By Michael Rubin, MD
Professor of Clinical Neurology, Weill Cornell Medical College
SYNOPSIS: In a population-based, self-reporting survey of patients with immune-mediated myopathy and myasthenia gravis, the frequency of both mild and severe acute adverse events appeared to be no more frequent than in the general population. COVID-19 vaccinations are safe for this population of patients.
SOURCE: Gil-Vila A, Ravichandran N, Selva-O’Callaghan A, et al. COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies. Muscle Nerve 2022;66:426-437.
Vaccination for patients with immune-mediated disease remains an ongoing debate. Influenza vaccination may result in a slight but significant risk of Guillain-Barré syndrome. Yellow fever and H1N1 vaccination may be associated with activation or exacerbation of multiple sclerosis. Vaccination increases mean anti-Ro/SSA and anti-La/SSB antibodies in Sjögren syndrome in the year following vaccination, without significant change in disease course, and autoimmune disease exacerbation may be of greater theoretical concern when using high-dose vaccines or vaccines with novel adjuvants (e.g., recombinant zoster [shingles] vaccine). Is there a short-term risk from COVID-19 vaccine for patients with idiopathic inflammatory myopathy (IIM) and other systemic autoimmune and inflammatory disorders (SAID)?
Using an international, online, cross-sectional, patient-self-reported, multicenter, electronic survey, circulated by more than 110 physicians in 94 countries, consisting of 36 COVID-19- and SAID-related questions, data were obtained and analyzed from 10,900 respondents. Patients’ responses to questions permitted assessment of active and inactive disease in the four weeks prior to, as well as adverse drug events in the week following, vaccination. Statistical analysis included Chi-square and Mann-Whitney U tests, with P < 0.05, using the Bonferroni-corrected P value for univariate analysis, taken as significant.
Respondents comprised 16,328 individuals, of whom 2,866 had not been vaccinated at the time of survey completion and 2,562 who did not fully respond to the survey, leaving 1,227 with idiopathic inflammatory myopathy (11.2%); 4,640 with other systemic autoimmune and inflammatory disorders (42.6%), comprising anti-synthetase disorder, necrotizing myositis, overlap myositis, and juvenile dermatomyositis; and 5,033 healthy controls (46.2%). Mean age was 42 years, 74% were female, 45% were Caucasian, and 69% were fully vaccinated. Among IIM patients, 34% had dermatomyositis, 17% had polymyositis, and 23% had inclusion body myositis. Adverse events (AEs) of any type were reported in 76.5% of IIM patients, with 4.6% reporting major AEs requiring medical attention, including severe rash, throat closure, difficulty breathing, and anaphylaxis. Minor AEs included myalgia, body aches, chills, fever, nausea, vomiting, rash, fatigue, diarrhea, abdominal pain, tachycardia, palpitations, hypertension, syncope, dyspnea, dizziness, or chest pain.
Patients with active IIM were more likely to report AEs, and more frequently had rash compared to healthy controls, potentially caused by flare of a dermatomyositis rash. Minor AEs were more frequent among IIM patients with active disease prior to vaccination, with no differences found among different forms of IIM, and hospitalizations were similar among those with IIM and healthy controls. Injection site pain, major AEs, and hospitalizations were similar in IIM and other SAID. Although COVID-19 vaccination may result in rash or minor AEs in dermatomyositis, in the short-term (seven days) it is safe in patients with IIM and other systemic autoimmune and inflammatory disorders.
COMMENTARY
Anti-SARS-CoV-2 vaccination also is safe in patients with myasthenia gravis (MG). Literature review of vaccines and MG, comprising 29 relevant articles discussing influenza and vaccines, including anti-SARS-CoV-2 vaccination, as well as retrospective review of 80 vaccinated MG patients at Treviso Hospital, Padua, Italy, seen between January and December 2021, revealed no convincing association in the literature between vaccination and disease exacerbation.1 Among the 80 patient cohort, four (5%) patients experienced MG exacerbation within six weeks of the second vaccine, with two responding promptly to increased steroid or immunosuppression and two requiring plasma exchange or intravenous immunoglobulin for bulbar exacerbation or myasthenic crisis, all occurring after the second dose of the Pfizer BNT162b2 vaccine, with one additional case of new onset post-vaccine MG. The benefit outweighs any significant risk of MG following administration of the anti-SARS-CoV-2 vaccine.
REFERENCE
- Sansone G, Bonifati DM. Vaccines and myasthenia gravis: A comprehensive review and retrospective study of SARS-CoV-2 vaccination in a large cohort of myasthenic patients. J Neurol 2022;269:3965-3981.
