Good news for South Korea after Merck (known as MSD outside the United States and Canada), and Samsung Bioepis announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea.

Quote:

---

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. BRENZYS is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older).

The approval of BRENZYS in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch BRENZYS in South Korea by the end of this year or early next year.

“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of BRENZYS in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our collaboration with Merck.”

“The approval of BRENZYS in Korea is a key milestone in Merck’s longstanding commitment to improving access to important medicines,” said Dora Bibila, general manager, Merck Biosimilars. “We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of BRENZYS – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis.”

Merck’s launch of BRENZYS will include comprehensive education and support services for healthcare professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.

The approval of BRENZYS in Korea was supported by rigorous analytical structural and functional testing, as well as a Phase 1 crossover pharmacokinetics study and a Phase 3 clinical study comparing BRENZYS to the originator medicine.

hi every fellow sufferer i have come to realise that creams and moisterises wont cure psoriasis the cure must come from within with that in mind i recently had a bad flare up which affected my body and face i realised i had eaten a lot of biscuits and bread so i decided to give up eating anything which contains wheat let me tell you its in nearly everything so i am carefull to read the ingrediants.
i also have a nutri bullet its a smoothie maker so every day i have one which includes fresh banana and carrot,frozen spinach because its eaier to keep fresh and green vedgtables are very good for the skin also frozen fruits like strawberrys,blueberrys ect.
i avoid drinking tap water because of the flouride i noticed since only using bottled water in my kettle the element is still like new wow since i started this diet about two weeks my psoriasis has faded i no longer have it on my face and i look healthy,it just goes to show i must be doing something right its not difficult the nutri bullet did cost me about £100 but its the best £100 ive ever spent apart from the £130 i paid for my guitar.
so if anyone wants to give it a go the worst thing that can happen is you might loose some weght which in my case is welcome as i weigh 17 stone 
i just hope i can help a fellow sufferer god bless dougie

Evening all

I have got psoriasis on knees and elbows. I have had it for several years and have only tried prescribed creams.

Has anyone tried kalawalla and has it made a difference.

Cheers

Matt

Hi peoples,

Thought i'd post a time-line of what ( and no doubt i'm not alone here )  how where what why etc., regarding the beginnings and following treatments
and whatnot

My psoriasis started after a massive RTA in which i was a helpless passenger.  This RTA was '87 and i was in a ward for 2 months, and another 2 years recovery, wheelchairs, walking sticks, some bone complications, due to the fractures and hip dislocations,  but over the following years, i've got back to almost normal , physically, but with metal hips, and many scars , most of which thankfully, have faded a lot

But 2 years after that in '89 i developed psoriasis, and the med staff tell me that it was probably the crash that kicked it off.  Massive impact trauma can do that, although they also told me that its hereditary.  I've never known any of my immediately family to have P  ( mum, dad and one older sister )  and maybe if i'd thought about it, i could have asked my dad or sister at the time. Mum had already been slaughtered by cancer at the age of 44  so she wasn't around by the time P started, and now my dad is the only one left, as my darling older sister was also taken by cancer at 59 years, 4 years ago

Still,  knowing who else had it is not important to me really. But going back to '89 and the kick starting of P, i was,  like many,  given a succession of useless creams over the next 18/19 years. I'm sure someone benefits from creams or ointments, but they did nothing for me whatsover.
And its not like i had vicious psoriasis like some folk.

Plaque on elbow tips, nothing vast ..about 1" to 1.5" across on each elbow, inside ears, back of ears,  scalp line  ( minimal again )  , a bit in mustache  and beard areas, and centre of chest,  some dotted around on the scars from the previous RTA  ( P seems to love scar tissue for some reason )

That was just about the extent of plaque

Under arms and top of inner thighs where i had the inverse.

Skipping the long boring 18/19 years of useless creams, i get to the point where i get offered tablets.

Those consisted of  MTX,  Acitretin, Cyclosporin, and now Fumaderm 

MTX was the most brilliant drug out of anything i'd ever been given. It killed my P dead, everywhere.  But MTX is a nasty old piece of work, as most know, and during the constant and essential 2 weekly blood tests,  eventually they revealed the start of liver hep. and had to come off the MTX. No problem, the liver recovers. I never felt a thing so its a good job i had the blood tests or i wouldn't have even known. The other side effects  were livable with

Acitretin .. horrible. Nasty. Peeled like a leper on hands and feet to such a degree that i didnt even leave the house. Other side effects were equally nasty. 
Didnt do a lot, weaker than MTX with worse side effcts ( apart from liver damage )

Cyclosporin .. not bad at all, but not in MTX's league. Got shot of all P except inverse top of inner thighs , and it almost got that, but not quite. Side effects not quite as bad as Acitretin but still bad enough.  Kidney functions probolem picked up by blood tests ended the course of Cyclo. Still didnt feel a thing , so, good job the blood tests picked up on the kidney probs, as i wouldn't have known

Fumaderm.. started 9 months ago on initial, and progressed to the max 6 tabs a day.  Again, they have kept all plaque P at bay, ihave none at all. But as with all the others apart from MTX, the top of inner thighs is THE most stubborn area. It simply will not give it up.
The firece red patches ( elephants ears ? )  are a faded pink, but they still look like  P patches, and although i'm grateful that all the plaque disappeared years ago, and the only bit of P i have now is those 2 inverse patches, i'm still greedy and want to clear those up.

