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Human medicines European public assessment report (EPAR): Ilaris, canakinumab, Date of authorisation: 23/10/2009, Revision: 31, Status: Authorised

Periodic fever syndromes

Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period. In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment). In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all. The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.

A fourth study in 181 patients with other periodic fever syndromes found that Ilaris was more effective than placebo in achieving a response (symptoms resolved with no new flare ups). The response rates with Ilaris and placebo were 46% and 8%, respectively in patients with TRAPS, 35% and 6% in patients with HIDS/MKD, and 61% and 6% in patients with FMF.

Still’s disease

A study in 84 patients with childhood Still’s disease (also known as systemic juvenile idiopathic arthritis, SJIA) found that Ilaris was more effective than placebo at reducing symptoms of arthritis: around 84% of patients who received Ilaris achieved the required reduction in symptoms, compared with about 10% of patients who received placebo. In a second study in childhood Still’s disease (177 patients), the risk of experiencing a disease flare was reduced by 64% with Ilaris, compared with placebo. Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.

Because of the similarities between childhood Still’s disease and the adult form (adult-onset Still’s disease, AOSD), Ilaris is expected to have similar benefits in adults.

Gouty arthritis

Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain. In patients taking Ilaris, after 3 days, the pain level was reduced from 74 to 25 (on a standard rating scale from 0 to 100), whereas in patients taking the comparator the pain level was reduced from 74 to 35. The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).

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