Immunogenicity and safety to SARS-Cov-2 vaccination in patients with systemic vasculitis

Erika Biegelmeyer¹Mariana Freitas de Aguiar¹Priscila Dias Cardoso Ribeiro¹Ketty Machado²Camila Maria Paiva França Telles³Sandra Lúcia Euzébio Ribeiro³Natália Sarzi Sartori⁴Rodrigo Poubel Vieira De Rezende⁵Ana Karla Guedes de Melo⁶Vitor Alves Cruz⁷Rejane Maria Rodrigues De Abreu Vieira⁸Adriana Maria Kakehasi⁹Maria Cecília Dias Corrêa¹⁰Valderilio feijó Azevedo¹¹Olindo Assis Martins Filho¹²Flávia Maria Matos Melo Campos Peixoto¹Vanessa De Oliveira Magalhães¹Maria Da Penha Gomes Gouvea²Thaís Evelyn Karnopp⁴Katia Lino Baptista⁵Tâmara Santos Melo⁶Jozelia Rêgo⁷Adah Sophia Rodrigues Vieira⁸Anna Carolina Faria Moreira Gomes Tavares⁹Victória Dornelas Paz Carvalho¹⁰Vanessa Peruhype Pascoal¹²Laiza Hombre Dias²Raquel Lima De Lima³Kimberly Rossana da Silva Gonçalves⁴Natália Rodrigues Querido Fortes⁵Débora Marques Veghini²Jônatas Almeida Amorim³Raiza Casian Tuão²Karina Rosemarie Lallemand Tapia²Cristiane Kayser¹Charlles Heldan De Moura Castro¹Maressa Barbosa²Juliana Bühring³Ricardo Machado Xavier⁴Andréa Teixeira-Carvalho¹²Viviane Angelina De Souza¹⁰Odirlei André Monticielo⁴Gilda Aparecida Ferreira⁹Marcelo M Pinheiro¹Edgard Torres dos Reis Neto¹Emilia Inoue Sato¹Valeria Valim²Gecilmara Salviato Pileggi¹Alexandre Wagner Silva De Souza^1*

• ¹Universidade Federal de Sao Paulo Escola Paulista de Medicina, São Paulo, Brazil
• ²Universidade Federal do Espirito Santo, Vitoria, Brazil
• ³Universidade Federal do Amazonas, Manaus, Brazil
• ⁴Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
• ⁵Universidade Federal Fluminense Faculdade de Medicina, Niterói, Brazil
• ⁶Universidade Federal da Paraiba, João Pessoa, Brazil
• ⁷Universidade Federal de Goias, Goiânia, Brazil
• ⁸Universidade de Fortaleza, Fortaleza, Brazil
• ⁹Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
• ¹⁰Universidade Federal de Juiz de Fora Hospital Universitario, Juiz de Fora, Brazil
• ¹¹Edumed - Educação em Saúde S/S Ltda, Research institute, Curitiba, Brazil
• ¹²Fundacao Oswaldo Cruz Instituto Rene Rachou, Belo Horizonte, Brazil

Background/Objectives: Patients with systemic vasculitis faced the risk of severe COVID-19 and high mortality during the pandemic. Although SARS-CoV-2 vaccination mitigates these outcomes, vaccine hesitancy persists, and data on immunogenicity and safety in vasculitis is still limited. This study aims to assess response to primary and booster doses of SARS-CoV-2 vaccination in systemic vasculitis. Methods: This multicenter cohort study including systemic vasculitis included patients from SAFER study (Safety and Efficacy of COVID-19 Vaccines in Rheumatic Diseases). We evaluated serum IgG levels against the SARS-CoV-2 spike protein receptor-binding domain (IgG anti-RBD) at baseline and 28 days post-vaccination, disease activity scores, new cases of COVID-19 infections, and adverse events. Results: Seventy-three patients with systemic vasculitis were included. Behçet's disease (n=39), Takayasu arteritis (n=15), and antineutrophil cytoplasmic antibody-associated vasculitis (n=14) were the most common vasculitis forms. The majority of the patients had no comorbidities and were in remission. Seventy patients received one, 65 two, and 60 three vaccine doses. ChAdOx1 nCoV-19 (AstraZeneca/Oxford) (n=36) and CoronaVac (Sinovac) (n=25) were primarily the most common vaccines, while BNT162b2 (Pfizer–BioNTech) was usually the booster vaccine. ChAdOx1 nCoV-19 induced higher IgG anti-RBD than CoronaVac after two doses (p=0.002), but this difference disappeared after the booster dose. No differences in vaccine response were noted between heterologous and homologous regimens or vasculitis types. The new cases of COVID-19 (16.9%), hospitalization (1.5%), and mortality (1.5%) rates were relatively low following vaccination. Disease activity remained stable, and adverse events were mostly mild. Only one severe adverse event was observed. Conclusion: Different SARS-CoV-2 vaccines demonstrated immunogenicity and clinical effectiveness in systemic vasculitis. The three-dose schedule was safe without increasing relapse risk.