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The adverse event rate was 2.2% for patients with IBD following 1 dose of the vaccine.
New research confirms that the SARS-CoV-2 vaccinations are safe and effective for patients with inflammatory bowel disease (IBD).
A team, led by Abhishek Bhurwal, MD, Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson School of Medicine, evaluated the safety and efficacy of the SARS-CoV-2 vaccine in patients with IBD.
Since the beginning of the COVID-19 pandemic there has been concerns regarding outcomes and increased risk of infections for patients with IBD, particularly those who are treated with immunosuppressive therapies.
In the systematic review and meta-analysis, the investigators reviewed available studies on the response of the vaccines in patients with IBD. The studies included all randomized controlled trials, prospective studies, or retrospective studies of patients with IBD undergoing SARS-CoV-2 vaccination, studies describing the seroconversion following vaccination in patients with IBD, and studies with information available to evaluate the incidence of seroconversion and SARS-CoV-2 breakthrough infection following vaccination.
The studies also must be available in English and have at least 10 patients with IBD to avoid bias from small sample sizes.
The investigators sought primary outcomes of pooled seroconversion rate SARS-CoV-2 vaccination in patients with IBD, the comparison of breakthrough COVID-19 infection rate SARS-CoV02 vaccination in patients with IBD with a control cohort, and pooled adverse event rates of the SARS-CoV-2 vaccine.
The team also defined severe adverse events as acute myocardial infarction, anaphylaxis, facial nerve palsy, coagulopathy, deep vein thrombosis, pulmonary embolism, Guillain-Barré syndrome, transverse myelitis, immune thrombocytopenia, disseminated intravascular coagulation, myocarditis, pericarditis, hemorrhagic stroke, non-hemorrhagic stroke, appendicitis, narcolepsy, and encephalomyelitis.
They also included severe adverse events reported in primary studies and other adverse events including myalgia, arthralgia, febrile episode, injection site reaction, and headache.
The team evaluated the outcomes for both 1 and 2 dose vaccination series and assessed the probability of publication bias using funnel plots with Egger’s tests.
Overall, they evaluated 21 studies from the original 278 studies identified. There was a pooled seroconversion rate of 73.7% (95% CI, 38.1-92.7%) and 96.8% (95% CI, 94-98.3%) in patients with IBD following 1 and 2 doses of SARS-CoV-2 vaccine, respectively.
After conducting a sub-group analysis, the investigators found non-statistically significant differences between different immunosuppressive treatment regimens for seroconversion.
Patients not currently on medications or being treated with 5-aminosalicylic acid (5-ASA)-based therapy had a pooled seroconversion rate of 95.6% (95% CI, 91.3-97.8%).
Patients treated with anti-Tumor Necrosis Factor alpha (anti-TNF α) had a pooled seroconversion rate of 95.4% (95% CI, 88.9-98.1%), compared to 97.2% (95% CI, 93.3-98.9%) for patients treated with anti-integrin therapy.
In addition, there was not a statistically significant difference in seroconversion rates of patients treated with anti-TNF α therapy and anti-integrin therapy (P = 0.43).
The pooled seroconversion rate for patients treated with anti-interleukin 12/23 therapy was 96.2% (95% CI, 89.6–98.7%) (compared to anti-TNF α therapy, P = 0.77; compared to anti-integrin therapy, P = 0.66) and the pooled seroconversion rate was 92.2% (95% CI, 68.9–98.4%) with Janus Kinase Inhibitor therapy (compared to anti-TNF α, P = 0.57; compared to anti-integrin therapy, P = 0.26).
Finally, immunomodulator therapy alone—azathioprine, mercaptopurine, or methotrexate—had a pooled seroconversion rate of 96.5% (95% CI, 88.7-99%).
For breakthrough infections, the investigators identified 29 total infections in 6765 patients with IBD after vaccinated with 1 dose and 33 infections in 12,674 patients with IBD following 2 doses.
There was no statistically significant difference in breakthrough infection in patients with IBD compared to control cohort after 1 dose (OR, 0.99; 95% CI, 0.71–1.38%; P = 0.96) or 2 doses (OR, 0.72; 95% CI, 0.29–1.77%; P = 0.48)
Following a meta-regression analysis, the investigators found that vaccine type and study location independently influenced seroconversion rates. There was also no statistically significant difference in breakthrough infections for patients with IBD compared to the control group following vaccination.
Finally, for safety, the pooled severe adverse event rate following 1 dose was 2.2% (95% CI, 1.4-3.6%) and .09% (95% CI, 0.01-0.091%) following 2 doses.
“In summary, this systematic review and meta-analysis shows that the overall seroconversion rate after COVID-19 vaccination in IBD patients is high and improves with a second dose, with no statistical differences in antibody response associated with different immunosuppressive therapies,” the authors wrote. “Even though, the rates of breakthrough SARS-CoV-2 infection after vaccination were low, further studies are necessary to accurately determine this risk.”
The study, “Effectiveness and safety of SARS-CoV-2 vaccine in Inflammatory Bowel Disease patients: A systematic review, meta-analysis and meta-regression,” was published online in Alimentary Pharmacology & Therapeutics.