Comparative analysis of adverse events and flares across COVID-19 vaccine platforms in SLE patients

Direct comparison of adverse events (AEs) and flares among the coronavirus disease 2019 (COVID-19) vaccine platforms in systemic lupus erythematosus (SLE) patients has rarely been determined. This study aimed to compare AEs and flares among 3 different COVID-19 vaccine platforms in SLE patients. Risk factors for SLE flares following vaccination were also determined. Adult SLE patients completing 2 doses of primary series COVID-19 vaccine (inactivated virus, adenovirus-vectored, and mRNA vaccines), were included in this study. The patients were followed up until 3 months after the 2nd vaccine dose or study censor. SLE disease activity and flares were determined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) and Safety of Estrogens in Lupus Erythematosus National Assessment - SLEDAI Flare Index, but the modified SLEDAI-2K score was used instead of the original SLEDAI-2K. Sixty-seven, 19, and 46 patients received inactivated virus, adenovirus-vectored, and mRNA vaccines, respectively. The incidence rate and 95% confidence interval (IR [95% CI])/100 patient-months was not different for overall AEs (38.2 [27.6-53.0], 44.2 [23.8-82.2], and 49.3 [35.7-68.0], respectively, P = .496) and flares (10.4 [6.1-17.5], 14.6 [6.1-35.2], and 7.1 [3.8-13.3], respectively, P = .561). Severe flares were more common than mild-to-moderate ones, primarily due to renal flare, regardless of vaccine types. There was no significant change in SLE disease activity after vaccination across the vaccine types. High number of the 1997 American College of Rheumatology classification criteria and use of combination immunosuppressive drugs at 1st vaccine dose were independent risk factors for flares. There was no significant difference in overall AEs, changes in SLE disease activity, frequency, and severity of flares, regardless of the vaccine platforms.