i started fumaderm 6 weeks ago, my stomach is in bits i am soiling myself a lot which i can help too, i am on 2 blue tablets, my psoriasis isnt any better, i am going off them tomorrow, i am covered in psoriasis, any ideas as i heard seaweed suppose to be great

Insurance in the States can be quite complicated, so this is a general guide to help those wanting information.  

First, the new Affordable Care Act (aka ObamaCare).  The official site is at: healthcare.gov

Through the Marketplace, people who previously couldn't afford insurance should be able to find a plan that fits there needs.  Some states have their own Marketplace while others use the one set up by the Federal Government.  This link provides where you would need to go (by state) to access the Marketplace.

obamacarefacts dot com/state-health-insurance-exchange

You can also call your local governement agency for information (usually through Family and Children Services)  or through this site:  

localhelp.healthcare dot gov

and also by calling the marketplace helpline at 1-800-318-2596.
Enrollment is November 15, 2014 - February 15, 2015.

For people who are able to acquire health insurance via their workplace, your human resource department is the best place to start for information.  One thing that continues to confuse people is whether they want an HMO plan or a PPO plan (depending on what is offered, there are many different plans available so it's impossible to cover them all).  So if you have a choise between HMO or PPO, this short description may help.

HMO - Health Maintenance Organization.  This plan is where doctors either work or contract for the HMO.  You are usually required to only see doctors within the HMO network (unless it's an emergency.)  You usually are required to have a PCP (Primary Care Physician) who will refer you to other doctors as needed. Premiums are usually lower for HMO plans. Your deductible and co-pays are also usually lower but you may not have an out of pocket limit.  

PPO - Preferred Provider Organization.  With a PPO you do not have to have a PCP (Primary Care Physician) and you pay less if you use doctors within the PPO network. But you are not limited to certain doctors (however, if you go out of network you will most likely pay more and MAY have to file the claim yourself, always ask!)  The deductible usually runs a bit higher but there is also (usually) a limit on your out of pocket expenses.  You also are not required to have a referral from your doctor to see another physician.

That is the general difference between the two most common health plans. I used the word "usually" a lot as there are so many plans available, there isn't a "one size fits all" answer.

Medicare Insurance is available at age 65 or sooner if you are declared disabled by the government. Their website is:

medicare dot gov

Also, Fred had this information posted, adding it to this post since it's great info:

Adalimumab - Humira Say on their website "If you cannot afford your medication, contact:  
pparx dot org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

Etanercept - Enbrel Have a dedicated payment support page:
enbrel dot com/pay-for-ENBREL.jspx

Ustekinumab – Stelara Also have a dedicated payment support page:
janssenprescriptionassistance...assistance

Is this the start of the UK getting a better deal for psoriasis patients? We are often talking about the cost of treatments and saying how it's time the governments started taking control and dictating the price. Well it looks like it's time to pat the British government on the back for working a deal for the use of Stelara in psoriatic arhtritis.

I reported at the beginning of the year that the UK was the only country not to accept that Stelara can help psoriatic arthritis, you can read that here: England rejects Stelara for psoriatic arthritis But it's been reported that a deal has been done that could change that decision.

Quote:

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The National Institute for Health and Care Excellence (NICE) is set to backtrack on negative guidance for a drug for psoriatic arthritis after agreeing a discount with its manufacturer.

NICE, which provides healthcare guidance for the NHS in England and Wales, issued a recommendation in May this year against extending the use of Janssen's Stelara (ustekinumab) to cover active psoriatic arthritis, a serious, progressive condition that can lead to progressive erosion of the joints.

However, the health watchdog has now issued new draft guidance that recommends the drug in this indication in “certain circumstances”, although only if Janssen provides the drug at a discount through a patient access scheme.

The circumstances required by NICE include if a person with psoriatic arthritis is unable to use one of several drugs already recommended for NHS reimbursement, or if a person has been treated with one or more of these drugs.

The medicines referenced by NICE are Janssen's own Simponi (golimumab) and Remicade (infliximab), AbbVie's Humira (adalimumab) and Pfizer's Enbrel (etanercept).

The draft guidance states that if a patient fits into the criteria outline by NICE, and Stelara is provided at the agreed discount through the patient access scheme, then the NHS should fund treatment with the drug.

