Following on from this report Enbrel biosimilar candidate, SB4 accepted for review by European Medicines Agency
Biogen announced it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali™ (etanercept). Previously known as SB4.

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Biogen announced further progress as part of its commitment to biosimilars. Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali™ (etanercept). Previously known as SB4, Benepali is a biosimilar candidate to the reference product Enbrel®1. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). If approved, Benepali could be the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there.

“The positive CHMP recommendation for Benepali is a great step forward for patients, physicians and payers in Europe. Biosimilars have the potential to help improve access to important biologic treatments for those who need them most,” said Alpna Seth, vice president and global head of the biosimilars business unit at Biogen. “As a biotechnology leader with more than 35 years of experience in developing, manufacturing and commercializing advanced biologics, we look forward to bringing an array of anti-TNF biosimilar medicines to patients across Europe.”

The CHMP’s positive opinion was based on a robust preclinical and clinical data package submitted to the EMA by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development, and manufacturing expertise, together with confirmatory data from head-to-head Phase 1 and Phase 3 clinical trials of Benepali compared to its reference product Enbrel 2,3. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy across 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Results showed an ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel.

My 76 year old husband has been on Fumaderm since the Summer, building up the dose to 120 x 2 x 3 which is a total dose of 720. In fairness, his psoriasis is now under control. But he does have other serious health issues. He is very anaemic and has just been started on iron pills which do seem to be causing digestion problems. He was put on this high dose late September and I sort of assumed we would get an appointment with the consultant, and providing it was under control, start weaning him down to keep him on the lowest possible dose that would control the condition. (I have no medical knowledge but this is what we do with cats when we are trying to give 'quality of life' with potentially potent drugs if used long term,  such as steroids and metacam)
My question is how dangerous is Fumaderm long term at such a high dose? As anyone else been on this dose long term? He also had a very bad cough and we phoned 111 - our surgery closed for staff training. The doctor phoned him back sent him to A and E saying that the Fumaderm could have caused a drop in the white blood cells and he needed a blood test within 2 hours. He went and 9 hours later was discharged as ok.
He is having blood tests twice monthly.
He has very little appetite and his weight is now 7st 10. He has had a endoscopy which aws clear apart from gastritis and also has had a recent colon scan - waiting results. I do know that the GP is worried about potential internal bleeding but the anaemia started way before the Fumaderm so probably is not connected.
Thanks for reading - still worried that this product is not licensed in the UK and wonder if the trials included people over 65? A lot of trials do not....
Helena

Anyone ever used Prednisolone (steroids) for their Psoriasis? I'm going back on a 6 week course for today for my IBD, but I'm sure I've had clearance with it before. The problem is every time I've been on steroids, I've also been on another meds, so unsure whether it was just coincidence or a mixture of the two.

I also apologise now for any steroid rage/emotions

Evening everyone,

I came across these forums after an epic Google session on secukinumab..  I have just finished reading angels thread on it and have decided I might want to give it a go.

Well about me.. I am 32 and was told I had exzema around three years ago.. Allot of trips to the doctor resulted in a visit to the dermo.   Within five minutes I was told I have psoriasis and that I am likely to develop psoriatic arthritis as I have some in my fingernails.  I was handed some leaflets and a prescription for dovobet gel and was told to quit smoking and drinking.  

My patch coverage is: two elbows, one knee,  one back thigh, one bum cheek.  I have a few spots on one hand and on my shins.  I also have all my nails a little pitted.  The patches on my knee and elbow were the first to appear and never disappeared since. 

I immediately quit smoking and cut down on the drink.  I have totally transformed my diet in an attempt to cleanse my insides and started regular exercise.  There are many things I have tried including a few months on a 80% 20% diet from a book I read.  (Not sure if I can mention it).   This actually helped with itching but no reduction.    Aside from this I have tried black garlic, tumeric, ginger, home made moisturisers, apple cider vinegar.. Topically and internally    One knee is still yellow from the tumeric and clinfilm wrap two weeks later. 

I always feel better when I try something.. The hour or so whilst I'm on my cure missions to get supplies at the local supermarket are the happiest I usually have.  

On Friday I'm going to the doctors to request secukinumab,  I am too fare for the uv phototherapy according to my dermo and the other stuff topically hasn't reduced or helped.  The systemic drugs that are available have scary warnings that put me off.. Basically from what I understand they scattergun the immune system and can cause liver damage etc...   So when I heard these new drugs have entered the market and have no major long term risks I feel now is the time to try. 

