Journal Article

Impact of SARS-CoV-2 Vaccination on Disease Activity and Severity of COVID-19 Infection in Patients with Systemic Lupus Erythematosus: A Multicenter Cohort Study

De Souza, Alexandre Wagner Silva, Kayser, Cristiane, Vieira, Adah Sophia Rodrigues, Pamplona Bueno de Andrade, Nicole, Valim, Valéria, Cruz, Vitor Alves, Xavier, Ricardo Machado, Pretti, Flavia Zon, Magalhães, Vanessa de Oliveira, Grillo, Luiza Lorenzoni, Sartori, Natália Sarzi, Ferreira, Gilda Aparecida, Athayde, Paula dos Santos, dos Reis-Neto, Edgard Torres, da Silva, Vanezia Gonçalves, da Costa, Pollyana Vitoria Thomaz, Tapia, Karina Rosemarie Lallemand, Miyamoto, Samira Tatiyama, Sousa Dias, Marcos Mavignier, Biegelmeyer, Erika, Ribeiro, Priscila Dias Cardoso, Castro, Charlles Heldan de Moura, Monticielo, Odirlei André, Pileggi, Gecilmara Salviato, Burian, Ana Paula Neves, Gaudio, Rodrigo Cutrim, de Rezende, Rodrigo Poubel Vieira, Kakehasi, Adriana Maria, Baptista, Katia Lino, Gouveia, Maria da Penha Gomes, Oliveira dos Santos, Sérgio Henrique, Ramos, Sabrina de Souza, Telles, Camila Maria Paiva França, Pinheiro, Marcelo de Medeiros, Peruhype-Magalhães, Vanessa, de Aguiar, Mariana Freitas, Vieira, Rejane Maria Rodrigues de Abreu, Machado, Ketty Lysie Li

2025

Overview

Background: To prospectively evaluate the safety and clinical impact of SARS-CoV-2 vaccines in patients with systemic lupus erythematosus (SLE). Methods: Subanalysis of the Brazilian multicenter observational study “Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER)”, which included SLE patients vaccinated with CoronaVac, ChAdOx1, or BNT162b2. Patients with HIV infection, pregnant women, or those with immunosuppression not related to SLE were excluded. Safety data related to adverse events and underlying disease activity were assessed. Additionally, COVID-19 cases were monitored throughout the follow-up period. Results: The study included 373 patients with systemic lupus erythematosus (SLE), with a mean age of 36 years, the majority being women (89.8%). The most common adverse events after SARS-CoV-2 vaccination were injection site reactions and headache, observed both after the first and subsequent doses. The ChAdOx-1 vaccine was associated with a higher frequency of adverse events compared to CoronaVac. At baseline, 38.3% of patients were in remission, 32.8% had low disease activity, and 28.9% had moderate to high activity. Following CoronaVac vaccination, there was an increase in remission rates (from 34.6% to 51.1%) and a significant reduction in moderate to high activity (from 37.6% to 15.0%) after the first dose, with this reduction partially maintained after the second dose. In contrast, patients vaccinated with ChAdOx-1 showed an increase in moderate to high activity (from 14.5% to 38.2% after the first dose), a trend that persisted after the second dose. No statistically significant changes in disease activity were observed among those who received BNT162b2. During follow-up, 44 cases of COVID-19 were reported, all mild, with no deaths or need for intensive care unit admission. Conclusions: Vaccination against SARS-CoV-2 demonstrated a favorable safety profile in patients with SLE, with a low frequency of serious adverse events. While analysis of disease activity revealed variations across vaccine platforms, most notably an increased proportion of moderate to high disease activity among those receiving ChAdOx-1 compared with CoronaVac and BNT162b2, the overall occurrence of COVID-19 during follow-up was limited to mild cases, with no severe outcomes. These findings highlight that, despite potential risks of disease exacerbation, the clear protection against severe COVID-19 supports vaccination as a beneficial strategy for this immunocompromised population.

• Publisher: MDPI AG,Multidisciplinary Digital Publishing Institute (MDPI)
• Subject: Adverse events / Autoimmune diseases / Chronic conditions / COVID-19 / COVID-19 vaccination / COVID-19 vaccines / Disease prevention / Dosage and administration / Drug dosages / Ethics / Health risks / Immunosuppression / Infections / Inflammatory diseases / Lupus / Medical diagnosis / Observational studies / Pandemics / Population / Prevention / Public health / Remission / Risk factors / Safety / Severe acute respiratory syndrome coronavirus 2 / Skin cancer / Software / Statistical analysis / Surveillance / Systemic lupus erythematosus / vaccination against SARS-CoV-2 / Vaccines / Viral diseases / Viral vaccines