Novartis has announced that the Phase IIIb CLEAR study for Cosentyx (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. 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.
Achieving clear skin is the ultimate aim of psoriasis treatment for patients. Data from the Cosentyx clinical trial programme has also shown a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life. In addition, 50% of psoriasis patients are not content with current therapies, including biologic treatments.
"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."
The study involved 679 moderate-to-severe plaque psoriasis patients and will be submitted for presentation at an international medical congress in 2015.
Topline results follow a positive CHMP opinion for Cosentyx as a first-line systemic treatment for patients with moderate-to-severe psoriasis. Currently, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe. In addition, the FDA Advisory Committee voted unanimously for the approval of Cosentyx in the US.
Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis.