Apparently the doctors will only prescribe it if the other systemic treatments fail.. But logically shouldn't they prescribe the safest option?  Reading up on the il17 inhibitor they cost the U.K. Govt 1500 pounds for two shots.  So I guess it's down to financial reasons.  I am preparing for a battle with the docs and getting my facts in order before I make my case.  If anyone has any advice I would certainly appreciate it.  

Well that was nice to get off my chest.. 

I am still very new to all this so go easy on me 

Cheers 

Con

Hello all,

I'm not that great at telling stories, so I'll just be brief.

The strongest natural treatment for psoriasis/eczema I've used is indigo powder, the same product that is sold as a natural hair dye, has greatly improved my skin. My skin is near 100% healed.

It's relatively very inexpensive, so it's definitely worth trying out. It's a natural product and its completely safe. There are studies on indigo that say it works. The studies are for Indigo Naturalis, which is hard to find and expensive. Indigoferra Tinctoria  is readily available and cheap. I used the Indigoferra Tinctoria and it worked for me.

If you buy indigo powder on amazon, it will be Indigoferra Tinctoria, so you don't have to worry about which one you're buying. Indigo powder comes with instructions on how to apply it, so just follow that. All you do is mix it with water to the desired consistency.

I've bought a couple different indigo powder brands off amazon and one has been the strongest for me (REMOVED BY FRED). It causes me the most pain. The burn is good; no pain no gain.,

Hi all, just wondering if anyone has been offered this drug yet or currently using? I've been offered by my derm and doing a bit of research before I make the decision.
On stellara since April. Doing fantastic on my skin nearly 100 percent clear but have had more joint problems. Joints that have never swelled before are swelling for week 2 after an injection till about week 7 to 8. Next injection is week 12 Not getting much in between. Anyone else any experience with this on stellara? Does it get better maybe if stay with stellara? Another side effect is contant upper respiratory infection that I can't clear and from what I have so far the cosentyx has the same side effect, has any anyone also had any experience of this?
Thanks in advance for any advise

I've suffered from mild plaque psoriasis for the last ten years.  I started with it in and around my ears and it progressed to a patch on left knee, a patch on my  right shin and has been on a off my elbows ever since. I've also a small patch on my back which I can't reach.  I've been using Dovonex on and off and it don't appear to reduce the size of the patch's at all just maybe helps the thickness of the white scales and I try to keep the patchs to just a red mark by having long soaks in the bath where I cover the patches with aqueous cream before I gently rub off the white scaly skin build up using the tips of my fingers.  I've also been getting small patches on my eyelids for last couple of years and have been using a mild 1% steroid cream on them.    

I've just bought a uvb lamp off ebay from Poland with a Genuine PHILIPS PL-S 9W/01 G23 bulb which i'm hoping to use it to reduce the size of the  the patches on my legs and elbows.
However the instructions are very basic as you can see from my pics.  It says increase the dosage by 8 seconds per treatment and for the final dosage it must be recommended by a doctor based on skin reaction.  Which doesn't help as I wasn't going to go to the doctors as this treatment has not been prescribed by them.  So can any one help with at what point to you stop increasing the exposure time and at what point do you stop or start to decrease the expose times or do you just increase the duration between treatments.   Thank-you. 
   

Hi,
I am wondering if anyone has used hemp body butter has experienced any side effects. Such as swelling and hives.
Thanks

Ixekizumab has once again showed it can significantly Improve signs and symptoms of psoriatic arthritis, and report less progression of structural joint damage when treated for 24 weeks.

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Eli Lilly announced today that psoriatic arthritis (PsA) patients treated with ixekizumab for 24 weeks achieved significant improvements in signs and symptoms of their disease when compared to placebo, while also experiencing significantly less progression of radiographic structural joint damage, reduced disability when performing certain physical functions and improved skin clearance of plaque psoriasis.

"The SPIRIT-P1 data show that ixekizumab may be able to address unmet or underserved needs that many patients living with psoriatic arthritis have, including the reduction of painful and debilitating skin and joint inflammation, which are the hallmarks of this chronic disease," said Philip Mease, M.D., chief of rheumatology research, Swedish Medical Center, and clinical professor, University of Washington, Seattle. Dr. Mease is a SPIRIT-P1 study investigator.

