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ORENCIA

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Opinions on drugs - Posted on Jan 05 2011

Reason for request

Inclusion on the list of medicines approved for hospital use in the extension of indication “treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor”.

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Clinical Benefit

Substantial

This proprietary medicinal product is a third-line treatment for JIA. It is designed for patients who have not responded sufficiently to, or have not tolerated, other disease-modifying treatment including at least one TNF inhibitor.

No other medicine has been granted marketing authorisation specifically for children at this stage of the disease.
The actual benefit of this proprietary medicinal product for this indication is substantial.


Clinical Added Value

no clinical added value

Though this is the first biotherapy to be granted marketing authorisation for use in patients suffering from juvenile idiopathic arthritis who have not responded sufficiently to at least one TNF inhibitor, the Transparency Committee is of the opinion that, given :

- the limited efficacy data which make it impossible to evaluate the benefits of ORENCIA (abatacept) in this indication (only 16% of the patients evaluated during the double-blind phase of the study matched the patients targeted in the indication), and

- the fact that tolerance information is only available for a short period and is inconclusive,

ORENCIA in combination with methotrexate provides no improvement in actual benefit (IAB V) in terms of therapeutic strategy.


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