Sandoz a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer's EU-licensed Enbrel.

Quote:

---

Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer's EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis - more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs) and approximately 3.7 million Europeans with psoriasis.

"Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options** such as etanercept" said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. "The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics" McCamish continued.

The regulatory submission to the EMA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide clinical confirmation of similarity to the reference product established in extensive prior analytical comparability studies.

Sandoz has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader and currently markets three biosimilars. On 3 September, 2015 Sandoz launched the first biosimilar in the United States and recently had its regulatory submissions for biosimilar etanercept and biosimilar pegfilgrastim accepted by the FDA. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programs in Phase III clinical trials or registration preparation. The company plans to make 10 regulatory filings over a three year period (2015-2017). As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

I am experiencing an outbreak after a long time in area I had not had problems with for years. The curious thig was that prior to my elbows flaring up I noticed i had lost all the pigment in those areas, it was totally white,then it happened on my ankles a few weeks later the scaling, but pigment is still missing, has anyone else experienced this, its a first for me.

EDIT By Fred: Mention of website removed.

What is an Autoimmune Disorder?

Your body's immune system is responsible for fighting what is perceived to be foreign invaders threatening your body's health: bacteria, viruses and fungi are just a few examples. Your good health depends partly on two important features of the immune system:

It should be able to recognize all tissues and organs within your body as "self" and therefore exempt them from attack by the immune system.
It should be able to identify foreign invaders as "other" to participate in their destruction and mobilize other parts of the immune system to participate in this attack.
Unfortunately, when you have an autoimmune disease, your body's immune system mistakenly confuses what is "self" with what is "other." Instead of protecting your body, the immune system produces cells and chemicals that attack your own body, causing damage and disease. Rheumatoid arthritis; some types of thyroid diseases; and anemia, lupus, celiac disease and type 1 diabetes are also autoimmune diseases.

Why is Psoriasis an Autoimmune Disorder?

As part of its defense against foreign invaders, your body's bone marrow and thymus gland collaborate to pump out specialized white blood cell warriors called "T cells." Under normal circumstances, T cells are programmed to identify and coordinate an attack on enemy combatants.

When you have psoriasis, T cells mistakenly identify your skin cells as "other" and attack them. This attack injures the skin cells, setting off a cascade of responses in your immune system and in your skin, resulting in skin damage (that is, swelling, reddening and scaling).

In an effort to heal, your skin cells begin reproducing rapidly. Activities that should take a month take place in only days, and abnormally large numbers of new skin cells push their way to the surface of your skin. This occurs so quickly that older skin cells and white blood cells aren't shed quickly enough. These discarded cells pile up on the surface of the skin, creating thick, red plaques with silvery scales on their surface: the hallmark of the classic form of plaque psoriasis.

This small study suggests EDIL3  (epidermal growth factor-like repeats and discoidin I-like domains 3), AMOT (angiomotin) and ECM1 (extracellular matrix protein 1) is altered in DMSCs (dermal mesenchymal stem cells) in psoriasis.

Quote:

---

Background:
Dermal microvasculature expansion and angiogenesis are prominent in psoriasis. Our previous microarray study showed that the angiogenesis-related genes EDIL3 (epidermal growth factor-like repeats and discoidin I-like domains 3), AMOT (angiomotin) and ECM1 (extracellular matrix protein 1), had high expression levels in dermal mesenchymal stem cells (DMSCs) from psoriatic skin lesions.

Aim:
To investigate the mRNA and protein expressions of EDIL3, AMOT and ECM1 in DMSCs derived from psoriatic skin in order to better determine the molecular mechanisms of angiogenesis in the skin.

Methods:
DMSCs from 12 patients with psoriasis and 14 healthy controls (HCs) were cultured to passage 3, and identified by morphology, immunophenotype and multipotential differentiation. The mRNA and protein expressions of EDIL3, AMOT, and ECM1 in the DMSCs were determined using real-time reverse transcription PCR and western blotting.

Results:
DMSCs displayed spindle-like morphology and surface protein expression, and were able to differentiate into osteoblasts, chondrocytes and adipocytes. mRNA expression analysis showed that EDIL3, AMOT and ECM1 were expressed at 2.54-fold, 2.11-fold, and 1.90-fold higher levels, respectively, in psoriatic DMSCs compared with HC DMSCs (all P < 0.05). Protein analysis showed significantly (all P < 0.01) higher concentrations of EDIL3, AMOT and ECM1in the psoriasis group than in the HC group.

