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KINERET (anakinra), immunosuppressant

RARE DISEASE - New medicinal product
Opinions on drugs - Posted on Jan 20 2015

Reason for request

Inclusion

Significant clinical added value in the management of patients with cryopyrin-associated periodic syndromes

 

  • KINERET, an interleukin-1 antagonist for daily injection, has Marketing Authorisation in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in patients from the age of 8 months, including: Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), Neonatal-Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS).
  • It has been shown to be effective in reducing the intensity of symptoms in the most serious form of CAPS (the CINCA form) during a study with methodological limitations.

 


Clinical Benefit

Substantial

In the indication : Cryopyrin-Associated Periodic Syndromes (CAPS).
Substantial

Low

In the indication : rheumatoid arthritis in combination with methotrexate
Low


Clinical Added Value

important

In the indication: Cryopyrin-Associated Periodic Syndromes (CAPS)
Given its demonstrated efficiency in severe forms of cryopyrinopathies (CINCA syndrome/NOMID) despite the methodological limitations of the studies available, its ability to cross the blood-brain barrier, the absence of any available alternative treatment in patients aged under 2 years and despite the need for daily injections, KINERET, like ILARIS, provides significant improvement in actual benefit (level II) in the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents, children and babies aged 8 months or older with a body weight of 10 kg or above.

no clinical added value

In the indication : rheumatoid arthritis in combination with methotrexate
These proprietary medicinal products are additions to the range that do not provide an improvement in actual benefit (level V) in comparison with the other previously registered presentations.