Ilaris Approval Expanded to Include Treatment of Gout Flares

The Food and Drug Administration (FDA) has approved Ilaris^® (canakinumab) for the symptomatic treatment of adult patients with gout flares in whom nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

The approval was based on data from two 12-week, double-blind, active-controlled trials. In the β-RELIEVED study (ClinicalTrials.gov Identifier: NCT01029652) patients were randomly assigned to receive canakinumab 150mg subcutaneously (SC) (n=115) or triamcinolone acetonide 40mg intramuscular (IM) (n=115). In the β-RELIEVED-II study (ClinicalTrials.gov Identifier: NCT01080131) patients were randomly assigned to receive canakinumab 150mg SC (n=112) or triamcinolone acetonide 40mg IM (n=114). Treatment was administered at baseline and thereafter upon a new flare.

Among enrolled patients, 33.5% of the canakinumab group and 36.7% of the triamcinolone group had documented inability to use both NSAIDs and colchicine; the remainder had intolerance, contraindication or lack of response to either treatment. In both studies, the co-primary endpoints were the time to first new gout flare over 12 weeks and patient’s assessment of gout flare pain intensity at the most affected joint at 72 hours postdose (measured on a 0-100mm visual analogue scale).

These endpoints were also evaluated in a third double blind, active-controlled trial (ClinicalTrials.gov Identifier: NCT01356602) that randomly assigned patients to canakinumab 150mg SC (n=132) or triamcinolone acetonide 40mg IM (n=132). Approximately 44% of patients in this study were unable to use NSAIDs and colchicine.

Findings from all 3 studies showed that among patients unable to use NSAIDs and colchicine, pain intensity of the most affected joint at 72 hours postdose was consistently lower for those treated with canakinumab compared with triamcinolone acetonide. Canakinumab treatment was also associated with a reduction in the risk of a new flare when compared with triamcinolone acetonide. The benefits of canakinumab were found to be comparable in the overall study population for both endpoints.

The most common adverse reactions reported with canakinumab were nasopharyngitis, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, and back pain.

Ilaris is supplied as a 150mg/mL solution in single-dose vials. The recommended dose for adult patients with a gout flare is 150mg SC. For those who require retreatment, there should be an interval of at least 12 weeks before a new dose may be given.

Ilaris, an interleukin-1β blocker, is also indicated for the treatment of periodic fever syndromes and active Still disease.