AstraZeneca/Amgen's Brodalumab Positive in Psoriasis Trial – Analyst Blog

Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.

AstraZeneca ( AZN ) and partner Amgen ( AMGN ) announced encouraging results from the pivotal, multi-arm phase III AMAGINE-3 study (n>1800) on their psoriasis candidate, brodalumab.

The study evaluated the safety and efficacy of brodalumab (140 mg and 210 mg) doses given every two weeks to patients suffering from moderate-to-severe plaque psoriasis in comparison to placebo and Johnson & Johnson's ( JNJ ) Stelara. Amgen and AstraZeneca said that the primary as well as secondary endpoints were achieved.

Results showed that a greater proportion of patients treated with brodalumab 210 mg (36.7%) and brodalumab 140 mg (27%) achieved total clearance of skin disease as measured by the Psoriasis Area Severity Index (PASI 100) compared to Stelara (18.5%) and placebo (0.3%).

As far as PASI 75 score (at least a 75% improvement in disease severity) is concerned, results showed that a higher number of patients on brodalumab 210 mg (85.1%) achieved the same as compared to those on brodalumab 140 mg (69.2%), Stelara (69.3%) and placebo (6%).

We note that the companies' AMAGINE program consists of three phase III studies - AMAGINE-1, AMAGINE-2 and AMAGINE-3. While results from the AMAGINE-2 study are expected by year end, AstraZeneca and Amgen have already revealed encouraging results from the AMAGINE-1 study (read more: Amgen-AstraZeneca Psoriasis Drug Scores ).

We are encouraged by the positive results so far from the AMAGINE program on brodalumab. However, the psoriasis market looks extremely crowded given the presence of products like Stelara, Enbrel and Otezla. The successful development of brodalumab, an important candidate for both AstraZeneca and Amgen, is crucial. Brodalumab is also being developed for the treatment of asthma. According to AstraZeneca, analyst estimates for brodalumab range between $0.5 billion to $1.5 billion.

Amgen and AstraZeneca are both Zacks Rank #3 (Hold) stocks. A better-ranked stock in the health care sector is AMAG Pharmaceuticals, Inc. ( AMAG ) carrying a Zacks Rank #1 (Strong Buy).

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AstraZeneca/Amgen's Brodalumab Positive in Psoriasis Trial - Analyst Blog

Dumaguing: Know More about Psoriasis

FIRST and foremost, psoriasis is NOT a contagious disease. This strong statement hopefully, will remove, once and for all, the prevailing notion that psoriasis is a communicable and contagious disease, a misconception which has directly and indirectly put patients or if you may, sufferers of the disease, into pitiful situations like not being allowed to board a plane or eat in a high-end restaurant or even just being a seatmate in a classroom.

Second fact is that psoriasis is an inherited ailment. There is a trait handed down from parents to children, although not necessarily affecting all siblings. Genetic mutation has also been found to be a cause of the illness. The characteristic triad of psoriasis is thickening, redness and scaling. The extreme redness of the skin gives the impression to onlookers that there might be an infection, thus, their worry and eventual avoidance of close contact with the person.

The skin is now considered as the biggest organ in the human body, in terms of surface area. It has three layers; the epidermis being the outermost, serving as an effective protective barrier not only against microbes but also to harmful solar rays from the sun. The dermis is the middle, thickest and so-called vascular layer, whose blood vessels supply oxygen and nutrients to the overlying epidermis. The subcutaneous layer or tela subcutanea is made of fatty tissue, oleic acid being most abundant fat in it, colored bright orange-yellow because of the pigments carotene and xanthophyll. In normal, healthy individuals, it takes 28-30 days for the process of epidermidization - the replacement of the dead topmost layer of skin cells by new, young skin cells. In the case of persons with psoriasis, this process is much shorter that the skin cell turnover takes place within 3-5 days, thus resulting to an excessive accumulation of dead surface cells which later develop into scales and even bigger plaques. Dry and dead skins cells eventually slough off and shed leaving a fresh, reddish raw skin underneath the scales or plaques. Of course, itchiness or pruritus is a disturbing symptom which would make a person scratch the lesion and this invites infections especially with streptococcus and staphylococcus.

