Patients with high-risk triple-positive antiphospholipid syndrome (APS) were not found to have severe COVID-19 outcomes and tolerated COVID-19 vaccination well, according to study results published in Rheumatology.

Researchers have suggested that COVID-19 and COVID-19 vaccination could induce a thromboembolic event in patients with high-risk triple-positive APS.

This study was aimed at evaluating the severity of COVID-19 and adverse reactions following COVID-19 vaccination among high-risk patients with APS.

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Patients with confirmed high-risk triple-positive APS were identified at 9 participating centers in the US. Enrolled patients were followed up to determine previous infection with COVID-19 and adverse events following COVID-19 vaccination.

Severity of COVID-19 infection was graded from 0 (asymptomatic) to 3 (admission to the intensive care unit [ICU]). Adverse events following vaccination were graded from 0 (no adverse reaction apart from transient local injection site signs/symptoms) to 5 (potentially life-threatening reactions). Data were collected based on outcomes that occurred within a 30-day period.

Researchers surveyed a total of 161 patients. Among 18 (11%) who had a confirmed case of COVID-19, 3 were asymptomatic, 12 were treated by their general practitioner, and 3 were hospitalized in a non-ICU. None of the patients died or were hospitalized in an ICU.

A total of 146 (92%) patients received their first vaccine dose and 129 (80%) received the second vaccine dose. Vaccination was well tolerated. Most patients reported no adverse reaction or minimal injection site reactions (grade=0; 83% after the first dose and 68% after the second dose). Other reactions included flu-like symptoms lasting less than 1 day (grade=1; 12% after the first dose and 22% after the second dose), flu-like symptoms lasting more than 1 day (grade=2; 4% after the first dose and 8% after the second dose), and symptoms requiring medical intervention (grade=3; 1% after the first dose and 2% after the second dose). Of the 15 patients who did not receive COVID-19 vaccination, most refused due to fear or vaccine disbelief.

Limitations of the study included variable recollection among responders, influence of psychologic status on data reporting due to responders’ perception of COVID-19, and inconsistent intervals between vaccination and survey questions.

The study authors concluded, “COVID-19 and COVID-19 vaccination did not result in severe adverse events in [patients with] high-risk triple-positive APS…. These results should reassure patients and caregivers especially on the safety of COVID-19 vaccination. Moreover, the results of this survey may also be translated to lower risk patients with incomplete positive [antiphospholipid antibodies] profile (double and single positivity).”


Pengo V, Del Ross T, Tonello M, et al. Impact of COVID-19 and COVID-19 vaccination on high-risk patients with antiphospholipid syndrome: a nationwide survey. Rheumatology. Published online April 12, 2022. doi:10.1093/rheumatology/keac224