ABSTRACT
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination plays a crucial role as pivotal strategies to curb the coronavirus dis-ease-19 (COVID-19) pandemic. Despite the mass-scale vaccination, literature data about the incidence of disease fares in IIM patients are still not reported as well as the immunological condition. Objectives: The present study aimed to describe the clinical status of patients affected by IIM after vaccination against COVID19 in order to assess the number of relapses or immune-mediated reactions in a cohort of Italian patients with such disease. Methods: We included all patients affected by IIM and followed by Myositis Clinic, Rheumatology and Respiratory Diseases Units, Siena University Hospital, Bari University Hospital, Policlinico Umberto I, Sapienza University, Rome, and Policlinico Paolo Giaccone, Palermo. Inclusion criteria were a recent (<3 months) clinical and serological assessment before the survey and a defnite diagnosis of dermatomyosi-tis, polymyositis and anti-synthetase syndrome. All patients underwent a telephone survey in order to establish their clinical status and potential relapses after vaccination. Results: A total of 119 IIM patients (median, IQR 58 (47-66) years;32 males) were consecutively enrolled. Fifty had a diagnosis of DM, 39 had PM and 30 had ASS. The median months of disease duration was 79.62±83.98. According to number of organs involvement, forty-two had only one, 45 had two organs involvement, 20 had three, 11 had four and one had five. The majority of them received two doses of COVID-19 vaccine, except four patients who refused the vaccination: 94 (78.9%) Cominarty, 16 (13.4%) Moderna, 5 (0.04%) AZ. Seven (0.06%) patients had fare after vaccination, the majority of them were mild except one major with three organs involved and one life-threatening with systemic involvement. In order to understand or predict the effect of demographic and clinical features on the fare development after vaccination, a logistic regression analysis was performed. The goodness-of-ft statistics showed a Chi2 associated with the Log ratio (L.R.) of 0.045. From the probability associated with the Chi-square tests, the Type II analysis showed the variable that most influences the development of fare was the number of organs involved (p=0.047). Sixty-eight patients received the third dose of COVID-19 vaccination: 51 (75%) Cominarty and 17 (25%) Moderna. Only one (0.01%) patient (the same who had life-threatening fare with systemic involvement after two doses) had fare after third dose and eventually died. Conclusion: Vaccines against SARS-CoV2 have provided, both in registratory studies and in preliminary real-life evidence, an overall good efficacy and safety. Nevertheless, only scanty data are available for rheumatic patients in general and the ones affected by IIM in particular. To the best of our knowledge, ours represent the largest cohort of IIM patients in which immunogenicity of anti-SARS-CoV2 vaccine was assessed. In line with real-life data from other diseases, we found a non-statistically signifcant risk of relapse in our patients, which occurred seldom, usually mild and in patients with a more severe and aggressive course of disease.
ABSTRACT
Background and Aim: Incidence of pericarditis (PC) after SARSCoV2 vaccination is about 2 events for 100.000 vaccinated. Incidence of recurrence of PC after vaccination is still not ascertained in the population previously diagnosed with PC. Methods: We administered a questionnaire recording data about eventual recurrences and inclination towards further vaccination in a population of pts with a previous diagnosis of PC. Results: 136 pts completed the questionnaire. 120 (88,2%) were vaccinated. Among vaccinated pts, 10 cases (8.3%, 7 F, 3M, average age 39.8 y) had a recurrence of pericarditis;1 case 32 days after the second dose, 9 within 25 days from vaccination (mainly after the second dose). 4 after Astra Zeneca and 6 after mRNA vaccine. 7/10 pts were treated as outpatients, while 3/10 required hospital admission. Of all recurrences, 60% were on maintenance therapy for PC, while 40% were not in therapy. Among 120 vaccinated patients, 90,8% reported they were favorable to complete vaccination cycle, 1,7% patients stated they would not complete vaccination and 7,5% were not sure. Among 10 patients with a recurrence after vaccination, only 1 declared that he wouldn't do it again. Conclusions: In a cohort of 120 patients with a diagnosis of PC undergoing vaccination for SARS-CoV2, 8,3% reported an exacerbation of signs or symptoms of PC;however, 90% of them reported they would do the vaccine dose again.