TY - JOUR
T1 - COVID-19 vaccination in autoimmune diseases (COVAD) study
T2 - Vaccine safety and tolerance in rheumatoid arthritis
AU - COVAD Study Group
AU - Naveen, R
AU - Parodis, Ioannis
AU - Joshi, Mrudula
AU - Sen, Parikshit
AU - Lindblom, Julius
AU - Agarwal, Vishwesh
AU - Lilleker, James B
AU - Tan, Ai Lyn
AU - Nune, Arvind
AU - Shinjo, Samuel Katsuyuki
AU - Salim, Babur
AU - Ziade, Nelly
AU - Velikova, Tsvetelina
AU - Edgar Gracia-Ramos, Abraham
AU - Saavedra, Miguel A
AU - Day, Jessica
AU - Makol, Ashima
AU - Distler, Oliver
AU - Chinoy, Hector
AU - Agarwal, Vikas
AU - Aggarwal, Rohit
AU - Gupta, Latika
AU - Nikiphorou, Elena
N1 - Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.
PY - 2023/7
Y1 - 2023/7
N2 - Objectives: The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in RA patients.
Methods: An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs). Descriptive and multivariable regression analyses were performed.
Results: Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA; they had a mean (s.d.) age of 50.7 (13.7) years, 74.2% were women and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both odds ratio [OR] = 0.7; 95% CI: 0.5, 0.9), and injection site pain (OR = 0.6; 95% CI: 0.5, 0.8) with similar major AE and hospitalization frequencies.
Conclusion: Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs, providing reassurance as to the safety of COVID-19 vaccination.
AB - Objectives: The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in RA patients.
Methods: An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs). Descriptive and multivariable regression analyses were performed.
Results: Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA; they had a mean (s.d.) age of 50.7 (13.7) years, 74.2% were women and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both odds ratio [OR] = 0.7; 95% CI: 0.5, 0.9), and injection site pain (OR = 0.6; 95% CI: 0.5, 0.8) with similar major AE and hospitalization frequencies.
Conclusion: Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs, providing reassurance as to the safety of COVID-19 vaccination.
KW - Adverse effects
KW - autoimmune diseases
KW - COVID-19
KW - RA
KW - vaccination
UR - https://www.scopus.com/pages/publications/85149134170
U2 - 10.1093/rheumatology/keac624
DO - 10.1093/rheumatology/keac624
M3 - Article
C2 - 36315075
AN - SCOPUS:85149134170
SN - 1462-0324
VL - 62
SP - 2366
EP - 2376
JO - Rheumatology (United Kingdom)
JF - Rheumatology (United Kingdom)
IS - 7
ER -
