Hello Guest, Welcome To The Psoriasis Club Forum. We are a self funded friendly group of people who understand.
Never be alone with psoriasis, come and join us. (Members see a lot more than you) LoginRegister
Psoriasis Club is a friendly on-line Forum where people with psoriasis or psoriatic arthritis
can get together and share information, get the latest news, or just chill out with others who understand. It is totally
self funded and we don't rely on drug manufacturers or donations. We are proactive against Spammers,
Trolls, And Cyberbulying and offer a safe friendly atmosphere for our members.
So Who Joins Psoriasis Club?
We have members who have had psoriasis for years and some that are newly diagnosed. Family and friends of those with psoriasis
are also made welcome. You will find some using prescribed treatments and some using the natural approach. There are people who
join but keep a low profile, there are people who just like to help others, and there are some who just like
to escape in the Off Topic Section.
Joining Couldn't Be Easier: If you are a genuine person who would like to meet others who understand,
just hit the Register button and follow the instructions.
Members get more boards and privileges that are not available to guests.
OK So What Is Psoriasis?
Psoriasis is a chronic, autoimmune disease that appears on the skin. It
occurs when the immune system sends out faulty signals that speed up the
growth cycle of skin cells. Psoriasis is not contagious. It commonly
causes red, scaly patches to appear on the skin, although some patients
have no dermatological symptoms. The scaly patches commonly caused by
psoriasis, called psoriatic plaques, are areas of inflammation and
excessive skin production. Skin rapidly accumulates at these sites which
gives it a silvery-white appearance. Plaques frequently occur on the
skin of the elbows and knees, but can affect any area including the
scalp, palms of hands and soles of feet, and genitals. In contrast to
eczema, psoriasis is more likely to be found on the outer side of the
joint.
The disorder is a chronic recurring condition that varies in severity
from minor localized patches to complete body coverage. Fingernails and
toenails are frequently affected (psoriatic nail dystrophy) and can be
seen as an isolated symptom. Psoriasis can also cause inflammation of
the joints, which is known as (psoriatic arthritis). Ten to fifteen
percent of people with psoriasis have psoriatic arthritis.
The cause of psoriasis is not fully understood, but it is believed to
have a genetic component and local psoriatic changes can be triggered by
an injury to the skin known as Koebner phenomenon. Various
environmental factors have been suggested as aggravating to psoriasis
including stress, withdrawal of systemic corticosteroid, excessive
alcohol consumption, and smoking but few have shown statistical
significance. There are many treatments available, but because of its
chronic recurrent nature psoriasis is a challenge to treat. You can find more information
Here!
Got It, So What's The Cure?
Wait Let me stop you there! I'm sorry but there is no cure. There are things that can help you
cope with it but for a cure, you will not find one.
You will always be looking for one, and that is part of the problem with psoriasis There are people who know you will be
desperate to find a cure, and they will tell you exactly what you want to hear in order to get your money. If there is a
cure then a genuine person who has ever suffered with psoriasis would give you the information for free. Most so called cures
are nothing more than a diet and lifestyle change or a very expensive moisturiser. Check out the threads in
Natural Treatments first and save your money.
Great so now what? It's not all bad news, come and join others at Psoriasis Club and talk about it. The best help is from accepting it and talking
with others who understand what you're going through. ask questions read through the threads on here and start claiming
your life back. You should also get yourself an appointment with a dermatologist who will help you find something that can
help you cope with it. What works for some may not work for others
So hey, im lori and im new to this site! ?
Im 29 and have suffered with psoriasis since i was 12 ?
Believe it or not i didnt realise till recently how common it was as i dont know anyone that has psorisis so havent really spoken to other sufferers! So please bare with me ?
Posted by: Fred - Tue-15-09-2015, 20:09 PM
- No Replies
Following on from XenoPort starts phase 2 trial of XP23829 in patients with psoriasis there are reports that xenport shares have taken a knock of 25% following their release of the results, though they said they met their primary endpoint in both 800 mg and 400 mg doses of the drug XP23829 investors have been put off by side effects, particularly diarrhea rates ranging from 22 percent to 40 percent at the highest, most effective dose. Other gastrointestinal side effects included nausea, abdominal pain and vomiting, and 15 percent of psoriasis patients treated with the highest dose of XP23829 discontinued the study compared to 2 percent for placebo patients.
Quote:
XenoPort, Inc. announced today positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis. XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score. XP23829 is a patented prodrug of monomethyl fumarate (MMF) in a novel oral formulation that was designed to potentially offer physicians and patients an effective, better tolerated and easier to use therapeutic option to currently available fumarate products.
Richard Kim, M.D., chief medical officer of XenoPort, stated, "We believe these clinical data demonstrate for the first time that a MMF prodrug other than dimethyl fumarate (DMF) can be effective in reducing lesions in psoriatic patients. The magnitude of XP23829's effect on the primary efficacy endpoint met our expectations for this relatively short duration trial and we are particularly encouraged by the results with 800 mg once-daily dosing. Based on what is known about fumarates, we believe that the efficacy of XP23829 is likely to improve with a more extended duration of treatment beyond 12 weeks. We are also pleased with the safety and tolerability profile of XP23829 emerging from this study. We believe that this demonstration of efficacy, safety and tolerability of XP23829 could lead to a differentiated product in psoriasis. We also believe that there is potential for the observations from this study to read through to other potential indications such as multiple sclerosis (MS)."