Conclusions:
Our data demonstrate for the first time that expression of EDIL3, AMOT and ECM1 is altered in DMSCs in psoriasis, suggesting that EDIL3, AMOT and ECM1 are involved in the excessive angiogenesis and vasodilation observed in psoriasis.

This is a population-based cross-sectional study which set to evaluate the association between psoriasis, serum uric acid levels and gout in a cross-sectional study using the US National Health and Nutrition Examination Survey (NHANES) database.

Quote:

---

Background:
Psoriasis has been reported to be associated with raised serum uric acid levels and gout, and uric acid has been demonstrated to mediate inflammatory pathways via secretion of pro-inflammatory chemokines.

Aim:
To evaluate the association between psoriasis, serum uric acid levels and gout in a cross-sectional study using the US National Health and Nutrition Examination Survey (NHANES) database.

Methods:
Data on clinical history of psoriasis, gout and other relevant medical conditions from the questionnaire as well as laboratory parameters for serum uric acid and lipid levels in the periods 2003–2006 and 2011–2012 were analysed. Multivariate analysis with logistic regression modelling was performed, with hyperuricaemia as the dependent variable, and age, sex, ethnicity, body mass index, metabolic syndrome, current smoking status, alcohol consumption and history of psoriasis as the independent variables.

Results:
Of the 11 282 study participants, 297 (2.6%) reported a history of psoriasis and 1493 (13.2%) were found to have hyperuricaemia. Patients with psoriasis were at increased risk of having hyperuricaemia, compared with those without psoriasis (OR = 1.37; P = 0.04). They were also more likely to report a history of gout (OR = 1.83; P < 0.05). However, neither association was significant after adjusting for potential confounders with multivariate logistic regression.

Conclusion:
In conclusion, there was insufficient evidence to show that psoriasis is an independent risk factor of hyperuricaemia or gout. A raised serum uric acid level may be a consequence of metabolic syndrome, which in turn is associated with psoriasis.

According to the British Association of Dermatologists (BAD) the NHS UK are wasting millions of £s on GP's prescriptions for psoriasis. They estimate that the NHS could save around £2million a year if dermatology items listed were obtained from NHS manufacturers and not from pharmacists. For example, one treatment used for psoriasis, coal tar 10% ointment, is listed in the Tariff3 at £274.27, an item which is available from an NHS Specials manufacturer for £15.49 (a 17-fold increase, or an increase of 1670%).

Quote:

---

The British Association of Dermatologists is urging the government to revisit a policy that allows certain medicines prescribed by GPs to cost up to 17 times more than the same drugs prescribed in hospitals, needlessly wasting the NHS millions of pounds each year.

Most drugs prescribed by doctors are ‘licensed’ medicines which have been approved for sale in the UK. When suitable licensed medicines are not available, the Medicines Act allows doctors to prescribe unlicensed medicines. For many common skin diseases including psoriasis and eczema, the range of licensed medicines is limited. As a result, doctors rely greatly on unlicensed creams and ointments, known as special-order medicines, or ‘Specials’. Such medicines are commonplace in dermatology - the British Association of Dermatologists (BAD), for example, recommends 39 Specials for use in skin disease treatment.

However, the BAD has learnt that prices for Specials when prescribed in the community, as opposed to in hospital, are up to 1670 per cent, or 17 times, higher than the same drugs for secondary (hospital) care patients. This huge cost to the NHS is resulting in patients being denied access to treatment, as GPs and the Clinical Commissioning Groups who oversee them are unable to justify such high costs. And the problem is not limited to dermatological Specials, with medicines for other disease areas also being prescribed at greatly inflated prices.

Specials on the Drugs Tariff

In England, when a community pharmacist supplies a patient with a medicine that has been prescribed by a GP, the pharmacist receives a payment from the NHS for this drug. The amount they receive is a set amount, specified in the ‘NHS Drug Tariff’,1 and nine of the dermatology Specials on the BAD’s recommended list of 39 are listed on this Tariff.

The price set out in this Tariff has been decided by the Department of Health, based on an average of costings provided only by members of the Association of Pharmaceutical Specials Manufacturers (APSM), all of whom are private companies, and the Tariff price does not take into account much cheaper quotes from NHS manufacturers.

However, the majority of dermatology Specials are made within NHS hospitals, by hospital manufacturing units, who provide Specials to the NHS at prices reflecting lower manufacturing costs. Among the reasons for the lower costs is the fact that these units are able to produce the medicines in large batches. Conversely, APSM members provide the same drugs at far higher prices, in part due to the bespoke, non-batch approach to the manufacturing.

This system means that in England, Wales and Northern Ireland, a whole-of-market quote has not been obtained for Specials, leading to excessively high prices charged to the NHS for these drugs.