During the 24-week, double-blind period of this Phase 3 study, patients who had never received a biologic disease-modifying antirheumatic drug (bDMARD) were treated with either 80 mg of ixekizumab once every two weeks or every four weeks (following a 160 mg starting dose); adalimumab at the approved dose of 40 mg every other week; or placebo. Adalimumab was employed as an active control in the SPIRIT-P1 study and was not powered for comparison with ixekizumab treatment groups.

In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements compared with placebo in disease activity of PsA as demonstrated by the proportion of patients achieving an ACR20 response at 24 weeks, the study's primary objective. Improvements were experienced by ixekizumab-treated patients as early as one week after treatment initiation. ACR20 represents at least a 20 percent reduction in a composite measure of disease activity as defined by the ACR. Other measures included ACR50 and ACR70, which represent 50 percent and 70 percent reductions in disease activity.

At 24 weeks, 62 percent of patients treated every two weeks and 58 percent of patients treated every four weeks with ixekizumab achieved ACR20 compared with 30 percent of placebo-treated patients. The proportions of ixekizumab-treated patients who achieved ACR50 when treated every two weeks or every four weeks were 47 percent and 40 percent, respectively, compared with 15 percent of patients treated with placebo. Furthermore, 34 percent of patients treated with ixekizumab every two weeks and 23 percent of those treated every four weeks experienced a 70 percent reduction in disease activity. Six percent of patients treated with placebo achieved this level of improvement.

Patients treated with ixekizumab at both dosing regimens also experienced significantly less radiographic progression of structural joint damage than those treated with placebo, as measured by the change from baseline in the van der Heijde modified total Sharp score (mTSS) for PsA at 24 weeks. Structural joint damage caused by PsA may lead to permanent joint deformity and reduced physical function.

Ixekizumab treatment groups also experienced significant improvements compared with placebo in other key secondary measures, including physical function as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), and improved skin clearance of plaque psoriasis as measured by the Psoriasis Area and Severity Index (PASI), including PASI75, 90 and 100. A PASI75 score indicates at least a 75 percent reduction in a patient's plaque psoriasis from the patient's baseline assessment, while PASI90 reflects a 90 percent reduction and PASI100 represents a 100 percent reduction, reflecting complete skin clearance.

Efficacy results with adalimumab compared with placebo during the SPIRIT-P1 study were significant on most measures. At 24 weeks, 57 percent of patients treated with adalimumab, the study's active control, achieved ACR20, while 39 percent and 26 percent achieved ACR50 and ACR70, respectively.

The incidence of treatment-emergent adverse events (TEAE) was greater with ixekizumab treatment compared with placebo. The most common (≥4 percent) adverse events observed with ixekizumab treatment were injection site reaction, injection site erythema and nasopharyngitis. These events are consistent with those reported in the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (UNCOVER 1, 2, 3). Serious adverse events and discontinuation rates due to adverse events were not significantly different between treatment groups.

Following on from Cosentyx recently getting approval in Europe for psoriatic arthritis Cosentyx gets psoriatic arthritis approval in Europe. This latest news release reveals that 84% of psoriatic arthritis patients showed no further progression in joint damage.

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Novartis announced today new results for Cosentyx® (secukinumab) showing no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment.

Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to demonstrate efficacy in Phase III studies in PsA - a life-long inflammatory disease that affects the skin and joints. If not treated effectively, it can lead to irreversible joint damage and disability caused by years of inflammation.

"Psoriatic arthritis patients need therapies that can prevent the progression of this debilitating disease. In this two-year study, Cosentyx showed no further progression in joint damage in over 80% of PsA patients while maintaining improvements in joint and skin disease, physical function, and quality of life," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "These results show the potential for Cosentyx to create an important new option for the treatment of psoriatic arthritis".

New medicines with an alternative way of working are needed as many patients do not achieve an adequate response from current treatments, such as disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatories or anti-tumor necrosis factor (anti-TNF) therapies. Many patients do not respond to or tolerate these therapies, with approximately 45% of PsA patients dissatisfied with their treatments.

These results from the FUTURE 1 study represent the longest Cosentyx Phase III study in PsA to date. Responses in joint and skin disease, physical function, and quality of life at Week 24, were maintained over two years. After two years of treatment, 67%* of patients (n=202) treated with Cosentyx 150 mg achieved the standard treatment goal of an ACR 20 response (American College of Rheumatology response criteria). In addition, 84% of patients showed no further progression in joint damage as shown by x-ray assessment. Cosentyx was well tolerated with a safety profile consistent with that observed in previous studies.

