The Role of Sinopharm BIBP COVID-19 Vaccine Immunization in Systemic Lupus Erythematous Flare-up

Abstract

Background: This study aimed to investigate the incidence and clinical characteristics of flare-ups in patients with systemic lupus erythematosus (SLE) following immunization with inactivated SARS-CoV-2 vaccines. Methods: In this cross-sectional study at Imam Hossein Hospital's Rheumatology Clinic (Iran), we investigated 72 SLE patients in remission who received the Sinopharm BIBP inactivated COVID-19 vaccine. Their post-vaccination status was monitored for 3 months using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) checklist by an internal medicine specialist. Results: Fourteen patients (19.44%) experienced symptom flare-ups after vaccination. The most common symptoms were arthritis (64.29%) and skin rash (21.43%). Age, sex, organ involvement, and treatment regimen did not significantly differ between those with and without symptom recurrence (P > 0.05). The second vaccine dose led to more flare-ups compared to the first dose (12.12% vs. 8.33%, P < 0.001). However, the severity of symptom recurrence, measured by the SLEDAI-2K score (P = 0.763), and the interval from vaccination to symptom recurrence (P = 0.075) did not significantly differ between the 2 groups. Except for 2 patients, none of the participants required hospitalization, and flare-up symptoms were effectively managed by prednisolone dosage adjustments. For these 2 patients, the treatment regimen was changed, and the steroid dose was increased; one of them was admitted to the hospital, and the other one was managed on an outpatient basis. Conclusions: The incidence of flare-ups in SLE patients in remission following COVID-19 vaccination with Sinopharm BIBP vaccine was low; most of them were mild and did not require hospitalization, except for 1 patient who was hospitalized after the first dose of vaccination and received rituximab due to vasculitis flare. These findings highlight vaccine safety and underscore the importance of close monitoring, especially after the second dose.