1 September 2015 - Secukinumab (trade name: Cosentyx) has been approved since January 2015 for adults with moderate to severe plaque psoriasis. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier, however: in patients who are candidates for systemic treatment, an indirect comparison provided no suitable data because the minimum study duration had not been reached. In adults in whom other systemic treatments have been unsuccessful or unsuitable, the results from a direct comparison showed no statistically significant differences in comparison with the comparator group.

The drug manufacturer presented an indirect comparison with methotrexate as comparator therapy for adults with plaque psoriasis who are candidates for systemic treatment and/or phototherapy. Placebo was used as common comparator.

A chronic condition such as moderate to severe plaque psoriasis requires long-term treatment. Studies with a minimum duration of 24 weeks are therefore needed to assess an added benefit. However, the five studies on secukinumab treatment presented by the company only lasted 12 weeks each; and the only study on methotrexate treatment lasted only 16 weeks. Hence the manufacturer dossier provided no suitable data and therefore no hint of an added benefit for this patient group.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/secukinumab-in-plaque-psoriasis-manufacturer-dossier-provided-no-hint-of-an-added-benefit.6879.html