BackgroundThe approved COVID-19 vaccines showed clear safety and efficacy in reduction of severe SARS-CoV-2 disease. Patients with idiopathic inflammatory myopathies (IIM) were not well represented in these vaccine trials and there are limited data in the literature about development of confirmed disease flare after COVID-19 vaccination.ObjectivesTo evaluate frequency, features and outcome of disease relapses in patients with IIM following SARS–CoV-2 vaccination.MethodsA cohort of 176 IIM patients (mean age:57.6 years, 117 females, 59 males, 106 PM, 70 DM) were interviewed after the 3rd wave of COVID-19 pandemic and prospectively followed. Relapses were determined using the IMACS disease state criteria, outcome of the flares with myositis response criteria, calculating the total improvement score (TIS).ResultsA total of 146 (82.9%) patients received vaccination and 17/146 (11.6%) patients had relapse within 3 months and 13/146 (8.9%) patients within one month. The relapse rate of unvaccinated patients (1/30; 3.3%) was not significantly different (p>0.1). No fatal flare has been observed. Three months after the post-vaccination relapses, 70.6% of the patients (12/17) achieved improvement of disease activity (average TIS score:30±15.81; 7 minor, 5 moderate and 0 major improvement). Six months after flares improvement was detected in 14/16 (87.5%) of relapsed patients (average TIS score: 43±20.17; 3 minimal, 7 moderate and 4 major). Forward stepwise logistic regression analysis revealed that the active state of myositis at time of injection (p<0.0001; OR: 31.2 CI: 9.0 – 108) and the application of BNT162b2 vaccination (p=0.026; OR: 4.06 CI: 1.1 – 14.7) were significantly associated with the occurrence of relapse.ConclusionMinority of the vaccinated IIM patients had confirmed disease flare after COVID-19 vaccination and majority of the relapses improved after individualized treatment. Active disease state at the time of vaccination probably contributes to the increased risk of post vaccination myositis flare.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
BackgroundPandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov2/COVID19) determines the life of clinicians and patients since 2 years. Limited information is available on the nature, prognosis, and complications of SARS-Cov2 virus infection in patients with idiopathic inflammatory myopathies (IIM). There are also few data on triggered humoral response, side effects and disease course after COVID19 infection or vaccination in IIM.ObjectivesThe primary goals of the current research were to assess frequency and outcome of COVID-19 disease and to determine the vaccination rate and effect in our IIM cohort. Secondary objectives were to search for risk factors of infection, predictive factors of hospitalization and to assess incidence of vaccination adverse events, complications and post vaccination breakthrough infections.MethodsWe retrospectively identified the confirmed COVID19 positive patients and assessed the symptoms, disease course and outcome on 01/06/2021 then patients were prospectively followed. Incidence and complications of vaccination were determined by questionnaires. Anti-SARS-CoV-2 S enzyme electrochemiluminescent immunoassay has been used to assess seroconversion, which measures total antibody (IgM and IgG) to the SARS-CoV2 S protein and SARS-CoV2 N protein. Disease activity was determined by physician global activity.ResultsA total of 176 patients were screened and 101 participated in the study. By 01/06/2021, the COVID infection rate was 34,7% (mean age: 49.54 years, 72.72% women), which was significantly higher than the national prevalence at that time (8.2%). A third of these infections occurred asymptomatically or mild but 20% of the infected patients were hospitalized, one patient died. Longer disease duration (8.67 vs. 17.87 years; p=0.003) and higher incidence of anti-Jo-1 antibody (57% vs. 10% p=0.018) were significantly associated with hospitalization. All of COVID infected patients became seropositive regardless of immunosuppressive therapy or symptoms severity. 53,4 % of the patients received anti-COVID19 vaccine, 75,9 % choose the mRNA type. The titer of antibodies against the spike protein induced by vaccines showed high variance, but 72,3% of patients became seropositive after vaccination. Higher antibody titer against spike protein was detected after Pfizer-BioNTech vaccination compared to others (177,1 U / ml vs. 81.1 U / ml; p <001). Patients receiving steroid therapy had decreased post-vaccination antibody response compared to those without steroid treatment (94,03 U/ml vs. 165.6 U/ml; p = 0.008). With the follow-up of vaccinated patients, we did not found short term vaccine related major adverse events, but long term data revealed 7,4 % post vaccination disease relapse. Breakthrough infection was detected in 9.25 % of the vaccinated patients, one cancer associated patient without post vaccination seroconversion died due to COVID pneumonia. All the fatal COVID infections occurred in patients with seronegativity to anti- SARS-CoV2 S protein.ConclusionBased on our results, myositis may be associated with an increased risk of infection with SARS-CoV-2. Independent risk factor for hospitalization is anti-Jo1 positivity and longer disease duration. Anti-SARS-CoV2 vaccines are safe, tolerable and strongly recommended for IIM population, but further investigation is required to assess clinical significance of post-vaccination disease flare.Disclosure of InterestsNone declared
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