Regardless of where a community pharmacist sources a Special medication from - be it a costly version from a private company or a cheaper version from an NHS manufacturing unit - the pharmacist receives the same reimbursement from the NHS as defined by the Tariff, allowing for large profit margins.

For example, one treatment used for psoriasis, coal tar 10% ointment, is listed in the Tariff3 at £274.27, an item which is available from an NHS Specials manufacturer for £15.49 (a 17-fold increase, or an increase of 1670%). Even allowing for some margin and procurement costs for supplying community pharmacists, a mark-up of £258.78 on an item costing £15.49 is wildly excessive. Salicylic acid 20% ointment (used to treat hard skin build-up in skin disease) is available for £27.25 from NHS manufacturers but has gone on Tariff at £246.93 (806% increase), while another medicine, salicylic acid 2% / sulfur 2% in aqueous cream, is available at £28.68 but has gone on Tariff at £215.85 (652% increase).

In Scotland, NHS Tariff prices are far lower, for example 5% coal tar ointment, used to treat psoriasis, is on the Scottish Tariff at £26.47 and on the English Tariff at £231.28, while 2% eosin solution (used for skin infections in leg ulcers) is listed at £27.60 versus £229.13 in England.

Dr Deirdre Buckley, Chairman of the Specials Working Group of the British Association of Dermatologists said: “The tariff-setting system used by the Department of Health in England relies on an arrangement with the APSM, a body representing only private manufacturers, rather than a mixture of NHS and private. An average of prices paid to members of the APSM, which are much higher than NHS manufacturers’ quotes, are used by the DH to decide the NHS Tariff price.

“The margins of over a thousand per cent attached to NHS Dermatology Special medicines during the Department of Health's tariff-setting process seem wildly excessive. It appears to us that the taxpayer is being overcharged for the sole benefit of community pharmacists and some private Specials pharmaceutical manufacturers, or more worryingly, our patients are denied the medications they need because they are too expensive.”

The British Association of Dermatologists acknowledges that the current tariff-setting process, put in place by the Department of Health in 2011, has led to savings for the NHS, but is asking the government to review the process in light of the highlighted issues, and to ensure further cost savings by including NHS manufacturing units in the equation.

Health Canada has approved Beteflam (betamethasone valerate topical patch), a novel, patent-protected treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients.

Quote:

---

Cipher Pharmaceuticals Inc. today nnounced that Health Canada has approved PrBeteflam™ (betamethasone valerate topical patch), a novel, patent-protected treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients.

"We are pleased to make Beteflam available as a valuable new treatment option to Canadian dermatologists and to the patients who suffer from this disease," said Shawn O'Brien, President and CEO of Cipher. "Psoriasis affects one million Canadians1 and can profoundly impact the quality of life for many patients. Once the product is launched in Q2 2016, Beteflam is expected to be our fourth marketed product in Canada behind Epuris®, Vaniqa®, and Actikerall™. With potentially six commercial products on the Canadian market by the end of 2016, we have multiple new near-term revenue streams as we work toward our goal of reaching $50 million in annual sales in our Canadian dermatology business."

Topical corticosteroids remain the primary treatment for steroid-responsive inflammatory skin diseases, including mild to moderate chronic plaque psoriasis. Occlusion with plastic film dressings is a widely accepted procedure to enhance their efficacy, especially in the treatment of psoriasis. Beteflam is a patch that is applied once daily to the affected region and may be cut to fit the particular size and shape of the psoriatic lesion thereby reducing potential contact of the steroid with healthy areas of skin.

Cipher licensed the Canadian rights to Beteflam from Institut Biochimique SA ("IBSA"). The efficacy and safety of Beteflam was demonstrated by two randomized, active-controlled studies involving 555 patients with mild-to-moderate chronic plaque psoriasis, of which 281 patients received Beteflam. The results of the clinical program demonstrated that the clinical efficacy of  Beteflam  was superior to that of  betamethasone valerate 0.1% cream and comparable to that of Dovobet 50 µg calcipotriol plus 0.5 mg betamethasone dipropionate ointment. The commonly reported adverse drug reactions that occurred in patients using Beteflam were skin and subcutaneous tissue disorders, occurring in < 5% of patients treated.

