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Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial.

Publication ,  Journal Article
Schumacher, HR; Sundy, JS; Terkeltaub, R; Knapp, HR; Mellis, SJ; Stahl, N; Yancopoulos, GD; Soo, Y; King-Davis, S; Weinstein, SP; Radin, AR ...
Published in: Arthritis Rheum
March 2012

OBJECTIVE: To evaluate the interleukin-1 inhibitor rilonacept (Interleukin-1 Trap) for prevention of gout flares occurring in the first few months following initiation of urate-lowering therapy. METHODS: In this double-blind study, adult patients with hyperuricemia and gout were randomized to receive rilonacept administered subcutaneously once per week (loading dose 320 mg followed by 160 mg weekly) or placebo, and started on allopurinol (300 mg/day, titrated to serum urate <6 mg/dl). At study visits, physical and laboratory assessments were performed and information on any adverse events was ascertained. RESULTS: Baseline characteristics were similar between the rilonacept and placebo groups (n = 41 and n = 42, respectively). The mean number of gout flares per patient through week 12 (primary efficacy end point) was markedly lower in the rilonacept group than in the placebo group (0.15 [6 flares] versus 0.79 [33 flares]; P = 0.0011). Fewer flares were observed with rilonacept as early as 4 weeks after initiation of treatment (P = 0.007). The proportion of patients experiencing a flare during the 12 weeks was lower in the rilonacept group than in the placebo group (14.6% versus 45.2%; P = 0.0037). No rebound in the flare rate was observed for 6 weeks after discontinuation of rilonacept or placebo at week 16. Adverse events were similar between groups, and no deaths or serious infectious adverse events were reported; the most common adverse events were infections (14.6% and 26.2% of rilonacept- and placebo-treated patients, respectively) and musculoskeletal disorders (14.6% and 21.4%, respectively). A higher percentage of rilonacept-treated patients (98%) compared with placebo-treated patients (79%) completed the primary 12-week evaluation period (P = 0.015). CONCLUSION: The current findings indicate that rilonacept significantly reduces the frequency of gout flares during the initial period of treatment with urate-lowering therapy, with a favorable safety profile.

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Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

March 2012

Volume

64

Issue

3

Start / End Page

876 / 884

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Hyperuricemia
  • Humans
  • Gout Suppressants
  • Gout
  • Female
 

Citation

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Schumacher, H. R., Sundy, J. S., Terkeltaub, R., Knapp, H. R., Mellis, S. J., Stahl, N., … 0619 Study Group, . (2012). Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum, 64(3), 876–884. https://doi.org/10.1002/art.33412
Schumacher, H Ralph, John S. Sundy, Robert Terkeltaub, Howard R. Knapp, Scott J. Mellis, Neil Stahl, George D. Yancopoulos, et al. “Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial.Arthritis Rheum 64, no. 3 (March 2012): 876–84. https://doi.org/10.1002/art.33412.
Schumacher HR, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR, 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876–884.
Journal cover image

Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

March 2012

Volume

64

Issue

3

Start / End Page

876 / 884

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Recombinant Fusion Proteins
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Hyperuricemia
  • Humans
  • Gout Suppressants
  • Gout
  • Female