment group (biologics, immunomodulators, combination therapy or no immunosuppression). The majority of studies emphasize that patients with immune-mediated inflammatory diseases receiving biologic therapies do not run any extra risk for AEs after COVID-19 vaccination [7][8][9]25,26] when compared with the general population. However, in the recently published PREVENT-COVID study anti-TNFa and vedolizumab use were associated with severe systemic reactions to D2 [10] while there is one report showing that the AE risk might even be reduced while on biologics [7].…”

“…Although IBD patients on all sorts of immunosuppressive agents were excluded from clinical trials preceding vaccine EUA [4][5][6], emerging data suggest that they-even those under immunosuppressants-are not at higher risk of developing adverse events (AEs) after COVID-19 vaccination, when compared with control cohorts [7][8][9]. This applies both to mild and severe AEs or AEs of special interest, both topical and systemic.…”

“…Young age, female gender, vaccine type and prior COVID infection have all been associated with AEs in healthy controls as well as in the IBD subpopulation [7,10]. Regarding a possible impact of vaccines on disease activity, no correlation has been found as assessed by steroid need or changes in clinical disease activity scores [8,9].…”