Vaccines (Apr 2023)

Multicentric Observational Study on Safety and Tolerability of COVID-19 Vaccines in Patients with Angioedema with C1 Inhibitor Deficiency: Data from Italian Network on Hereditary and Acquired Angioedema (ITACA)

  • Roberta Parente,
  • Silvio Sartorio,
  • Luisa Brussino,
  • Tiziana De Pasquale,
  • Alessandra Zoli,
  • Stefano Agolini,
  • Ester Di Agosta,
  • Paolina Quattrocchi,
  • Paolo Borrelli,
  • Donatella Bignardi,
  • Angelica Petraroli,
  • Riccardo Senter,
  • Valentina Popescu Janu,
  • Chiara Cogliati,
  • Maria Domenica Guarino,
  • Oliviero Rossi,
  • Davide Firinu,
  • Stefano Pucci,
  • Giuseppe Spadaro,
  • Massimo Triggiani,
  • Mauro Cancian,
  • Andrea Zanichelli

DOI
https://doi.org/10.3390/vaccines11040852
Journal volume & issue
Vol. 11, no. 4
p. 852

Abstract

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Angioedema due to C1 inhibitor deficiency (AE-C1-INH) is a rare disease characterized by recurrent and unpredictable attacks of angioedema. Multiple trigger factors, including trauma, emotional stress, infectious diseases, and drugs, could elicit angioedema attacks. The aim of this study was to collect data on the safety and tolerability of COVID-19 vaccines in a population of patients affected by AE-C1-INH. Adult patients with AE-C1-INH, followed by Reference Centers belonging to the Italian Network for Hereditary and Acquired Angioedema (ITACA), were enrolled in this study. Patients received nucleoside-modified mRNA vaccines and vaccines with adenovirus vectors. Data on acute attacks developed in the 72 h following COVID-19 vaccinations were collected. The frequency of attacks in the 6 months after the COVID-19 vaccination was compared with the rate of attacks registered in the 6 months before the first vaccination. Between December 2020 and June 2022, 208 patients (118 females) with AE-C1-INH received COVID-19 vaccines. A total of 529 doses of the COVID-19 vaccine were administered, and the majority of patients received mRNA vaccines. Forty-eight attacks of angioedema (9%) occurred within 72 h following COVID-19 vaccinations. About half of the attacks were abdominal. Attacks were successfully treated with on-demand therapy. No hospitalizations were registered. There was no increase in the monthly attack rate following the vaccination. The most common adverse reactions were pain at the site of injection and fever. Our results show that adult patients with angioedema due to C1 inhibitor deficiency can be safely vaccinated against SARS-CoV-2 in a controlled medical setting and should always have available on-demand therapies.

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