Impact of biologic therapy on SARS-CoV-2 infection and immunity in patients with inflammatory bowel disease

Conditions

COVID-19 (SARS-CoV-2 infection), inflammatory bowel disease Infections and Infestations

Liu Z, Le K, Zhou X, Alexander JL, Lin S, Bewshea C, Chanchlani N, Nice R, McDonald TJ, Lamb CA, Sebastian S, Kok K, Lees CW, Hart AL, Pollok RC, Boyton RJ, Altmann DM, Pollock KM, Goodhand JR, Kennedy NA, Ahmad T, Powell N, CLARITY study investigators.

2022-12-0532 citations

10.1016/s2468-1253(22)00389-2

Vaccine escape, increased breakthrough and reinfection in infliximab-treated patients with IBD during the Omicron wave of the SARS-CoV-2 pandemic

Nicholas A. Kennedy, Malik Janjua, Neil Chanchlani, Simeng Lin, Claire Bewshea et al. (23 authors)

Gut2022-07-2841 citations

10.1136/gutjnl-2022-327570

Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines in patients with IBD

Nicholas A. Kennedy, Simeng Lin, James Goodhand, Neil Chanchlani, Benjamin Hamilton et al. (26 authors)

Gut2021-04-26275 citations

10.1136/gutjnl-2021-324789

Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab

Nicholas A Kennedy, James R Goodhand, Claire Bewshea, Rachel Nice, Desmond Chee et al. (31 authors)

Gut2021-03-22165 citations

10.1136/gutjnl-2021-324388

Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab.

Nicholas A. Kennedy, James Goodhand, Claire Bewshea, Rachel Nice, Desmond Chee et al. (32 authors)

Edinburgh Research Explorer (University of Edinburgh)2021-02-10163 citations

10.17863/cam.66211

Interventions

Workflow 1: Retrospective study of SARS-CoV-2 seroprevalence across the UK using surplus serum samples. Using the Roche Elecsys assay the researchers will test >7500 serum samples from IBD patients f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 5 years and over 2. Diagnosis of inflammatory bowel disease 3. Current treatment with infliximab or vedolizumab for 6 weeks or more 4. Written informed consent obtained from patient or parent/guardian

Exclusion criteria

Exclusion criteria: Patients participating in a vaccine trial

Design outcomes

Primary

Measure	Time frame
Workflow 1– retrospective study: Cumulative seropositivity of anti-SARS-CoV-2 antibodies, measured using the Roche Elecsys assay between 01/01/2020 and 30/09/2020 Workflow 2: Positive anti-SARS-CoV-2 antibody test, using the Roche Elecsys assay, at week 0 or week 40	—

Secondary

Measure	Time frame
Workflow 1: In patients with more than one test, change in anti-SARS-CoV-2 antibody positivity and cut-off index (COI) measured using the Roche Elecsys assay between 01/01/2020 and 30/09/2020 Workflow 2: 1. Proportion of patients with symptomatic COVID-19 disease and a positive PCR test prior to week 0 and prior to week 40 2. Proportion of patients with symptomatic COVID-19 disease and a positive anti-SARS-CoV-2 antibody test measured using the Roche Elecsys assay prior to week 0 and prior to week 40 3. Anti-SARS-CoV-2 antibody COI measured using the Roche Elecsys assay at week 0 and 40 4. Proportion of patients with symptomatic COVID-19 disease, a positive PCR test, and hospitalisation or death, prior to week 0 and prior to week 40 5. In patients with detectable anti-SARS-CoV-2 antibodies at week 0, time in days to a reduction in antibody COI by at least 50% or undetectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay between week 0 and week 40 6. In patients with detectable anti-SARS-CoV-2 antibodies at week 0, time in days to a reduction in antibody COI by at least 75% or undetectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay between week 0 and week 40 7. Proportion of patients with detectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay at week 0 who acquire PCR-positive COVID-19 disease between week 0 and week 40	—

Measure

Time frame

Workflow 1: In patients with more than one test, change in anti-SARS-CoV-2 antibody positivity and cut-off index (COI) measured using the Roche Elecsys assay between 01/01/2020 and 30/09/2020 Workflow 2: 1. Proportion of patients with symptomatic COVID-19 disease and a positive PCR test prior to week 0 and prior to week 40 2. Proportion of patients with symptomatic COVID-19 disease and a positive anti-SARS-CoV-2 antibody test measured using the Roche Elecsys assay prior to week 0 and prior to week 40 3. Anti-SARS-CoV-2 antibody COI measured using the Roche Elecsys assay at week 0 and 40 4. Proportion of patients with symptomatic COVID-19 disease, a positive PCR test, and hospitalisation or death, prior to week 0 and prior to week 40 5. In patients with detectable anti-SARS-CoV-2 antibodies at week 0, time in days to a reduction in antibody COI by at least 50% or undetectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay between week 0 and week 40 6. In patients with detectable anti-SARS-CoV-2 antibodies at week 0, time in days to a reduction in antibody COI by at least 75% or undetectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay between week 0 and week 40 7. Proportion of patients with detectable anti-SARS-CoV-2 antibodies measured using the Roche Elecsys assay at week 0 who acquire PCR-positive COVID-19 disease between week 0 and week 40

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Countries

England, United Kingdom

Contacts

Public ContactClaire Bewshea

Outcome results

None listed