Final guidance is still pending, however, and until then NHS bodies should make decisions locally on the funding of Stelara.

Peter Barnes, medical director at Janssen's UK subsidiary, said he was “pleased” with the new guidance.

“NICE's decision supports Janssen's view that ustekinumab offers value to the NHS as well as being clinically valuable. We are delighted that patients living with this condition may have access to another treatment option.”

Stelara is already recommended by NICE to treat the skin disease plaque psoriasis.

Hi All,

Looking for a little assistance. I've had psoriasis for the past 38 years on and off (mostly on for the past 16 years). After each level of treatment has effectively lost it's impact on my condition I progress to the next (topical, UVB, PUVA) and now I'm being lined up for a Systemics Clinic on the 15th December.

The drugs being mentioned are Fumaderm, Metatraxate and Ciclosporin.

What I'm looking for are positive stories in relation to Fumaderm and side effects. It would appear from reading peoples blogs that the side effects(gastro and higher frequency of infections due to lower immune system defences) are a given.

I would like to hear from people who have taken Fumaderm who experienced minimal side effects.

Thanks

Patrick

Morning fellow P sufferer's.

I know us P sufferer's are different with our lotions & potions etc but i found by mixing pine oil into the coconut oil & covering my P has reduced the scaling right down big time.

Has anyone else tried these items before ?

GB

Afternoon all,
joined up on here as i have had P for 24 years now & wanted to see what happens on here & if possible, give some poor sod some advice about P if i can help ?
I am hoping to get the Ustekinumab jab soon as i feel like a dog with fleas at the moment.
Sorely tempted to use a large wire brush to relieve the itching

Happy scratching everyone

GB

Hi all, I am a lost soul from another psoriasis site that appears to have closed down. I did not know that you existed until I was introduced to your site by one of your members.
I am 67 years old and started with P and PA in my mid 20s though the PA started a little later than the P. I have been in hospital three times with the P when it got to a stage when it almost covered me, in last 40 odd years I must have had most treatments known to man in fact when I first went in hospital I had tar baths which just shows how far we have come in that time.
I am now taking Stelara in 90mg doses and has given me 99.9% clearage however in the past I was on MTX for nine years ,six years 25mg oral and three years by 20mg injection. I have also had Cyclosporine which I had a very bad reaction to and another one that slips my mind but caused my toe nails to grow sideways through my toe, it's a great problem P !!.
I will not even go into all the lotions and creams I have used as I am sure that everybody has a similar story but I am looking forward to looking round your site and having a chat .

Hi,
I am new here and have a question about Psorinovo. I'm 27 years old and have psoriasis since elementary school. Till now I have tried all kind of medications and my psoriasis had it's ups and downs. My doctors treated me with Beloderm, Belosalic, Monsalic or Elocom. I have tried phototherapy once but the results were poor. This week I changed my doctor from dermatologist to homeophat doctor who has an M.D. He prescribed me Psorinovo but didn't have concrete answers about using it before getting pregnant. I want to have a baby but maybe will have to go to I.V. next year, he told me if I get pregnant to stop the treatment.
Does anyone have any data about Psorinovo and pregnancy? Should I even start the treatment? I know it takes some time to get the results and don't want to wait that long with having a baby. Is it enough to stop using Psorinovo once I find out I'm pregnant or should I stop using it months before my pregnancy?

An early view of a little study published in Photodermatology, Photoimmunology & Photomedicine that assess the effectivity of a low-emission UV device used daily for the treatment of psoriasis.

Quote:

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Background/Purpose:
Hospital-based phototherapy is a widely accepted treatment modality in psoriasis patients. It, however, requires several hospital visits weekly, interfering with (school)work. Home ultraviolet (UV) treatment has been proven effective before but is only available in certain countries, and safety aspects play a part in reluctancy to prescribe this treatment. Patients, however, are usually keen on the use of phototherapy as it is effective and gives them the possibility of reducing the amount of topical treatment needed. In this study, we assess the effectivity of a low-emission UV device used daily.

Methods:
Sixty-two patients were treated for 6 months either with daily low-emission UV treatment and mometasone ointment 0.1% or with mometasone ointment 0.1% alone. Psoriasis severity scores, quality of life, vitamin D level, and blood pressure were monitored every 2 months during the study.