The author has been fortunate to watch the interview of Mr. Joseph de Guzman, President of Philippine Psoriasis Association and the doyenne of the VMV Skin Research Center, Dr. Vermen. M. Verallo-Rowell. The lady dermatologists, known both locally and internationally emphasized the two spikes of the occurrence of psoriasis in the lifetime of humans; the first being 18-25 years and the second spike when the person is 40-50 years old. There are sites of predilection; usually the scaling starts in the scalp, so much that dandruff or seborrheic dermatitis could be mistaken as psoriasis, although the amiable doctor said that the scalp scaling could be part and parcel of the disease. Skin folds particularly the knees and the elbows are also favored sites of psoriasis.

A whole body physical exam under natural light is imperative in the diagnosis of psoriasis, which could be mistaken as eczema, atopic dermatitis, or skin asthma. Contact dermatitis is the redness and inflammation of skin like earlobes wrist or fingers allergic to costume jewelries especially those containing nickel and alloy of metals. The treatment, although both Mr. de Guzman and Dr. Rowell were quite careful about declaring an absolute cure - depends on the extent of body surface involvement; less than 5 percent of the body would be mild, moderate if from 5-10 percent and severe if more than 15 percent of the body is involved in which, on top of the topical creams and lotions, the patient must take capsules or even receive injections to manage the signs and symptoms of psoriasis.

A very endearing and shall we say, nationalistic statement from Dr. Verallo-Rowell, who had extensive training abroad, extolled the virtues of our own coconut oil, especially if freshly-obtained. Zinc oxide applied properly serves as a skin barrier repair. While topical steroid creams significantly reduce the inflammatory skin reactions, Mr. de Guzman was quick to share experiences of his colleagues that more than two-weeks use could lead to thinning of the skin, making it susceptible to bacterial infection. Dr. Rowell encourages patients to get early morning sunshine, and swim in the sea preferably before 9 am and after 4 pm. Swimming pool has chlorine and hydrochloric acid in it so it may not be good for the psoriatic patient. Of course, for the real problematic cases, the cancer medicine Methotrexate or MTX is an effective last resort.

Dr. Verallo-Rowell clarified that a diagnosis of psoriasis is not as morbid as a death toll, sharing experiences with patients who, monitored regularly and obediently took their medicines, have had no flare-ups and in fact, brave and confident enough to walk down the ramp amidst glaring light of fashion shows or the scrutinizing close up on television interviews. More than that, she implored the public not to cast a disdainful look at persons with psoriasis but rather give them a compassionate, accepting and friendly smile.

Let's shake hands to that. Or better yet, why not a beso beso? Cheers!

Next Week: Let's hear it for deafness

Published in the Sun.Star Baguio newspaper on November 15, 2014.

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Dumaguing: Know More about Psoriasis

Penn Medicine Study Finds Increased Risk of Cardiac Events in Those with Psoriatic Arthritis, Psoriasis, and …

PHILADELPHIA Those experiencing psoriasis, psoriatic arthritis, and rheumatoid arthritis are at higher risk for major adverse cardiovascular events (MACE) and cardiovascular death, according to a multi-institutional study led by Penn Medicine researchers published online last month in Annals of the Rheumatic Diseases.

The researchers used primary care records from The Health Improvement Network (UK) between from 1994 to 2010 of adults 18 to 89 years old, including 8,700 with psoriatic arthritis (PsA), 138,000 with psoriasis, nearly 42,000 experiencing rheumatoid arthritis (RA), and 82,000 controls experiencing none of the conditions.

Slightly more than half the studys psoriatic arthritis and rheumatoid arthritis patients were prescribed a disease-modifying antirheumatic drug. At least 65 percent of patients with PsA and RA were prescribed non-steroidal anti-inflammatory drugs compared with 24 percent of those with psoriasis and 47 percent of controls.

