Beneficial effect of interleukin 1 inhibition with anakinra in adult-onset Still's disease. An open, randomized, multicenter study

J Rheumatol. 2012 Oct;39(10):2008-11. doi: 10.3899/jrheum.111549. Epub 2012 Aug 1.

Abstract

Objective: To study the efficacy of anakinra versus disease-modifying antirheumatic drugs (DMARD) in refractory adult-onset Still's disease (AOSD).

Methods: In a 24-week study, 22 patients with AOSD taking prednisolone ≥ 10 mg/day received anakinra (n = 12) or DMARD (n = 10). The primary endpoint was achievement of remission.

Results: At 8 and 24 weeks, 7/12 and 6/12 receiving anakinra and 5/10 and 2/10 receiving DMARD achieved remission. Anakinra induced greater improvement in physical health measured by Medical Outcomes Study Short-Form 36 (SF-36; p < 0.011). During an open-label extension (OLE) of 28 weeks, 7/14 patients taking anakinra and 2/3 taking DMARD were in remission.

Conclusion: Anakinra induced more beneficial responses than DMARD in patients with AOSD and was favored in the OLE phase. (ClinicalTrials.gov Protocol Registration NCT01033656).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antirheumatic Agents / therapeutic use*
  • Azathioprine / therapeutic use
  • Female
  • Humans
  • Interleukin 1 Receptor Antagonist Protein / therapeutic use*
  • Isoxazoles / therapeutic use
  • Leflunomide
  • Male
  • Methotrexate / therapeutic use
  • Middle Aged
  • Receptors, Interleukin-1 / antagonists & inhibitors*
  • Remission Induction
  • Still's Disease, Adult-Onset / drug therapy*
  • Sulfasalazine / therapeutic use
  • Treatment Outcome

Substances

  • Antirheumatic Agents
  • Interleukin 1 Receptor Antagonist Protein
  • Isoxazoles
  • Receptors, Interleukin-1
  • Sulfasalazine
  • Leflunomide
  • Azathioprine
  • Methotrexate

Associated data

  • ClinicalTrials.gov/NCT01033656