ABSTRACT
OBJECTIVE: COVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs), however hesitancy continues to persist among these patients.Therefore, we studied the prevalence, predictors, and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys. METHODS: The 1st and 2nd COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analyzed using regression models in different groups. RESULTS: We analyzed data from 18,882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) [OR 0.26; 95%CI: 0.24-0.30, p < 0.001]. However, concerns/fear over long-term safety had increased [OR 3.6;95% CI:2.9-4.6, p < 0.01].We noted with concern greater skepticism over vaccine science among patients with IIMs than AIRDs [OR:1.8; 95%CI: 1.08-3.2, p = 0.023] and HCs [OR: 4; 95%CI: 1.9-8.1, p < 0.001], as well as more long-term safety concerns/fear [IIMs vs AIRDs; OR: 1.9; 95%CI: 1.2-2.9, p = 0.001; IIMs vs HCs; OR: 5.4 95%CI: 3-9.6), p < 0.001].Caucasians [OR 4.2 (1.7-10.3)] were likely to be more hesitant, while those with better PROMIS physical health score were less hesitant [OR 0.9 (0.8-0.97)]. CONCLUSION: Vaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function.
ABSTRACT
OBJECTIVES: Disease flares in the post COVID-19 vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022 respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history, and vaccination details.Flares of IIMs were defined as a. patient self-reported, b. immunosuppression (IS) denoted, c. clinical sign directed, and d. with >7.9-point MCID worsening of PROMISPF10a score. Risk factors of flares were analyzed using regression models. RESULTS: Of 15165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians), and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7%, and 19.6% patients by definitions a-d respectively with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR:1.2; 95%CI:1.03-1.6, p = 0.025) were prone to flares, while those receiving Rituximab (OR:0.3; 95%CI:0.1-0.7, p = 0.010) and Azathioprine (OR:0.3, 95%CI:0.1-0.8, p = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in immunosuppression. Asthma (OR: 1.62; 95%CI: 1.05-2.50, p = 0.028) and higher pain VAS (OR: 1.19; 95%CI: 1.11-1.27, p < 0.001) were associated with disparity between self-reported and IS-denoted flares. CONCLUSION: A diagnosis of IIMs confers an equal risk of flares in the post COVID-19 vaccination period to AIRDs, with active disease, female gender, and comorbidities conferring a higher risk. Disparity between patient and physician reported outcomes represents a future avenue for exploration.
ABSTRACT
OBJECTIVE: Flares of autoimmune rheumatic disease (AIRDs) following COVID-19 vaccination are an outstanding concern in vaccine-hesitant individuals. Therefore, we investigated the incidence, predictors and patterns of flares following vaccination in individuals living with AIRDs using global COVID-19 Vaccination in Autoimmune Diseases (COVAD) surveys. METHODS: The COVAD surveys were used to extract data on flare demographics, comorbidities, COVID-19 history, and vaccination details among patients with AIRDs. Flares following vaccination were identified as patient-reported(a), increased immunosuppression(b), clinical exacerbations(c) and worsening of PROMIS scores(d). We studied flare characteristics and used regression models to differentiate flares among various AIRDs. RESULTS: Of 15165 total responses, the incidence of flares in 3453 patients with AIRDs was 11.3%, 14.8%, 9.5%, and 26.7% by definitions a-d, respectively. There was moderate agreement between patient-reported and immunosuppression-defined flares (K = 0.403, p = 0.022). Arthritis (61.6%) and fatigue (58.8%) were the most commonly reported symptoms. Self-reported flares were associated with higher comorbidities (p = 0.013), mental health disorders (MHD) (p < 0.001), and autoimmune multimorbidity (AIDm) (p < 0.001).In regression analysis, the presence of AIDm (OR = 1.4;95%CI:1.1-1.7;p=0.003), MHD (OR = 1.7;95%CI:1.1-2.6;p=0.007), and Moderna vaccine (OR = 1.5;95%CI:1.09-2.2;p=0.014) recipients were predictors of flares. Mycophenolate (OR = 0.5;95%CI:0.3-0.8;p=0.009) and glucocorticoids (OR = 0.6;95%CI:0.5-0.8;p=0.003) were protective.A higher frequency of patients with AIRDs reported overall active disease post-vaccination compared to before vaccination (OR = 1.3;95%CI:1.1-1.5;p<0.001). CONCLUSION: Flares occur in nearly one in ten individuals with AIRDs after COVID vaccination, with people with comorbidities, especially AID multimorbidity, mental health disorders and use of the Moderna vaccine being particularly vulnerable. Future avenues include exploring flare profiles and optimizing vaccine strategies for this group.
ABSTRACT
Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.