ILARIS (canakinumab), interleukin 1 inhibitor
RARE DISEASE - New indication
Opinions on drugs -
Posted on
Mar 06 2018
Reason for request
Extension of indication
- ILARIS has Marketing Authorisation in the treatment of three forms of hereditary recurrent fevers in adults, adolescents and children aged 2 years and older:
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TNF-associated periodic syndrome (TRAPS),
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hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and
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familial Mediterranean fever (FMF).
- Its superiority relative to placebo has been demonstrated in these 3 diseases in terms of resolution of the initial attack at 15 days and absence of new flare-up within 4 months after treatment.
- ILARIS has not shown to have a long-term effect in the prevention of secondary amyloidosis, a source of morbidity and mortality.
Clinical Benefit
Substantial |
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Clinical Added Value
minor |
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Economic analysis
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