Distinct AEs Seen Among Patients with Chronic Inflammatory Disease After COVID-19 Vaccination

Patients with chronic inflammatory disease (CID) displayed a significantly distinct adverse event (AE) profile following COVID-19 vaccination, according to a new study published in Arthritis Care and Research.

The authors undertook the study to specifically understand the degree of severity and individual symptoms experienced by patients with CID, as well as the impact of immunosuppressive medications. “Our objective was to characterize the AE profile of CID patients following SARS-CoV-2 vaccination and understand the relationship between reactogenicity and immunogenicity of SARS-CoV-2 vaccines,” the authors wrote.

All 441 participants (322 patients with CID and 119 controls) completed 3 study visits — one before administering the vaccine, another after first dose, and another after second dose —at which blood and clinical data were collected. Adverse effects such as injection site pain, injection site redness, headache, fever, rash, myalgia, arthralgia, fatigue, nausea, and diarrhea, were evaluated within 7 days of each dose.

Patients with CID reported greater symptom severity after the first dose (p=0.0001), including more myalgia and fatigue (p<0.05). In terms of immunogenicity, among patients with CID, a higher symptom severity after first dose and more symptoms after second dose were associated with higher antibody titers (p<0.05). Each increase of 1 symptom was associated with 15.1% increase in antibody titer. Symptom association was strongest with site pain after first dose (105%, p=0.03) and fatigue after second dose (113%, p=0.004).

The study provided evidence that patients with CID have a distinct reactogenicity profile following the first dose of the vaccine compared to controls. Furthermore, there is an association between increased reactogenicity and increased vaccine response.

Understanding the relationship of immunogenicity and reactogenicity among patients with CID may be of clinical importance to better inform physicians and patients regarding expectations. “Overall, this study serves to provide much needed safety data for patients with CID and as an initial step to better understand the link between reactogenicity and immunogenicity following SARS-COV-2 vaccines,” the authors concluded.

—Priyam Vora

Reference:

Yang M, Taylor K, Peez D et al. Reactogenicity of the mRNA SARS-CoV-2 Vaccines Associates with Immunogenicity in Patients with Autoimmune and Inflammatory Disease. Arthritis Care Res. Published on April 12, 2022; DOI: https://doi.org/10.1002/acr.24894