Daily Archives: December 16, 2014

Download Psoriasis Types Triggers and Treatment Strategies Dermatology Laboratory and Clinical
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By: Teofila Negrete

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Download Recent Advances in Psoriasis The Role of the Immune System PDF
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By: Teofila Negrete

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Download Psoriasis The Struggle and the Triumph A Healthy Transformation for Everyone Living with P
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By: Teofila Negrete

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Psoriasis Free For Life Book | Amazing Psoriasis Free For Life Book By Katy Wilson
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By: Vanessa Castle

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Psoriasis Free For Life Book | Amazing Psoriasis Free For Life Book By Katy Wilson - Video

About 50% of psoriasis sufferers experience psoriasis of the scalp, ranging from mild, itching and scattered red spots to thick, burning patches of silvery scales that spread onto the face and neck. The severity of your scalp psoriasis will determine the best course of treatment, and although it can take some time to bring the symptoms under control, many patients are able to manage and even improve their condition in the long run.

Theres no universal treatment for scalp psoriasis, but there are several possible ways to reduce or eradicate the symptoms. Typically, its best to begin with a milder form of treatment, working up to more powerful medications as needed. Here are a few:

Severe cases of scalp psoriasis may not respond to topical treatment or light therapy. These cases will call for a more invasive approach to eradicate the plaques:

Psoriasis on the scalp is generally superficial in nature, but in some cases, the itching, flaking and dryness can lead to more serious problems:

Living with scalp psoriasis can be physically and emotionally challenging, and although its a chronic disease that will call for long-term management, you dont have to deal with constant flare-ups. Work with your doctor and a dermatologist to adapt your treatment plan according to your changing needs and youll very likely be able to keep the symptoms under control.

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Scalp Psoriasis - New Life Outlook | Psoriasis

On Friday, Novartis Novartisannounced that its anti-IL17A antibody secukinumab (Cosentyx) demonstrated clear superiority over its rival, Stelara ustekinumab from Johnson & Johnson Johnson & Johnson, an antibody against IL-12 and IL-23, in the treatment of psoriasis.

What marks this out as significant is not the potential commercial impact for $NVS, nor the step-change in efficacy this delivers for patients suffering from psoriasis though quite clearly both are true.

Instead, its the commitment prior to approval to test the drug head-to-head against arguably its stiffest competitor. This kind of direct comparison is exactly what the medical profession needs without it, doctors are left with two comparable sets of data from different trial designs and little hope of determining which agent is most suited to the patient in front of them. But the industry has, in the past, been very wary of providing such unequivocal comparative evidence.

Changes, though, are being forced on drug companies. Whereas once upon a time, regulatory approval alone was sufficient to secure meaningful sales, increasingly that is no longer true. Even after the stiff battle with regulators has been won, new product launches today face an arguably even stiffer test: to win over doctors and payers.

While the options for treatment for a particular disease were limited, knowing a drug was safe and effective (the hurdles for regulatory approval) is sufficient to justify use. But almost every large indication today already boasts a slew of approved therapeutics options, all of which are safe and effective. Against such a landscape, it is increasingly obvious that driving significant use requires direct comparison trials such as the CLEAR trial in psoriasis that Novartis reported last week.

Such trial designs are double-edged swords however success will surely drive sales of the new agent, but failure to demonstrate superiority would equally certainly consign the expensively-approved newcomer to the trash can. How many people want to play double or quits with their newly-approved (or, worse still, perhaps, not-yet-approved) blockbuster candidate?

In an industry renowned for its conservative decision-making, its not surprising that owners of newly-launched drugs have tended to test the water first, and only resort to comparative trials if sales are low and slow. With Crestor rosuvastatin, for example, where AstraZeneca AstraZenecawere already selling more than $5billion a year of product, head-to-head comparison with its competitor Lipitor atorvastatin were only contemplated more than five years after approval when the impending loss of patent protection for atorvastatin threatened Crestor sales. Even when those trials failed to demonstrate any material superiority, the established sales were unaffected. That hardly counts as risk-taking.

