Effectiveness and Safety of the COVID-19 Vaccine in Patients with Rheumatoid Arthritis in a Real-World Setting

• Published in: Vaccines (Basel) Vol. 12; no. 6; p. 672
• Main Authors: Torres-Rufas, María, Vicente-Rabaneda, Esther F, Cardeñoso, Laura, Gutierrez, Ainhoa, Bong, David A, Valero-Martínez, Cristina, Serra López-Matencio, José M, García-Vicuña, Rosario, González-Gay, Miguel A, González-Álvaro, Isidoro, Castañeda, Santos
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.06.2024; MDPI
• Subjects: Analysis; Antibodies; Antirheumatic agents; Arthritis; Care and treatment; Chronic obstructive pulmonary disease; Complications and side effects; COVID-19; COVID-19 vaccine; COVID-19 vaccines; Diagnosis; Disease transmission; Drug dosages; Effectiveness; Flares; humoral response; Immune response; Immunogenicity; Immunomodulation; Infections; Medical research; mRNA; Pandemics; Patient compliance; Population; Population studies; Regression analysis; Rheumatoid arthritis; Rheumatoid factor; Rheumatology; RNA; Safety; Safety and security measures; Serology; Severe acute respiratory syndrome coronavirus 2; Statistical analysis; Vaccination; Vaccines; Variables; Viral infections; Spain; United Kingdom > UK; United States > US; effectiveness; COVID-19 vaccine; rheumatoid arthritis; safety; humoral response
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines12060672

Novel mechanisms of COVID-19 vaccines raised concern about their potential immunogenicity in patients with rheumatoid arthritis (RA) undergoing immunomodulatory treatments. We designed a retrospective single-center study to investigate their effectiveness and safety in this population, analyzing data from the first vaccination program (December 2020-October 2021). Inclusion criteria were availability of post-vaccination serology and a minimum subsequent follow-up of 6 months. Binding antibody units (BAU/mL) ≥ 7.1 defined an adequate serological response. Post-vaccine COVID-19 incidence and its timing since vaccination, adverse events (AEs), and RA flares were recorded. Adjusted logistic and linear multivariate regression analyses were carried out to identify factors associated with vaccine response. We included 118 patients (87.2% women, age 65.4 ± 11.6 years, evolution 12.0 ± 9.6 years), of whom 95.8% had a complete vaccination schedule. Adequate humoral immunogenicity was achieved in 88.1% of patients and was associated with previous COVID-19 and mRNA vaccines, whereas smoking, aCCP, age, and DMARDs exerted a negative impact. Post-vaccine COVID-19 occurred in 18.6% of patients, a median of 6.5 months after vaccination. Vaccine AE (19.5%) and RA flares (1.7%) were mostly mild and inversely associated with age. Our results suggest that COVID-19 vaccines induce adequate humoral immunogenicity, with an acceptable safety profile in RA patients.