An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist

N Engl J Med. 2009 Jun 4;360(23):2426-37. doi: 10.1056/NEJMoa0807865.

Abstract

Background: Autoinflammatory diseases manifest inflammation without evidence of infection, high-titer autoantibodies, or autoreactive T cells. We report a disorder caused by mutations of IL1RN, which encodes the interleukin-1-receptor antagonist, with prominent involvement of skin and bone.

Methods: We studied nine children from six families who had neonatal onset of sterile multifocal osteomyelitis, periostitis, and pustulosis. Response to empirical treatment with the recombinant interleukin-1-receptor antagonist anakinra in the first patient prompted us to test for the presence of mutations and changes in proteins and their function in interleukin-1-pathway genes including IL1RN.

Results: We identified homozygous mutations of IL1RN in nine affected children, from one family from Newfoundland, Canada, three families from The Netherlands, and one consanguineous family from Lebanon. A nonconsanguineous patient from Puerto Rico was homozygous for a genomic deletion that includes IL1RN and five other interleukin-1-family members. At least three of the mutations are founder mutations; heterozygous carriers were asymptomatic, with no cytokine abnormalities in vitro. The IL1RN mutations resulted in a truncated protein that is not secreted, thereby rendering cells hyperresponsive to interleukin-1beta stimulation. Patients treated with anakinra responded rapidly.

Conclusions: We propose the term deficiency of the interleukin-1-receptor antagonist, or DIRA, to denote this autosomal recessive autoinflammatory disease caused by mutations affecting IL1RN. The absence of interleukin-1-receptor antagonist allows unopposed action of interleukin-1, resulting in life-threatening systemic inflammation with skin and bone involvement. (ClinicalTrials.gov number, NCT00059748.)

Publication types

  • Research Support, N.I.H., Intramural

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Autoimmune Diseases / drug therapy
  • Autoimmune Diseases / genetics*
  • Base Sequence
  • Child
  • Female
  • Genes, Recessive
  • Homozygote
  • Humans
  • Infant
  • Infant, Newborn
  • Inflammation / drug therapy
  • Inflammation / genetics
  • Inflammation / immunology*
  • Interleukin 1 Receptor Antagonist Protein / deficiency
  • Interleukin 1 Receptor Antagonist Protein / genetics
  • Interleukin 1 Receptor Antagonist Protein / therapeutic use*
  • Interleukin-1 / genetics
  • Interleukin-1 / physiology
  • Interleukin-1beta / antagonists & inhibitors
  • Male
  • Mutation
  • Pedigree
  • RNA, Messenger / metabolism
  • Receptors, Interleukin-1 / antagonists & inhibitors*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • IL1RN protein, human
  • Interleukin 1 Receptor Antagonist Protein
  • Interleukin-1
  • Interleukin-1beta
  • RNA, Messenger
  • Receptors, Interleukin-1

Associated data

  • ClinicalTrials.gov/NCT00059748