Following on from India getting a biosimilar of Remicade last year, it's now also been launched in Europe by Hospira under the name Inflectra.

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Hospira, Inc, a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis and plaque psoriasis.

Infliximab is a cornerstone treatment for many inflammatory diseases, with over 15 years' worth of clinical data and experience. Inflectra is a biosimilar medicine to the reference product, Remicade® (infliximab), and is the first biosimilar mAb to be approved by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.

Remicade (infliximab) has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013. The savings generated by introducing competition in the marketplace could save the European healthcare system millions of Euros, with biosimilars expected to produce savings of over €20 billion by 2020.

"Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications. We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra. This supports Hospira's commitment to provide patients with better access to high-quality, more affordable care," said Paul Greenland, Vice President Biologics, Hospira.

Inflectra received its license from the EC in September 2013, following adoption of the EMA Committee for Medicinal Products for Human Use (CHMP) positive recommendation for granting marketing authorization. Review by the EMA included detailed analysis of biophysical properties and safety, efficacy and tolerability data from an extensive preclinical and clinical trial program.

In a phase III randomized, double-blind study involving 606 patients, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In this study, using the ACR20 scoring system, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with Remicade. In the same study, 42.3% of patients receiving Inflectra achieved a greater than or equal to 50% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR50 scoring system), compared with 40.6% treated with Remicade.8 Comparable safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. There were no marked differences in the immunogenicity profile of the two products up to 54 weeks, and the impact of anti-drug antibodies on efficacy and safety was comparable.

Inflectra is being launched in several major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden. With the launch of the product in these new markets, Inflectra is now available in 24 European countries. Hospira's partner, Celltrion, has also submitted an application to the U.S. Food and Drug Administration for biosimilar infliximab.

VBL Therapeutics today announced it will no longer be continuing with developing its experimental inflammatory drug VB-201 to fight psoriasis after it failed to meet their primary endpoints, and the company does not plan to continue development of VB-201.

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VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer, today announced that its Phase 2 studies evaluating lead Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. The Company does not plan to continue development of VB-201 in these indications.

"We continue to focus on advancing VB-111 into Phase 3 for recurrent glioblastoma (rGBM). We believe that this drug candidate has significant potential as an anti-angiogenic agent for the treatment of cancer and we look forward to initiating the trial," commented Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are disappointed by the outcome of these Phase 2 studies in psoriasis and ulcerative colitis. Immune-inflammatory conditions are difficult-to-treat diseases with a limited array of effective treatments. We were honored to work with an excellent team of clinical investigators and would like to thank the patients who participated in the clinical studies for these drug candidates."

In a simultaneous press release, VBL also announced today that the U.S. Food and Drug Administration (FDA) determined that VBL may proceed with a pivotal Phase 3 trial in rGBM and removed the clinical hold previously imposed on the study. VBL plans to initiate this trial in mid-2015 under a special protocol assessment with the FDA.

Psoriasis Study Details:

This Phase 2 randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of VB-201 dosed at 80 mg or 160 mg daily for 24 weeks. The study evaluated 194 patients with moderate to severe plaque psoriasis. The primary efficacy endpoint of the study was PASI 50, or the proportion of patients who achieve at least 50 percent improvement from baseline PASI score, at weeks 16 and 24.

No effect of VB-201 compared to placebo was observed on the primary or secondary endpoints at either dose level tested. The PASI 50 for VB-201 patients was 26.4% at 16 weeks and 34% at 24 weeks, with no significant difference between the 80 mg and 160 mg dose cohorts. The placebo PASI 50 at week 16 was 38%.

Hello to everyone ( those who know me and those who have yet to become acquainted ).
It's a long story but I have had PPP for some time now. Managed (eventually) to stabilise on cyclosporine to the point where I got a full time job. But now I have been kicked off them by a new Dermatologist (another long story).
My dilemma at this point is that the new treatment proposed has the potential to take weeks to kick in, if indeed it does. I haven't been to work for a week. Deterioration has been swift to the point where I can walk no further than 50 yards.
Every morning I have to call in sick and I have been told I have to get sick notes to qualify for SSP. I was under the impression that my employer doesn't pay sick pay so is SSP different? Are they legally obliged to pay me it for 28 weeks? Only £81 a week I think but better than nothing I suppose.
I was originally thinking it was best just to give notice but am not sure now where I would stand ( metaphorically not physically ).
Sorry for the convoluted post and if I have posted in the wrong section.

