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.