Given all the talk about the amazing, wonderful recovery of a baby with leukaemia after gene therapy, I wondered if it will ever be possible to apply to other conditions such as psoriasis - or is there no faulty gene at work in psoriasis?
Maybe someone with a better grasp of this might know if it's a potential future treatment?

I got prescribed Mometasone Furoate this morning by my Dermatologist. Never heard of it Anyone ever used it for their Psoriasis?

Chronic Plaque Psoriasis sufferer for 45 years who's having an interesting experience with Novatretin, the Canadian-sourced generic form of Acitretin. I'm in New Zealand.

Acitretin (as NeoTigason) has been my go-to miracle drug for flare-ups. I've taken it 8 times previously (over 30 years) at a dosage of 35mg/6 weeks then 25mg/6 weeks then discontinued. Results have always been fantastic: significant thinning and fading all over by end of week four or five, then complete fading by weeks 8-10. Often I've stopped taking it with a couple of weeks to go since clearance has been so good. Rash slowly returns over next year but is usually well-behaved only requiring topicals for the next few years until the next flare-up.

In the last couple of years my rash had become a little nasty with spots and patches all over which I was managing with Daivonex and a low dose steroid for the scalp. I didn't have a flare-up but decided to get Acitretin from my derm who thought it was a good idea to try a lower dose regime.

Neotigason is no longer funded so Novatretin was substituted. I began 20mg/day on Aug 12. I anticipated a slower improvement and indeed it took about 2-3 weeks before I noticed any fading which was only on some areas of my body. But by week 6 I noticed some new spotting and some increased activity in the patches that had started to fade. I particularly noticed heat and activity on my palms and especially soles which had been wonderfully clear for the last 2 years.

So now at week 7 the rash is about the same as it was when I started, perhaps worse if I add in my soles. It's disturbing to me that after a mild initial improvement things have returned to their original state.

I've got a couple of theories:

- the lower dose is enough to provide some initial improvement but also just enough to be antagonistic resulting in an overall unsatisfactory result and worsening in some areas
- the generic is simply not as good as NeoTigason

I've just had my second round of blood tests so I intend contacting my derm with my experience and concerns. I will suggest increasing the dosage to 30mg and see what he thinks.

Other side effects are hardly noticeable with a little dryness and increased sun sensitivity. But this is very mild compared to what happens at my normal dose of 35mg.

I'm wondering if anyone else has had experience with generics when they've previously had excellent and consistent results with the regular brand.

Now I understand that some folks experience flare ups or worsening before improvement but since my long term experience has been quite different it seems very strange to me that this time my reaction is so distressingly different. By now, every time without fail, my rash has been radically reduced and almost cleared, and that's after a major flare-up.

Any thoughts welcome.

Hi There Everyone,

I hope everyone is doing well. My name is Jim and I’m here because my life has turned somewhat upside down within the last 24 hours. I’m not entirely sure what I hope to get out of this post, but perhaps a Psoriasis sufferer that has dealt with similar characteristics can help me focus my train of thought. I do apologize for how winded this may be, but if you don’t mind, it will help me process all that has happened.
 
Before last week, I was a 30 year old relatively healthy male with no history of any skin-related issue, aside from puberty and the occasional pimple brought on by stressing for a big work meeting here and there. Last week, I had an itch on my legs that wouldn’t go away. When I actually pulled up my pant leg to investigate the “bug bite”, I noticed I had a long red rash that carried ½ way around my calf, right at my dress sock line. It literally looked like I had worn socks that were too tight. The odd thing is, I have almost the EXACT same marking around my other leg. Same color, general length and location (sock line, wrapped around ½ my calf). I originally thought maybe I was having a reaction to the type of fabric (I did just buy new socks…….so much talk of socks…how boring…I’m sorry!). I then started to notice little red marks on the backs of my hands/wrists. They seem to bunch in the area in between my thumb and index finger, on both hands. All of these marks have been somewhat pale red, with flaky dryness on top. The point here is….aside from a dot here and there on different areas of my body, this “rash” has been so contained to these two areas (calves and back of hands) and they are almost symmetrical in pattern.
 
