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The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study.

Publication ,  Journal Article
Terkeltaub, R; Sundy, JS; Schumacher, HR; Murphy, F; Bookbinder, S; Biedermann, S; Wu, R; Mellis, S; Radin, A
Published in: Ann Rheum Dis
October 2009

BACKGROUND: Recent studies suggest that blockade of the NLRP3 (cryopyrin) inflammasome interleukin 1beta (IL1beta) pathway may offer a new treatment strategy for gout. OBJECTIVE: To explore the potential utility of rilonacept (IL1 Trap) in patients with chronic active gouty arthritis in a proof-of-concept study. METHODS: This 14-week, multicentre, non-randomised, single-blind, monosequence crossover study of 10 patients with chronic active gouty arthritis included a placebo run-in (2 weeks), active rilonacept treatment (6 weeks) and a 6-week post-treatment follow-up. RESULTS: Rilonacept was generally well tolerated. No deaths and no serious adverse events occurred during the study. One patient withdrew owing to an injection-site reaction. Patients' self-reported median pain visual analogue scale scores significantly decreased from week 2 (after the placebo run-in) to week 4 (2 weeks of rilonacept) (5.0 to 2.8; p<0.049), with sustained improvement at week 8 (1.3; p<0.049); 5 of 10 patients reported at least a 75% improvement. Median symptom-adjusted and severity-adjusted joint scores were significantly decreased. High-sensitivity C-reactive protein levels fell significantly. CONCLUSIONS: This proof-of-concept study demonstrated that rilonacept is generally well tolerated and may offer therapeutic benefit in reducing pain in patients with chronic refractory gouty arthritis, supporting the need for larger, randomised, controlled studies of IL1 antagonism such as with rilonacept for this clinical indication.

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Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

October 2009

Volume

68

Issue

10

Start / End Page

1613 / 1617

Location

England

Related Subject Headings

  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Pain Measurement
  • Middle Aged
  • Male
  • Interleukin-1beta
  • Humans
  • Gout Suppressants
  • Female
  • Epidemiologic Methods
 

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Terkeltaub, R., Sundy, J. S., Schumacher, H. R., Murphy, F., Bookbinder, S., Biedermann, S., … Radin, A. (2009). The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis, 68(10), 1613–1617. https://doi.org/10.1136/ard.2009.108936
Terkeltaub, R., J. S. Sundy, H. R. Schumacher, F. Murphy, S. Bookbinder, S. Biedermann, R. Wu, S. Mellis, and A. Radin. “The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study.Ann Rheum Dis 68, no. 10 (October 2009): 1613–17. https://doi.org/10.1136/ard.2009.108936.
Terkeltaub R, Sundy JS, Schumacher HR, Murphy F, Bookbinder S, Biedermann S, et al. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis. 2009 Oct;68(10):1613–7.
Terkeltaub, R., et al. “The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study.Ann Rheum Dis, vol. 68, no. 10, Oct. 2009, pp. 1613–17. Pubmed, doi:10.1136/ard.2009.108936.
Terkeltaub R, Sundy JS, Schumacher HR, Murphy F, Bookbinder S, Biedermann S, Wu R, Mellis S, Radin A. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis. 2009 Oct;68(10):1613–1617.

Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

October 2009

Volume

68

Issue

10

Start / End Page

1613 / 1617

Location

England

Related Subject Headings

  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Pain Measurement
  • Middle Aged
  • Male
  • Interleukin-1beta
  • Humans
  • Gout Suppressants
  • Female
  • Epidemiologic Methods