Postvaccination Symptoms After a Third Dose of mRNA SARS-CoV-2 Vaccination in Patients With Inflammatory Bowel Disease: Results From CORALE-IBD

Li, Dalin; Debbas, Philip; Mujukian, Angela; Cheng, Susan; Braun, Jonathan; McGovern, Dermot P.; Melmed, Gil Y.; Banty, Andrea; Feldman, Edward J.; Ha, Christina; Lee, Susie; Rabizadeh, Shervin; Stein, Theodore; Solomon, Theodore; Syal, Gaurav; Targan, Stephan R.; Vasiliauskas, Eric; Ziring, David; Bonthala, Niru; Botwin, Gregory S; Hampton, Melissa; Mengesha, Emebet; Khanishian, Elizabeth; Pozdnyakova, Valeriya; Gu, Phillip; White, Shane; Zamudio, Cindy; Gonzalez, Daniel; Parry, Alyssa; Hanna, Mary; Chan, Joshua L.; Ebinger, Joe; Joung, Sandy; Wu, Min; Hoang, Amy; Wynter, Timothy; Sun, Nancy; Figueiredo, Jane C.; Merchant, Akil; Merin, Noah; Reckamp, Karen L.; Appel, Keren; Boland, Brigid S.; Charabaty, Aline; Chiorean, Michael; Cohen, Erica; Flynn, Ann D.; Valentine, John F.; Ehrlich, Adam C.; Fudman, David; Horizon, Arash; Karayev, Dmitry; Kretzmann, Benjamin; Hou, Jason K.; Hwang, Caroline; Lazarev, Mark; Lum, Donald; Fausel, Rebecca; Reddy, Swapna; McConnell, Ryan; Mattar, Mark; Metwally, Mark; Ostrov, Arthur; Parekh, Nimisha K.; Raffals, Laura H.; Rubin, David T.; Sheibani, Sarah; Siegel, Corey A.; Wolf, D.; Younes, Ziad; Damas, Oriana M.

doi:10.1093/ibd/izac174

Cited by 10 publications

(9 citation statements)

References 9 publications

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“…Booster vaccines were shown to be safe in IBD patients and several studies analysed booster vaccine-elicited immune responses in different subgroups of immunocompromised patients. [21][22][23][24][25][26][27] However, to our knowledge, this is the first study to when comparing them to IBD patients without immunosuppressive treatment. [24][25][26][28][29][30] Importantly, it must be noted that the reduced antibody responses found in this study, might at least partially be influenced by already reduced antibody concentrations in anti-TNFtreated patients after two vaccine doses as shown before.…”

Section: Discussionmentioning

confidence: 97%

“…Therefore, vaccination campaigns worldwide recommend a SARS‐CoV‐2 booster vaccine for immunosuppressed patients. Booster vaccines were shown to be safe in IBD patients and several studies analysed booster vaccine‐elicited immune responses in different subgroups of immunocompromised patients 21–27 . However, to our knowledge, this is the first study to prospectively characterise the humoral and functional cellular immune responses following a third dose with SARS‐CoV‐2 mRNA vaccines in IBD patients receiving immunosuppressive treatment and healthy controls.…”

Section: Discussionmentioning

confidence: 99%

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Systemic and T cell‐associated responses to SARS‐CoV‐2 immunisation in gut inflammation (STAR SIGN study): effects of biologics on vaccination efficacy of the third dose of mRNA vaccines against SARS‐CoV‐2

Woelfel

Dütschler

König

et al. 2022

Aliment Pharmacol Ther

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Background: Immunosuppressed patients with inflammatory bowel disease (IBD) experience increased risk of vaccine-preventable diseases such as COVID-19. Aims: To assess humoral and cellular immune responses following SARS-CoV-2 booster vaccination in immunosuppressed IBD patients and healthy controls. Methods: In this prospective, multicentre, case-control study, 139 IBD patients treated with biologics and 110 healthy controls were recruited. Serum anti-SARS-CoV-2 spike IgG concentrations were measured 2-16 weeks after receiving a third mRNA vaccine dose. The primary outcome was to determine if humoral immune responses towards booster vaccines differ in IBD patients under anti-TNF versus nonanti-TNF therapy and healthy controls. Secondary outcomes were antibody decline, impact of previous infection and SARS-CoV-2-targeted T cell responses.Results: Anti-TNF-treated IBD patients showed reduced anti-spike IgG concentrations (geometric mean 2357.4 BAU/ml [geometric SD 3.3]) when compared to non-anti-TNF-treated patients (5935.7 BAU/ml [3.9]; p < 0.0001) and healthy controls (5481.7 BAU/ml [2.4]; p < 0.0001), respectively. In multivariable modelling, prior infection (geometric mean ratio 2.00 [95% CI 1.34-2.90]) and vaccination with mRNA-1273 (1.53 [1.01-2.27]) increased antibody concentrations, while anti-TNF treatment (0.39 [0.28-0.54]) and prolonged time between vaccination and antibody measurement (0.72 [0.58-0.90]) decreased anti-SARS-CoV-2 spike antibodies. Antibody decline was comparable in IBD patients independent of anti-TNF treatment and antibody