All that aside, I saw the dermatologist yesterday and instead of giving me some cream for a reaction I thought I was having, she instead gave me a lifelong commitment to battling Psoriasis. I still just don’t understand…..I have so many questions and I won’t burden anyone…..it just doesn’t make a lot of sense to me right now. The doctor’s first action was to check my elbows and knees (I guess these are common outbreak areas?), though I have no markings there. She kind of pushed my comments aside about how oddly symmetrical the leg markings were…..which I thought was the original ground zero site all along…..she took a biopsy, which I am awaiting the results from. In the meantime, she told me to stop taking the steroid tablets that the Urgent Care gave me two days before (I was worried about it and didn’t want to wait for my derm appointment), then she told me the outbreak will get worse now once I come off the steroids (awesome!) and then she basically just threw some trial spray of something called Kenalog at me. Everything happened so fast….and I now have a mountain of questions and concerns and once I hear back about the biopsy, I do plan to meet with her (or another derm) to really go over proper care, warning signs, etc.
 
I just feel a little lost right now…….and I guess I’m wondering if anyone has had similar Psoriasis flare-ups, specifically with characteristics that somewhat mimic mine?
 
Regardless, thanks for your time….and apologies again for the lengthy post.

Hello everyone , I have been living with psoriasis for over 50 years . in hospital 3 maybe 4 times over 80 percent a few times .I have had a few periods of over 5 years when it has been under control.
I have learned a lot if anyone has any questions.

Hi I am Keith i am a 49 year old Builder from Consett Northeast England.
I have called this post " How i repaired my body " Because i believe that's what you need to do , and Psoriasis is a result of something else
no matter what the doctors say. But I'm just a builder remember
My Psoriasis started in 2012 just on my elbows and knees, so i went to see the doc, got some cream to wash with and keep in moisturise he said
I did but it just got worse ,went back and got Dovobet , at first i thought it was helping, but then it seemed spread , this went on over about 2 years , i was referred to Durham hospital, given other creams and tablets  can't remember the name off the tablets but they made me bad and i packed them in after a few days as i could hardly walk 
So being a biulder i started to look at it more practically, if a wall in your house is damp there is a multitude of things and ways to cover it up or mask it but, it if you don't fix the problem it will not go away.
I stopped all the creams the consultant had given me  i think dovobet is horrible stuff.

These photos where taken on the 27/10/2014 its the only ones i have to give you some idea ,I don't know how bad this would be classed as but it was bad to me, i had it everywhere my legs were as bad as my arms, hands ,feet ,scalp, ears ,some on my face to and and finger nails,, nothing helped


SO i read a lot of things  on the internet about all sorts of herbal stuff and all sorts, they say infections thrive in an acidic body, i got a ph test kit off eBay and sure enough i was acidic.
Also it seems most people in the west are magnesium deficient even with a balanced diet. The minerals just are not in food and water like they used to be due to modern farming treatments and mineral depletion in soil and modern water treatment. 
I started taking Magnesium and Zinc about 3 times the dose they recommend  for about 2 months then dropped to what they recommend.  It can not hurt you it also has a alkaline effect on the body.
I believe i had a yeast (candida) infection in my intestine and that the psoriasis was my body telling me there was something wrong ,
so i also started taking coconut oil. Its the best thing to kill yeast overgrowth in the body, its also anti fungal and anti bacterial.

I started on hemp oil for the pains in my joints, its the best balance of the omega oils for humans there is , after 3 weeks i really felt different on it ,it is also good for depression too.
Also one lemon a day - the citric acid has a alkaline effect on the body ,but make sure you clean your teeth after as the lemon juice is not good for your teeth. 

The only cream i put on was a little vaseline but only for about 6 weeks then stopped and i don't put anything on my skin. 
The psoriasis started to calm down after few week and small bits went after about a month.
I told the consultant i refused the other treatments, she just looked at me as if i was from another planet ,but i did do the light treatment for about a month, i don't know if that helped as it had already started to go before that, but the nurse was amazed at the difference and said just keep doing what i was doing.

So 1 year later to the day apart from a couple of dots on my knees that will be gone soon,  its gone from everywhere.  My nails are back to normal, the bulk of it went in about 4 months and it stopped itching in a couple of weeks. 

