- Date 25 June 2014
- Documents : 2
- History
- (Restricted access link)
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Reason for request
Re-assessment of the Actual Benefit at the Transparency Committee's request. Re-assessment of the IAB at the company's request
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Clinical Benefit
| Substantial |
Substancial |
Clinical Added Value
| minor |
Given a modest efficacy and the lack of data in severe forms of renal and neurological involvement and the uncertainties regarding long term safety, the improvement in actual benefit provided by BENLYSTA, as an add-on to the usual treatment, remains minor (IAB IV) in the treatment of adult patients with active, autoantibody positive systemic lupus erythematosus with a high degree of disease activity despite treatment with synthetic antimalarials, NSAIDs, corticosteroids and possibly immunosuppressants, depending on the specific organ involvement. |
