- the therapeutic need for treatment in patients with gouty arthritis attacks who do not respond adequately to NSAIDs and colchicine and cannot receive corticosteroids ;
- the likely efficacy of canakinumab in these patients but the low level of evidence of available data (post hoc sub-group analysis) and possible adverse effects ;
the Transparency Committee considers that ILARIS provides a minor improvement in actual benefit (level IV) in the treatment of gouty arthritis attacks in a population restricted only to those patients who have frequent gouty arthritis attacks who do not respond adequately to NSAIDs, colchicine and corticosteroids or who cannot receive these treatments.