COVID-19 Vaccination in Patients With Systemic Lupus Erythematosus: Adverse Events and Rating Agreement of Flares Between Patients and Physicians.

OBJECTIVES

To compare adverse events and flares among different doses and types of COVID-19 vaccines in patients with systemic lupus erythematosus (SLE).

METHODS

All consecutive SLE patients in a lupus cohort, seen between March and October 2022, were invited to join this retrospective study. Inclusion criteria were aged ≥ 20 years and had received at least one dose of COVID-19 vaccine. Data regarding adverse events after vaccination, clinical disease activity and flares within 30 days postvaccination were reviewed.

RESULTS

A total of 201 SLE patients received 524 vaccine doses, with 201, 199, and 124 patients received 1, 2, and 3 doses, respectively. The vaccines included inactivated virus vaccine, adenovirus-vectored vaccine, and mRNA vaccines in 183 (35%), 128 (24%), and 213 (41%) doses, respectively. Regardless of the dose and type of vaccine, adverse events occurred in 50%-70% of patients. Pain and swelling at the injection site were common local symptoms, whereas constitutional, neurological, musculoskeletal, and mucocutaneous symptoms were among systemic ones. The majority of these symptoms were mild to moderate. Patients reported they had disease flares after vaccination in 5%-6%, while actual flares determined by physicians occurred in 8%-13% of them, giving fair to moderate rating agreement between patients and physicians (Cohen's kappa: 0.21-0.44). There was no significant difference in mean mSLEDAI-2K between pre- and 30 days postvaccination.

CONCLUSIONS

Adverse events after vaccination were common, regardless of the dose or type of COVID-19 vaccines, but only a small proportion of patients had severe symptoms. Flares were uncommon. The rating agreement of flares between patients and physicians as fair to moderate.