CLEAR study reported at AAD meeting for Cosentyx (secukinumab) shown superior to Stelara (ustekinumab) in Psoriasis-Novartis

Novartis announced results from the CLEAR study demonstrating that Cosentyx (secukinumab) is significantly superior to Stelara (ustekinumab), a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, USA.

Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index (PASI) 90 response, known as clear to almost clear skin, at Week 16 (79.0% vs. 57.6%, P<0.0001). PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin (PASI 100) at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara (44.3% vs. 28.4%, P<0.0001). In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara (50.0% vs. 20.6%, P<0.0001). The safety profile of Cosentyx was comparable to Stelara and consistent with previously reported Phase III clinical trials for Cosentyx.

Comments:A National Psoriasis Foundation survey found that 52% of patients surveyed were dissatisfied with their disease management for psoriasis.The success of the new therapies for psoriasis will be affected by the arrival of biosimilar etanercept offering reduced prices for traditional anti- TNF alpha therapies. Secukinumab has shown superiority over Enbrel (etanercept) and has reported reduction of psoriasis symptoms by at least 90% over 16 weeks.