tetano
Editor, Senior Moderator
J Pers Med
. 2021 Dec 2;11(12):1283.
doi: 10.3390/jpm11121283.
COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases
Larisa Pinte[SUP] 1 2 [/SUP], Florentina Negoi[SUP] 2 [/SUP], Georgeta Daniela Ionescu[SUP] 2 [/SUP], Simona Caraiola[SUP] 1 2 [/SUP], Daniel Vasile Balaban[SUP] 1 3 [/SUP], Camelia Badea[SUP] 1 2 [/SUP], Diana Mazilu[SUP] 1 4 [/SUP], Bianca Dumitrescu[SUP] 1 5 [/SUP], Bogdan Mateescu[SUP] 1 2 [/SUP], Ruxandra Ionescu[SUP] 1 4 [/SUP], Magda Ileana Parvu[SUP] 2 [/SUP], Cristian Baicus[SUP] 1 2 [/SUP]
Affiliations
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.
Keywords: COVID-19; SARS-CoV-2; autoimmune; disease activity; flare-up; immune-mediated diseases; safety; vaccine.
. 2021 Dec 2;11(12):1283.
doi: 10.3390/jpm11121283.
COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases
Larisa Pinte[SUP] 1 2 [/SUP], Florentina Negoi[SUP] 2 [/SUP], Georgeta Daniela Ionescu[SUP] 2 [/SUP], Simona Caraiola[SUP] 1 2 [/SUP], Daniel Vasile Balaban[SUP] 1 3 [/SUP], Camelia Badea[SUP] 1 2 [/SUP], Diana Mazilu[SUP] 1 4 [/SUP], Bianca Dumitrescu[SUP] 1 5 [/SUP], Bogdan Mateescu[SUP] 1 2 [/SUP], Ruxandra Ionescu[SUP] 1 4 [/SUP], Magda Ileana Parvu[SUP] 2 [/SUP], Cristian Baicus[SUP] 1 2 [/SUP]
Affiliations
- PMID: 34945754
- DOI: 10.3390/jpm11121283
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.
Keywords: COVID-19; SARS-CoV-2; autoimmune; disease activity; flare-up; immune-mediated diseases; safety; vaccine.