Results:
Patients treated with daily low-emission UV treatment showed a significant improvement in psoriasis severity, quality of life, amount of steroid ointment used, and vitamin D levels.

Conclusion:
Daily low-emission UV therapy is an effective treatment for psoriasis patients, diminishing the amount of steroid ointment needed and improving disease activity, quality of life, and vitamin D scores. Further investigation, however, is necessary.

India has got it's first biosimilar of Remicade (infliximab) called Infimab for the treatment of Psoriatic Arthritis and will be marketed at a very significant discount compared with Remicade.

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Ranbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, today announced the launch of InfimabTM (BOW015), the first *Remicade® (Infliximab) biosimilar in India. The product was launched at the Indian Rheumatology Association Conference (IRACON) in Chandigarh, in the presence of over a thousand rheumatologists and doctors from around the country.

InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

InfimabTM marks Ranbaxy’s entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Talking about the significance of the newly launched InfimabTM, Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, “InfimabTM offers a new opportunity in the management of conditions like rheumatoid arthritis. The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.”

Rheumatoid arthritis is one of the most common chronic inflammatory diseases that cause disability. The literature estimates a prevalence of 0.5% to 0.75% in India. To manage the disease, Indian rheumatologists are using Infliximab to treat only a select set of patients because it is very expensive.

Dr. Arvind Chopra, Consultant Rheumatologist, Pune who was also the Principal Investigator of Clinical Trial conducted in India with InfimabTM (BOW015), stated, “There has been an inordinate interest among the medical fraternity in India regarding the launch of InfimabTM as it is an affordable therapeutic alternative to Infliximab with equivalent clinical effectiveness. The availability of the new drug has widened our options to treat several forms of arthritis. This will increase patient access and many more Indian patients will benefit from this biologic treatment. The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. InfimabTM also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis”.

Amit Munshi, president and CEO of EPIRUS, stated, “We are delighted to partner with Ranbaxy to bring InfimabTM to India. InfimabTM represents an affordable solution for patients and may expand patient access to this important medicine”.

It is well established through studies that if a biologic treatment is started relatively early and patients adhere for the required duration as recommended by the physician, significant improvement in overall treatment outcome can be achieved. Along with the affordable pricing of InfimabTM, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support program for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade®, a reduced cost of therapy, and patient support program, InfimabTM may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.

Hello. I've been without health care for nearly fifteen years and unfortunately that's just about when bouts of severe psoriasis started cropping up on my sides, lower back, stomach, elbows, knees, legs, and now hands and forearms. My self treatment has been trying to stay on an alkaline diet (which I struggle to stick with for long periods and 'cheat'). I also drink as much water as I can stand (usually 4 to 6 8oz. glasses daily), and recently started trying either one teaspoon of bacon soda or Bragg's apple cider vinegar with water daily to help create a more alkaline chemistry in the body. With all the above failing to stop flare-ups I've managed to get a supply of 0.05% betamethasone dipropionate skin cream which no longer is working well to stop the redness and flaking on the troubled spots. Many of the worse spots have remained for months on end now and they're increasing in size. I believe the use of the cream has thinned my skin as I'm bruising easily and the skin on my knees actually splits if I squat quickly or land on them in a fall. Needless to say I'd better stop the cream. My problem is I don't know what to do next for the escalating inability to clear the troubled areas. I believe I have either psoriatic arthritis, rheumatoid arthritis, or both because I've developed extreme joint pain in the legs, shoulders, and arms over the past two years and a few of my fingers and toes have developed nodules (swollen joints that don't go away) and no longer bend. One pinky is now deformed and bent totally out of shape from the swelling. I guess by now you've noticed I'm a mess. I stumbled upon this site and I hope others will have some advice for me as I honestly can't afford a primary doctor or health insurance, and I don't have medicare yet. Any suggestions? Thanks Nelson.

This study evaluated candidal colonization and specific humoral responses against Candida albicans in patients with psoriasis.

Candida is a genus of yeasts and is the most common cause of fungal infections worldwide. Candida albicans is the most commonly isolated species, and can cause infections (candidiasis or thrush)

Quote:

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Background:
Psoriasis is an inflammatory skin disease that can considerably affect a patient's quality of life. Environmental and genetic factors, as well as superantigens and toxins from Candida species, may play various roles in the exacerbation and persistence of psoriasis. In the present study, we evaluated candidal colonization and specific humoral responses against Candida albicans in patients with psoriasis.

