Decreased Immune Response to COVID-19 mRNA Vaccine in Patients with Inflammatory Bowel Diseases Treated with Anti TNFα

  1. Hadar Edelman-Klapper
  2. Eran Zittan
  3. Ariella Bar-Gil Shitrit
  4. Keren Masha Rabinowitz
  5. Idan Goren
  6. Irit Avni-Biron
  7. Jacob E. Ollech
  8. Lev Lichtenstein
  9. Hagar Banai-Eran
  10. Henit Yanai
  11. Yifat Snir
  12. Maor H. Pauker
  13. Adi Friedenberg
  14. Adva Levy-Barda
  15. Arie Segal
  16. Yelena Broitman
  17. Eran Maoz
  18. Baruch Ovadia
  19. Maya Aharoni Golan
  20. Eyal Shachar
  21. Shomron Ben-Horin
  22. Tsachi-Tsadok Perets
  23. Rami Eliakim
  24. Sophy Goren
  25. Michal Navon
  26. Noy Krugliak
  27. Michal Werbner
  28. Joel Alter
  29. Moshe Dessau
  30. Meital Gal-Tanamy
  31. Natalia T. Freund
  32. Dani Cohen
  33. Iris Dotan
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Abstract

Background

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.

Aim

to assess immune responses to mRNA-COVID-19 vaccine, and safety profile, in patients with IBD stratified according to therapy, compared to healthy controls (HC).

Methods

Prospective, controlled, multi-center Israeli study. Subjects enrolled received two BNT162b2 (Pfizer/BioNTech) doses. Anti-spike (S) antibodies levels and functional activity, anti-TNFα levels and adverse events (AEs) were detected longitudinaly.

Results

Overall 258 subjects: 185 IBD (67 treated with anti-TNFα), and 73 HC. After the first vaccine dose all HC were seropositive, while some patients with IBD, regardless of treatment, remained seronegative. After the second dose all subjects were seropositive, however anti-S levels were significantly lower in anti-TNFα treated compared to untreated patients, and HC (p<0.001; p<0.001, respectively). Neutralizing and inhibitory functions were both lower in anti-TNFα treated compared to untreated patients, and HC (p<0.03; p<0.0001, respectively). Anti-TNFα drug levels and vaccine responses did not affect anti-S levels. Infection rate (∼2%) and AEs were comparable in all groups. IBD activity did not change in response to BNT162b2.

Conclusions

In this prospective study in patients with IBD stratified according to treatment all patients mounted an immune response to two 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 immune response longevity in this group may be limited, vaccine booster dose should be considered.

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