COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases

Abstract

Background: Reports describing post-vaccine autoimmune phenomena, in previously healthy individuals, increased the concerns regarding the risk of disease flare-ups in patients with immune diseases. We aimed to assess the potential risk of disease flare-up, after receiving the COVID-19 (Coronavirus disease 2019) vaccine, during a follow-up period of 6 months. Methods: We performed a prospective cohort study, enrolling the patients with autoimmune- and immune-mediated diseases who voluntarily completed our questionnaire, both online and during hospital evaluations. Based on their decision to receive the vaccine, the patients were divided into two groups (vaccinated and non-vaccinated). Participants who chose not to receive the vaccine served as a control group in terms of flare-ups. Results: A total of 623 patients, 416 vaccinated and 207 non-vaccinated, were included in the study during hospital evaluations (222/623) and after online (401/623) enrolment. There was no difference concerning the risk of flare-up between vaccinated and non-vaccinated patients (1.16, versus 1.72 flare-ups/100 patients-months, p = 0.245). The flare-ups were associated with having more than one immune disease, and with a previous flare-up during the past year. Conclusions: We did not find an increased risk of flare-up following COVID-19 vaccination in patients with autoimmune-/immune-mediated diseases, after a median follow-up of 5.9 months. According to our results, there should not be an obvious reason for vaccine hesitancy among this category of patients.

The Flare of Rheumatic Disease After SARS-CoV-2 Vaccination: A Review

“…In another study, biologics didn't show any protection against flare, as the frequency of flare within one month after vaccination shows no difference between the biological and non-biological group (22). As for the corticosteroid, bivariate analysis in the study of Pinte et al revealed a positive association between taking corticosteroids and disease flare after vaccination (25). A similar tendency was also observed in Connolly's study (21).…”

“…However, many RD patients with moderate-high disease activity also received the vaccination due to the severe pandemic, and an increased risk of side effects after vaccination was observed in these patients (18). Besides, RD patients with flare history within one year were consistently associated with an increased risk of flare after COVID-19 vaccination (16,21,25,31). Thus, it is recommended that patients with RD are having inactive disease or low disease activity before vaccination to reduce the risk of flare (3,48,49).…”

“…Fragoulis et al reported a marginal association between treatment discontinuation due to COVID19 vaccination with disease flare (24). Pinte et al also reported a higher risk of flare in patients who stopped their treatment; even the difference didn't reach a statistical significance (4/31 vs. 21/385, p=0.105) (25).…”

Relapses of idiopathic inflammatory myopathies after vaccination against COVID-19: a real-life multicenter Italian study

“…In line with these findings, there is a paucity of data for patients with a previous diagnosis of IIM who subsequently underwent anti-SARS-CoV-2 vaccine. To the best of our knowledge, roughly 100 myositis patients, coming from multicenter studies [14,27,28,[32][33][34][35], were included in studies focusing on vaccine safety, while other ones, although larger, did not include IIM [29,36]. Moreover, only two papers specifically assessed the risk of flares among these patients [27,28], while none of them stratified patients according to disease activity, number of organs involvement, current and previous treatments nor assessed risk of flares after booster doses.…”

Flare of adult-onset Still’s disease following mRNA COVID-19 vaccination: a case report and review of literature

“…Fortunately, new-onset or flare of AOSD due to broadly used vaccines such as influenza, pneumococcal, and hepatitis vaccines were also rare [ 17 – 22 ]. In addition, a prospective cohort study has also been published that COVID-19 vaccine does not increase the risk of disease flare-ups in patients with autoimmune diseases [ 42 ]. The largest study reported on the use of viral vectors or mRNA vaccines in patients with AIAIDs on anti-IL-1/6 biologics also showed no serious concerns, such as hospital admissions and deaths, about COVID-19 vaccination [ 43 ].…”