Head-to-head psoriasis study demonstrates superiority of Novartis Cosentyx(TM) to Stelara® in clearing skin

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• Cosentyx showed superiority to Stelara®; meeting the primary endpoint of achieving PASI 90, which represents clear or almost clear skin at Week 16 and secondary endpoint of achieving PASI 75 at Week 4 for psoriasis patients[1]
   

CLEAR is the second head-to-head study for Cosentyx following the Phase III FIXTURE study that showed Cosentyx was superior to Enbrel® (etanercept)[2]
 

CHMP recommended Cosentyx as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients in Europe
 

In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[2]

Basel, December 12, 2014 - Novartis announced today that the Phase IIIb CLEAR study for Cosentyx^TM (secukinumab, formerly known as AIN457) demonstrated superiority to Stelara^®* (ustekinumab) and met its primary endpoint of achieving PASI 90, which represents clear or almost clear skin at Week 16 for psoriasis patients[1]. The study also met the secondary endpoint of achieving PASI 75 at Week 4[1]. Safety results were consistent with previously reported Phase III clinical trials for Cosentyx.

The CLEAR study is the second head-to-head study for Cosentyx versus established psoriasis biologic treatments. It follows on from the Phase III FIXTURE study, which showed that Cosentyx was superior to Enbrel^®** (etanercept), a current standard-of-care, in clearing psoriasis skin with a comparable safety profile[2].

Achieving clear skin is the ultimate aim of psoriasis treatment for patients. Data from the Cosentyx clinical trial program has also shown a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life[3]. Additionally, 50% of psoriasis patients are not content with current therapies, including biologic treatments[4]-[7].

"We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx."