Category Archives: Psoriasis

NEW YORK - People with chronic gum disease seem to be slightly more likely to develop the skin condition psoriasis, according to a new study.

Taiwanese researchers found that in a group of more than 230,000 people, those with gum disease were 54 percent more likely to get psoriasis over five years.

The study is among the first to investigate the link between the two conditions and doesn't necessarily mean gum disease can cause psoriasis.

"We don't know very much about what the risk factors are for chronic inflammatory diseases like psoriasis," said Dr. Joel Gelfand, a dermatologist at the University of Pennsylvania in Philadelphia, who was not involved in the new research.

"This study points in a potentially new direction for a potential risk factor thatin theorycould be modified and thus lower the risk of psoriasis in the future," he told Reuters Health. "That being said, this finding needs to be confirmed by more-rigorous, more-controlled studies to determine if the findings are real."

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Gum disease linked to psoriasis: Taiwanese study

Psoriasis

NEW YORK (Reuters Health) - People with chronic gum disease seem to be slightly more likely to develop the skin condition psoriasis, according to a new study.

Taiwanese researchers found that in a group of more than 230,000 people, those with gum disease were 54 percent more likely to get psoriasis over five years.

The study is among the first to investigate the link between the two conditions and doesn't necessarily mean gum disease can cause psoriasis.

"We don't know very much about what the risk factors are for chronic inflammatory diseases like psoriasis," said Dr. Joel Gelfand, a dermatologist at the University of Pennsylvania in Philadelphia, who was not involved in the new research.

"This study points in a potentially new direction for a potential risk factor that - in theory - could be modified and thus lower the risk of psoriasis in the future," he told Reuters Health. "That being said, this finding needs to be confirmed by more-rigorous, more-controlled studies to determine if the findings are real."

Psoriasis is thought to be caused by a mistaken immune reaction directed at the body's own cells, leading to inflamed patches of red, scaly skin.

It's not the first time the condition has been linked to other health problems. Earlier this year, a study of people evaluated for heart disease found 84 percent of patients with psoriasis had coronary artery disease, compared to 75 percent of patients without the skin condition. (See Reuters Health article from January 10, 2012.)

Oral health has also been tied to other conditions, with two studies from this year finding links to heart disease and dementia. (See Reuters Health articles from April 19 and 21, 2012.)

But until now only one other study had looked at the link between psoriasis and chronic periodontitis, the advanced stage of the gum disease gingivitis.

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Study: People with gum disease 54% more likely to develop psoriasis

NEW YORK (Reuters Health) - People with chronic gum disease seem to be slightly more likely to develop the skin condition psoriasis, according to a new study.

Taiwanese researchers found that in a group of more than 230,000 people, those with gum disease were 54 percent more likely to get psoriasis over five years.

The study is among the first to investigate the link between the two conditions and doesn't necessarily mean gum disease can cause psoriasis.

"We don't know very much about what the risk factors are for chronic inflammatory diseases like psoriasis," said Dr. Joel Gelfand, a dermatologist at the University of Pennsylvania in Philadelphia, who was not involved in the new research.

"This study points in a potentially new direction for a potential risk factor that - in theory - could be modified and thus lower the risk of psoriasis in the future," he told Reuters Health. "That being said, this finding needs to be confirmed by more-rigorous, more-controlled studies to determine if the findings are real."

Psoriasis is thought to be caused by a mistaken immune reaction directed at the body's own cells, leading to inflamed patches of red, scaly skin.

It's not the first time the condition has been linked to other health problems. Earlier this year, a study of people evaluated for heart disease found 84 percent of patients with psoriasis had coronary artery disease, compared to 75 percent of patients without the skin condition. (See Reuters Health article from January 10, 2012.)

Oral health has also been tied to other conditions, with two studies from this year finding links to heart disease and dementia. (See Reuters Health articles from April 19 and 21, 2012.)

But until now only one other study had looked at the link between psoriasis and chronic periodontitis, the advanced stage of the gum disease gingivitis.

For the new research, published in the British Journal of Dermatology, Dr. Joseph J. Keller from Taipei Medical University and his colleague turned to a database of Taiwan's national health system.

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Gum disease linked to psoriasis: study

Switzerland-based pharmaceutical company, Novartis AG (NVS) recently announced phase II data on its pipeline candidate, AIN457 (secukinumab), which is being developed for the treatment of moderate-to-severe plaque psoriasis on the hands, feet and nails.

Data from the double-blind phase II study showed that during the first month, weekly treatment with AIN457 helped reduce pain associated with moderate-to-severe plaque psoriasis on the hand and feet almost three times more than placebo (54.3% versus 19.2%).