Methods:
A total of 100 patients with psoriasis vulgaris and 50 healthy control individuals were enrolled in the study. Skin and oral specimens from all participants were cultured on CHROMagar Candida medium. Isolated yeast-like fungi were identified using the sequence of the D1/D2 domain of the 26S rRNA gene. Enzyme-linked immunosorbent assays (ELISAs) were used to detect immunoglobulin M (IgM), IgA, and IgG antibodies against C. albicans in sera of patients and healthy individuals.

Results:
Candida species were isolated from the skin of 15% of patients and 4% of controls and from oral specimens of 60% of patients and 20% of controls. There was a significant difference in candidal colonization between patients and controls (P < 0.05). Serum IgM, IgA, and IgG levels against C. albicans were significantly lower in patients with psoriasis than in controls (P < 0.05). There was no significant association between serum levels of specific antibodies against C. albicans or the frequency of candidal colonization with the clinical severity of the disease (P > 0.05).

Conclusions:
The results of the present study show a higher rate of candidal colonization in patients with psoriasis in comparison with controls and a reduction in humoral immune responses in patients.

Hi guys I was wondering what I should expect when I take my first stot I've been reading your post and they have been a great deal of info but other stuff I've read kind of makes me not want to take the shot I was given a 90 dose to start as my psoriasis is really bad. All info would be appreciated thx

Hello there,
Newbie here, not sure where to go or what to do. I just stumbled across your site after feeling quite disappointed with my bodys' reaction to the treatments I have had so far. I am feeling very disillusioned and quite poorly and wondered what other peoples' experiences have been with their treatments.
Any information or discussion would be most appreciated.

BTW - I have never used a forum before - so any help or pointers there would be a help too !![/font][/size]

Following on from Otezla getting FDA approval back in March for psoriatic arthritis, Celgene have now received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for it's use in Europe.

Quote:

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Celgene Corporation, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA® (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:

For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

Psoriasis is an immune mediated skin condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe2 and about 125 million people worldwide.3 Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing about 80 percent of cases.4 Up to 30 percent of people with psoriasis may develop psoriatic arthritis, which involves pain and swelling in jointsand other manifestations and may lead to significant disability.

"This CHMP positive opinion is an important step forward for people with psoriasis and psoriatic arthritis in Europe. These immune mediated diseases are frequently debilitating and cause severe physical and emotional pain to the individual," stated Tuomo Pätsi, President, Celgene Europe, the Middle East and Africa (EMEA). "We are proud to have moved one step closer to offering patients OTEZLA®, a new, oral treatment approach that could significantly help control their symptoms and make a considerable difference to their quality of life."

In the ESTEEM studies, which form the basis of CHMP's positive opinion for apremilast in psoriasis, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint.6,7 Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients' quality of life and perception of disease severity.

In the PALACE program, which forms the basis for CHMP's positive opinion for apremilast in psoriatic arthritis, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary endpoint. 7,11 Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.

In the two Phase III programs, PALACE and ESTEEM, the clinical response of OTEZLA was maintained through week 52 across multiple endpoints.

Across these phase III clinical studies, the most commonly reported adverse reactions were consistently diarrhoea, nausea, upper respiratory tract infection, tension headache and headache.6,11 These adverse reactions were mostly mild to moderate in severity. Gastrointestinal adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks.6,11 During the placebo-controlled phase of the clinical trials, the rate of major adverse cardiac events, serious infections, including opportunistic infections, and malignancies, was comparable between placebo and apremilast groups.

OTEZLA® was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In Canada, OTEZLA was approved for the treatment of moderate-to-severe plaque psoriasis in November 2014. A New Drug Submission (NDS) for psoriatic arthritis was submitted to Canadian Health Authorities in the second quarter of 2013. Marketing authorisation applications are ongoing in other countries, including Australia and Switzerland.

The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

Bad news for Stelara as Health Canada issue Important Safety Information on their website. Though rare, Health Canada say serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis) have been reported in patients treated with Stelara.

