New Novartis data show more Cosentyx-treated psoriasis patients achieved clear or almost clear skin (PASI 90 …

EAST HANOVER, N.J., March 20, 2015 /PRNewswire/ --Novartis today announced results from the CLEAR study demonstrating Cosentyx (secukinumab) improved skin clearance at Week 16 in significantly more moderate-to-severe plaque psoriasis patients compared to Stelara* (ustekinumab), a widely used biologic. 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. Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved to treat adult patients with moderate-to-severe plaque psoriasis.

"As a clinician I have seen first-hand the impact that moderate-to-severe plaque psoriasis can have on patients' lives and the frustration some feel when they are unable to achieve clear or near clear skin," said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center and lead study investigator. "The CLEAR data are an important step forward for clinicians and patients as they demonstrate Cosentyx compares favorably to Stelara, a widely used biologic."

In this Phase IIIb study, Cosentyx met the primary endpoint of 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). The secondary endpoint found 50% of Cosentyx patients achieved PASI 75 at Week 4 compared to 20.6% of Stelara patients (P<0.0001).

PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e., a 75% reduction is known as PASI 75 and a 90% reduction is known as PASI 90). PASI 90 is a higher standard of skin clearance compared to PASI 75.

In an exploratory analysis, 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%).

"Helping psoriasis sufferers achieve clear skin remains the goal for both patients and their physicians, yet many patients still do not achieve this," said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation. "The findings from the CLEAR study demonstrate that Cosentyx helps a majority of patients relieve the thick, red, scaling and extensive plaques that are common in those living with psoriasis. The data reinforce the importance of Cosentyx as a beneficial new treatment option, offering hope to psoriasis patients so they can take control of this often isolating disease."

The safety profile of Cosentyx was comparable to Stelara and consistent with previously reported Phase III clinical trials for Cosentyx. In the study, the most common adverse events (AEs) in the Cosentyx-treatment arm were headache (7.8%), nasopharyngitis (6.9%), diarrhea and fatigue (4.2% each), and arthralgia (3.9%). The most common AEs in the Stelara-treatment arm were nasopharyngitis (10.1%), headache (8.0%), arthralgia (4.2%), diarrhea (3.6%), and fatigue (2.7%). Infections and infestations were comparable between the Cosentyx and Stelara treatment groups (29.3% and 25.3%, respectively). Non-fatal serious adverse events in both treatment groups were the same (3%). No deaths have been reported, to date.

About the CLEAR studyCLEAR (Comparison to assessLong-termEfficacy, sAfety and toleRability of secukinumab vs. ustekinumab), a 52-week, multicenter, randomized, double-blind study, is a head-to-head Phase IIIb study initiated with Cosentyx, and compares the efficacy, long-term safety and tolerability of Cosentyx (secukinumab) versus Stelara (ustekinumab), in patients with moderate-to-severe plaque psoriasis. Twenty-four countries across North America, Europe, Asia and Australiaparticipated in the single study, with enrollment reaching 679 patients in record time.

The primary endpoint measured at Week 16 is PASI 90. PASI 90 is considered a more robust measure of the extent of skin clearance compared to the standard efficacy measures used in most psoriasis clinical studies, such as PASI 75. Additionally the secondary endpoint measured at Week 4 is PASI 75. PASI 100 at Week 16 was one of the exploratory endpoints. Week 52 data will follow in due course.

About Cosentyx (secukinumab) and interleukin-17A (IL-17A) Cosentyx (secukinumab, previously known as AIN457) is a human monoclonal antibody (mAb) that selectively binds to interleukin-17A (IL-17A) and inhibits its interaction with the IL-17 receptor. It is the first IL-17A antagonist approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy).

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New Novartis data show more Cosentyx-treated psoriasis patients achieved clear or almost clear skin (PASI 90 ...