Description of the Trial:
This randomized, double-blind, placebo-controlled Phase 2 clinical trial of XP23829 was conducted in 33 sites in the United States in subjects with moderate-to-severe chronic plaque-type psoriasis. Two hundred eligible subjects were randomized to placebo or one of three treatment arms of XP23829: 400 mg or 800 mg once daily (QD) or 400 mg twice daily (BID). The 12-week treatment period included a three-week titration period followed by nine weeks of treatment at the targeted dose. There was a washout phase of up to four weeks prior to randomization for subjects who were previously taking systemic agents for the treatment of psoriasis. Treatment assignment was stratified based on prior biologic use and approximately 35% of randomized subjects had previous experience with biological treatments for their psoriasis.
XP23829 was safe and generally well tolerated. There were no deaths or life-threatening adverse events. No subjects met the safety discontinuation criteria and the majority of treatment emergent adverse events were non-serious and mild or moderate in severity. Diarrhea adverse event rates were consistent with other drugs in the fumaric acid ester class ranging from 22% to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache. The incidence of flushing in the XP23829 dose groups was similar to placebo. Gastrointestinal events were the most frequent adverse event leading to withdrawal during XP23829 treatment. There were two treatment emergent serious adverse events assessed as possibly related to treatment with XP23829: acute cholecystitis and enterocolitis. Both subjects recovered.
No subjects experienced Grade 3 or Grade 4 lymphopenia. Less than 5% of subjects in any XP23829 treatment group reached Grade 2 lymphopenia and less than 15% reached Grade 1 at any visit. Lymphocyte levels in all subjects experiencing lymphopenia returned to within normal limits after treatment.
"I'm excited to have participated in this phase 2 study with positive efficacy data that we believe justifies further development of XP23829 into moderate-to-severe chronic plaque-type psoriasis," stated Alice Bendix Gottlieb, M.D., Ph.D., Dermatologist-in-Chief; Harvey B. Ansell Professor of Dermatology, Tufts University School of Medicine and Lead Investigator for the XP23829 trial. "Despite the wide availability of biologics, there still remains a significant unmet medical need for a more effective, safe, well-tolerated, and convenient oral treatment for patients with psoriasis. Fumarates have been the leading treatment for psoriasis in Germany for more than 2 decades. With this long-term real-world fumarate experience and these data in consideration, I look forward to the potential of seeing XP23829 in Phase 3 development for moderate-to-severe chronic plaque-type psoriasis."
"We are extremely pleased by the preliminary top-line results from this Phase 2 study. I want to thank the clinical investigators and the psoriasis sufferers who participated in the study. We look forward to getting the complete data set for this trial later this month and to presenting more comprehensive results at future medical conferences and in publications," stated Ronald W. Barrett, Ph.D., chief executive officer of XenoPort.
Dr. Barrett continued, "In the near future, we intend to share these data with psoriasis and multiple sclerosis experts, speak with regulatory authorities regarding next steps and explore potential partnerships that could accelerate the development of XP23829 globally. We recently completed non-clinical development studies and manufacturing activities necessary to support Phase 3 development and we believe we will be ready to potentially initiate Phase 3 studies in 2016."
I've just joined the site and I thought I'd introduce myself.
I was diagnosed around five years ago and have tried a variety of topical treatments, varied diets and have very recently been prescribed acetretin so I'm hoping for positive results.
The psoriasis* is spreading pretty much everywhere and it has knocked my confidence for six. My partner is really supportive and I owe so much to her. I guess I'm in a similar if not exact situation to many other members here.
I've joined as I would like to hear others stories regarding treatment, diet and how they get on with smoking and drinking. I smoke and drink but not in any particular quantity.
*I'm a little funny about calling psoriasis 'my' psoriasis. I don't own it. It doesn't belong to me, I didn't ask for it therefore it is not mine. I hope everyone is ok with me using this terminology and in my posts, I will be referring to it as exactly that.
I look forward to discussing everything psoriasis with you all and I will keep the forums posted with progress and personal feelings about it, and the treatment.
I am currently having a lovely time in Menorca whilst I am really enjoying (if a little paranoid) about getting my skin out in the sun so if I don't respond immediately, please don't be put off. I will respond to all posts and I hope to play a positive part as a community member on this board.
Hi I'm Lindsay..... A newbie to this site but has psoriasis on hands and feet for the last 20 odd years!
I've have been on the Cosentyx trial for the last year and now able to continue using i. Although I'm not clear I am 80% better and almost pain free. I'm looking forward to following the progress of Cosentyx users.
I've never been on drugs for psoriasis, but I do find that sunlight helps tremendously. So all summer and into the fall, I'm doing ok. But then winter comes. The sunlight isn't very strong and I'd get frostbite if I went out without clothes. Things get worse and I find I'm just holding on until spring.
