Category Archives: Psoriasis

MetrioPharm is set to advance its psoriasis asset into phase 2b after bringing the drug through an early test of its safety and potential efficacy. Top-line data from the phase 2a suggest MP1032 is safe and hint at its potential to lessen the severity of psoriasis symptoms.

Zurich, Switzerland-based MetrioPharm tested oral macrophage modulator MP1032 in 44 patients with moderate to severe psoriasis. Half of the subjects were randomized to receive MP1032, while the rest were given twice-daily doses of placebo. Investigators at four sites in Germany gave subjects these regimens for six weeks, after which they kept tabs on the patients for a further four weeks.

MetrioPharm was primarily looking for evidence its drug is safe enough to move into a larger trial. On this count, the study delivered for the Swiss-German biotech. Investigators saw the same set of moderate to mild adverse eventscommon cold, headache and itchingacross both arms of the study. And with the study being free from serious adverse events, effects on blood-count parameters and tolerability-related dropouts from theMP1032 cohort, a key part of MetrioPharms vision for the positioning of the asset remains viable.

From a clinical point of view, an oral drug with a better tolerability profile than currently available drugs, is desirable, Wolfgang Vanscheidt, M.D., one of the study's principal investigators, said in a statement. I am looking forward to seeing how MP1032 performs in upcoming clinical trials.

The upcoming clinical trial referred to by Vanscheidt is three-month phase 2b that will give higher doses of MP1032 in a bid to build on the hint of efficacy seen in the phase 2a.

In making its case for the efficacy of MP1032, MetrioPharm focused in on the 16 patients from the treatment arm whose exposure levels to the drug topped 120 ng*hr/ml. Among these subjects, scores on the PASI scale of psoriasis severity fell by a median of 25% from baseline, compared to a 12% drop in the placebo arm. In the four weeks after stopping treatment, the PASI scores of the treatment group moved back toward baseline levels while the those of the placebo arm, remained relatively unchanged.

With MP1032 showing the clearest sign of efficacy in subjects whose exposure levels topped a certain level and the safety data coming in clean, MetrioPharm has decided toincrease the dose above the twice daily administrations of 100 mg used in the phase 2a.

The data from the phase 2b will go some way to validating the approach taken by MetrioPharm. MP1032 is the lead candidate from a platform MetrioPharm thinks can improve outcomes in immune-mediated inflammatory diseases by targeting shared areas of their pathways. As such, while MetrioPharm is initially assessing the effect of MP1032s modulation of the H2O2-mediated activation state of macrophages and downregulation of the M1 state in psoriasis, it thinks the oral asset could also treat patients with conditions including tendinopathy and arthrosis.

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MetrioPharm advances psoriasis drug after phase 2 readout - FierceBiotech

Katie Lowes may battle psoriasis, but she isnt allowing the diagnosis to dictate her life.

At the age of 28, the Scandal star was living out the best year of her life. I was engaged to my then-boyfriend, now-husband. I booked Scandal, which was the biggest acting job I had ever booked, she exclusively tells PEOPLE.

But the stress that accompanied the excitement seven years ago compounded, and sparked her psoriasis, which started at the base of her head and all down the back of her neck and spread to the upper part of her back and behind the ears.

The stress really from the year of wedding planning and just having a lot of eyes on me from being on a show that people were watching and Id never gone through something like that before triggered psoriasis outbreaks to start happening and getting worse and worse and worse, says Lowes, 35.

Although she was a star on the highly-rated ABC drama series, Lowes admits she felt alone and self-conscious because of the skin disease.

I know that for myself, I felt alone for a really long time. And I also felt incredibly embarrassed and ashamed, especially in Hollywood where theres such a pressure to look and be perfect. Im on a television show and Im in hair and makeup trailer getting ready and people are looking at me up close and personal at work, on the red carpet, says Lowes. And even in my day-to-day life thats more similar to other people you know, dates with my husband and vacations with my husband where Im in bathing suits and my skin is out and Im having a flair-up.

She adds: I felt the pressure, too. At the beginning especially, I was like Oh my gosh, I dont want anyone to ever know. This is so embarrassing and so not sexy. What happens if I get hired to play a sexy role?

