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Abstract Number: 1672

Association of COVID-19 Vaccinations with Flares of Systemic Rheumatic Disease: A Case-Crossover Study

Genna Braverman1, Medha Barbhaiya2, Minerva Nong1, Vivian Bykerk3, Nathaniel Hupert4, Colby Lewis V4 and Lisa Mandl2, 1Hospital for Special Surgery, New York, NY, 2Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, 3Department of Rheumatology, Hospital for Special Surgery, New York, NY, 4Weill Cornell Medicine, New York, NY

Meeting: ACR Convergence 2023

Keywords: autoimmune diseases, COVID-19, Disease Activity, Epidemiology

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Session Information

Date: Monday, November 13, 2023

Title: Abstracts: Infection-related Rheumatic Disease

Session Type: Abstract Session

Session Time: 4:00PM-5:30PM

Background/Purpose: Fear of flare contributes to COVID-19 vaccine hesitancy in patients with systemic rheumatic diseases (SRD). Accurately ascertaining post-vaccine SRD flares and differentiating them from routine vaccine side effects is difficult. We evaluated the association of COVID-19 vaccination with SRD flares using a case-crossover design, which is ideal for studying outcomes triggered by transient within-person exposures with short windows of time-to-effect.

Methods: Adults ≥18 years enrolled in a COVID-19 Rheumatology Registry at a tertiary center were invited to participate in this study assessing SRD flares. COVID-19 vaccine dates and brands were obtained from self-report and electronic health records. International Classification of Disease-10 algorithms identified SRD diagnoses. Subjects with rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE) and scleroderma (SSc) had their diagnoses validated by classification criteria; 138 (31.8%), 55 (12.7%), 44 (10.1%) and 15 (3.5%) of 434 participants met criteria for RA, PsA, SLE and SSc, respectively. Participants self-reported both SRD flares and SRD quiescence. “Hazard periods” were defined as time before self-reported flares, and “control periods” as time before self-report of no flare. We used univariate conditional logistic regression, stratified by participant with a log likelihood equivalent Cox proportional hazards model, to evaluate for an association between flare and vaccination in the preceding 2, 7 and 14 days. (Figure 1). Subgroup analyses were performed.

Results: Of 9361 Registry participants, 1797 opted into the SRD flare study and 434 (24.2%) subjects (mean age 59 years [±13], 84.1% female, 81.9% White) contributed both hazard and control periods between 3/5/21 and 9/6/22. Most had an inflammatory arthritis or a connective tissue disease (Table 1). 96.1% of subjects received at least 1 dose of a COVID-19 vaccine and 93.1% received at least 2 doses. Of the 1316 COVID-19 immunizations received during the study, 31.7% were 1st doses, 30.7% 2nd doses and the remainder ≥ 3rd doses; 58.5% were Pfizer-BioNTech, 39.5% were Moderna and 1.4% were Johnson & Johnson. 997 flares were reported. There was no association between COVID-19 vaccination and SRD flares using lookback windows of 2, 7 or 14 days (OR 1.46 [95% CI, 0.86-2.46], OR 1.09 [95% CI, 0.76-1.55], OR 0.85 [95% CI, 0.64-1.13] respectively; p=NS for all) (Table 3). Subanalyses stratified on sex, age, SRD subtype and vaccine brand similarly showed no association with flare. Information on vaccine side effects was available for 897/1316 (68.2%) doses; 468 (52.2%) and 491 (54.7%) of 897 doses were complicated by CDC-defined local and systemic vaccine side effects, respectively. There was no association between reporting a vaccine side effect and reporting an SRD flare (p=0.09). Information on whether reported flares were consistent with a subject’s “typical” flare was available for 813/997 (81.5%) flares, of which 664/813 (81.7%) were typical.

Conclusion: In this cohort of participants with SRD and high vaccine uptake, COVID-19 vaccination was not associated with SRD flares. These data are reassuring and can inform shared decision-making on COVID-19 immunization.

Supporting image 1

Figure 1. Case-Crossover Design

Supporting image 2

Table 1. Study Participant Demographics at Time of Registry Enrollment

Supporting image 3

Table 2. Case-Crossover Analysis: Association of COVID_19 Vaccination with SRD Flares


Disclosures: G. Braverman: None; M. Barbhaiya: None; M. Nong: None; V. Bykerk: AbbVie, 2, Bristol Myers Squibb, 1, 2, 5, Pfizer, 1, 2; N. Hupert: None; C. Lewis V: None; L. Mandl: Annals of Internal Medicine, 12, Associate Editor, Regeneron Pharmaceuticals, 5, Up-to-Date, 9.

To cite this abstract in AMA style:

Braverman G, Barbhaiya M, Nong M, Bykerk V, Hupert N, Lewis V C, Mandl L. Association of COVID-19 Vaccinations with Flares of Systemic Rheumatic Disease: A Case-Crossover Study [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/association-of-covid-19-vaccinations-with-flares-of-systemic-rheumatic-disease-a-case-crossover-study/. Accessed .
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