Additionally, after 12 weeks of treatment with AIN457, 39% of the patients experienced either clear or minimal psoriasis. AIN457 was also found to reduce signs and symptoms of finger nail psoriasis in patients, when compared to placebo.

Further data presented at the European Academy of Dermatology and Venereology (:EADV), by Novartis, for the relief in signs and symptoms of moderate-to-severe plaque psoriasis showed that 12 weeks of treatment with AIN457, improved the quality of life (skin-related) in 25 times more patients in comparison to placebo.

Novartis stated in its press release that plaque psoriasis affects about 2% of the worlds population, out of which more than one third of patients suffer from its moderate-to-severe form.

Novartis is currently on track with pivotal phase III studies on AIN457 and expects data in 2013. The company is planning to file for regulatory approval once phase III results are available.

Novartis is also studying AIN457 in phase II trials for the treatment of multiple sclerosis.

We note already approved drugs for the treatment of moderate-to-severe plaque psoriasis include Johnson & Johnsons (JNJ) Stelara, Abbott Laboratories (ABT) Humira and Pfizer Inc. and Amgen Inc.s (PFE/AMGN) Enbrel.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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Novartis Progresses with AIN457

Research links psoriasis, Type 2 diabetes

While psoriasis and Type 2 diabetes seem like completely different medical problems, a new study of more than 100,000 psoriasis patients shows there is a link, and doctors are taking note.

Psoriasis is caused by an imbalance in the immune system, and it affects 2 percent to 4 percent of the population worldwide. The symptoms of psoriasis include red, scaly, itchy patches on the skin.

Mercy Medical Center dermatologist Dr. Janet Lin said psoriasis patients have several other health issues they need to keep their eye on, including a new one researchers are just learning about.

"Psoriasis is an independent risk factor for heart disease, for stroke, for obesity and for depression, and now they're even finding that if you have severe psoriasis, you're twice as likely to develop Type 2 diabetes," Lin said.

The study was done in the United Kingdom and published earlier this year in the "Archives of Dermatology."

"The most recent studies show there was an increased risk with the severity of the psoriasis. We think that's due to inflammation in the blood stream. The psoriasis releases some markers, increases inflammation and leads to insulin resistance and, eventually, Type 2 diabetes," said Dr. Amber Taylor, the director of the Diabetes Center at Mercy.

She said although the risk is fairly low for most psoriasis patients, they should still be screened.

Brenda Phipps said she's been suffering with psoriasis for 16 years.

"It takes a toll on my life, daily. I have my good days, and I have my bad days. It's very depressing," she said.

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Study: Psoriasis patients more prone to diabetes

Dear Drs. Donohue and Roach Please give me new medicine information for psoriasis. I break out on my scalp very bad and also on my face, back, chest and arms. It's getting worse. M.T.

Answer Psoriasis is another illness you can blame the immune system for. It sends signals to the skin that prompt the lowest layer of cells to rise to the surface so quickly that they lack the maturity to protect the underlying layers of skin cells. Red patches covered with silvery scales result. Often, psoriatic patches itch.

The choice of medicine rests on where the patches are, how severe the outbreak is and the type of psoriasis a person has. Topical medicines are chosen to treat moderate to mild outbreaks. "Topical" indicates that the medicine is applied directly to the skin. Dovonex (a synthetic version of vitamin D) and Vectical ointment are two widely used topicals.

Stronger medicines belong to the cortisone family. Temovate and Diprolene are two examples.

Methotrexate and cyclosporine are two oral medicines that correct the immune system's excesses.

The newest psoriasis treatments are biological agents designed to rein in the wayward immune system. Their names include Enbrel, Remicade, Humira, Amevive and Stelara.

Dear Drs. Donohue and Roach I recently was diagnosed with shingles. I was given a week-long course of Valtrex. Two of the symptoms I experience are some chest pain and mild shortness of breath.

May I still get the shingles vaccine when this clears? P.R.

Answer The chest can be painful if the rash spreads across it. Shortness of breath, however, isn't a common symptom unless the chest pain is forcing you to take shallow breaths.

Let your doctor know what's going on.

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Many options for psoriasis treatments

RESEARCH TRIANGLE PARK, N.C., Sept.28, 2012 /PRNewswire/ --Stiefel, a GSK (GSK) company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old.

"Studies have shown that in at least 50 percent of psoriasis cases, the scalp is involved," said Susan Learned, PharmD, MD, PhD, Medicines Development Leader, Dermatology Research and Development, Stiefel. "We believe this additional indication for Sorilux Foam will help meet the needs of both patients and physicians."