Despite working day in and out with the Scandal cast for the past five years, Lowes reveals that she kept her diagnosis under wraps from her costars, and only told hair and makeup crew on-set about her diagnosis. It was such an embarrassing time where I also because I was so new to having a hotshot Hollywood job you just feel like, Oh gosh, I dont want anyone to know. I kept it on the quiet, she says. The only people I really told at Scandal were the hair and makeup people because they have to deal closely with how I look on camera. So Ill be curious to see what the Scandal cast says.

Though Lowes was at the highest point in both her personal and professional life, she says the moment she said enough is enough was when she canceled an engagement photo shoot as a result of a terrible flair-up.

I didnt feel like I had an appropriate outfit to wear. Id have to wear my hair down, Id have to wear a scarf and dress couldnt be backless and all this stuff. I canceled it because I was feeling terrible in my own skin and that was kind of the straw that broke the camels back, she tells PEOPLE.

Finally, Lowes decided to take control. After visiting numerous doctors in the Los Angeles area, the actress found the treatments that work for her through many trial and errors.

Now, the ABC star is confident in her skin and is thankful for her husband, Adam Shapiro, her family and support system for helping get her through the difficult time. To encourage the 7.5 million Americans battling the disease, Lowes has partnered with Janssen Biotech Inc. and the National Psoriasis Foundation for Psoriasis: The Inside Story, which aims to empower those living with psoriasis to take action and live their fullest life.

FROM COINAGE: The Most Expensive TV Shows of All Time

Im at a really good place with the disease personally, says Lowes. Ive come to a place where Ive managed the symptoms really well and come to a place where I feel mentally healthy. I almost feel like Ive come to a side of it where I feel really strong and empowered that I was able to spend a bunch of years early on, like from 28-30, really working with finding the doctor that would be the best fit for me. Finding a treatment after trying a bunch of different ones and not giving up and being my own best advocate to find a way that I can minimize these symptoms and live a day-to-day life that is not filled with embarrassment and shame.

In addition to Lowes, other leading advocates are offering their personal perspectives and support on Psoriasis: The Inside Story, where visitors gain access to resources and support.

If I can inspire even one person to push themselves to find a doctor that works for them, find a treatment that works for them, and to get their day-to-day life in a place that they can be proud of, then I will lay my head on the pillow with a big fat smile on it, says Lowes.

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Katie Lowes Reveals Psoriasis Diagnosis: 'I Felt Embarrassed and ... - PEOPLE.com

Is your skin plagued by dry, itchy, red patches? You aren't alone. According to the American Academy of Dermatology, the common condition known as psoriasis affects 7.5 million people in the United States alone.

Psoriasis is a chronic inflammatory disease that not only affects the skin, it may also affect the joints, fingernails, toenails, the insides of the mouth and soft tissues of the genitals.

In the video above, Health.com shares six things you can do to make psoriasis better, from losing weight to avoiding harsh skincare products and monitoring your exposure to the sun.

Psoriasis can be triggered by many factors, including diet, stress, injury, medication and infection. Obesity can increase your risk of psoriasis while losing weight has been known to improve the condition.

According to the National Psoriasis Foundation, up to 30 per cent of people with psoriasis will develop psoriatic arthritis that can cause swelling, stiffness and pain in the joints. If diagnosed early, treatment of psoriatic arthritis can relieve pain and prevent joint damage.

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Treating Psoriasis: 6 Things You Can Do To Soothe Scaly Skin - Huffington Post Canada

Dr Ranj and Dr Sara Kayat joined This Morning hosts Phillip Schofield and Holly Willoughby to give the callers a second opinion on their health concerns.

Laila called the GP to talk about her scalp, which she described as extremely flaky.

She said shampoos arent easing the symptoms of the condition and sought advice from the GPs.

Dr Ranj said Laila could be suffering with psoriasis.

GETTY/ITV

He said: It usually occurs on the arms and the trunk or the legs.

A lot of people have scalp problems.

Some people that have scalp psoriasis can try their treatments can move them around, as prolonged treatment can mean some shampoos will stop working.

Psoriasis is a chronic skin condition characterised by thick, flaking patches of skin.

Getty Images/Cultura RF

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Resist the itch - Eczema is almost always itchy no matter where it occurs on the body and although it may be tempting to scratch affected areas of the skin, this should be avoided as much as possible

GETTY

A lot of people have scalp problems

Dr Ranj Singh

These patches normally appear on elbows, knees, scalp and lower back, but can appear anywhere on the body. Most people are only affected with small patches but the skin can become itchy or sore.

