Category Archives: Psoriasis

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By RTT News, November 11, 2014, 04:14:00 PM EDT

(RTTNews.com) - Amgen ( AMGN ) and AstraZeneca ( AZN ) Tuesday announced that AMAGINE-3, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara (ustekinumab) and placebo at week 12.

In the trial, Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100).

When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75).

A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1). All key secondary endpoints comparing brodalumab with Stelara and placebo were also met.

Results showed that 36.7 percent of patients in the brodalumab 210 mg group, 27.0 percent of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100).

In addition, 85.1 percent of patients in the brodalumab 210 mg group, 69.2 percent of patients in the brodalumab 140 mg group, 69.3 percent of patients in the Stelara group and 6.0 percent of patients in the placebo group achieved PASI 75.

"Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals," said Sean Harper, executive vice president of Research and Development at Amgen. "These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase 3 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis."

The most common adverse events that occurred in the brodalumab arms (more than 5 percent of patients in either group) were common cold, joint pain, upper respiratory tract infection and headache. Serious adverse events occurred in 1.4 percent of patients in the 210 mg group and 1.6 percent of patients in the 140 mg group compared with 0.6 percent for Stelara and 1.0 percent for placebo during the placebo-controlled period.

Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F, A/F and C) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestation of plaque psoriasis.

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Amgen Reveals Positive Data For Brodalumab In Patients With Plaque Psoriasis

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There is an estimated, 1.8 million people in the UK who are living with psoriasis, a chronic autoimmune condition that affects the skin and joints.

The condition causes red, flaky, crusty patches of skin covered with silvery scales which normally appear on the elbows, knees, scalp and lower back but can appear anywhere on your body.

It can start at any age, but most often develops in adults under 35 and can affect men and women equally.

To mark Psoriasis Awareness Week, the Psoriasis Association has launched a new range of leaflets to provide patients with comprehensive information about their psoriasis and the care options available on the NHS so patients do not have to suffer in silence.

The leaflets have been developed in response to a mounting call for high quality patient information - revealed in a number of independent reports published over the last 18 months.

A report published last month Patients in Control: why people with long-term conditions must be empowered found more than half of respondents were not offered support or information on their long-term condition at diagnosis.

The series of leaflets aims to address that information gap with information beyond the basics of what the condition is and are available through doctors and on the Psoriasis Association website.

Chairman Ray Jobling, who lives in Cambridge and has suffered with psoriasis for nearly 60 years, said they wanted to make people aware of the different treatments available.

People who have psoriasis, and in some cases sadly have it for quite a long while, they get stuck on the same form of treatment, he said. We like to try and keep people up to date, theres lots of new treatments coming in, and good ways for how people can support themselves.

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The Psoriasis Association launches series of leaflets for people living with the condition

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