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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Is this the new psoriasis cure?

March 16, 2015

Credit: Thinkstock

Brett Smith for redOrbit.com Your Universe Online

Psoriasis is a medical condition typically marked by the emergence of itchy or burning patches of red, scaly skin, and those who suffer from it typically try to cope with the use of anti-inflammatory drugs and vitamin D supplements.

Now, according to a new study in The Journal of Allergy and Clinical Immunology, researchers at eight different research centers have developed a treatment that shows potential to cure the disease.

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For years, scientists have known that an inflammation-causing protein called interleukin-23 could be a key to a cure. However, past efforts have not produced very promising results.

The striking result we achieved using a human antibody that targets the signal interleukin-23 suggests we are on the threshold of doing something very different from our current model of treating psoriasis with immunosuppressive drugs throughout an adult lifetime, said study author James Krueger, head of the Laboratory of Investigative Dermatology at Rockefeller University in New York City. It raises the possibility of working toward long-term remission in other words, a cure.

In 2004, a team including Krueger indicated a major role for interleukin-23 in the disease, and study since then has backed this hypothesis. Researchers say that interleukin-23 commences a sequence of events that leads to inflammation in the skin, abnormal growth of skin cells, and dilation of blood vessels.

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Is this the new psoriasis cure?

New antibody therapy dramatically improves psoriasis symptoms in clinical trial

Only a single treatment produced what researchers describe as 'rapid, substantial, and durable clinical improvement'

IMAGE:A sample from one psoriasis patient shows thickening of the outer layer of skin, known as the epidermis (top). Eight weeks after treatment, the epidermis has thinned to a normal... view more

Credit: Laboratory of Investigative Dermatology at Rockefeller University/Journal of Allergy and Clinical Immunology

Many patients suffering from psoriasis showed significant recovery after just a single dose of an experimental treatment with a human antibody that blocks an immune signaling protein crucial to the disease, researchers report. By the end of the trial, conducted at Rockefeller University and seven other centers, nearly all of the 31 patients to receive treatment saw dramatic, if not complete, improvement in their symptoms.

"The striking result we achieved using a human antibody that targets the signal interleukin-23 suggests we are on the threshold of doing something very different from our current model of treating psoriasis with immunosuppressive drugs throughout an adult lifetime," says study author James Krueger, director of the Milstein Medical Research Program, D. Martin Carter Professor in Clinical Investigation and head of the Laboratory of Investigative Dermatology. "It raises the possibility of working toward long-term remission -- in other words, a cure." The Journal of Allergy and Clinical Immunology published the results on Thursday (March 12).

Psoriasis is a debilitating disease in which the body's immune system mistakenly turns on the skin, producing red, itchy, scaly patches. In 2004, Krueger and colleagues suggested a dominant role for interleukin-23 in the disease, and research since then has supported this hypothesis. It appears that interleukin-23, a type of immune signaling molecule known as a cytokine, kicks off a cascade of interactions that leads to inflammation in the skin and excessive growth of skin cells and dilation of blood vessels.

The discovery of interleukin-23's role has led to tests of a number of new antibody-based therapies that target it, but the compound, known as BI 655066, stands out. BI 655066 is a human antibody that targets interleukin-23 and blocks it from binding to the receptors on cells that respond to it. Only a single treatment produced what the team describes as "rapid, substantial, and durable clinical improvement in patients with moderate-to-severe psoriasis." On average, patients who received the treatment had a more than 80 percent improvement in the severity and extent of their skin lesions that continued until tracking ended six weeks after treatment. Meanwhile, genetic sequencing from skin samples revealed that the antibody's action reduced the expression of many of the cytokines and other molecules that define psoriasis.

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New antibody therapy dramatically improves psoriasis symptoms in clinical trial