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Belimumab for lupus erythematosus: Added benefit not proven
Date:8/29/2012

Belimumab (trade name Benlysta ) has been approved since July 2011 as an add-on therapy for adult patients with the autoimmune disease systemic lupus erythematosus (SLE). This monoclonal antibody is only considered as treatment when the disease is still active in spite of standard therapy. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of this drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).

According to the findings, there is no proof that belimumab provides added benefit as the manufacturer's dossier does not contain any relevant studies for the assessment of added benefit.

Belimumab in comparison to optimized standard therapy

The Federal Joint Committee (G-BA) specified that the appropriate comparator therapy should be an optimized standard therapy with various drugs that have been approved in Germany. A (standard) therapy is said to be "optimized" when the treatment has been adapted to the individual patient with respect to tolerability, effect and clinical course. The dossier - or its assessment by IQWiG - was supposed to answer the question as to whether the additional administration of belimumab offers advantages in comparison with the optimization of standard therapy alone.

Adaptation of standard therapy was only possible in the studies to a limited extent

The manufacturer uses two approval studies in the dossier (BLISS52 and BLISS76). However, these are not suited to prove added benefit, as the study protocols inappropriately restricted the possibilities for adapting the standard therapy. In particular, the administration of glucocorticoids was explicitly restricted.

This restriction is a consequence of the intended purpose of these studies. In drug approval the main focus is on proving efficacy. If the adaptation of the standard therapy had not been restricted, the differences in the e
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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