Fumaderm seems pretty good ( not as good as MTX in my book ) the side effcts are minimal. I've had the burning, bit in 9 months i've probably had it about 3 times and each time lasted about 1 or 2 minutes.  I sneeze a lot, though it never turns into a cold, and my sleep patterns are pretty grim, but all these are laughable.

At one point, before the Fumaderm was given, i asked about Biologics, as i had read about this on the net, and these were never ever mentioned before by my derm consultant. Well i soon found it why ... the answer given was ' too expensive ' and you have to have pretty bad P to be given Biologics, due to this cost.

Fair enough !

Next derm visit is November, and the consultant has juggled with the idea  ( at my insistance ) of perhaps going back on MTX, just to to get over that last hurdle, and it wouldn't take long for the MTX to do its job, since it would be starting at a point that was much further along the line than when i first had MTX, when it had to deal with what looked burns from a house fire.

Once the MTX had killed the last of it, then back to Fumaderm to keep it down and managed.

Phew !

As you were

Just popping into the intro section to say hello and will be posting  soon.

My sleep patterns keep me awake and then i sleep for 10 hours - weird

Hi new to this site.I am 42 years old and I have had psoriasis since I was 14 years old.I started taking methotrexate about 18 months ago.Started off really well with it.After 6 months during the winter months the effects started to wear off.I came back off holiday on 20th of July and I was totally clear(as is usually the case when I have had 2 weeks in the sun) but usually after being back for about 3 weeks my psoriasis slowly starts to reappear.However this year has been different.I was told by a couple of ladies how marvellous extra virgin raw organic coconut oil was and the health benefits that come with it.I thought I would give it a try and purchased a 1l jar.I used it as a moisturiser all over my body twice a day.Nearly 2 months after my holiday and I am still totally clear and my skin has a really healthy glow about it.Even my elbows and knees are really soft and showing so signs of dryness.People have even commented on how healthy and glowing I look.Thought I would pass this on as I am really made up with its results.Feel free to contact if anyone has any questions.Thanks.

Here's an interesting study that looked at the S100 group of proteins to see if there is a biomarker for disease activity in patients with psoriasis, it suggests S100A12 showed the closest association with disease activity and therapeutic response and might therefore provide a valuable biomarker for psoriasis.

Quote:

---

Background:
Psoriasis is a chronic skin disease with deregulation of proteins in the immune system. These proteins include members of the heterogeneous S100 family, which have been discussed as potential biomarkers for disease severity.

Objective:
The aim of this study was to evaluate the impact of S100A7, S100A8, S100A9 and S100A12 as possible markers for disease activity in patients with psoriasis skin disease.

Patients and Methods:
S100A7, S100A8, S100A9 and S100A12 mRNA expression was determined in the skin of patients with psoriasis and controls (N = 341) by gene expression analyses. In addition, S100 serum levels were investigated by ELISA in an independent cohort of psoriasis patients (i) untreated, with different manifestations (skin/joints), (ii) under treatment (etanercept) and (iii) healthy controls, (N = 55).

Results:
All S100-subtypes included are significantly upregulated in psoriasis skin lesions when compared with atopic dermatitis, lichen ruber and healthy donors. In untreated psoriasis patients, S100A12-serum levels showed the closest association with disease activity (PASI) (r = 0.542; P < 0.01). Serum levels decreased under treatment with etanercept (P < 0.05).

Conclusion:
Among the investigated S100-proteins, S100A12 showed the closest association with disease activity and therapeutic response and might therefore provide a valuable biomarker for psoriasis.

NICE (National Institute for Heath and Care Excellence) have finally said No to Otezla for the treatment of psoriatic arthritis, it's been heading that way for a while but now it's official.

Quote:

---

NICE has published final draft guidance today which does not recommend apremilast (Otezla, Celgene) for adults with active psoriatic arthritis that has either not responded to disease-modifying antirheumatic drug (DMARD) therapy, or where such therapy is not tolerated.

