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Abstract Objective This study aimed to analyze the safety and efficacy of COVID-19 vaccines among patients with chronic immune-mediated inflammatory disease (IMID) in China. Methods Participants who were diagnosed with a chronic IMID were eligible for inclusion in this study. Age- and sex-matched healthy vaccinated individuals were set as the control group. All participants received two doses of the inactivated CoronaVac vaccine or three doses of the recombinant protein subunit vaccine ZF2001. Adverse events, IMID activity after vaccination, and the rate of COVID-19 in the two groups were compared. Results There were 158 patients in the IMID group, with an average age of 40 ± 14 years old, and 98 female subjects. In the IMID group, 123 patients received the inactivated CoronaVac vaccine, and 35 patients received the recombinant protein subunit vaccine ZF2001. There were 153 individuals in the control group, including 122 who received the CoronaVac vaccine and 31 who received the recombinant protein subunit vaccine ZF2001. The frequency of vaccine-related adverse events in the IMID group was less than that in the control group, all of which were mild local effects, and no serious events occurred. Of note, no disease flares occurred in the IMID group. No participants in either group subsequently got COVID-19, so the incidence rate was 0% in both groups. Conclusion COVID-19 vaccination was found to be safe for IMID subjects, any adverse events were mild, and vaccination did not increase the risk of disease activity. Meanwhile, vaccination could effectively reduce the incidence of COVID-19 in IMID patients. In the future, studies with a larger sample size and a longer duration are needed.
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OBJECTIVE: Tumor necrosis factor-alpha (TNF-alpha) inhibitors are used as a treatment in various immune-mediated inflammatory diseases (IMIDs). Tuberculosis (TB) risk is reported in several meta-analyses in patients treated with TNF-alpha inhibitors. The purpose of this study is to collect, review, and evaluate the TB risk in TNF-alpha inhibitors according to IMIDs indications and between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors. METHODS: A systematic literature search on systematic reviews and meta-analyses was performed in PubMed, MEDLINE, Cochrane library, and EMBASE. We identified meta-analyses that evaluated TB infection risk of TNF-alpha inhibitors in IMIDs patients. RESULTS: Thirteen meta-analyses including 41 study results were included in this umbrella review. IMIDs patients treated with TNF-alpha inhibitors had an increased risk of TB than control group (placebo with or without standard therapy patients) (relative risk ratio (RR) 2.057, 95% confidence interval (CI) 1.697 to 2.495). Among them, RA patients with TNF-alpha inhibitors had a higher risk of TB than control group (RR 1.847, 95% CI 1.385 to 2.464), and non-RA patients with TNF-alpha inhibitors had an increased risk of TB (RR 2.236, 95% CI 1.284 to 3.894). In subgroup analysis on TB risk between soluble-receptor TNF-alpha inhibitor and monoclonal-antibody TNF-alpha inhibitors in RA patients, the analysis indicated that monoclonal-antibody TNF-alpha inhibitors had higher risk of TB than solublereceptor TNF-alpha inhibitor (RR 2.880, 95% CI 1.730 to 4.792). CONCLUSION: This umbrella review confirms that the risk of TB is significantly increased in TNF-alpha inhibitor treated patients compared to control group.