Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

Inclusion Criteria: * Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992). * Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD. * Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator. * Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication. Exclusion Criteria: * Use of corticosteroids (prednisolone equivalent \<10 mg/day. * History of recurrent or chronic infection, including: * tuberculosis * any malignancy * any other major chronic inflammatory disease syndrome * drug or alcohol abuse * known positivity for hepatitis B, C or HIV. * Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.