Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from Safer-Study

Debora Cerqueira Calderaro; Valéria Valim; Gilda Ferreira Oliveira; Ketty Lysie Libardi Lira Machado; Priscila Dias Cardoso Ribeiro; Sandra Lúcia Euzébio Ribeiro; Natália Sarzi Sartori; Rodrigo Poubel Vieira Rezende; Ana Karla Guedes Melo; Vitor Cruz; Adah Sophia Rodrigues Vieira; Adriana Maria Kakehasi; Aline Teixeira Landa; Ana Paula Neves Burian; Flávia Maria Matos Melo Campos Peixoto; Camila Maria Paiva França Telles; Rafaela Cavalheiro do Espírito Santo; Katia Lino Baptista; Yasmin Gurtler Pinheiro Oliveira; Vanessa de Oliveira Magalhães; Raquel Lima Lima; Erika Biegelmeyer; Pietra Zava Lorencini; Andréa Teixeira-Carvalho; Edgard Torres Reis-Neto; Emilia Inoue Sato; Marcelo Medeiros Pinheiro; Odirlei André André Monticielo; Viviane Angellina de Souza; Ricardo Machado Xavier; Gecilmara Salviato Pileggi

doi:10.20944/preprints202408.0111.v1

How to cite: Calderaro, D. C.; Valim, V.; Oliveira, G. F.; Machado, K. L. L. L.; Ribeiro, P. D. C.; Ribeiro, S. L. E.; Sartori, N. S.; Rezende, R. P. V.; Melo, A. K. G.; Cruz, V.; Vieira, A. S. R.; Kakehasi, A. M.; Landa, A. T.; Burian, A. P. N.; Peixoto, F. M. M. M. C.; Telles, C. M. P. F.; do Espírito Santo, R. C.; Baptista, K. L.; Oliveira, Y. G. P.; Magalhães, V. D. O.; Lima, R. L.; Biegelmeyer, E.; Lorencini, P. Z.; Teixeira-Carvalho, A.; Reis-Neto, E. T.; Sato, E. I.; Pinheiro, M. M.; Monticielo, O. A. A.; de Souza, V. A.; Xavier, R. M.; Pileggi, G. S. Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from Safer-Study. Preprints 2024, 2024080111. https://doi.org/10.20944/preprints202408.0111.v1 Calderaro, D. C.; Valim, V.; Oliveira, G. F.; Machado, K. L. L. L.; Ribeiro, P. D. C.; Ribeiro, S. L. E.; Sartori, N. S.; Rezende, R. P. V.; Melo, A. K. G.; Cruz, V.; Vieira, A. S. R.; Kakehasi, A. M.; Landa, A. T.; Burian, A. P. N.; Peixoto, F. M. M. M. C.; Telles, C. M. P. F.; do Espírito Santo, R. C.; Baptista, K. L.; Oliveira, Y. G. P.; Magalhães, V. D. O.; Lima, R. L.; Biegelmeyer, E.; Lorencini, P. Z.; Teixeira-Carvalho, A.; Reis-Neto, E. T.; Sato, E. I.; Pinheiro, M. M.; Monticielo, O. A. A.; de Souza, V. A.; Xavier, R. M.; Pileggi, G. S. Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from Safer-Study. Preprints 2024, 2024080111. https://doi.org/10.20944/preprints202408.0111.v1

Abstract

Breakthrough COVID-19 (occurring in fully vaccinated people) has been described. Data on its characteristics among immune mediated rheumatic disesases (IMRD) patients are scarce. This study describes breakthrough COVID-19 among IMRD patients participating of SAFER-study, a Brazilian multicentric cohort evaluating safety, effectiveness and immunogenicity of SARS-Cov-2 vaccines in autoimmune diseases. Descriptive analysis and a binary logistic regression model, to evaluate predictors of COVID-19-related hospitalization, were performed. P-value < 0.05 was significant. The included 160 patients were predominantly females (83.1%), with mean (SD) age 40.23 (13.19) years. Patients received 2 (19%), 3 (70%) or 4 (11%) vaccine doses. The initial two-dose series was mainly with ChAdOx1 (Oxford/AstraZeneca) (58%) or BBIBP-CorV (Sinopharm-Beijing) (34%). The first booster (n=150) was with BNT162b2 (BioNtech/Fosun Pharma/Pfizer) (63%) or ChAdOx1 (29%). The second booster (n=112) was with BNT162b2 (40%) or ChAdOx1 (26%). COVID-19 hospitalization rate was 17.5%. IMRD moderate/high activity (OR: 5.84, CI: 1.9-18.5, p=0.002) and treatment with corticosteroids (OR: 2.94, CI: 1.02-8.49, p=0.0043) associated with higher odds of hospitalization, while the increasing number of vaccine doses was protective (OR: 0.37, CI: 0.15-0.9, p=0.032). These findings, along with previous reassuring results about the safety of the COVID-19 vaccines, argue in favour of booster vaccination in IMRD patients.

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Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from Safer-Study

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