Safety and clinical assessment of the AIIRD
The participants were contacted by telephone within 2–8 weeks following the second and third vaccine doses and completed a questionnaire regarding local and systemic side-effects.
Medical history and the use of medications were recorded. Immunomodulating medications were continued throughout the study period. Treatment was not withheld before or after the vaccine dose. Data regarding disease activity up to 3 months before vaccination were retrieved from the patients’ medical records. Post-vaccination disease activity was assessed by in-person clinical examination within 3 months after each vaccine dose and at 1-year intervals after the first vaccine.
The following disease activity indices were included: Juvenile Arthritis Disease Activity Score 10 for JIA, SLEDAI for SLE, and patients’ and physicians’ global assessments (PGA, PhGA respectively), using a visual analogue scale of 0–10 mm, for JIA, SLE, vasculitis, inflammatory myositis, scleroderma, uveitis, and autoinflammatory syndromes.