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POS0274 (2023)
PROSPECTIVE EVALUATION OF THE EFFECT OF THE VACCINE AGAINST SARS-COV-2 IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: DATA FROM SAFER STUDY
N. Sartori1, F. M. Matos Melo Campos Peixoto2, P. Dias Cardoso Ribeiro2, K. Lysie Libardi Lira Machado3, J. Geraldo Mill4, F. Z. Pretti4, M. Gomes Gouveia4, Y. Gurtler Pinheiro de Oliveira4, S. T. Miyamoto4, V. Gonçalves Da Silva4, A. P. Neves Burian4, K. Rosemarie Lallemand Tapia4, D. Veghini4, M. Deorce de Lima4, P. Athayde4, A. C. Simões Moulin4, L. Lorenzoni Grillo4, H. Corona4, L. Fiorotti Albertino4, L. Pizzol Pasti4, S. Ramos4, H. Filipe Surlo4, L. Gonçalves Rodrigues Aguiar4, P. Zava Lorencini4, M. Pinheiro2, V. Oliveira Magalhães2, M. Freitas de Aguiar2, E. Biegelmeyer2, C. Kayser2, A. Wagner Silva de Souza2, C. H. D. M. Castro2, A. A. Gasparin1, V. Hax1, R. Poubel Vieira de Rezende5, K. Lino Baptista5, R. C. Gaudio5, J. Buhring6, S. Ribeiro6, S. H. Dos Santos6, C. Pinheiro Martins6, J. Rodrigues6, M. M. Sousa Dias6, B. Guimarães Dutra6, C. Telles6, S. E. B. Dias6, V. Cruz7, J. Rêgo7, R. M. R. Vieira8, A. Sophia Rodrigues Vieira8, A. Kakehasi9, A. C. Faria Moreira Gomes Tavares10, V. Dornelas11, R. Azevedo11, V. F. Azevedo12, V. Valim4, A. Teixeira-Carvalho13, O. Assis Martins-Filho13, R. Xavier1, V. De Souza11, G. Ferreira10, G. Salviato Pileggi2, E. Sato2, E. Torres Dos Reis Neto2, O. Monticielo1
1Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Serviço de Reumatologia, Porto Alegre, Brazil
2Universidade Federal de São Paulo, Serviço de Reumatologia, São Paulo, Brazil
3Hospital Universitário Cassiano Antônio Moraes da Universidade Federal do Espírito Santo, (HUCAM-UFES), Espírito Santo, Brazil
4Hospital Universitário Cassiano Antônio Moraes da Universidade Federal do Espírito Santo, (HUCAM-UFES), Vitória, Brazil
5Universidade Federal Fluminense, Unidade de Reumatologia, Niterói, Brazil
6Universidade Federal do Amazonas, Serviço de Reumatologia, Manaus, Brazil
7Universidade Federal de Goiás, Serviço de Reumatologia, Goiania, Brazil
8Hospital Geral de Fortaleza (HGF) e Universidade de Fortaleza (UNIFOR), Serviço de Reumatologia, Fortaleza, Brazil
9Hospital das Clínicas, Universidade Federal de Minas Gerais, Serviço de Reumatologia, Minas Gerais, Brazil
10Hospital das Clínicas, Universidade Federal de Minas Gerais, Serviço de Reumatologia, Belo Horizonte, Brazil
11Universidade Federal de Juiz de Fora, Serviço de Reumatologia, Juiz de Fora, Brazil
12Edumed - Educação em Saúde S/S Ltda., Unidade de Reumatologia, Curitiba, Brazil
13Instituto Renè Rachou, Fundação Oswaldo Cruz (FIOCRUZ-Minas), Belo Horizonte, Brazil

 

Background Systemic lupus erythematosus (SLE) is an autoimmune disease, which presents an immune disorder that leads to the production of autoantibodies with potential involvement of multiple organs. Infections are one of the most frequent causes of hospitalization and death in lupus patients, and SARS-CoV-2 infection has been a global threat since March 2020. Immunization of these patients has been strongly recommended, although vaccine evaluation studies have not included this profile of patients.

Objectives To evaluate the immunogenicity and safety after 2 doses of the vaccine against SARS-CoV2 in patients with SLE.

Methods Subgroup of SLE patients from the prospective multicenter cohort of patients with immune-mediated diseases “SAFER” – Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease, a phase IV study. Vaccination against SARS-CoV-2 took place with vaccines approved by Brazilian regulatory bodies CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) and this project followed in line with the guidelines of the National Immunization Plan in Brazil. Patients aged 18 years or older with a previous diagnosis of SLE (according to the 2019 ACR/EULAR criteria) were included. Patients were evaluated by telephone contact and in a face-to-face visit on the 28th day after each dose. Patients were followed up by means of blood collection for measurement of IgG antibody against SARS-COV-2 by chemiluminescence and disease activity assessed using SLEDAI-2K score.

Results A total of 367 individuals with SLE were included, of whom 207 received 2 doses of CoronaVac, 128 received 2 doses of ChadOx-1 and 32 received 2 doses of BNT162b2. 90% of the subjects were female with a mean age of 37 years. About 42% (154) of the individuals included did not have any other associated comorbidity. 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38% (140) of patients had zero SLEDAI-2K at baseline and 41% (147) had zero SLEDAI-2K 28 days after the 2nd dose. Anti-DNA positivity was 30.7% (16/52) at inclusion and 32.6% (17/52) 28 days after the 2nd dose. Complement consumption was present in 18% (10/55) at inclusion and in 14.5% (8/55) 28 days after the 2nd vaccine dose. The geometric mean titers of IgG antibodies against SARS-COV-2 increased in the different vaccine groups, log 2.27 BAU/mL at inclusion and log 5.58 BAU/mL 28 days after the 2nd dose. Antibody titers after second dose varied between different vaccines, 4.96 BAU/mL CoronaVac, 6.00 BAU/mL ChadOx-1 and 7.31 BAU/mL BNT162b2 vaccine, p < 0.001. Only 3.54% (13/367) patients had covid-19 infection after the 15th day of the second dose of immunization, 9 of them having received 2 doses of CoronaVac, 4 of them of ChadOx-1 and none of them receiving BNT162b2, with p-value of 0.63.

Conclusion This study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Induction of immunogenicity occurred in different vaccine regimens. Only 3.5% of individuals had COVID-19 infection with no difference between the types of vaccines evaluated. Future analyzes to explore the association of the effect of immunosuppressive medication, as well as the impact of booster doses and longer follow-up on clinical outcome will be performed.

References

  1. Mason A, et al. Lupus, vaccinations and COVID-19: What we know now. Lupus. 2021;30(10):1541-1552.
  2. Furer V, Eviatar T, Zisman D, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: A multicentre study. Ann Rheum Dis. 2021;80(10):1330-1338.
  3. Izmirly PM, Kim MY, Samanovic M, et al. Evaluation of Immune Response and Disease Status in SLE Patients Following SARS-CoV-2 Vaccination. Arthritis Rheumatol. Published online 2021.

Acknowledgements: NIL.

Disclosure of Interests None Declared.

Keywords: COVID, Vaccination/Immunization, Systemic lupus erythematosus

DOI: 10.1136/annrheumdis-2023-eular.5035

Citation: , volume 82, supplement 1, year 2023, page 377
Session: All about COVID-19 in Rheumatology (Poster Tours)