So I'm wondering what the options are for home phototherapy. Is anyone actually doing this? If so, what equipment would be recommended?
It's mostly in my nails, but I have wondered if the winter time arthritis I get is also related.
I didn't take up the flu jab when I was on mtx but now I'm on Humira I'm feeling the pressure to conform.. However I know more than one person who gave the flu jab a go for a couple of years, and were very poorly after. One ended up on very specific unpleasant antibiotics to clear a chest infection which began straight after and would not go away.
Now, don't shout me down, I have biology a level and I understand that the jab is not a live vaccine so you can't catch the flu from the jab. But this doesn't help explain the anecdotes which have put me off.
So, I thought I'd have a look on the nhs website to see what ingredients are in it, and was surprised by the number of people who say they were ill straight after and many said it left their arm weak and painful for a long time. I have booked myself in but I'm not sure I want to go through with it (like all medicines I get given lol)
Who on here does take up the annual flu jab and have you had any issues please?
Manu thanks in advance, and anyone who doesn't read this properly and starts the lecture on how you can't catch flu from the jab is getting deleted
Posted by: Jerry - Wed-09-09-2015, 15:24 PM
- Replies (17)
My skin is 50% affected with psoriasis and my doctor treat me with 2x of 25g of Mtx every 12hrs for 3x then followed by folic acid on the next 6 days. After 3 weeks of treatments my psoriasis totally gone with only white scars remain on my skin. She advise me also to stop using soap and shampoo instead I use VCO as a soap on my skin then not using harsh detergents on my clothes. I stop also using fabric conditioner. I'm really happy about the result then I started to expose my skin to the sun to balance the color of my skin, but after a month a red dot with itchy feeling started to grow again on my skin. I'm worried to take Mtx again although base on my blood test I'm still good with normal readings. In your experience did the Mtx need to take every 1 month to control our skin problem?
Posted by: Fred - Tue-08-09-2015, 21:57 PM
- Replies (2)
Here's a potential treatment for psoriasis, psoriatic arthritis, and other autoimmune disorders. VTP-43742 is Vitae's first-in-class, wholly owned product candidate for the potential treatment of a variety of autoimmune disorders and orphan diseases.
Quote:
Vitae Pharmaceuticals, a clinical-stage biotechnology company, today announced positive top-line results from its Phase 1 single ascending dose clinical study of VTP-43742 in autoimmune disorders. VTP-43742 is Vitae's first-in-class, wholly owned RORγt inhibitor being developed for the treatment of a range of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and irritable bowel disease (IBD), as well as numerous orphan diseases.
In this double-blind, randomized, placebo-controlled study that evaluated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of single oral doses of VTP-43742 in 53 healthy human volunteers, VTP-43742 was safe and generally well tolerated at all dose levels across a 60-fold dose range. No serious adverse events were reported and there were no drug-related clinical laboratory or electrocardiogram (ECG) abnormalities.
VTP-43742 was also evaluated in an ex vivo assay for its ability to inhibit the production of pro-inflammatory cytokine IL-17A in blood obtained from study subjects. Subjects receiving VTP-43742 showed a dose-dependent suppression of RORγt dependent IL-17A production by more than 90 percent, with the effect largely sustained over the full 24-hour measurement period.
In animal studies, steady inhibition of RORγt was necessary to achieve full therapeutic efficacy, indicating the importance of a relatively long plasma half-life. The plasma half-life of VTP-43742 was observed to be approximately 30 hours in this clinical trial, supporting the potential for effective once-a-day dosing in humans.
"VTP-43742's robust and sustained lowering of IL-17A production observed in the ex vivo blood assay, paired with its favorable safety, tolerability and PK profile, demonstrate that this first-in-class drug candidate has the potential to safely and effectively treat a range of autoimmune conditions," said Dr. Richard Gregg, Chief Scientific Officer of Vitae. "We are extremely encouraged by the PK and PD data, and look forward to reporting additional clinical results, including top-line proof-of-concept data in psoriasis patients, by the end of the year."
Vitae is currently conducting a Phase 1 multiple ascending dose clinical trial of VTP-43742, which was initiated in August 2015. This trial includes both healthy human volunteers and patients with moderate to severe psoriasis. The Company plans to begin dosing psoriatic patients in the second half of 2015, with top-line clinical efficacy results expected by the end of 2015.
Posted by: Fred - Tue-08-09-2015, 13:58 PM
- Replies (2)
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.
Posted by: dougie - Tue-08-09-2015, 09:06 AM
- Replies (10)
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
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.
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.
Posted by: Fred - Thu-03-09-2015, 21:13 PM
- Replies (3)
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.
Posted by: Fred - Thu-03-09-2015, 19:13 PM
- Replies (3)
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.
Posted by: Fred - Wed-02-09-2015, 11:13 AM
- Replies (24)
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.
Posted by: myname - Tue-01-09-2015, 00:12 AM
- Replies (8)
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.
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!!
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In 2012 there were approximately 36.5 million prevalent cases of psoriasis, and by 2022, GlobalData epidemiologists forecast that this figure will reach approximately 40.93 million.
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