Colon to Rectum

Gastroenterology. 2022;162(2):454–67

Edelman-Klapper H, Zittan E, Bar-Gil Shitrit A, Rabinowitz KM, Goren I, Avni-Biron I, Ollech JE, Lichtenstein L, Banai-Eran H, Yanai H, Snir Y, Pauker MH, Friedenberg A, Levy-Barda A, Segal A, Broitman Y, Maoz E, Ovadia B, Golan MA, Shachar E, Ben-Horin S, Perets TT, Ben Zvi H, Eliakim R, Barkan R, Goren S, Navon M, Krugliak N, Werbner M, Alter J, Dessau M, Gal-Tanamy M, Freund NT, Cohen D, Dotan I; REsponses to COVid-19 vaccinE IsRaeli IBD group (RECOVER)

Lower serologic response to COVID-19 mRNA vaccine in patients with inflammatory bowel diseases treated with anti-TNFα

Background and aim: Patients with inflammatory bowel diseases (IBD), specifically those treated with anti-tumor necrosis factor (TNF)α 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-spike antibody levels and functional activity, anti-TNFα levels and adverse events (AEs) were detected longitudinally.
Results: Overall, 258 subjects: 185 IBD (67 treated with anti-TNFα, 118 non-anti-TNFα), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas approx. 7% 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-TNFα-treated compared with non-anti-TNFα-treated patients, and HCs (both p < 0.001). Neutralizing and inhibitory functions were both lower in anti-TNFα-treated compared with non-anti-TNFα-treated patients, and HCs (p < 0.03; p < 0.0001, respectively). Anti-TNFα drug levels and vaccine responses did not affect anti-spike levels. Infection rate (approx. 2%) and AEs were comparable in all groups. IBD activity was unaffected by BNT162b2.

Conclusions: In this prospective study in patients with inflammatory bowel diseases 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-TNFα, 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.

DOI: DOI: 10.1053/j.gastro.2021.10.029