Key result
BNT162b2 in SLE and RA is linked to ~120% higher fatigue risk versus healthy controls.
Why the study?
Patients with rheumatic diseases such as SLE and RA were largely excluded from COVID-19 vaccine phase 3 trials, creating uncertainty about vaccine safety and reactogenicity in this population.
Does the BNT162b2 COVID-19 vaccine cause increased reactogenicity in patients with systemic lupus erythematosus and rheumatoid arthritis compared to healthy controls?
Observational (n=285)
No
Does the BNT162b2 COVID-19 vaccine cause increased reactogenicity in patients with systemic lupus erythematosus and rheumatoid arthritis compared to healthy controls?
The BNT162b2 COVID-19 vaccine is associated with more frequent but not more severe reactogenicity in patients with SLE and RA compared to healthy controls.
Answers are grounded in this paper and cite their sources.
Supports counseling on reactogenicity for SLE/RA patients receiving BNT162b2; leaves open need for confirmatory prospective studies.
Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were launched in December 2020. Vaccination of patients with rheumatic diseases is recommended, as they are considered at higher risk of severe COVID-19 than the general population. Patients with rheumatic disease have largely been excluded from vaccine phase 3 trials. This study explores the safety and reactogenicity of BNT162b2 among patients with rheumatic diseases. Patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), median age 58.8 years, 285 subjects in total, were vaccinated twice with the BNT162b2 (Pfizer/BioNTech). Questionnaires on reactogenicity matching the original phase 3 study were answered seven days after completed vaccination. The majority of SLE and RA patients experienced either local (78.0%) or systemic reactions (80.1%). Only 1.8% experienced a grade-4 reaction. Compared to the original study, we found more frequent fatigue [Odds ratio (OR) 2.2 (1.7-2.8)], headache [OR 1.7 (1.3-2.2)], muscle pain [OR 1.8 (1.4-2.3)], and joint pain [OR 2.3 (1.7-3.0)] in patients. In contrast, the use of antipyretics was less frequent [OR 0.5 (0.3-0.6)]. Patients with SLE and RA experience reactogenicity to the Pfizer-BioNTech BNT162b2 COVID-19 vaccine. Reactogenicity was more frequent in patients, however, not more severe compared with healthy controls.
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Bartels et al. (2021) conducted an observational in Systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) (n=285). BNT162b2 COVID-19 vaccine vs. Healthy controls from the original phase 3 trial was evaluated on Fatigue seven days after second vaccination (OR 2.2, 95% CI 1.7-2.8). Patients with systemic lupus erythematosus and rheumatoid arthritis experienced more frequent, but not more severe, reactogenicity to the BNT162b2 vaccine compared to healthy controls, including increased fatigue (OR 2.2) and joint pain (OR 2.3).
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