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Table 1 Current European Medicines Agency and US Food-and-Drug Administration drug approval status for autoinflammatory diseases

From: Consensus protocols for the diagnosis and management of the hereditary autoinflammatory syndromes CAPS, TRAPS and MKD/HIDS: a German PRO-KIND initiative

TreatmentLEuropean Medicines Agency (EMA)Food-and-Drug Administration (FDA)
CAPS
 Canakinumab1BCINCA/NOMID, MWS and severe FCAS ≥2 years and ≥ 7.5 kgFCAS and MWS ≥ 4 years
 Rilonacept1BnoneFCAS and MWS ≥ 12 years
 Anakinra2Aall CAPS patients ≥8 months and ≥ 10 kgNOMID/CINCA only
TRAPS
 Canakinumab1BTRAPS ≥2 years and ≥ 7.5 kgTRAPS in all adults and children
 Anakinra2Bnonenone
 Etanercept2Bnonenone
HIDS (MKD)
 Canakinumab1BMKD ≥2 years and ≥ 7.5 kgMKD in all adults and children
 Anakinra2Bnonenone
 Etanercept3Bnonenone
 Adalimumab3Bnonenone
 Tocilizumab4nonenone
  1. The table summarizes indications and specifications for autoinflammatory drug approval as of July 2019. Evidence levels were adapted from the Oxford Centre for Evidence-based Medicine levels of evidence and grades of recommendation [24]: 1B individual randomised controlled trial; 2A systematic review of cohort studies; 2B individual cohort study; 3B, individual case-control study, non-consecutive cohort study; 4 case series