Naveen R, Thakare DR, Kuwana M, Pauling JD, Day J, Joshi M, Parodis I, Sen P, Jagtap K, Nikiphorou E, Saha S, Agarwal V, Chatterjee T, Lilleker JB, Kardes S, Milchert M, Gheita T, Salim B, Velikova T, Gracia-Ramos AE, Tan AL, Nune A, Cavagna L, Saavedra MA, Shinjo SK, Ziade N, Knitza J, Distler O, Chinoy H, COVAD Study Group , Aggarwal R, Gupta L, Agarwal V, Makol A
Rheumatol Int - (-) 1-11 [2023-03-31; online 2023-03-31]
The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.