Hello everyone,

I decided to join tonight, I like many have been dealing with this for years, 1993 to be exact, I was using a topical treatment that helped for the most part. Then went through a divorce and could no longer afford the doctors visits or medication. For the last 13 years  I have been basically just using hand cream , my areas that were affected were limited to my ankles so socks is a constant .  I must admit the last doctor I went to years ago when I showed him my legs which was very bad at the time, well he almost looked disgusted, so I am reluctant to show another doctor, I am sure they will want to know why I have not sought treatment before now.  Over the last two weeks I noticed the skin color had changed on my elbows an area where I had problems years ago, it looked as if all my pigment was gone  then about a week later I had scales again in the areas that had been clear for years.  I am now experiencing it on the palms of my hands and it itches like crazy.  Because I am in at a better place financially i have am considering  making an appointment with a dermotogogist and see if any of these new products I hear about can help.  I get so scared though when they start listing symptoms for so many of these new drugs like lymphoma, so I ask myself is it worth the risk.  I am hoping to hear what is working for others and hopefully gain some confidence to seek help.

I my names Ali ..had psoriasis for a long time now ..covers most of me body ..never been clear just always thier ..tryed loads of steroid creams ..find doublebase moisture seems to easy it little.  Anyway thank-you for letting join cheers

Hi, I'm Rosella, poke my nose in and isn't sure what's my type as suffer as well, had use home clinic provided cream and other. I gain a lot of weight for foot pain because it's where it start. I won't say I'm frustrated, because telling myself it isn't to live with. 

I saw Foundation on twitter, and screw my moody issue to come here because my friend always cheers on her favorite idol Misha Collins and cast. I don't have foot pain any more, but random small patches had show up back of the neck and up into hair scalp. Back of foot heal partially as whole should be, at least it is better than last time, nearly cover two toes.

I agree to see clinic soon as don't want to scare them with my back of neck and hair scalp also starting to show. This few years are despondent.

I've been given this piece of information from one of our roving reporters and thought it may be of interest to our members from the USA. If any member from the USA has more information please add it here or let me know, but this is all I have for now.

Quote:

---

The FDA is holding a public meeting to gain patient perspectives on treatments for psoriasis.

The meeting — scheduled for March 17, 2016 — is part of the agency’s Patient-Focused Drug Development initiative. Under that initiative, the agency plans to obtain patient perspectives on at least 20 disease areas during the course of PDUFA V. For each area, the agency will conduct a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefits that matter most to patients, and patients' perspectives on the adequacy of the available therapies.

The meeting will focus on patients' perspectives for plaque psoriasis, nail psoriasis and guttate psoriasis.

The public can submit comments to regulations gov

Morning Everyone!!
                  It's a wonderful morning sitting at my computer waiting for the sun to come up and thinking about stuff! So i was thinking about making a doctors appointment and maybe trying to get on one of those new meds......I was on Methotrexate about 6 years ago and it cleared me right up but I was the most tired I have ever been in my life and it was hard working feeling like there was a bag of rocks tied to me 24 hours a day. And where I live is in the middle of nowhere and getting anything done is a severe pain in the a$$!!! So what I'm asking is.....will it be worth it??? I'm ok most days about my skin as it's ugly but bearable....I would post pics but it doesn't seem that easy....anyway any feedback would be appreciated.

I had my first outbreak of psoriasis in 1998. I was 22 I'm now 41. I have plaque psoriasis and it's super aggravating and I would say I'm moderate to mostly severe. I have tried creams, lotions, ointments and methotrexate. Methotrexate worked the best for me but it really screwed with my liver levels so I no longer take it. I am wondering if anyone has tried Otezla? I live in Canada and can not find where to buy this medication and I also can't find any reviews on it. 
TIA

Stumbled onto some article in the new scientist magazine (Dutch version) about CRISPR. This is a technology, no a "thing" in the DNA, that interacts with the immune system.
It looks promising as it is a gene changing technique and it is possible that it might produce a cell type or a change in a cell that increases the resistance against inflammatory reactions e.g. against arthritis.
So basically it might be a possibility to attack autoimmune diseases by gene adaptation.

If your search for Breakthrough DNA Editor CRISPR on google you can find information on it better than I can describe.

The interesting thing again is.... It is not patentable as it is in all cells in your body. Which is of course great, because now everyone on earth can work with it and the money rats cannot touch it.

I joined this site just one week ago, and have already appreciated its true value. Having suffered with psoriasis for 24 years it was well over due! But I'm glad I did. Never a friendlier bunch of crazy people have I encountered in one space (apart from maybe my Facebook friends), but the big difference is our shared experience of this unpleasant (and for many, distressing) condition.

If anyone should stumble upon this site just as I did, please stay and join in, you will be made very welcome

And so my journey begins. I started taking Fumaderm on 5th November 2015, so I shall back track a little to create a fuller picture.

