Epidemiology affects anywhere from less than 10% to between 20% and 40% of people after acute infection; up to 50%–70% of patients because of COVID-19 may continue to have symptoms months following hospital discharge. 10–15 Patients with SARDs may be vulnerable to PASC due to altered immunity, immunosuppres- sive therapy, and increased risk for severe acute COVID-19. While vaccination against SARS-CoV-2 decreases the risk of severe acute outcomes, there are limited data regarding the effect of vaccination on PASC risk. 16 17 Previous studies of patients without SARDs have suggested a decreased risk of PASC in those who were vaccinated prior to COVID-19 infection. 18–20 However, many patients with SARDs have impaired responses to the SARS-CoV-2 vaccine and may not similarly benefit from vaccination with regard to the risk of PASC. 21–25 In this study, we investigated the association of SARS-CoV-2 vaccination with the risk of PASC in patients with SARDs. We performed a prospective study in Mass General Brigham (MGB), a large, multicentre healthcare system that includes 2 tertiary care hospitals (Massachusetts General Hospital and Brigham and Women’s Hospital), 12 community hospitals and their associated primary and specialty outpatient centres in the greater Boston, Massachusetts, area. We identified patients within MGB who were ≥18 years of age, had a positive test result for SARS-CoV-2 by PCR or antigen nasopharyngeal test between 1 March 2020 and 8 July 2022, and had an immune- mediated disease diagnosis based on billing codes. Our study population was limited to patients with confirmed SARDs. Diag- nosis of a prevalent SARD at the time of infection was confirmed by manual review of the electronic health record (EHR) in our final study population. This approach has been previously described. 2 6 7 METHODS Study population and patient identification Patient recruitment for prospective study From this population, we invited patients who survived their acute infection to participate in a prospective, longitudinal study: COVID-19 and Rheumatic Diseases (RheumCARD). As previously described in detail, potential participants were invited to participate either via secure online EHR portal or US mail. 2 Initial invitations were sent on 11 March 2021, and as new subjects with confirmed infection were identified, subsequent patients were invited on a rolling basis, approximately once per month, at least 28 days following their COVID-19 diagnosis date. Data Collection Demographic data assessed in the survey included age, sex, race and ethnicity. Smoking status was assessed as never, past or current. The comorbidity count was derived as the sum of comorbidities queried. COVID-19 symptoms assessed in the survey included fever, sore throat, new cough, nasal congestion/ rhinorrhoea, dyspnoea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhoea, anosmia, dysgeusia and joint pain. The symptom count was calculated as the sum of these self-reported symptoms. We collected details of the acute COVID-19 course, including symptom duration, treatments and details of hospitalisation (if applicable). Time to COVID-19 symptom resolution and vaccination status were collected. SARDs were categorised broadly as inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, juve- nile idiopathic arthritis, axial spondyloarthropathy or other
inflammatory arthritis), vasculitis (including ANCA-associated vasculitis, giant cell arteritis and/or polymyalgia rheumatica, or other vasculitis such as Takayasu arteritis or Kawasaki disease), connective tissue disease (CTD, including systemic lupus erythe- matosus, mixed connective tissue disease, undifferentiated connective tissue disease, idiopathic inflammatory myopathy or Sjogren’s syndrome) or other (sarcoidosis, Behcet disease, IgG 4 - related disease or relapsing polychondritis). Use of immunomod- ulator medications at the time of acute COVID-19 infection was assessed. Exposure of interest The exposure of interest was being fully vaccinated at COVID-19 onset vs partially vaccinated or unvaccinated. Based on patient report, we classified patients as fully vaccinated at the index date (date of COVID-19 diagnosis) if infection was ≥14 days after completion of their primary vaccine series according to the US Centers for Disease Control and Prevention (CDC) defi- nition: two doses of a messenger RNA (mRNA) SARS-CoV-2 vaccine (ie, either BNT162b2 (Pfizer-BioNTech) or mRNA- 1273 (Moderna)) or one dose of the Ad26.COV2.S (Johnson & Johnson-Janssen) vaccine. 26 Other patients were classified as either partially vaccinated or unvaccinated at the index date. Outcome assessments The primary outcome was PASC, defined as any persistent symptom at least 28 days post-COVID-19 infection (US CDC definition). 9 A secondary outcome was PASC, as defined by any persistent symptom at least 90 days post-COVID-19 infection (WHO definition). 8 All patients were enrolled at least 28 days after their COVID-19 diagnosis. Only those who completed the surveys at least 90 days following their COVID-19 diagnosis were included in the analysis of the WHO definition of PASC. Symptom duration (in days) and symptom-free days were other secondary outcomes; days of symptoms were counted from the index date through the time of symptom resolution or date of survey completion if symptoms were ongoing. Patients with missing data regarding symptom duration or vaccination status were excluded. Other secondary outcomes included pain (measured by the short-form McGill Pain Questionnaire (SF-MPQ 27 ), fatigue (Fatigue Symptom Inventory (FSI 28 29 ) and functional status (modified Health Assessment Questionnaire (mHAQ 30 ). The 12-item SF health survey (SF-12) was used as a general measure of both physical and mental health status. 31 A Physical Compo- nent Summary Score (PCS-12) and Mental Component Summary Score (MCS-12) were calculated. Among those who developed PASC, we compared pain, fatigue, functional status and overall health status scores between those with PASC following break- through versus non-breakthrough COVID-19 infection. We also assessed rheumatic disease activity following COVID-19 infection, based on self-reported SARD flare, participant global assessment, and disease activity, as assessed by the RAPID-3 score. Outcomes were assessed from 11 March 2021 (the time of completion of the first survey) to 8 August 2022 (the time of completion of the last survey at the time of manuscript preparation). Statistical analysis Categorical variables are presented as number (percentage), and continuous variables are presented as mean±SD or medi- an±IQR, as appropriate. Continuous variables were compared
Patel NJ, et al . Ann Rheum Dis 2023; 82 :565–573. doi:10.1136/ard-2022-223439
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