Quote:

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Dear Healthcare Professional:

Subject: Risk of exfoliative dermatitis and erythrodermic psoriasis with STELARA® (ustekinumab)

Janssen Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding the risk of exfoliative dermatitis and erythrodermic psoriasis associated with the use of STELARA®.

STELARA® is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

Cases of exfoliative dermatitis and erythrodermic psoriasis have been reported rarely in psoriasis patients receiving STELARA®. These skin conditions can occur within a few days of the patient receiving STELARA®. They can be severe and lead to hospitalization.

The Product Monograph for STELARA® will be updated to include the adverse events of exfoliative dermatitis and erythrodermic psoriasis. Please refer to the STELARA® Product Monograph for full prescribing information.

The symptoms of exfoliative dermatitis may be indistinguishable from erythrodermic psoriasis. Advise your patients to watch for and report these symptoms. In case of occurrence of these symptoms, appropriate therapy should be initiated. Treatment with STELARA® should be discontinued if a drug reaction is suspected.

There have been rare (≥1/10,000 to<1/1,000) reports of exfoliative dermatitis and erythrodermic psoriasis in psoriasis patients receiving ustekinumab. Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.

Physicians should be alert for symptoms of exfoliative dermatitis. These can appear as redness and shedding of the skin over almost the entire area of the body, which may be itchy and/ or painful.

A copy of this letter and the Canadian Product Monograph can be accessed at the Health Canada Web site and on the Janssen Inc. Web site.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious exfoliative dermatitis or erythrodermic psoriasis or other serious or unexpected adverse reactions in patients receiving STELARA® should be reported to Janssen Inc. or Health Canada.

We're often talking on Psoriasis Club about the costs of treatment and you may find this interesting as (Secukinumab) now going under the name Cosentyx could be pressured into offering a low price, after getting recommended approval as a first line treatment for psoriasis by the Committee for Medicinal Products for Human Use (CHMP)

Quote:

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A recommendation from the CHMP generally translates into an approval by the European Medicines Agency (EMA). Therefore, the drug can be expected to be launched early next year.

Cosentyx is an IL-17 inhibitor that targets the interleukin-17A, a pro-inflammatory protein. It is also being evaluated against other auto-immune diseases. The CHMP recommended the drug as a first-line treatment for the disease. This puts Novartis’ drug ahead of Johnson & Johnson’s Stelara and Pfizer Inc. and Amgen, Inc.’s co-marketed drug Enbrel.

Psoriasis is an auto-immune inflammatory disease, characterized by the formation and accumulation of scaly silver patches on the skin, with redness and itchiness. Patients are first treated with systematic therapies, such as methotrexate or ciclosporin. These therapies can be hard to tolerate, with severe side-effects. Some patients may not even respond to them. In such cases, patients are treated with drugs like Stelara or Enbrel. Stelara is a monoclonal antibody. On the other hand, Enbrel is a TNF inhibitor that blocks the action of tumor necrosis factor (TNF), associated with the body’s inflammatory response.

The first-line indication gives the drug an advantage over other available options. In earlier studies, Cosentyx was shown to have greater effectiveness than Enbrel. Novartis is currently conducting studies to evaluate Cosentyx's comparative efficacy with Stelara, results of which are due in the current quarter. Stelara generated sales of $1.5 billion in 2013. However, the drug is also prescribed for other inflammatory diseases, so not all sales can be attributed to the Psoriasis market. Amgen reported $4.5 billion in revenues from Enbrel, which is also approved for rheumatoid arthritis and psoriatic arthritis.

Cosentyx was approved for the same indication by the US Food and Drug Administration (FDA) in October. However, it is likely to face troubles on the pricing front. It will directly compete with methotrexate and other systematic treatments, for which many cheap generics are available.

Enbrel costs nearly $17,270 per year. Due to Cosentyx’s superioty, Novartis is likely to keep a higher price tag. Enbrel and Stelara are used only after first-line treatment has failed. Therefore, if Cosentyx is priced higher, insurance providers may limit its use to first-line treatment given to patients suffering from the severe stage of the disease, and not as a replacement for the two drugs.

Enbrel, which has been in the market for years and is widely used, is already being sold at heavily negotiated prices. Therefore, healthcare providers may be reluctant to shift to Cosentyx.

