Rituximab and COVID-19 vaccinatio
- Conditions
- immune-mediated dermatologic diseases treated with rituximabCOVID-19 vaccine immunogenicityRituximabvaccinationCOVID-19 vaccinesimmune-mediated dermatologic diseases
- Registration Number
- TCTR20221213001
- Lead Sponsor
- Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
- Brief Summary
The regression analysis demonstrated a negative association between rituximab exposure status and SR but not with SARS-CoV-2-specific IgG levels. Nine-month rituximab-to-vaccination cut-off fulfilled our prespecified diagnostic performance (SR difference between groups [95%CI]: -2.6 [-23.3, 18.1], LR+: 2.6) and coincided with the repopulation of naive B lymphocytes in these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 113
1. Being participants of our previous prospective cohort study or the one conducted parallel to ours by rheumatologists in the same institution, which evaluated immunogenicity of various types of COVID-19 vaccines in patients with immune-mediated dermatologic diseases (TCTR20220317008)
2. Subjects who received at least one course of rituximab using any protocols before vaccination were included as an exposed group.
3. Rituximab-naive subjects were recruited as an unexposed group.
*exposed and unexposed group were matched for age and sex.
1. Subjects received rituximab or were diagnosed with COVID-19 between the first dose vaccination to the vaccine's immunogenicity assessment date
2. The vaccine's immunogenicity data were missing
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Humoral immune response 28 days post-vaccination Seroconversion rates (positive tests for SARS-CoV-2 IgG, SARS-CoV-2-specific surrogate viral neutralization or micro-neutralization assays)
- Secondary Outcome Measures
Name Time Method /A N/A N/A