Intense itching of the scalp can affect sleep and everyday life - and it can lead to hair loss.

Psoriasis occurs due to an over-reaction of the immune system, which causes inflammation and rapid growth of skin cells.

Skin cells are normally made and replaced every three to four weeks, but in psoriasis this process only lasts about three to seven days.

NHS Choices said psoriasis affects around 2 per cent of people in the UK. It can start at any age, but most often develops in adults under 35 years old.

ITV

GETTY

The GP said people can go to their GP to try different creams.

Vitamin D, which people can get from the sun, is it vital for bone health as well as obesity and diabetes, but it can also help with psoriasis.

The other thing I will say is some people find sunlight is beneficial, he said.

If itch is a problem, control stress as much as you can, he said.

NHS Choices said: In most cases, the first treatment used will be a topical treatment, such as vitamin D analogues or topical corticosteroids. Topical treatments are creams and ointments applied to the skin.

What is guttate psoriasis? The skin condition YOU should be aware of

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Psoriasis treatment: Dr Ranj explains how to tackle a flaky scalp - Express.co.uk

The FDA has approved anti-interleukin-17 receptor monoclonal antibody brodalumab (Siliq, Valeant Pharmaceuticals) to treat adults with moderate-to-severe plaque psoriasis.

The injectable systemic therapy blocks the receptor for IL-17, so it has a mechanism of action similar to approved biologics secukinumab (Cosentyx, Novartis) and ixekizumab (Taltz, Eli Lilly), which also block the receptor for IL-17, according to Mark Lebwohl, M.D., professor and chair of dermatology, Icahn School of Medicine at Mount Sinai, who was involved with the clinical trials that paved the way for brodalumabs FDA approval.

Dr. LebwohlBrodalumab is as effective or more effective than any other FDA-approved drug to treat psoriasis, according to Dr. Lebwohl, who was lead author on the New England Journal of Medicine paper examining phase 3 studies comparing brodalumab with ustekinumab (Stelara, Janssen), for psoriasis.1

In its phase 2 data, it (brodalumab) was the most effective drug that we had ever seen. Nearly two-thirds of plaque psoriasis patients achieved (psoriasis area-and-severity index) PASI 100. Thats a number weve never seentwo-thirds of people not having a dot of psoriasis left, Dr. Lebwohl says.

Phase 3 studies PASI 100 percentages were lower, but still unprecedented, according to Dr. Lebwohl.

Researchers reported in the NEJM that PASI 75 response rates at week 12 were 86% with the 210-mg brodalumab dose and 67% with 140-mg of the biologic, versus 6% in the placebo group. In two other studies, from 44 to 37% of psoriasis patients on 210 mg of brodalumab achieved PASI 100 at 12 weeks, versus 22 to 19% of patients on ustekinumab. The approved dose is 210 mg.

Suicide a concern for FDA

The downside, which will appear in the label, is that there were a small number of suicides. In the psoriasis trials, there were four (suicides) out of 4,000 treated patients. In all the trials, there were six (suicides) out of 6,000 treated patients. Although it is not clear that the suicides had anything to do with the drug, that raised an alarm at the FDA, and they put it into the package insert, Dr. Lebwohl says.

Concerns about suicide helped to make brodalumabs road to approval a rocky one. In January 2016, the National Psoriasis Foundation published an article that Amgen, which along with AstraZeneca had been developing brodalumab, stopped developing the biologic because of suicidal thought and behavior concerns during clinical trials. AstraZeneca later auctioned off brodalumab to Valeant.

According to FDA, subjects in the trials were more likely to think about suicide or commit suicide if they had a history of suicidality or depression. But a causal association between treatment with brodalumab and increased suicidal ideation and behavior risks has not been established.

Dr. Lebwohl says he is familiar with each of the patients who committed suicide during the psoriasis trials and thinks it was more bad luck than a pattern in treated patients. But because of the black box warning, dermatologists and other prescribers need to counsel patients about the potential risk, he says.

I, interestingly, have a patient who I have taken care of for many years and has failed every treatment out there. I actually hospitalized her in 2002 because I was worried she was going to commit suicide, Dr. Lebwohl says. This is the first drug after all those years that was able to clear her completely. Since the trials ended, she has been on the other IL-17 drugs with either a minor or moderate response. So, shes waiting to get back on this when it comes out.