Despite strong trial results, Cosentyx’s success will also depend on the pricing. It can have an advantage over Stelara if ongoing trials prove its superiority over it. Stelara can cost between $28,000 and $55,000 per year, depending on the dosage. Hence, both the drugs can compete on pricing. Novartis should also expect to face pricing pressures from UK cost-watchdog National Institute for Health and Care Excellence (NICE). The agency recommends the drugs to be used by UK’s National Health Services, based on their costs, compared to additional benefits over current standard-of-care treatments. NICE can be considerably strict in its evaluations of cost-benefit analysis for new drugs. It did not approve the use of Stelara for psoriatic arthritis in March this year.

I am also a sufferer of psoriasis. Have had this horrible affliction for bout 12 years now and nothing has worked so far apart from light treatment but this was only short lived. I am now starting Fumaderm only on my 4th day. Today developed a red prickly heat rash on chest, back and arms for bout 20 mins. Is this what they call flushing? Can't wait to hear from anyone

Following on from other reports recently about Secukinumab showing good results when up against Enbrel, Novartis have announced it has received positive opinion recommending approval from the Committee for Medicinal Products for Human Use (CHMP) for a first line treatment of moderate-to-severe plaque psoriasis in adults.

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Cosentyx™ (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This recommendation would mean doctors could use secukinumab first-line to treat their psoriasis patients, as an alternative to other first-line systemic treatments, which have significant side effects. Currently, all biologic treatments for psoriasis, including anti- tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe.

Secukinumab (at a dose of 300 mg) is the first interleukin-17A (IL-17A) inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe. Secukinumab works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by the disease.

"This positive CHMP opinion for secukinumab as a first-line treatment of psoriasis brings us one step closer to approval in Europe and making clear skin a reality for psoriasis patients," said David Epstein, Division Head, Novartis Pharmaceuticals. "With this exciting news, we may change the way psoriasis is treated, as 50% of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time."

The ultimate aim of psoriasis treatment is clear skin for patients. In clinical studies, 70% or more patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) with secukinumab 300 mg during the first 16 weeks of treatment.

The CHMP opinion was based on the positive results of the Phase III clinical trial program in moderate-to-severe plaque psoriasis and follows the unanimous recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA).

The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted in approximately two months of the CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.

Otezla is once again showing good results, and this time it's two years use for psoriatic arthritis.
This follows on from the announcement last March which can be found here: Otezla gets FDA approval for Psoriatic Arthritis

Quote:

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Celgene Corporation, today announced that results from long-term (104-week) efficacy and safety analyses of OTEZLA® (apremilast) from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Boston. OTEZLA is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

In PALACE 1, 84 percent (144/171) of patients who completed one year (52 weeks) of 30 mg twice daily therapy continued to receive OTEZLA at two years (104 weeks). Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104.

Similar findings were observed in PALACE 4. In this trial, nearly 84 percent (168/201) of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively.

In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (inflammation of an entire digit), two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.

"Given the chronic nature of this condition, dealing with psoriatic arthritis can be an ongoing struggle for many people," said Alvin Wells, M.D., Ph.D., director, Rheumatology and Immunology Center, Franklin, WI. "Evidence-based data show that different treatment options are frequently required to continue to manage a patient's symptoms. At our center, we see patients with active psoriatic arthritis who present with significant disease activity despite effective prior treatments. These new data from ongoing open-label studies add to our understanding of how apremilast may help meet treatment goals in such patients."

Similar to adverse events (AEs) reported during weeks 0 to 52 in PALACE 1 and 4, most AEs reported during weeks 52 to 104 were mild or moderate in severity. The rates of diarrhea, nausea, headache and upper respiratory tract infection (URTI)—AEs reported in at least five percent of patients receiving OTEZLA 30 mg twice daily at 52 weeks in both studies—decreased or were similar between weeks 52 to 104 compared with the 0 to 52 week period. Rates of diarrhea, nausea, headache and URTI at week 104 in PALACE 1 and 4 respectively, were as follows: diarrhea (1.8 percent and 2.0 percent), nausea (0.6 percent and 2.0 percent), headache (4.7 percent and 1.0 percent) and URTI (4.7 percent and 4.5 percent). Serious AEs occurred in 4.7 percent and 5.0 percent of patients, respectively. In addition, discontinuation rates due to AEs in both studies decreased during the 52 to 104 week period compared with the 0 to 52 week period.