Covid-19 Severity and Vaccine Breakthrough Infections in Idiopathic Inflammatory Myopathies, Other Systemic Autoimmune and Inflammatory Diseases, and Healthy Individuals: Results from the Covid-19 Vaccination in Autoimmune Diseases (Covad) Study

ABSTRACT

Background. Significant gaps are present in the evidence of the spectrum and severity of COVID-19 infection in idiopathic inflammatory myopathies (IIMs). Patients with IIMs typically require immunosuppressive therapy, may have multiple disease sequelae, and frequent comorbidities, and thus may be more susceptible to severe COVID-19 infection and complications. The possibility of attenuated immunogenicity and reduced efficacy of COVID-19 vaccines due to concomitant immunosuppressive medication is a major concern in these patients, and there is little data available on COVID-19 vaccine breakthrough infections (BI) in IIMs Methods. We developed an extensive patient self-reporting electronic-survey (COVAD survey) featuring 36 questions to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the COVAD survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. BI was defined as COVID-19 infection occurring more than 2 weeks after receiving 1st dose of a COVID-19 vaccine. We analysed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type. Results. Data from 10,900 respondents [42 (30-55) years, 74% females, 45% Caucasians] were analysed. Most were HCs (47%), followed by SAIDs (42%) and IIMs (11%). All respondents included in the final analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfizer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). IIM patients were older, had a higher Caucasian representation and higher Pfizer uptake than other SAIDs, and HC. A higher proportion of IIM patients received immunosuppressants than other SAIDs. After adjustment for covariates, COVID-19 severity and BIs were comparable among patients with IIMs, SAIDs, and HCs, except for all-cause hospitalisation prior to vaccination (IIMs vs. HCs, OR=2.5, 95%CI 1.1-5.8) and COVID-19 cases prior to vaccination (IIMs vs. SAIDs, OR=0.6, 95%CI 0.4-0.8, and IIMs vs HCs, OR=0.4, 95%CI 0.3-0.5). BIs in IIMs were uncommon, with only 17 (1.4%) patients reporting BIs, of whom 13 were on immunosuppressants, and 3 required hospitalisation. Unvaccinated individuals with IIMs were at 4.6 (95%CI 2.7-8.0) times higher odds for developing COVID-19, and the 2nd vaccine dose had a protective effect on BI occurrence (Figure 1). Conclusion. IIMs patients reported fewer COVID-19 prior to vaccination than SAIDs and HCs, but had higher odds of all-cause hospitalisation than HCs. Vaccination protected patients with IIMs against COVID-19. COVID-19 breakthrough infections were uncommon in IIMs, with a similar symptom profile, disease duration, and severity in comparison to patients with SAIDs and HCs.