Real-world data on tolerability of COVID-19 vaccination in patients with rheumatoid arthritis based on patient-reported outcomes.

Objectives To assess tolerability of COVID-19 vaccination in patients with RA and controls based on patient-reported outcomes (PROs). Methods In total, 266 study participants were included at 6 ± 1 weeks after their second vaccination (BioNTech/Pfizer (72.2%), AstraZeneca (18.8%) and Moderna (9.0%)). In a cross-sectional, observational study design, PRO data were recorded regarding both total and symptom-level tolerability. Results Overall tolerability was very high according to the patients' self-assessment scores (1.71 for the first and 1.72 for the second vaccination, 6-point Likert scale [1 (very good) to 6 (very poor)]) and did not differ significantly between patients with RA (n  = 204) and controls (n  = 62). Self-rated overall tolerability regarding first vaccination was significantly better (P  = 0.002) in patients receiving mRNA vaccines (n  = 193, mean tolerability 1.59) as compared with vector-vaccinated patients (n  = 73, mean tolerability 2.04). Homologous or heterologous vaccination regimens had no statistically significant effect on vaccine tolerability (P  = 0.131). Reservations about the vaccination were rare (6.4% for the first and 6.0% for the second vaccination) but significantly associated with poorer overall tolerability (P  < 0.001) and significantly reduced willingness to recommend vaccination to others (P  < 0.001 for the first and P  = 0.004 for the second vaccination). Conclusion Based on these real-world data, tolerability of COVID-19 vaccination was very good in both RA patients and controls. Reservations against COVID-19 vaccination were rare overall, but if present, associated with a significantly worse tolerability and a significantly lower degree of recommendation. [ABSTRACT FROM AUTHOR]