Siliq should be available to patients in the second quarter of 2017, he says.

Disclosure: Dr. Lebwohl has been an investigator for the makers of brodalumab.

1 Lebwohl M, Strober B, Menter Alan, Gordon K, Weglowska J, Puig L, et al. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med 2015; 373:1318-1328

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Brodalumab approved for psoriasis - ModernMedicine

- By Alberto Abaterusso

Janssen Research & Development LLC, part of Johnson & Johnson (JNJ) Pharmaceutical Research and Development reported last March 3 through the PRNewswire the results from two Phase 3 clinical trials, VOYAGE 2 and NAVIGATE.

During the studies the pharmaceutical company assessed its guselkumab for the treatment of adult patients affected by severe plaque psoriasis.

The patients treated with Janssen Research & Development's guselkumab achieved meaningful improvement in terms of skin clearance and other disease activity's measures versus the placebo and AbbVie's (ABBV) Humira (adalimumab).

At the end of the VOYAGE 2 clinical trial, in 84.1% of patients affected with severe plaque psoriasis and treated with Janssen Research & Development's guselkumab, a clear or minimal disease at week 16 was observed versus 8.5% of patients under placebo and versus 67.7% of patients taking Humira.

During the NAVIGATE clinical trial, the patients experienced a significantly greater improvement in skin clearance. These patients failed to respond adequately to an IL-12/23 monoclonal antibody (Stelara) and switched to guselkumab.

Results from VOYAGE 2 and NAVIGATE trials were presented at the 2017 American Academy of Dermatology Annual Meeting in Orlando, Florida, from March 3 to March 7.

The company says that "guselkumab is a human monoclonal antibody with a novel mechanism of action that specifically targets the protein interleukin (IL)-23 and is currently under review by health authorities in the U.S. and in Europe as a subcutaneously administered therapy for the treatment of adults living with moderate to severe plaque psoriasis."

Johnson & Johnson was trading at $123.61 per share Wednesday, down 22 cents or minus 0.19% from the previous trading day.

The 52-week range is between $106.07 and $126.07. The forward price-earnings (P/E) ratio is 16.79, and the stock is trading at 4.69 times its sales computed over the 12 trailing months period, at 4.64 times the book value and 13.01 times the EBITDA.

The stock is less volatile than the stock market with a beta of 0.68. It is uptrending and gained 7.48%.

As of Dec. 31, 2016, the company has $41.91 billion in cash on hand and securities and the total debt amounts to $27.13 billion, of which 82.6% is the portion of long-term debt.

The total debt to equity ratio is 38.52 versus an industry average of 11.52. The company is more indebted than its peers, however, the interest coverage ratio is 50.53. This means that the company can easily pay interest expenses on the outstanding debt.

Over the 12 trailing months time frame the company generated cash flow of $18.77 billion from its operations.

The free cash flow was $15.54 billion and part of this has been used to distribute dividends to the shareholders. Johnson & Johnson pays a quarterly dividend of 80 cents per share that leads to an annual dividend of $3.20 for a dividend yield of 2.59%.

The company has approximately 2.71 billion shares outstanding of which 0.02% is held by insiders and 67.30% by institutions.

Among the top institutional holders, the Vanguard Group Inc. stands out with 191,188,744 shares of Johnson & Johnson, or 7.03% of the company's total shares outstanding, valued $22.03 billion at Dec. 31, 2016.

AbbVie is trading at $64.12 per share, up 43 cents or plus 0.68% from the previous trading day.

Disclosure: I have no positions in any stock mentioned in this article.

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This article first appeared on GuruFocus.

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Results of Johnson & Johnson's Psoriasis Clinical Trials Impressive - Yahoo Finance

Psoriatic Arthritis Risk Increased by Depression Among Patients With Psoriasis Clinical Pain Advisor (registration) Researchers from Canada have demonstrated that depression is a significant risk factor for progression from psoriasis to psoriatic arthritis (PsA). Led by Ryan Lewinson, MD, PhD, from the Cumming School of Medicine at the University of Calgary, Alberta ...