Week 1, Day 1. Very excited! One dose of Fumaderm initial each day for one week. No adverse effects to report for the week.

Week 2, day 1. So far so good. Two initial doses, all good for a few days.

Week 2 day 3(approx). My first flush today around 2.00pm - wow! Looked and felt like a beacon, lasted around 20 minutes. Nothing there after.

Week 2, day 4. My first cramp - and I felt it. Happened around same time, accompanied by a milder flush. Was unpleasant but copable, lasted around 10 minutes then as good as new.

-this pattern continued for the rest of that week-

Week 3 day 1. Increased initial dose to 3 per day. First day, same as above though symptoms lessening.

Week 3, day 2. Woken with flushes but not severe (quite pleasant!).  Later, nausea lasting around 20 minutes. Not pleasant!

-these symptoms continued through the course of the week, though for brief periods -

Week 4, day 1. Increased dose to 1 x 120mg. Normal day, slight cramps and flushes.

Week 4, day 2. Woke to severe nausea and cramps. Very painful and unpleasant, lasted approx 30 minutes and felt  fatigued afterwards - worse day so far. When passed, felt normal for rest of day.

Week 4, day 3. Woke poorly again, severe cramps and nausea, flushes now extending to hands accompanied with itching. Once passes, very tired then all OK.

Week 4, day 4. Woken with severe cramps and nausea, this time extending to sickness, extreme fatigue afterwards, slept and woke half hour later feeling normal again.

Week 4, day 5. Woken with cramps/nausea and sickness again. Mild flushing. Lasted approx an hour, felt OK once passed. No side effects for rest of day. Took decision to change timing of meds from dinner to lunch time to avoid morning side effects. Experienced brief cramps in evening but very mild.

Week 4, day 6 (today). Woke this morning with no side effects at all! Took meds at lunchtime, experiencing a little nausea and cramp whilst writing this and feel a flush coming on but very mild all considered, compared to morning experiences.

That is all for now folks, will update when necessary.

Hi all am new here,had psoriasis all my life, just like everyone else looking for the way out.

Good morning everyone 

I'm looking for some recommendations for controlling the side effects I'm getting with Fumaderm. I've just finished the initial course where I suffered cramps and nausea, which passed quickly and I managed with a dose of liver salts when necessary.

Last night I took the first dose of 120 mg, and woke up early this morning with the worst cramps and nausea which led to vomiting for Wales (where I live ).  This has happened before though never as bad as today. They've passed now and I feel great!  My concern is that I start a new job next week and I really need to curb these side effects as much as possible not to allow it to affect it.

Can current Fumaderm users recommend may over the counter remedies that may prevent the severity of these side affects? I've still got a lot of increase in doseing to go and its worrying me a bit...

Thank you 

I'm sure lots of people get hangovers after drinking but I am zombie for a day or two after Cosentyx. So has anyone figured out how to sober up after an injection?

Following on from the report about Otezla getting refused by NICE (National Institute for Heath and Care Excellence) for psoriatic arthritis NICE says no to Otezla for psoriatic arthritis they have also now confirmed it will not be used for psoriasis.

Quote:

---

NICE does not recommend apremilast (also called Otezla and manufactured by Celgene) for treating adults with moderate to severe chronic plaque psoriasis.

People whose treatment with apremilast was funded by the NHS before this guidance was published should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Hi all,
I am new in the forum.
I have been having psoriasis for more than a year and a half now in my private areas (penis and scrotum).
I am mainly treating myself with Trimovate cream which I think is a corticoid (and I think that medicine has the danger of thinning the skin) but is the one that help me the most of all treatments.
I am also sometimes using Protopic cream 0.1% or Advantan cream and when I manage to control it I maintain with Dexeryl.
Last week I had the psoriasis coming bad again and I spend a week using twice a day Trimovate cream until I got a bit better.
After using the Trimovate for a week I had sexual relations with my girlfriend. The penis was extremely red and too sensitive after the sexual relations. The next day the penis was still red and still sensitive with a tiny superficial wound in it. I fear that the skin got thinner due to the use of the cream. 
How could I find out if the reason the skin in that area being so sensitive? how could I find out if is due to the psoriasis or to the skin becoming thinner there?
If part of the cause of this is the thinning of the skin: are they any solutions for this? or would I have a thin skin forever now and would have this problem now for good?.
Anyone with an experience similar to this?.
Any doctors/hospitals out there that are considered the best on this kind of psoriasis?.
I am only 40. Any hopes or ways to improve or recover from this situation?.

Any help or support would be greatly appreciated.