The approval of Sorilux Foam for treatment of plaque psoriasis of the scalp was based on a multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3b study of patients with moderate scalp and body psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas. The incidence of these adverse reactions was similar between the body and scalp. It is for use on the skin only. It is not for facial, oral, ophthalmic, or intravaginal use. More information about the clinical trial results can be found in the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Sorilux_Foam.pdf.

About Plaque Psoriasis

Psoriasis is a chronic (life-long) skin disease. It occurs when the immune system "speeds up" the growth cycle of skin cells. A normal skin cell matures and falls off the body in about a month. For people with plaque psoriasis, it can take only three or four days for new skin cells to develop. Instead of falling off, the cells remain on the skin and form thickened patches (lesions or plaques). While plaque psoriasis is a chronic condition, many patients experience times when their symptoms improve or worsen.

Plaque psoriasis is the most common form of psoriasis. It typically causes raised, red lesions covered with silvery white scales. Plaque psoriasis can occur on any part of the body, but most commonly on the scalp, knees, elbows, and torso. Sometimes, the lesions can appear in the same place on the left and right sides of the body.

Important Safety Information

Patients should not use Sorilux Foam if they have been told by their doctor that they have a high level of calcium in their blood (hypercalcemia). The medicine in Sorilux Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, patients are advised to stop using Sorilux Foam until calcium levels return to normal.

Sorilux Foam is flammable. Patients should avoid fire, flame, or smoking during and right after applying Sorilux Foam to the skin.

Patients should avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Patients are advised to wear a hat and clothes that cover the treated areas of the skin if they have to be in sunlight.

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Stiefel receives US FDA approval of Sorilux™ Foam, 0.005% for topical treatment of plaque psoriasis of the scalp

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/sn7nsz/psoriasis_event) has announced the addition of Decision Resources, Inc's new report "Psoriasis (Event Driven)" to their offering.

Despite the major impact psoriasis has on patients' quality of life, physicians believe many patients are untreated or undertreated, offering important commercial opportunities for current and emerging agents targeting this indication. During our ten-year forecast period, intense competition between the TNF-a inhibitors etanercept and adalimumab and the interleukin inhibitor ustekinumab has the potential to transform current treatment algorithms and define new market leaders. These current therapies will vie for share with several emerging agents with novel mechanisms of action and distinct risk-benefit profiles.

Key Topics Covered:

Executive Summary

What are the key parameters of the psoriasis market?

What factors are driving the market for psoriasis therapies?

What factors are constraining the market for psoriasis therapies?

What are the drug development activities of note in psoriasis?

What do the experts say?

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Research and Markets: Psoriasis (Event Driven)

COPENHAGEN, Denmark, September 30, 2012 /PRNewswire/ --

Data from the Burden of Psoriasis patient research were presented this weekend at the 21st EADV Congress in Prague, Czech Republic. The results from the research, which included a quantitative online survey completed by 3,822 patients with psoriasis, showed 73% of patients surveyed scored their psoriasis as having a moderate to high impact on their lives[1].

To view the Multimedia News Release, please click:

http://multivu.prnewswire.com/mnr/prne/leo-pharma/56611

People living with psoriasis experience flare-ups that can result in the appearance of thick, red, scaly skin lesions on any part of their body[2]. The skin is often sore and itchy[2],[3], but the current study emphasizes that the psychological impact of psoriasis can have an even greater impact on patients' everyday lives[1].

Factors analysed in the research included the influence of symptom burden, healthcare professional (HCP) relationships, patient factors and the psychosocial impact of psoriasis on how much the patient's psoriasis "dictates how they live their life"[1]. Factors that were most strongly associated dealt with daily activities, stigmatisation, isolation and anxiety. However, diagnosed symptom severity was not a significant indicator[1].

Commenting on the research Dr Anthony Bewley, Whipps Cross University Hospital & Barts & the London NHS Trust, UK, said, "The reality for patients is that the reactions of other people, real or perceived, can make life a real struggle. We need to ensure that we actively question our patients about these issues, and modify management accordingly. We plan further analysis of this comprehensive data set, which we believe will help to individualise care".

"The physical, psychological and social effects of psoriasis can have a serious impact on people's lives," said LEO Pharma President and CEO Gitte P. Aabo. "To give people with psoriasis the best chance of improving their quality of life, we need to address the issues that affect them individually. The Burden of Psoriasis patient research will help healthcare professionals learn more about the impact that psoriasis has on peoples' lives and hence inform and help evolve the way the disease is treated."