Psoriatic arthritis is an inflammatory disease affecting the joints and connective tissue, and is associated with psoriasis of the skin or nails. It is a lifelong, progressive disorder, ranging from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

People with psoriatic arthritis are usually treated initially with non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. Most people whose disease doesn’t respond to these drugs will be treated with a tumour necrosis factor alpha inhibitor (TNF-alpha inhibitor) starting with the lowest-cost drug as recommended in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis and golimumab for the treatment of psoriatic arthritis.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “Psoriatic arthritis is a chronic condition that can have a significant physical and psychological impact on an individual’s life, employment and social activities. Around 10% of patients stop TNF-alpha inhibitor treatment each year, either because it is contraindicated, or because of loss of effectiveness or adverse effects. There is, therefore, a clear clinical need for a range of treatment options.  

“The Committee considered the evidence on the use of apremilast both before and after TNF-alpha inhibitors and for people who aren’t able to take TNF-alpha inhibitors. The Committee concluded that apremilast is clinically effective compared with no other treatment. However, compared with TNF-alpha inhibitors, apremilast was the least clinically effective for treating psoriatic arthritis although some costs were saved by its use. Importantly, there was not enough robust evidence demonstrating that apremilast slows progression of the disease compared to TNF-alpha inhibitors. The Committee concluded that they were unable to recommend apremilast for treating active psoriatic arthritis because the costs saved were not sufficient to justify the health losses.”

This draft guidance does not mean that people currently taking apremilast will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until final guidance is issued to the NHS, NHS organisations should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Following on from the announcement that Amgen had dumped Brodalumab see here: Amgen dump brodalumab after some patients had suicidal thoughts. AstraZenaca announced they have granted an exclusive license for Valeant Pharmaceuticals International, Inc to develop and commercialise brodalumab.

Quote:

---

AstraZeneca today announced that it has entered into a collaboration agreement with Valeant Pharmaceuticals International, Inc. under which it will grant an exclusive license for Valeant to develop and commercialise brodalumab.

Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Under the agreement, Valeant will hold the exclusive rights to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen Inc., the originator of brodalumab. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in US and EU for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015.

Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100 million as well as additional pre-launch milestones of up to $170 million and further sales related milestone payments of up to $175 million following launch. After approval, AstraZeneca and Valeant will share profits.

Brodalumab is supported by data from the three AMAGINE Phase III pivotal studies1 . The results highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210 mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.

Pascal Soriot, Chief Executive Officer, said: “Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology.”

J. Michael Pearson, Chairman and Chief Executive Officer of Valeant, said, “We are delighted we were able to reach a licensing agreement with AstraZeneca to commercialize brodalumab, which is potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis. We remain fully committed to dermatology and will continue to advance our pipeline of internally developed and acquired products.”

The transaction is expected to complete in the fourth quarter of 2015, subject to customary closing conditions, and it does not materially impact AstraZeneca’s financial guidance for 2015. As AstraZeneca continues to retain a significant interest in brodalumab, the upfront payment and any potential subsequent milestone payments are expected to be reported as Externalisation Revenue.

I have been on a regimen of 0.8 ml MTX (20mg/ml) weekly to control my plaque Psoriasis. It has been wonderful and basically left me symptom free for 4 yrs . Recently I have noticed some recurrence of scalp issues....
I have monitoring labs every 8 wks, and all has remained "normal".
Anyone have any info on relapse in the face of ongoing treatment?
thanks.

Hi-

Brand new to this forum and interested in hearing others' experiences.

I was dx. with PsA Jan. 2014. I immediately went on the auto immune paleo diet and started Mtx8. I have significant shoulder tendon damage and cervical spine degeneration. I was on MtX8 for 14 months, in combination with Humira for 2 of those months. The Humira caused some infections immediately but the combo caused my WBC to tank. I took a break from the meds and have been on low dose naltrexone at varying doses for the past 2 months, at 4.5 mg. for the past 2 weeks. I went up rapidly to try and stay ahead of the increasing pain.

I'm not opposed to trying meds again but am wondering how long I should give LDN on it's own? Does anyone on this site take LDN with MtX8? I'm concerned that the combination of MtX8 and a biologic, in this case looking at Enbrel, will similarly impact my WBC. If so, maybe LDN can be used w/ Enbrel to reduce risk of antibodies?

OK! it has been suggested I start a thread about my Acitretin journey!!.. This is my back now its not as bad as it was because i had just come out of the sun and sea!!!!!I started the medication on Tuesday 18/8/15!  I will post another picture in a few weeks!!   I hope this is of some help to others starting out on this road!!  
[img][/img]

Hi everyone!  My name is Steve but everyone calls me fingers!..even my own son!!
I have had psoriasis for over 15 years! I have been on methotrexate and cyclosporin  over the years but was taken off ...I have just started Acitretin this week and stumbled across this forum while reading about it!!!....I hope I can exchange experiences and information with you good people!
I look forward to talking with you all....best wishes, fingers!