But $NVS adopted an entirely different strategy with Cosentyx. Comparitor trials were the mainstay of the late-stage development program, rather than an afterthought. First, in 2013, in the FIXTURE study, they demonstrated superiority over an anti-TNF product, Enbrel etanercept from Amgen Amgenin a head-to-head study. With that scalp under their belt, they set their sights on the then newly-approved Stelara ustekinumab. The CLEAR study is the product of that strategy, and with the demonstrated superiority completely vindicates it.

Lets be in no doubt: this brave new world is very much to the advantage of patients and payers. Better comparator data will, in itself, lead to better outcomes and saved dollars.

It may not, however, be universally such good news for the pharmaceutical industry. The biggest drag on capital efficiency in R&D is late risk that is, risk that can only be discharged at the end of the development cycle, when the vast majority of the costs have already been expended. Failure at the end of development, or worse still, in the marketplace, erodes capital returns very quickly. If the industry is forced (by the commercial landscape, rather than by regulators) to do more comparator studies of this type, then more late-stage failures will be the order of the day.

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Is This The Future Of Late-Stage Drug Development?

Source: Novartis

Novartis AG and Amgen have both recently reported data from late stage drug trials showing that each of their promising psoriasis drugs bested Johnson & Johnson 's top-selling Stelara. The positive results set the stage for potential FDA approvals that could mean a battle over market share next year.

First out of the gate Psoriasis is a big money indication affecting as many as 125 million people worldwide. In the U.S. alone, as many as 7.5 million people suffer from the condition. As a result, drugs like Stelara post sales of about $2 billion annually. Additionally, billions of dollars more are spent treating psoriasis with other autoimmune drugs every year, including the planet's top selling drug last year, AbbVie 's Humira.

Since the patient population and resulting revenue from the indication is so big, developing new therapies to treat psoriasis has been a major focus of drugmakers like Novartis.

Thanks to positive phase 3 trial results versus Amgen's Enbrel, a leading psoriasis treatment with $1 billion in quarterly sales, Novartis' Cosentyx has already been sent to the FDA for approval. Last month, the FDA's advisory committee gave Cosentyx a universal nod for approval, clearing the way for an FDA decision in January.

Since the FDA usually sides with the advisory committee recommendation, there's a good chance that Cosentyx will get the FDA's official go-ahead. If so, Novartis' recent report that Cosentyx achieved statistically better results than Stelara in clearing at least 90% of symptoms from psoriasis patients provides another powerful marketing message for Novartis' sales team to deliver to doctors.

Fast on its heels Eager to shore up its Enbrel psoriasis market share, Amgen has teamed up with AstraZeneca on brodalumab. During phase 3 trials, brodalumab reduced symptoms by 75% in 85% of patients. Those results outperformed J&J's Stelara, which reduced symptoms by a similar amount in about 69% of patients.

Those results are solid, but more compelling may be the fact that brodalumab achieved total clearance of symptoms in 44.4% of patients taking a 210 mg dose, compared to 21.7% of patients achieving total clearance while taking Stelara.

Now that Amgen has all the data on hand from its brodalumab late stage trials, Amgen will begin discussions with regulators over filing the drug for approval. If those discussions go well, then Amgen could submit the drug to the FDA next year, clearing the way for an FDA decision late next year or early in 2016.

Major shake up Celgene won approval of its autoimmune drug for use in psoriasis patients in September, so existing therapies like J&J's Stelara are already facing competitive threats. However, those threats will increase if the FDA approves Novartis' Cosentyx in January. If regulators eventually approve brodalumab, then there's likely to be significant market share shifts among all the various psoriasis treatments by the end of 2016. Regardless, since Novartis' drug could hit the market in the first quarter, investors that would like exposure to autoimmune drugs may want to focus their attention on its shares, rather than Amgen's.

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Novartis AG and Amgen Inc. Take Aim at Johnson & Johnson