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Efficacy and safety of the interleukin-1 antagonist rilonacept in Schnitzler syndrome: an open-label study.

AbstractBACKGROUND:
Schnitzler syndrome (SchS) is a rare disease with suspected autoinflammatory background that shares several clinical symptoms, including urticarial rash, fever episodes, arthralgia, and bone and muscle pain with cryopyrin-associated periodic syndromes (CAPS). Cryopyrin-associated periodic syndromes respond to treatment with interleukin-1 antagonists, and single case reports of Schnitzler syndrome have shown improvement following treatment with the interleukin-1 blocker anakinra. This study evaluated the effects of the interleukin-1 antagonist rilonacept on the clinical signs and symptoms of SchS.
METHODS:
Eight patients with SchS were included in this prospective, single-center, open-label study. After a 3-week baseline, patients received a subcutaneous loading dose of rilonacept 320 mg followed by weekly subcutaneous doses of 160 mg for up to 1 year. Efficacy was determined by patient-based daily health assessment forms, physician's global assessment (PGA), and measurement of inflammatory markers including C-reactive protein (CRP), serum amyloid A (SAA), and S100 calcium-binding protein A12 (S100A12).
RESULTS:
Treatment with rilonacept resulted in a rapid clinical response as demonstrated by significant reductions in daily health assessment scores and PGA scores compared with baseline levels (P < 0.05). These effects, which were accompanied by reductions in CRP and SAA, continued over the treatment duration. Rilonacept treatment was well tolerated. There were no treatment-related severe adverse events and no clinically significant changes in laboratory safety parameters.
CONCLUSION:
Rilonacept was effective and well tolerated in patients with SchS and may represent a promising potential therapeutic option.
AuthorsK Krause, K Weller, R Stefaniak, H Wittkowski, S Altrichter, F Siebenhaar, T Zuberbier, M Maurer
JournalAllergy (Allergy) Vol. 67 Issue 7 Pg. 943-50 (Jul 2012) ISSN: 1398-9995 [Electronic] Denmark
PMID22583335 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Copyright© 2012 John Wiley & Sons A/S.
Chemical References
  • Biomarkers
  • Inflammation Mediators
  • Interleukin-1
  • Recombinant Fusion Proteins
  • rilonacept
Topics
  • Aged
  • Biomarkers (metabolism)
  • Female
  • Humans
  • Inflammation Mediators (metabolism)
  • Interleukin-1 (antagonists & inhibitors)
  • Male
  • Middle Aged
  • Recombinant Fusion Proteins (adverse effects, therapeutic use)
  • Schnitzler Syndrome (drug therapy, metabolism, pathology)
  • Treatment Outcome
  • Urticaria (drug therapy, pathology)

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