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Psoriatic Arthritis Risk Increased by Depression Among Patients With Psoriasis - Clinical Pain Advisor (registration)

EAST HANOVER, N.J., March 6, 2017 /PRNewswire/ --Novartis announced today a new analysis (post hoc) of an uncontrolled extension study which shows moderate to severe plaque psoriasis patients treated with Cosentyx (secukinumab) rapidly regained clear or almost clear skin (Psoriasis Area Severity Index, PASI 100 or 90) following relapse during a treatment pause. The analysis also showed no anti-secukinumab antibodieswere observed during retreatment.1 PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in four regions of the body. Treatment efficacy is assessed by the reduction in the total score from baseline (i.e., a 75% reduction is known as PASI 75 and a 90% reduction is known as PASI 90). PASI 90 and 100 are higher standards of skin clearance compared to PASI 75. These findings were presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Fla., where Novartis presented over 35 scientific abstracts.

Previous data has shown favorable results for continuous over intermittent treatment, however sometimes patients have treatment pauses.3 This new analysis shows that if psoriasis patients relapse during treatment pauses, the majority can achieve previous high levels of efficacy after only 16 weeks of retreatment with Cosentyx.1

"It is very clear that patients get the best results from continuous treatment," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "However, if for some reason treatment has been interrupted, this analysis gives patients and clinicians the peace of mind that Cosentyx is likely to help people quickly achieve clear skin once again."

The data show the majority of patients with the highest response levels to Cosentyx (PASI 90, PASI 100) after one year of treatment on the 300 mg dose regained a high response level (PASI 75 or higher) 12-16 weeks after treatment re-initiation. For patients who previously achieved PASI 75 and relapsed after treatment discontinuation (n=136), this analysis shows that by Week 16 of retreatment with Cosentyx, 94% of patients regained a PASI 75 response, 79% of prior PASI 90 responders (n=117) regained a PASI 90 response and 67% of prior PASI 100 responders (n=67) regained a PASI 100 response. The median time to relapse was 28 weeks.1

In addition, the safety profile was consistent with that observed in previous studies. No patients in this analysis tested positive for anti-secukinumab antibodies. The most common adverse events (AEs) in the Cosentyx-treatment arm were nasopharyngitis (20.7 exposure adjusted Incidence Rate [IR] per 100 patient years), arthralgia (12.6 IR) and upper respiratory tract infections (12.4 IR).1

"This study addresses a common issue in clinical practice that happens when plaque psoriasis patients are on biologic therapy and have to stop for any number of reasons, and then re-start the biologic," said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center and lead study investigator. "Importantly, we found that stopping and re-starting Cosentyx led to good re-capture of clinical responses. Low immunogenicity associated with Cosentyx may offer a partial explanation of these results and warrants further analysis."

Cosentyx is the only IL-17A inhibitor approved in plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), and more than 30,000 U.S. patients have been prescribed Cosentyx in the post-marketing setting across all indications.2

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)

Launched in January 2015, Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.

Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis which includes the U.S., European Union countries, Japan, Switzerland, Australia and Canada. In the U.S., Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

In addition, Cosentyx is the first IL-17A inhibitor approved in more than 65 countries for the treatment of active AS and PsA, which includes the U.S. and European Union countries.

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Novartis is committed to ensuring patients and prescribers have access to Cosentyx. Cosentyx currently is covered on over 95% of U.S. commercial formularies across its three approved indications for plaque psoriasis, PsA and AS.4

About the Cosentyx retreatment study

An uncontrolled, extension study of ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), which compared Cosentyx with placebo, and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), which compared Cosentyx with placebo and etanercept. A total of 181 patients treated with Cosentyx 300 mg who achieved a PASI 75 response at the end of the core studies (Week 52) were re-randomized to receive placebo every four weeks until relapse. Upon relapse, patients were retreated with Cosentyx 300 mg.1

About psoriasis

Affecting about 7.5 million Americans, psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain.5Patients reported these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult.6-8 Additionally, patients with psoriasis are at increased risk for other chronic illnesses.9

INDICATIONS

COSENTYX (secukinumab)is a prescription medicine used to treatadults:

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections

COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

Before starting COSENTYX, tell your doctor if you:

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease

New cases of inflammatory bowel disease or "flare-ups"can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?

See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including Medication Guide.