References

1. Bewley A, Ersser S, Hansen M, Pevac C. Psychosocial and symptomatic burden of psoriasis for patients in Europe, the USA and Canada. Abstract presented at: EADV Congress, Prague, 27 - 30 September 2012 (ID number PRA12-0920).

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International Study Highlights Need to Support Patients With Psoriasis Suffering Feelings of Isolation, Stigmatisation ...

Phase II data show AIN457 given weekly during the first month of treatment improved hand/foot psoriasis at Week 12 (54% of patients vs 19% on placebo)[1] AIN457 selectively binds to and inhibits interleukin-17A, a key driver of immune-mediated diseases and a promising target for the next generation of therapy[2-4] AIN457 pivotal Phase III trials with more than 3,000 psoriasis patients on track with regulatory submissions expected in 2013 Psoriasis on the hands, feet and nails is traditionally difficult-to-treat, causes functional and social disability and can affect up to 55% of psoriasis patients[5],[6]

Basel, September 27, 2012 - Novartis announced today new Phase II data showing AIN457 (secukinumab) may significantly improve moderate-to-severe plaque psoriasis on the hands, feet and nails when used every week for the first month of treatment, compared to placebo[1],[7]. Additional analysis on patients with moderate-to-severe plaque psoriasis also showed that AIN457 may successfully improve quality of life by Week 12 in the study[8].

"These new AIN457 data are particularly welcome since they demonstrate significant improvement in the signs and symptoms of patients, even when difficult-to-treat areas are involved," said Prof. Kristian Reich, one of the study investigators and Professor of Dermatology, Venereology, and Allergology in Hamburg, Germany. "Many patients with hand, foot or nail psoriasis are restricted in their daily life and work because they may not be able to walk or use their hands, negatively impacting their quality of life."

The results will be presented today at the European Academy of Dermatology and Venereology (EADV) 21st Congress, in Prague, Czech Republic. They provide additional insight into the safety and efficacy of AIN457, following the presentation of the study`s primary endpoint at EADV in 2011.

The new data from the sub-analyses undertaken on the Phase II study show AIN457 was nearly three times more effective than placebo at reducing moderate-to-severe plaque psoriasis on the hands and/or feet when given every week during the first month of treatment (54.3% of patients vs. 19.2% respectively, p=0.005), as measured by the Investigator`s Global Assessment (IGA)[1]. Patients also benefited if they received AIN457 once every four weeks, with 39.0% experiencing either "clear" or "minimal" psoriasis after 12 weeks of treatment[1]. Another analysis found that these AIN457 treatment schedules also notably reduced the signs and symptoms of finger nail psoriasis compared to placebo[7].

The study safety analysis of these data showed a comparable safety profile between treatment and placebo, with the most common adverse events (AEs) observed being infections[1],[7].

Other new data presented at EADV in the total moderate-to-severe plaque psoriasis study population show that AIN457 improved skin-related quality of life in 25 times more patients after 12 weeks of treatment when given every week for the first month, compared to placebo (40.8% vs. 1.6%, p<0.001), as measured by the Dermatology Life Quality Index (DLQI)[8]. In this same treatment group, significantly more patients experienced improvements in pain and discomfort compared to placebo (36.2% vs. -1.5%) from baseline; and in anxiety and depression versus placebo (16.3% vs. 6.2%), as measured by EuroQol (EQ-5D)[8]. The effect of psoriasis on patients` health-related quality of life has been shown to be similar to diseases such as cancer, heart attack, arthritis, type 2 diabetes and depression[9].

"These encouraging results show that through its novel mode of action, AIN457 may significantly increase treatment success and improve the quality of life of patients suffering from moderate-to-severe plaque psoriasis," said John Hohneker, Head of Development for Integrated Hospital Care for the Pharmaceuticals Division of Novartis. "We look forward to receiving the results of the larger-scale and longer-term Phase III studies, which are expected in 2013."

All core pivotal trials for AIN457 in moderate-to-severe plaque psoriasis are on track, involving more than 3,000 patients worldwide, and indicating a high interest from both medical and patient communities. Phase III data in moderate-to-severe plaque psoriasis is expected in 2013, with regulatory submissions to follow shortly thereafter.

About the study Data are based on a double-blind, parallel group, placebo-controlled Phase II study involving 404 patients, which met its primary endpoint of PASI 75 (Psoriasis Area and Severity Index) responses at Week 12[10]. It was designed to evaluate the safety and efficacy of AIN457 in different regimens (weekly for the first month; once every four weeks; or single dose) of 150 mg given subcutaneously[10].

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Novartis data show AIN457 significantly reduced signs and symptoms in patients with hard-to-treat moderate-to-severe ...