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Category Archives: Psoriasis

Janssen Submits Application Seeking Approval Of STELARA In European Union For Pediatric Plaque Psoriasis

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BEERSE, Belgium, Oct. 10, 2014 /PRNewswire/ --Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.1

"Janssen is committed to the continued development of STELARA, especially in this underserved pediatric population," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from STELARA."

The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving STELARA compared with patients receiving placebo.

About CADMUS CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients ages 12 to 17 years with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed more than six months prior to first study agent administration with a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.

Patients were randomized 1:1:1 to receive subcutaneous placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].

About Psoriasis Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide, including 14 millionEuropeans.2-6 Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling.7 It is estimated that nearly 3 percent of the world's population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.2 Although the disease can present at any age, approximately one-third of people who develop psoriasis are under the age of 20 when the disease first surfaces.8 Prevalence in childhood and adolescence varies by region, ranging from 0.5 to 2 percent of the general population.1

About STELARA (ustekinumab)STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved in 79 countries for the treatment of moderate to severe plaque psoriasis. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in immune-mediated inflammatory diseases, including psoriasis and psoriatic arthritis.

In the European Union, STELARA is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen plus UVA). STELARA is also approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Janssen Biotech, Inc. discovered and developed STELARA, and the Janssen Pharmaceutical Companies maintain exclusive worldwide marketing rights to STELARA.

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Janssen Submits Application Seeking Approval Of STELARA In European Union For Pediatric Plaque Psoriasis

Amgen'biosimilar Phase3 Plaque Psoriasis Study Met Primary Endpoint For Efficacy

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By RTT News, October 08, 2014, 09:23:00 AM EDT

(RTTNews.com) - Amgen ( AMGN ) announced its Phase 3 study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.

The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment.

At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.

ABP 501 is being developed as a biosimilar to adalimumab, an anti-TNF- monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.

"Results from Amgen's biosimilar Phase 3 plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the Company's commitment to provide patients with access to high-quality medicines," said Sean Harper, M.D., executive vice president of Research and Development at Amgen.

Amgen said it has six biosimilar molecules in development and expects to launch the portfolio starting in 2017.

Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Instead of being shed, skin cells pile up, causing painful and itchy, red, scaly patches. Approximately 125 million people worldwide have psoriasis, and 80 percent of those patients have plaque psoriasis.

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Amgen'biosimilar Phase3 Plaque Psoriasis Study Met Primary Endpoint For Efficacy

Philips turns the light on psoriasis

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BlueControl can be strapped on to any part of the body

Sufferers of psoriasis, an incurable skin disease that breaks out in scaly red plaques and also causes the skin to peel, will shortly get a new ally in the management of the condition. Lighting giant Philips is about to launch BlueControl, an LED light unit that can help patients of mild and moderate cases with no side effects.

The device was developed based on findings from research showing that blue LED light treatment slows down the root cause of psoriasis, which is the rapid division of cells. It can also reduce skin inflammation. Philips designed an unobtrusive battery-powered strap-on unit that can be placed on the parts of the body that are affected by the irritating skin disease.

The system does not use regular LED lights, which are not always suitable for medical-grade applications such as BlueControl. Philips carried out research with academic and clinical partners in order to develop pulsed LED lights with higher intensities. Altogether, the system features 40 of those UV-free blue lights.

To test BlueControl, Philips teamed up with the University Hospital of Aachen in Germany. During the second of two clinical trials that spanned four months ending in June, patients showed an average reduction of 50 percent of symptoms based on a measurement system called Local Psoriasis Area Severity Index (PASI). The index measures the severity of psoriasis plaques in terms of thickness, redness and scaling. The trials also revealed that the blue LED lights produced no side effects.

Philips will present BlueControl at the European Academy of Dermatology & Venereology Congress, which takes place in Amsterdam between 8-12 October, before it goes on sale in The Netherlands, Germany and the UK.

Source: Philips

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UV-therapy allows the effective treatment of psoriasis, eczema and vitiligo in all skin areas – Video

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UV-therapy allows the effective treatment of psoriasis, eczema and vitiligo in all skin areas
The compact and very inexpensive UV-therapy device medisun 250 allows the effective treatment of psoriasis, eczema and vitiligo in all skin areas. Thanks to ...