DisclaimerThe foregoing release contains forward-looking statements that can be identified by words such as "launch," "can," "may," "launched," "committed," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Cosentyx, or regarding potential future revenues from Cosentyx. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Cosentyx will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Cosentyx will be commercially successful in the future. In particular, management's expectations regarding Cosentyx could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisLocated in East Hanover, NJ, Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novartis-cosentyx-shows-almost-all-psoriasis-patients-rapidly-regain-skin-clearance-following-a-treatment-pause-300418218.html

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Novartis' Cosentyx shows almost all psoriasis patients rapidly regain skin clearance following a treatment pause - Yahoo Finance

Orlando The advent of increasingly effective and still costly biologic drugs for psoriasis and psoriatic arthritis (PsA) has highlighted the fact that dermatologists do not know which patients would benefit most from preventative measures.

A key unanswered question in psoriasis is whether physicians can predict and therefore prevent progression to PsA, said Mark Lebwohl, M.D. He is Sol and Clara Kest Professor and Chairman, Department of Dermatology, Icahn School of Medicine at Mount Sinai.

Before biologics, "The drugs that we had helped the pain of arthritis but were not dramatically effective at preventing joint destruction. Methotrexate is a classic example patients still benefit from it today, but the joints continue to deteriorate as evidenced by x-rays."

Tumor necrosis factor (TNF) alpha inhibitors were the first drug class allowed to claim that they prevent radiographic progression of PsA. "Etanercept was the first, followed by infliximab and adalimumab. Then came golimumab and certolizumab. These 5 drugs are dramatically effective for psoriatic arthritis they don't just get rid of the pain, but they also prevent x-ray progression."

More recently, the interleukin (IL) 17 blockers secukinumab and ixekizumab have shown similar abilities. "We have quite a few tools now to prevent joint damage. If we knew in advance which patients with psoriasis were going to develop psoriatic arthritis, it would help us help our patients. We could put them on those drugs early to prevent joint damage."

Among patients with psoriasis and PsA, he said, 72% present with psoriasis first. MRIs can show bone marrow edema (a sign of impending joint damage), "But we need better tests to predict which patients will get psoriatic arthritis." To that end, said Dr. Lebwohl, several companies are investigating genetic markers, while physicians continue to explore use of imaging modalities. "A genetic or serologic marker would be most helpful."

Similarly, researchers are attempting to predict which patients will develop other comorbidities such as cardiovascular disease. "When the biologics came out, patients were put into registries. And we've been finding, particularly with the TNF blockers, that there's a dramatic reduction in heart attacks in people who take these drugs."

A third knowledge gap, Dr. Lebwohl said, is which patients will respond to which treatments. "The new treatments that are coming out are dramatically effective in almost everybody. The problem is, they all cost a fortune." Knowing which patients would likely respond best and which ones would do just as well with cheaper treatments will help dermatologists and their patients immensely, he said.

Disclosures: Dr. Lebwohl has been a clinical investigator for most manufacturers of drugs for psoriasis and psoriatic arthritis. All payments from these companies go not to him but to Mount Sinai.

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Research gaps persist in psoriasis, psoriatic arthritis | Dermatology ... - ModernMedicine

Results from a Phase 4 clinical trial, UNVEIL. evaluating Celgene's (CELG -0.6%) Otezla (apremilast) in patients with moderate plaque psoriasis with a body surface area of 5 - 10% showed a significant treatment benefit compared to placebo. The results were presented at the American Academy of Dermatology's Annual Meeting in Orlando, FL.

UNVEIL evaluated oral OTEZLA (30 mg twice daily) compared to placebo at week 16 in 221 subjects with moderate plaque psoriasis who had not been treated with systemic or biologic therapy. At baseline, 80% (n=177) had received topical therapy. The primary endpoint was the mean percent change from baseline in the product of PGA and BSA scores (two measures of psoriasis severity) at week 16.

The mean changes for the Otezla and placebo cohorts were -48.1% and -10.2%, respectively (p<0.0001). The proportions of patients who achieved at least a 75% improvement in symptoms were 35.1% and 12.3%, respectively (p<0.0001). The proportions of patients who achieved clear or almost clear skin were 30.4% and 9.6%, respectively (p<0.0001).

The most common treatment-relate adverse events were diarrhea (29%), headache (20%), nausea (18%), upper respiratory tract infection (7%) and vomiting (6%).

Otezla is currently approved to treat moderate-to-severe plaque psoriasis.

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Celgene's Otezla successful in late-stage study in expanded psoriasis population - Seeking Alpha