The researchers looked at the rate of MACE in psoriatic arthritis patients, psoriasis, and rheumatoid arthritis after adjusting for CV risk factors. Psoriatic arthritis patients were 36 percent more likely than the control group to experience a heart attack, whether or not they were prescribed a DMARD.

Psoriasis, a chronic immune disease, affects 7.5 million people in the U.S., according to the National Psoriasis Foundation. The Centers for Disease Control and Prevention report that 10 to 20 percent of those with psoriasis develop psoriatic arthritis. Rheumatoid arthritis afflicts more than 1 million U.S. adults, the American College of Rheumatology reports.

We expected the increased risk of heart disease in these patients, said Alexis Ogdie, MD, MSCE, assistant professor of rheumatology and lead author of the study. Previous studies link whole-body inflammation with premature plaque buildup in the arteries.

Senior author Joel M. Gelfand, MD MSCE noted that a surprising finding was that the increased risk of MACE and CV mortality in patients with more severe psoriasis was similar in magnitude to patients with rheumatoid arthritis.

This finding, Gelfand said, emphasizes the clinical significance of cardiovascular risk associated with more severe psoriasis.

Earlier studies linked psoriasis and rheumatoid arthritis to heart disease, but little was known about a link between psoriatic arthritis cases and heart disease. Gelfand and Ogdie are currently conducting clinical trials to determine if treatments used for psoriasis, psoriatic arthritis, and rheumatoid arthritis improve aortic vascular inflammation associated with these conditions (http://clinicaltrials.gov/show/NCT01553058).

Other Penn co-authors of thestudy include Kevin Haynes, Samantha Maliha, Yihui Jiang, Steven Kimmel, Sean Hennessy, David J Margolis, and Joel M. Gelfand.

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World Psoriasis Day – Swimming for Psoriasis – 28.10.2014 – Video


World Psoriasis Day - Swimming for Psoriasis - 28.10.2014
On October 28th, EADV invited the press, VIPs, politicians, dermatologists and patients associations to swim for psoriasis in the frame of the World Psoriasis Day. Psoriasis is not contagious,...

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Psoriasis Revolution By Dan Crawford | Amazing Psoriasis Revolution By Dan Crawford – Video


Psoriasis Revolution By Dan Crawford | Amazing Psoriasis Revolution By Dan Crawford
http://www.tinyurl.com/psoriasisrevolutionnow Psoriasis Revolution By Dan Crawford: Lots of people around the globe suffer from a horrible skin disease known as psoriasis, a chronic dermatological...

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Psoriasis Revolution By Dan Crawford | Amazing Psoriasis Revolution By Dan Crawford - Video

Amgen Reveals Positive Data For Brodalumab In Patients With Plaque Psoriasis

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

What Is The Definition Of Psoriasis vulgaris Medical School Terminology Dictionary – Video


What Is The Definition Of Psoriasis vulgaris Medical School Terminology Dictionary
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Psoriasis Revolution Review | Amazing Psoriasis Revolution Review By Dan Crawford – Video


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

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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

Psoriasis – National Psoriasis Foundation

Psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious.

Psoriasis is the most common autoimmune disease in the U.S. As many as 7.5 million Americans have psoriasis. Psoriasis has been linked to other serious health conditions, such as cardiovascular disease and depression. About 30 percent of people with psoriasis develop psoriatic arthritis.

The more you know about psoriasis, the more able you are to make good health care decisions. Learn more about psoriasis

Treating your psoriasis is critical to good disease management and overall health. What works for one person may or may not work for you. Learn more about the different treatment options

Research continues to show a link between psoriasis and several other serious health conditions known as "comorbidities," such as cardiovascular disease, diabetes and depression. About 30 percent of people with psoriasis develop psoriatic arthritis. Read more about comorbidities

Treating psoriasis in women requires extra considerations, especially if you are planning to become pregnant or are nursing. Studies show psoriasis has a significant impact on the emotional health of women. Learn more about women and psoriasis

Health care providers are becoming more aware of the impact psoriasis can have on a person's quality of life. Researchers are focused more now than ever on finding solutions to those challenges. Read more about life with psoriasis

Link:

Psoriasis - National Psoriasis Foundation