COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

Fragoulis, G.; Bournia, Vassiliki-Kalliopi; Mavrea, Eugenia; Evangelatos, Gerasimos; Fragiadaki, Kalliopi; Karamanakos, Anastasios; Kravariti, Eyrydiki; Laskari, Katerina; Panopoulos, Stylianos; Παππά, Μαρία; Mitsikostas, Dimos D.; Tektonidou, Maria G; Vassilopoulos, Dimitrios; Sfikakis, Petros P.

doi:10.1007/s00296-021-05039-3

Cited by 38 publications

(50 citation statements)

References 33 publications

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“…Vaccines for SARS-CoV-2 are effective in patients with systemic rheumatic disease (SRD) without exhibiting significant safety issues or causing disease flares, [1][2][3] whereas two doses of mRNA vaccines lead to significantly better outcomes of breakthrough (ie, despite vaccination) COVID-19 compared with unvaccinated patients. 4 Since a third (booster) dose is deemed necessary for better immunisation, 5 we aimed to examine hospitalisation rates and mortality of breakthrough COVID-19 in patients with SRD who had received three doses of the vaccine (booster-vaccinated), compared with those who received two doses (fully vaccinated) or were unvaccinated.…”

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confidence: 99%

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Clinical outcomes of breakthrough COVID-19 after booster vaccination in patients with systemic rheumatic diseases

et al. 2022

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confidence: 99%

“…To conclude, these results suggest that booster COVID-19 vaccination has beneficial effects in patients with SRDs, on par with what has been shown for the general population. 6 This, in combination with the reassuring results about the safety of vaccines, [1][2][3] argues in favour of booster vaccination in patients with SRD.…”

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confidence: 99%

Clinical outcomes of breakthrough COVID-19 after booster vaccination in patients with systemic rheumatic diseases

et al. 2022

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“…This condition also fits the results in RD patients ( 41 ). As for the risk of flare, most studies reported a higher risk after the second dose, while only two studies observed opposite results ( 16 , 18 , 21 , 22 , 24 – 26 , 34 , 35 ). Besides, the sample sizes of the two studies with conflicting results were both limited.…”

Section: Flare Rate In Different Vaccine Types Doses and Diseasesmentioning

confidence: 99%

“…However, treatment discontinuation may increase the flare risk of RDs. 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).…”

Section: Treatmentmentioning

confidence: 99%

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

Xie

Liu

2022

Front. Immunol.

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As the coronavirus disease 2019 (COVID-19) pandemic continues worldwide, vaccination has been considered an effective measure to protect people from the COVID-19 and end the pandemic. However, for patients with rheumatic diseases (RD), concern for the induction of RD flare may combat the enthusiasm for vaccination. In general, current evidence doesn’t support the increased risk of disease flare after COVID-19 vaccination. However, the disease flare of RDs may be triggered by COVID-19 vaccinations, especially for patients with high disease activity. Most of these flares after vaccination are mild and need no treatment escalation. Considering the benefits and risks, RD patients are recommended to receive the COVID-19 vaccination but should be vaccinated when the RDs are in stable states.

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COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study

Prontskus

Fresse

Yéléhé‐Okouma

et al. 2023

Clin Pharma and Therapeutics

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COVID‐19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID‐19 vaccination. We performed a “case–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID‐19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new‐onset vs. flare‐up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID‐19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID‐19 vaccines compared with the other nonlive vaccines was 0.66 (P < 0.0001). The FPVD reported 161 cases of RA with COVID‐19 vaccines, including 77 new‐onset RA and 84 cases of RA flare‐up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14 ± 21 days, and the delay was significantly shorter in the flare‐up group. We do not show a higher risk of RA after COVID‐19 vaccination compared with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.

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COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

Cited by 38 publications

References 33 publications

Clinical outcomes of breakthrough COVID-19 after booster vaccination in patients with systemic rheumatic diseases

Clinical outcomes of breakthrough COVID-19 after booster vaccination in patients with systemic rheumatic diseases

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

COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study

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