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UV-therapy allows the effective treatment of psoriasis, eczema and vitiligo in all skin areas - Video

Effects of psoriasis are not confined to the skin

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DEAR DOCTOR K: My doctor thinks my arthritis and heart disease are connected to my psoriasis. Is this possible? I thought psoriasis was a skin condition.

DEAR READER: Psoriasis (pronounced so-RYE-uh-sis) is named for an ancient Greek word meaning an itchy or scaly condition. It is classified as a skin disease, but psoriasis is the result of an immune system abnormality that can cause problems throughout the body.

With psoriasis, white blood cells of the immune system become overactive. They produce excess amounts of chemicals that trigger inflammation. The inflammation leads to abnormally rapid growth of cells in the skins outer layer. This causes plaques: raised, red patches covered with silvery scales on the elbows and knees the classic sign of psoriasis. (Ive put a photo of psoriasis plaques on my website, AskDoctorK.com.)

But the effects of psoriasis are not always confined to the skin. The disease also can cause inflammation throughout the body. This probably is the reason that people with psoriasis have higher rates of various diseases that also are associated with a constant state of inflammation. These include diabetes, heart disease, high blood pressure and several types of cancer.

Nearly one-third of people with psoriasis develop psoriatic arthritis, which causes stiff, painful joints and other symptoms.

Several eye problems are more common with psoriasis, including conjunctivitis, blepharitis (inflammation of the eyelids) and damage to the cornea.

When psoriasis involves only the skin, it often can be treated just by medicines applied to the skin. Very mild cases of psoriasis may improve with moisturizers and some sunlight. But most people need other treatments:

OINTMENTS, GELS OR LOTIONS. The most common are corticosteroids, which come in varying strengths. They quickly reduce inflammation and control itching. Long-term use of strong steroids can thin and damage skin.

PHOTOTHERAPY. This treatment uses carefully controlled exposure to ultraviolet (UV) light, which helps slow the growth of skin cells. UV light combined with medicines called psoralens often are more potent than just UV light (a treatment called PUVA).

SYSTEMIC THERAPY. If your psoriasis has caused more than skin problems, this can have implications for the kind of treatment your doctor may recommend. Treatments that fight inflammation in multiple parts of the body may be required. Medicines that do this include methotrexate, retinoids and cyclosporine.

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Effects of psoriasis are not confined to the skin

What Is The Definition Of Flexural psoriasis – Medical Dictionary Free Online – Video

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What Is The Definition Of Flexural psoriasis - Medical Dictionary Free Online
Visit our website for text version of this Definition and app download. http://www.medicaldictionaryapps.com Subjects: medical terminology, medical dictionary, medical dictionary free download,...

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What Is The Definition Of Flexural psoriasis - Medical Dictionary Free Online - Video

Talking About Your Psoriasis to Others

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When you know how to explain your psoriasis to others, it can relieve some of the stress that goes along with your skin condition.

"The more people around you that know about it, the more support you'll get," says Linda Cornish. She's a dermatology nurse who helps people with psoriasis at Kaiser-Permanente Medical Center in Oakland, CA. "And being open and honest can make you feel less self-conscious."

These six tips can help you talk about your psoriasis to friends and coworkers.

1. Choose the right time.

Figure out a time and a place that will make you feel comfortable.

"If you're relaxed and at ease, the person you're talking to is more likely to feel at ease," says Julie Nelligan, PhD. She's a health psychologist in private practice in Portland, OR.

The right setting is likely to depend in part on the person you're talking to. With a coworker, you may want to bring up the subject during a break or over lunch. If you're talking to someone you've begun dating, you may want to arrange a special time.

2. Think through what you want to say.

Plan it out. That can help make things easier. Chances are you'll also feel more relaxed. How much detail you give will depend on the person you're talking with.

A coworker may need to know only what psoriasis is and that they cant catch it. Your boss might need to know about your treatments if that means taking time off from work. When talking to a date, you may want to explain what living with psoriasis is like for you.

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Talking About Your Psoriasis to Others

Philips unveils BlueControl: a device that fights psoriasis with light therapy

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Following the companys recently-announced plans to merge its consumer technology and medtech divisions, Philips has just announced a new wearable medical device thats been clinically proven to control mild and moderate cases of psoriasis a skin condition that affects more than 125 million people worldwide.