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Systemic and T cell‐associated responses to SARS‐CoV‐2 immunisation in gut inflammation (STAR SIGN study): effects of biologics on vaccination efficacy of the third dose of mRNA vaccines against SARS‐CoV‐2

Woelfel

Dütschler

König

et al. 2022

Aliment Pharmacol Ther

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“…52 As in the PREVENT-COVID cohort, severe reactions after the third dose were less common than after the second. 53…”

Section: Safetymentioning

confidence: 99%

“…52 As in the PREVENT-COVID cohort, severe reactions after the third dose were less common than after the second. 53 Data from up to 30 days post vaccination has also been reassuring. Hadi et al identified 5562 patients with IBD who received a COVID-19 vaccine and found no difference in adverse events as compared to a propensity score matched population without IBD who received the COVID-19 vaccine.…”

Section: Safetymentioning

confidence: 99%

COVID-19 vaccination in adults with inflammatory bowel disease

Lutz

Lazarus

Caldera

2023

Therap Adv Gastroenterol

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Patients with inflammatory bowel disease (IBD) are not at increased risk of SARS-CoV-2 infection compared to the general population, and most are not at increased risk for severe disease. COVID-19 is nonetheless common, and vaccination is critical. Four safe and efficacious vaccines are now available for the prevention of COVID-19, with most data available for mRNA vaccines. Patients with IBD have a robust humoral response to vaccination with rates of seroconversion exceeding 95% following a two-dose mRNA vaccine series and 99% following a three-dose mRNA series, although those on certain therapies including anti-tumor necrosis factor α agents may have lower antibody concentrations and waning of antibodies over time. Additionally, rates of cell-mediated immune response, even in those patients with IBD who did not have evidence of humoral immunity, are high. Vaccines are safe and have not been associated with flares in disease activity. Gastroenterology providers should take an active role in ensuring patients with IBD are appropriately vaccinated against COVID-19.

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“…Overall, the short-term adverse events to SARS-CoV-2 vaccines in those with IBD are similar to the general population. A cohort study from the US showed that the most commonly reported adverse events after receiving a vaccine were: injection site pain, fatigue, and malaise; the rate of reporting in those with IBD was not different than healthy controls ( 40 ). Adverse events were classified as mild and short-lived (i.e., less than two days).…”

Section: Introduction: Crohn’s and Colitis Canada’s Covid-19 And Ibd ...mentioning

confidence: 99%

The 2023 Impact of Inflammatory Bowel Disease in Canada: COVID-19 and IBD

Kaplan,

Kuenzig,

Windsor

et al. 2023

Journal of the Canadian Association of Gastroenterology

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The COVID-19 pandemic had a monumental impact on the inflammatory bowel disease (IBD) community. At the beginning of the pandemic, knowledge on the effect of SARS-CoV-2 on IBD was lacking, especially in those with medication-suppressed immune systems. Throughout the pandemic, scientific literature exponentially expanded, resulting in clinical guidance and vaccine recommendations for individuals with IBD. Crohn’s and Colitis Canada established the COVID-19 and IBD Taskforce to process and communicate rapidly transforming knowledge into guidance for individuals with IBD and their caregivers, healthcare providers, and policy makers. Recommendations at the onset of the pandemic were based on conjecture from experience of prior viruses, with a precautionary principle in mind. We now know that the risk of acquiring COVID-19 in those with IBD is the same as the general population. As with healthy populations, advanced age and comorbidities increase the risk for severe COVID-19. Individuals with IBD who are actively flaring and/or who require high doses of prednisone are susceptible to severe COVID-19 outcomes. Consequently, sustaining maintenance therapies (e.g., biologics) is recommended. A three-dose mRNA COVID-19 vaccine regimen in those with IBD produces a robust antibody response with a similar adverse event profile as the general population. Breakthrough infections following vaccine have been observed, particularly as the virus continues to evolve, which supports receiving a bivalent vaccine booster. Limited data exist on the impact of IBD and its therapies on long-term outcomes following COVID-19. Ongoing research is necessary to address new concerns manifesting in those with IBD throughout the evolving pandemic.

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Postvaccination Symptoms After a Third Dose of mRNA SARS-CoV-2 Vaccination in Patients With Inflammatory Bowel Disease: Results From CORALE-IBD

Cited by 10 publications

References 9 publications

Systemic and T cell‐associated responses to SARS‐CoV‐2 immunisation in gut inflammation (STAR SIGN study): effects of biologics on vaccination efficacy of the third dose of mRNA vaccines against SARS‐CoV‐2

Systemic and T cell‐associated responses to SARS‐CoV‐2 immunisation in gut inflammation (STAR SIGN study): effects of biologics on vaccination efficacy of the third dose of mRNA vaccines against SARS‐CoV‐2

COVID-19 vaccination in adults with inflammatory bowel disease

The 2023 Impact of Inflammatory Bowel Disease in Canada: COVID-19 and IBD

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