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Ahmad reports that CLARITY IBD is a researcher-led COVID-19 study by the UK National Institute for Health Research COVID-19, funded by the Royal Devon and Exeter NHS Foundation Trust, Hull University’s NHS teaching hospital, and unrestricted educational grants from F. Hoffmann is financed. La Roche AG (Switzerland), Biogen GmbH (Switzerland), Celltrion Healthcare (South Korea), Takeda (Great Britain) and Galapagos NV (Belgium).
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Patients who received Remicade for inflammatory bowel disease had weakened anti-COVID-19 antibody responses after a single dose of vaccine, according to a study published in Gut.
In a prospective observational cohort study, the researchers compared the antibody responses and seroconversion rates in Remicade-treated (infliximab, Janssen) patients (n = 856) with entyvio-treated (vedolizumab, Takeda) patients (n = 428) 3 weeks to 10 weeks after receiving a single dose a SARS-CoV-2 vaccine.
According to study results, patients treated with infliximab had lower levels of anti-SARS-CoV-2 after a dose of BNT162b2 (6 U / ml versus 28.8 U / ml) and a ChAdOx1 nCoV-19 dose (4.7 U / ml). Antibody concentrations 13.8 U / ml). Multivariable analysis also found lower antibody levels for infliximab-treated patients compared to vedolizumab-treated patients after the BNT162b2 vaccine (fold change) [FC] = 0.29; 95% CI, 0.21-0.4) and the ChAdOx1 nCoV-19 vaccine (FC = 0.39; 95% CI, 0.3-0.51). The researchers found higher seroconversion rates in patients with previous SARS-CoV-2 infection after a single dose of either vaccine, as well as in patients who received two doses of the BNT162b2 vaccine.
Healio Gastroenterology spoke with Tariq Ahmad, D. Phil, MB, ChB, FRCP, Consultant gastroenterologist at the Royal Devon and Exeter Hospital and Honorary Associate Professor at the University of Exeter on the important takeaway news and how these findings affect future IBD management.
Tariq Ahmad
Healio: Why did your team conduct this study?
Ahmad: In the early months of the COVID-19 pandemic, there was significant concern that biological and immunomodulatory drugs used in the treatment of IBD could increase the risk and severity of COVID-19 and interfere with the protective immune responses that normally occur after infection or vaccination occur. In the absence of evidence to inform public health policy, the UK government advised patients treated with these drugs to adhere to strict social distancing measures, including screening.
We created the CLARITY IBD study to determine the effects of these drugs on COVID-19 infection and immunity. Previous studies had reported that anti-TNF drugs (including infliximab) increase the risk of serious respiratory infections and reduce protective immunity after certain vaccinations. Therefore, we hypothesized that anti-SARS-CoV-2 antibody responses would be impaired after SARS-CoV-2 infection and vaccination in infliximab-treated patients. To test this hypothesis, we compared the antibody responses in patients with IBD treated with infliximab to a reference cohort treated with vedolizumab, a well-selective anti-integrin alpha-4-beta-7 monoclonal antibody that did not associated with impaired or increased vaccine responses is susceptibility to systemic infections.
Healio: What’s the most important takeaway message?
Ahmad: In our first article, we reported that SARS-CoV-2 infection rates were similar in infliximab-treated and vedolizumab-treated patients with IBD, suggesting that infliximab does not increase the risk of infection. However, patients treated with infliximab were less likely to have a positive antibody test, both in the overall patient population and in patients with confirmed infection based on standard tests. The rate of positive antibody tests was lowest among participants who took other immunosuppressants such as azathioprine, mercaptopurine, or methotrexate in addition to infliximab. These data indicated the possibility that patients treated with anti-TNF are at risk for impaired vaccination reactions.
In our second article, we confirmed that anti-SARS-CoV-2 spike antibody levels and seroconversion rates are lower after a single dose of the Pfizer BioNTech and Oxford AstraZeneca vaccines in infliximab compared to vedolizumab-treated patients. Fortunately, however, the antibody concentrations and seroconversion rates were higher in patients with previous SARS-CoV-2 infection and after two vaccine doses.
Healio: How do these results affect IBD management in future patients receiving the COVID-19 vaccine?
Ahmad: We recommend patients with IBD to accept the approved SARS-CoV-2 vaccination.
Several countries have adopted a strategy to delay the second dose of vaccine to allow lower levels of protective immunity for a larger part of the population. The UK has demonstrated the success of this strategy in reducing the transmission and number of SARS-CoV-2 infections. However, a delayed second dose may put patients treated with anti-TNF drugs at risk of infection after a single dose. Patients should be aware that they may not be protected from SARS-CoV-2 infection.
We strongly recommend that patients continue anti-TNF treatment for three reasons. First, data from this and other studies suggest that these drugs do not pose an increased risk of SARS-CoV-2 infection in patients. Next, there may be benefits of anti-TNF therapy that reduces the severe inflammation that characterizes severe COVID-19 disease. Finally, protective antibody responses are seen in most patients after doses of vaccine.
Even after two antigen exposures, a small subgroup of patients failed to elicit an antibody response. While other parts of the immune system, including T-cell responses, may provide protection against SARS-CoV-2 infection, antibody tests and additional booster doses of the vaccine should be considered to protect these high-risk patients.
Healio: What is the next step in future research?
Ahmad: We continue to follow the CLARITY IBD cohort of 7,000 participants. We are currently investigating antibody levels and seroconversion rates after a second SARS-CoV-2 vaccine dose and will investigate the durability of antibody responses and the effectiveness of the vaccine over the 40-week follow-up period. We would like to publish our data on antigen-specific T cell reactions after the first and second dose of the SARS-CoV-2 vaccination in 2 months.
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