In a nutshell, psoriasis is caused by the overly-rapid division of skin cells on the epidermis. This exceedingly fast division usuallyleads to the formation of scaly patches and plaques, which are oftentimes itchy and painful. To treat these symptoms, most people generally rely onmedicated creams and ointments, but Philips has developed a new approach.

The companys latest device, called BlueControl uses a wearable array of 40 high-intensity LEDs to shine specific wavelengths of blue light onto the affected areas of a persons body. This helps to slow down the cell division, and in a number of clinical trials was shown to reduce the symptoms of psoriasis vulgaris by an average of 50 percent.

Its worth noting that Philips isnt the first to explore the prospect of treating psoriasis with light therapy. Medical scientists have long understood the benefits of sunlight for those who suffer from the condition, and special lamps have even been developed to treat patients. That being said, however, BlueConnect is significant for two reasons: 1.) its doesnt use harmful ultraviolet light, and 2.) its designed to be used at home.

Related:Light-therapy bus shelters set to cheer up Swedes in winter

The device comes in the form of small, battery-powered light pod that fits into a wearable strap. This strap is fully adjustable and can be placed virtually anywhere on the body, meaning patients can use it in the comfort of their own homes and cut down on visits to the doctors office.

Philips says BlueConnect will be prescribed by physicians, and available through distributors in the Netherlands, Germany, and the UK starting this month. No word on when itll roll out in the US, but weve reached out to company representatives and well update this post with additional info as soon as we get it.

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Philips unveils BlueControl: a device that fights psoriasis with light therapy

Amgen Announces Moderate-To-Severe Plaque Psoriasis Data To Be Presented At The 23rd Congress Of The European Academy …

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THOUSAND OAKS, Calif., Oct. 1, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it will present several studies related to brodalumab, Enbrel (etanercept) and ABP 501 (adalimumab biosimilar) at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV) in Amsterdam, Oct. 8-12, 2014. These data reinforce Amgen's continued commitment to delivering medicines that may help to improve the lives of people suffering from devastating dermatologic diseases.

"As a pioneer in psoriasis research and development, we are pleased to share scientific insights from our growing dermatology portfolio that may help improve care for the millions of people worldwide1 affected by this serious skin disease," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The data being presented at this year's congress demonstrate the breadth and depth of our biologics expertise in advancing treatments that address critical unmet needs for patients living with psoriasis."

Brodalumab data to be presented include an exploratory analysis of the Phase 2 trial evaluating efficacy and safety of brodalumab in moderate-to-severe plaque psoriasis patients with prior biologic exposure, along with an analysis from the open-label extension study of that same Phase 2 study evaluating patient response to treatment after nearly three years. Brodalumab is being co-developed by Amgen and AstraZeneca. Kyowa Hakko Kirin, which has an exclusive license to develop and commercialize brodalumab in Japan, China and certain other Asian countries, will present efficacy and safety data from its Phase 2 study evaluating brodalumab in Japanese patients with moderate-to-severe plaque psoriasis.

ENBREL data focus on step-down dosing compared with a high-dose regimen and patient-reported outcomes of treatment with ENBREL compared to treatment with ENBREL in combination with topical therapies. Additional data include the functional equivalence of proposed biosimilar ABP 501 to adalimumab and an analysis of the incidence of symptoms such as itching and pain in patients with psoriasis.

SELECTED ABSTRACTS OF INTERESTAbstracts are available to registered journalists at http://www.eadvamsterdam2014.org/press and updated data will be presented at the meeting.

Brodalumab Abstracts of Interest

ENBREL (Amgen-sponsored) Abstracts of Interest

Biosimilars Abstracts of Interest

Additional Abstracts of Interest

About Psoriasis Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at an accelerated rate.2 Instead of being shed, skin cells pile up, causing painful and itchy, red, scaly patches.3 Approximately 125 million people worldwide have psoriasis, and 80 percent of those patients have plaque psoriasis.1,4

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Amgen Announces Moderate-To-Severe Plaque Psoriasis Data To Be Presented At The 23rd Congress Of The European Academy ...


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