So this is what i do
1 table spoon of coconut oil
1 table spoon of hemp oil both dissolved in a little warm water and a squeezed lemon and drink it, I still don't like the taste of them but stick with it, it can repeat on you for the first few weeks but that seems to stop. 
I take magnesium and zinc and vitamin D3-  buy good quality ones. 
I also soak in the bath a couple times a week with a couple of big hand full of magnesium sulphate (epsom salts) in it its the best way to get magnesium into the body , 25kg bags on eBay are about £20 its a lot cheaper than small boxes of epsom salts.
 Thats it no creams, I never cut alcohol out or anything out my diet really either and its gone and so has the joint pains.

I haven't posted anything before so this is a first hope the photos show up as I'm not sure I've done that right, I'm not the prettiest but i hope  it helps

Hello I am new to the club. My name is David.

I am a disabled veteran from the United States Army. I spent 10 years in the service with four different deployments to Iraq before getting out in 2010. I started showing signs of psoriasis in 2008 while still active duty. In the last 8 months or so after several tests, treatments, steroid ointments, and doctors visits they tell me I have psoriatic arthritis. I'm just now trying to research different techniques on managing the symptoms and will likely have a lot of questions. I plan on spending some time reading as much of the posts in this club as I can before asking my questions in order to keep from asking something that has already been answered. 

I thank you all ahead of time for your help and support and I look forward to chatting with you all in the future.

Ideas for things that may be helpful to members

getting started Beginners guide to posting your introduction

Newbie tips Newbies Tips

how to put an internal link to other posts or threads Internal linking

Using codes in your post...Codes in your posts

starting a new thread Starting a new thread

how to keep up with the forum using unread post button View Unread Posts

putting photos in your post [Group Specific]... or. ... [Group Specific] ....or. [Group Specific]

using the portal. Showing last 20 posts etc Portal!

idea if you return to the forum and aren't sure where your posts are,  at the top of the front page there is a link to all your posts and threads, they can also be accessed from your profile page

Cosentyx has been given European approval for the treatment of Psoriatic Arthritis (PsA) by the Committee for Medicinal Products for Human Use (CHMP) the approval is applicable to all European Union and European Economic Area countries.

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Cosentyx™ (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients. Following two separate regulatory submissions, Cosentyx is now recommended for the treatment of active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of active PsA in adult patients alone or in combination with methotrexate (MTX) when the response to previous disease modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to be recommended for AS and PsA - conditions that affect around five million people in Europe. Both are life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal damage caused by years of inflammation.

"Novartis is pleased to be so close to bringing this life-changing medicine to people living with ankylosing spondylitis and psoriatic arthritis who are struggling to find the right treatment to control their symptoms," said David Epstein, Division Head, Novartis Pharmaceuticals. "With Cosentyx, we have seen major and rapid reductions in the signs and symptoms of disease, including pain, disease progression and joint damage, paving the way for a potential new standard of care."

New treatment options with an alternative way of working are needed for both conditions as many patients do not achieve an adequate response from standard treatments, such as DMARDs, NSAIDs or anti-TNF therapies. For example, with the current biologic standard of care - anti-TNFs - up to 45% of PsA patients and up to 40% of AS patients are dissatisfied with, do not respond to or do not tolerate their treatment.

Cosentyx Phase III studies have consistently demonstrated significant improvements in the signs and symptoms of AS and PsA. Clinical improvements were seen as early as Week 3 and through to Week 52, with benefits reported across the spectrum of patients who have either never taken or who have had prior treatment with anti-TNF therapies.

The safety profile of Cosentyx was shown to be consistent to that reported in clinical trials across multiple indications involving more than 9,600 patients.

The European Commission reviews the recommendations of the CHMP who then provide their final decision on approval, usually two months or earlier, following CHMP opinion. This is applicable to all European Union and European Economic Area countries. Cosentyx has been approved for the treatment of PsA in Japan since December 2014 and has received approval in 49 countries worldwide for the treatment of moderate-to-severe plaque psoriasis.

About the CHMP recommendation
For patients with AS and PsA, the recommended dose is Cosentyx 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. For PsA patients with concomitant moderate-to-severe plaque psoriasis, or who are anti-TNF inadequate responders, the recommended dose is Cosentyx 300 mg.

I am so happy to have a place to come for information. I have had psoriasis since 2005 and it is spreading. I find it very helpful reading the posts concerning the natural treatments rather that drugs. Don't like them and find they actually make things worse for hands and feet. Thank you for letting me join.