Impact of Holding Immunosuppressive Therapy in Patients with Inflammatory Bowel Disease Around mRNA COVID-19 Vaccine Administration on Humoral Immune Response and Development of COVID-19 Infection.

BACKGROUND AND AIMS: The BNT162b2 and mRNA-1273 COVID-19 vaccines are efficacious in patients with inflammatory bowel disease; but there are a lack of data examining if holding immunosuppressive therapy around vaccination improves immune response. We studied the effect of holding IBD medications around the time of vaccination on antibody response and breakthrough COVID-19 infection. METHODS: Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID is a prospective cohort of individuals with IBD receiving COVID-19 vaccination. Quantitative measurement of anti-receptor binding domain IgG antibodies to SARS-CoV-2 was performed 8 weeks after completing a vaccination series. RESULTS: 1,854 patients were included; 59% were on anti-TNF (10% of these on combination therapy), 11% on vedolizumab, and 14% on ustekinumab. 11% of participants held therapy before or after vaccine administration for at least 2 weeks. Antibody levels were similar in participants continuing versus holding anti-TNF monotherapy before or after the second vaccine (BNT162b2: 10 µg/mL vs 8.9 µg/mL, mRNA-1273: 17.5 µg/mL vs 14.5 µg/mL). Comparable results were seen in those on combination therapy. Antibody titers in those on ustekinumab or vedolizumab were higher compared to anti-TNF users, but there was no significant difference if drug was held or continued (BNT162b2: 22.5 µg/mL vs 23 µg/mL, mRNA-1273: 88 µg/mL vs 51 µg/mL). Holding therapy was not associated with decreased rate of COVID-19 infection compared to those not holding therapy (BNT162b2: 28% vs 29%; mRNA-1273 19% vs 31%). CONCLUSION: We recommend continuing IBD medications while receiving mRNA COVID-19 vaccination without interruption.

Impact of Holding Immunosuppressive Therapy in Patients With Inflammatory Bowel Disease (IBD) Around the Time of mRNA COVID-19 Vaccine Administration on Humoral Immune Response and Development of COVID-19 Infection

Methods: We reviewed data collected from the prospective cohort, Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID (PREVENT-COVID). Results: A total of 1,768 patients were included;69% with Crohn’s disease and 73% females. 49% were on anti-TNF monotherapy, 11% on combination therapy (anti-TNF and immunomodulator), 11% on vedolizumab, and 14% on ustekinumab. 11% of participants held therapy before or after vaccine administration. Antibody titers based on whether IBD therapy was held before, after, or any time before or after second BNT162b2 and mRNA-1273 COVID-19 vaccine administration Initial COVID-19 Antibody Titers by Whether Medication was Held Before Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Mediation Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 15 8.5 3.6, 19.0 426 9.9 4.5, 16.0 0.872 7 14 9.0, 24.0 228 17 9.7, 28.0 0.676 Combo therapy (TNF + thiopurine or MTX) 4 4.45 2.0, 10.2 110 5.1 2.3, 13.0 0.764 3 18 10.0, 23.0 73 15 6.7, 22.0 0.541 Novel Biologic (Uste or Vedo) 6 62 39.0, 161.0 264 22 13.0, 40.0 0.038 7 119 89.0, 203.0 167 51 28.0, 99.0 0.026 Thiopurine Only 4 12.65 8.3, 22.5 112 15 7.1, 23.5 0.976 4 55.5 38.5, 68.0 68 35.5 20.5, 66.0 0.434 Methotrexate Only 4 23 16.5, 105.0 22 18.5 13.0, 34.0 0.505 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632 Initial COVID-19 Antibody Titers by Whether Medication was Held After Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Medication Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 38 11 4.4, 19.0 403 9.8 4.5, 16.0 0.759 25 14 9.0, 27.0 210 17 9.7, 28.0 0.405 Combo therapy (TNF + thiopurine or MTX) 11 4 1.9, 6.4 103 5.3 2.3, 13.0 0.343 5 18 10.0, 23.0 71 15 6.7, 22.0 0.587 Novel Biologic (Uste or Vedo) 16 22.5 16.0, 49.0 254 22 13.0, 40.0 0.786 14 88.5 36.0, 119.0 160 51 28.5, 99.0 0.238 Thiopurine Only 4 9.65 8.3, 19.5 112 15 7.1, 23.5 0.763 5 49 28.0, 62.0 67 37 20.0, 69.0 0.732 Methotrexate Only 7 26 16.0, 148.0 19 19 11.0, 33.0 0.205 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632 Initial COVID-19 Antibody Titers by Whether Medication was Held Before or After Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Medication Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 42 10.15 4.4, 19.0 399 9.9 4.5, 16.0 0.833 27 14 9.0, 27.0 208 17.5 9.9, 28.5 0.255 Combo therapy (TNF + thiopurine or MTX) 13 4 1.9, 6.4 101 5.3 2.5, 13.0 0.369 5 18 10.0, 23.0 71 15 6.7, 22.0 0.587 Novel Biologic (Uste or Vedo) 22 29 18.0, 48.0 248 22 13.0, 40.0 0.285 14 88.5 36.0, 119.0 160 51 28.5, 99.0 0.238 Thiopurine Only 5 10 9.3, 16.0 111 15 7.0, 24.0 0.823 6 54.5 28.0, 62.0 66 35.5 20.0, 69.0 0.556 Methotrexate Only 8 23 17.0, 120.0 18 18.5 11.0, 33.0 0.213 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632