Background Vaccination against SARS-CoV-2 is particularly important for patients with systemic lupus erythematosus (SLE), who may be at increased risk of hospitalization for COVID-19. However, the most common reason for vaccine refusal in patients with SLE is fear of SLE disease flare. Additionally, SARS-CoV-2 mRNA vaccines could potentially induce interferon production, associated with increased SLE disease activity. Thus far, no population-based data exist regarding whether SARS-CoV-2 vaccines trigger SLE flares.
Methods We e-mailed a survey on March 5, 2021 to 7,094 outpatients evaluated in our Rheumatology Division in New York City, to assess vaccination outcomes. ICD-10 algorithms identified patients with SLE. A self-reported disease flare was defined as ‘a sudden worsening of your rheumatology condition or arthritis’ within two weeks of the vaccine dose.
Results As of March 30, 2021, 2714 rheumatology patients responded (36.2%). 136/466 (29.2%) patients with SLE (mean [SD] age 54.7 [13.9] years; 93.4% female; 67.7% White; 13.2% Hispanic/Latinx) reported receiving at least one COVID-19 vaccine dose. Eighty-one patients (59.6%) received Pfizer, 48 (39.3%) received Moderna, and 4 (2.9%) received Janssen. Of patients receiving Pfizer or Moderna, 72 (54.5%) received 2/2 doses. Twelve patients (8.8%) reported SLE flare within two weeks of any COVID-19 vaccination (table 1). Patients reporting SLE flare were older (59.0 [14.0] versus 54.3 [13.9] years) and White (83.3% versus 61.1%). Flares occurred in 12.5% of patients receiving Moderna and 7.4% receiving Pfizer (6 patients each). Out of 7 patients receiving both vaccine doses and who reported a flare, 2 flared after both doses (table 1).
Of the 14 flares, 9 occurred after the first dose, and 5 occurred after the second dose. Most flares after the first vaccine dose were mild (77.8%), whereas most after the second were moderate (60%). 12/14 flares (85%) were described as ‘typical’, predominantly characterized by joint pain, muscle aches, and fatigue. While 8/14 flares started 1 day after vaccination, 4/14 started 4-7 days later. Most SLE flares resolved within 7 days of onset; however, 4/14 lasted 8-21 days and 2/14 lasted >21 days.
Conclusions Interim data suggest >91% of SLE patients did not self-report a flare post-SARS-CoV-2 vaccination; of those that did, most had mild flares. Given most patients reported that their post-vaccine flare was ‘typical’ of their SLE flares, vaccine side effects alone may not explain these findings. Whether vaccine type or modifying immunosuppressive medications to enhance vaccine efficacy independently predicts SLE flare remains to be determined.
Acknowledgements Dr. Barbhaiya is currently supported by the Rheumatology Research Foundation Investigator Award and the Barbara Volcker Center for Women and Rheumatic Diseases at Hospital for Special Surgery. Dr. Mandl received grant support from Regeneron Pharmaceuticals, and is an Associate Editor at Annals of Internal Medicine. Dr. Siegel is supported by the National Center for Advancing Translational Sciences (NCATS) Grant # UL1TR02384 of the Clinical and Translational Science Center at Weill Cornell Medical College. The funders had no role in study design, data collection, analysis, decision to publish, or preparation of the manuscript.
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