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Vaccination against SARS-CoV-2 is crucial for patients with systemic rheumatic diseases (SRDs), who may be at increased risk of severe outcomes post-COVID-19.1 However, as patients with SRDs were not included in the mRNA vaccine trials (ie, Pfizer/BioNTech (BNT162b2) and Moderna (mRNA-1273)), no data exist regarding whether these vaccines might trigger SRD flares. Sparse data suggest that other vaccines may be associated with SRD flares,2 3 possibly from molecular mimicry triggering immune activation or non-specific adjuvant effects. As SRD flares are associated with disease deterioration, increased flares could have serious clinical implications.4
We report the interim results of a web-based survey evaluating SRD flare incidence post-SARS-CoV-2 vaccine. The survey was e-mailed 5 March 2021 to 3545 outpatients with SRDs seen at a large rheumatology division in New York City. ICD-10 algorithms were used to identify SRDs (online supplemental material). A self-reported disease flare was defined as ‘a sudden worsening of your rheumatology condition or arthritis’ within 2 weeks of the vaccine.
As of 12 April 2021, out of 1483 respondents (41.8% response rate), 1101 patients (74.2%) with SRDs reported receiving at least one dose of a SARS-CoV-2 vaccine and provided flare data (mean age: 60.8 years (14.2 years); 80.6% female; 86.0% White and 5.7% Hispanic/Latinx ethnicity). Five hundred and ninety seven patients (54.2%) received Pfizer vaccine, 483 (43.9%) received Moderna vaccine, 16 (1.5%) received Janssen vaccine and 3 (0.3%) received AstraZeneca vaccine. A total of 202 SRD flares were reported by 165 patients (14.9%). History of suspected/confirmed COVID-19 occurred in 7.9% with SRD flare and 6.7% without SRD flare. Mean age of patients reporting an SRD flare was 59.6 years (13.9 years) versus 61.0 years (14.2 years) in the non-flare group; the majority of both groups were female (89.7% vs 80.0%), White (88.5% vs 85.6%) and non-Hispanic/Latinx (95.2% vs 92.2%). 15.9% of patients receiving Moderna vaccine and 14.2% receiving Pfizer vaccine reported SRD flares.
Of the patients receiving either Pfizer or Moderna vaccines, 654 (59.4%) had received both doses. Of these patients, 113 (17.0%) flared, 26 (23.0%) flared only after the first dose, 48 (42.5%) flared only after the second dose and 37 (32.7%) flared after both doses. Flares after the first and second dose of Pfizer vaccine were 10.3% vs 10.9%, and flares after the first and second dose of Moderna vaccine were 9.6% vs 16.3%, respectively.
Both the flare and non-flare groups used medications for prevention and treatment of vaccine side effects (table 1). Most SRD flares were characterised as moderate to severe (57.3% after first vs 62.4% after second dose), and as qualitatively ‘typical’ SRD flares (70.9% after first dose vs 68.2% after second dose). Flares were predominantly reported as joint pain, joint swelling, muscle aches and fatigue (table 1). While 27.7% of flares started 1 day after vaccination, 61.4% began after 2–7 days and 10.9% occurred more than 7 days later (table 1). Most SRD flares resolved within 7 days of onset, but 26.2% lasted for 8–21 days and 8.9% for >21 days.
Interim data from our cohort demonstrate that >85% of patients did not report an SRD flare post-SARS-CoV-2 vaccination. This information is reassuring and can help inform vaccine decision-making for patients with SRDs. Although we did not collect laboratory studies, most SRD flares were described as ‘typical’, suggesting these symptoms are not vaccine’s adverse effects being misreported as disease flares. However, when patients did flare, the majority of flares were reported as moderate to severe, with some lasting >3 weeks. Therefore, it will be important to follow these patients prospectively, as well as to perform analyses which incorporate potential confounders to identify predictors of SRD flares post-vaccination. Whether vaccine manufacturer is an independent predictor of SRD flare remains to be determined.
Handling editor Josef S Smolen
Contributors All authors have made substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data; were involved in drafting the work or revising it critically for important intellectual content; provided final approval of the version published; and were in agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding MB is currently supported by the Rheumatology Research Foundation Investigator Award and the Barbara Volcker Centre for Women and Rheumatic Diseases at Hospital for Special Surgery. LAM received grant support from Regeneron Pharmaceuticals, and is an associate editor at Annals of Internal Medicine.
Disclaimer The funders had no role in study design, data collection, analysis, decision to publish or preparation of the manuscript.
Competing interests MB 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. LAM received grant support from Regeneron Pharmaceuticals, and is an associate editor at Annals of Internal Medicine. The funders had no role in study design, data collection, analysis, decision to publish or preparation of the manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.