I am posting on behalf of my 76 year old husband. We are having a lot of problems controlling the psoriasis although we are seeing the dermatologist on a regular basis. Ciclosporin did work but sadly blood tests showed that it also affected the liver and kidney function. The Doctor then tried reducing the dose but this did not help. My husband has been started on Fumaderm and took his first tablet on Wednesday night. He felt very sick today but I realise that this might be a side affect and am going to encourage him to keep taking it. He is still on Acetretin because the dermo felt he needed the overlap to prevent flare ups. I would say that the flare ups have been very bad and he has had to have antibiotics due to the infections. He is having a lot of problems walking due to the skin on his heels peeling.
I just wondered how others coped with Fumaderm?  The Dermo did say that around a  third of people have to come off it due to the side affects.....
If it does not work, the next option is injections but my husband is very against these. Also he has anaemia which is being investigated and the dermo wanted to find the cause of the anaemia before going down this route. He also has Lupus which is thankfully dormant at the moment. I do now understand that some of the medications initially used to treat the Lupus may well have made the psoriasis worse or even sparked it.
Thank you for reading. I do feel very out of my depth trying to help my husband - I am his carer, and he does get quite depressed at times especially when he is really struggling to walk or get his shoes on.

Hi I'm new to this and I've had psoriasis for over 14 years. I have tried all the usual creams light treatment, methotrexate and none have worked. I started on fumaderm initial 3 weeks ago and since my uptake has increased to 3 tablets a day I have suffered all of the side affects. The cramps are unbearable and I have a high pain threshold. I have also vomited. I don't want to stop the medication as it's improving slightly. Does anyone know what I can do to ease the cramps or how long they will last? Thanks in advance

I hope this helps one person ill be very happy since it cleared my husbands right up with no flare ups.  simple liquid iodine applied on affected area at night then wash off in morning plus one pill a day of potassium iodide. in 10 days it has disappeared.  please try and share if it helps great, we have battled this for 10 years taking every cream and pill tossed at him.

Does anyone else find that the sun seems to make no difference to their P? My plaques have been slowly but steadily growing this summer and I've been outside a lot.

I'm interested to know if I'm in a minority or perhaps not?

Hi,vim taking humira. After about 3-4 weeks since I started it, I noticed no difference until over the course of about 3 days my skin became completely clear. From 90% coverage to clear! But hen I woke up one day after injecting to see it coming back. And the next day, today, it's almost as bad as originally. I was wondering if this suggests my body will always find a way around it and whether or not I should expect to ever be clear on this again?

Many thanks

Smoking has for a long time been said to be bad for psoriasis, but could passive smoking also increase ones chance of getting psoriasis?

Quote:

---

Background:
Smoking is a potential risk factor for psoriasis. Both psoriasis and smoking habits are partly explained by genetic factors. However, twin studies investigating the association between these traits are limited.

Methods:
Questionnaire-based data on smoking habits and psoriasis were collected for 34,781 twins, aged 20–71 years, from the Danish Twin Registry. A co-twin control analysis was performed on 1700 twin pairs discordant for lifetime history of smoking. Genetic and environmental correlations between smoking and psoriasis were estimated using classical twin modeling.

Results:
After multivariable adjustment, age group (50–71 vs. 20–49 years) and childhood exposure to environmental tobacco smoke (ETS) were significantly associated with psoriasis in the whole population (odds ratio [OR] 1.15, 95% confidence interval [CI] 1.02–1.29 [P = 0.021] and OR 1.28, 95% CI 1.10–1.49 [P = 0.002], respectively). Risk for psoriasis increased substantially (OR 2.18, 95% CI 1.82–2.61; P < 0.001) for smokers with a history of >5 pack-years, even after adjusting for age, sex, and childhood ETS. Among twin pairs discordant for smoking, risk for psoriasis in the ever-smoking twin was lower among monozygotic twins (OR 1.23, 95% CI 0.59–2.56; P = 0.578) than among same-sex dizygotic twins (OR 2.21, 95% CI 1.36–3.58; P = 0.001). Genetic factors explained 20% (14–25%; P < 0.001) of the correlation between psoriasis and smoking, whereas non-shared environmental factors explained 8% (0–22%; P = 0.504).

Conclusions:
Tobacco consumption and childhood ETS are significantly associated with psoriasis. Results indicate shared genetic factors for smoking and psoriasis.

Hi All

Well 9 weeks in the waiting and funding is through, Bupa have called and all kicks off next week.

Skin - pure pants!! using lots of elecon, eumovate, ysp, and Drambuie.

Nurse due next Friday to train me.  So hopefully be easy and manage myself.

I've read to take out of fridge before she comes, and wondering any more tips and what to expect with Stelara?

My derm tells me to not expect it to work quickly and give it 12 weeks.

Hope your all well and will keep updating (or annoying you lot, with questions , ha )

Angie