SAFETY PROFILE OF VACCINES AGAINST SARS-COV-2 IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: DATA FROM PROSPECTIVE MULTICENTRIC STUDY - SAFER STUDY

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PV150 / #420 Poster Topic: AS17 - Miscellaneous Background/Purpose Systemic lupus erythematosus (SLE) patients are at greater risk of different infections when compared to the general population, due to abnormalities in the immunological response. Vaccination is the most effective measure for preventing infectious diseases, however, there is still low vaccination coverage due to its acceptance, mainly due to fear of adverse events related to immunization. The objective of this study was to evaluate the safety of vaccines against SAR-CoV-2 available in the Brazilian Public Health system. Methods Data from the multicenter study - SAFER “Study of safety, effectiveness and duration of immunity after vaccination against SARS-CoV-2 in patients with immune-mediated inflammatory disease,” a Brazilian, observational, prospective, phase IV cohort study were evaluated. Patients diagnosed with SLE who met the ACR/EULAR 2019 classification criteria and who received a complete vaccination schedule (2 doses + booster) against SARS-CoV-2, as recommended by the Brazilian National Immunization Plan, were included. All patients underwent clinical and laboratory evaluation before and after the vaccine dose associated with scheduled telephone monitoring and diary recording to monitor adverse events that could be related to the vaccine received. Results A total of 235 individuals with SLE with a complete vaccination schedule (initial scheme with 2 doses of CoronaVac, ChadOx-1 or Pfizer plus booster Pfizer) were included. Around 90% of participants were female with an average age of 38 years. The majority of patients without other significant comorbidities and a median time since disease diagnosis was 10 years. Based on SLEDAI-2K, the majority of patients were in remission or low disease activity (72.4%). Arthritis (15.74%), alopecia (14.04%), proteinuria (11.91%), consumption of complements (10.64%), anti-dsDNA antibody positivity (9.79%) and skin rash (9.36%) were the manifestations most frequently scored. Regarding the degree of immunosuppression, 135 (58.1%) were with a high degree of immunosuppression and 70 (30.1%) without immunosuppression. Of these participants, 116 patients received 2 doses of CoronaVac followed by 1 dose of BNT162b2 (PfizerBioNTech), 87 received 2 doses of ChadOx-1 (AstraZeneca) followed by 1 dose of BNT162b2 (PfizerBioNTech) and 32 received 3 doses of BNT162b2 (PfizerBioNTech). (Figure 1) The most common adverse events after receiving the vaccine were local hypersensibility, headache, musculoskeletal pain, these events being more frequent in both 3 doses received, but less commonly observed in patients in the group who received CoronaVac in the first and second doses when compared to those who received an initial regimen with Chadox-1 and Pfizer (p< 0.05) (Table 1). Evaluating the risk of flare of disease activity after vaccination, measured by SLEDAI-2K, a total of 136 patients were evaluated in relation to disease activity after the second dose and 69 after the third dose. No increase in disease activity was observed between groups (Table 2). Figure 1: Vaccine scheme according initial doses (1st and 2nd dose) Table 1. Table 2. Conclusions This study reveals the safety profile of vaccines against SARS-CoV-2 in patients with SLE and a complete vaccination schedule. Outcome that demonstrates adverse events mainly related to symptoms at the site of vaccine application and systemic symptoms not serious commonly observed in vaccines against other agents. Most importantly, no worsening of disease activity after a complete vaccination schedule regardless of the vaccine platform.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.