Hi. I just joined the forum last week.It has been very interesting reading all the different posts. As i said in my introduction i have had this problem for about 32 years. I have only ever had cream, and ointments to put on, and the doctor never ever sugested tablets. It´s only since i came onto this forum, that i ever heard of taking tablets to help with psoriasis.
So first i have seen different tablets been mentioned.Fumarates, Fumaderm, Acitretin, and i think Psorinov. So my question is firstly can i go to my doctor and tell him i want to try one of these tablets, or can he refuse me. By the way i live in the U/K. and the next question is which tablets are the best as it seems everyone is on different medication.

Also as i said in my introduction, i am at present in the Canarie Islands untill the end of June, and i am using Dovonex, But have read to keep out of the sun, while using it, which is quite difficult to say the least.

Hi ,

I have been stalking this forum for quite a while now, following most threads , particularly Fumaderm, which when I get time I will start a post or add to a previous one.

My history of P - diagnosed about 31 years ago. First told it was warts on my elbows and treated with wart paint! (Can't remember the name) . Usual creams, ointments, hospital stays, puva, UVB , diet, holistic, magic creams from internet (which were full of steroids - obviously claiming to be natural). Aceitrin, cyclosporine, methotrexate and now Fumaderm.

Didn't really start on the tabs until November 2013 when my P became erythrodermic . Had tried Aceitrin previously but hair fell out rapidly. Thanks to that, I never wanted another tablet again.

November 2013 had no choice but to accept cyclosporine as 90% coverage and legs had ballooned due to inflammation . Got out of hospital (in time for Xmas) , on and off cyclo , ( was told due to the amount of UVB I had, had in past I would be unable to take cyclo for any length of time). Next was Mtx , hated them, side effects horrendous. Had a fight on my hands to get them to offer me Fumaderm, which I am currently taking.

Not sure of my psoriasis score . For about 28 years I lived with my psoriasis being severe and would get UVB 3 months of the year so I could go on holiday. Rest of time I just got on with it. My turning point was when my p became erythrodermic and I was told I have used up my lifetimes ray's, I decided to go down the tablets route.

So here I am, hoping to get some advice .  On 6 Fumaderm from yesterday and my skin is showing a little improvement - not much.  Certainly less active , flatter and less red, but still all over.  Side effects - not so good. Probably better leaving the details for the prescribed threads. Was really hoping for notable improvement 9 weeks in.

Anyway good to be here, looking forward to hearing your views.  And Hi GB , how you doing ?

Angle

Have you ever made a new post only to find that someone has posted at the same time as you and you missed it?

Here's a little tip for you.

#1 Compose your post.

#2 Click "Preview Post"

#3 Scroll down and you will see Thread Review (Newest First)

That will show you the latest post made, so you may avoid missing a post whilst answering another. It won't always work because if someone posts the same time as you it won't show, but if it's a busy thread and you want to make sure you have seen the latest post it will help.

Click "Post Reply" and if your lucky you won't have missed a post that was made whilst you was posting.

I know what I'm on about.  

This is a snipit of an article ahead of publication that looked into the menstrual cycle and the skin, it found dermatoses that are exacerbated perimenstrually include acne, psoriasis, atopic eczema and irritant dermatitis, and possibly also erythema multiforme.

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Perimenstrual exacerbations of dermatoses are commonly recognized, yet our knowledge of the underlying pathophysiological mechanisms remains imperfect.

Research into the effects of oestrogen on the skin has provided evidence to suggest that oestrogen is associated with increases in skin thickness and dermal water content, improved barrier function, and enhanced wound healing. Research into the effects of progesterone suggests that the presence of various dermatoses correlates with peak levels of progesterone.

Dermatoses that are exacerbated perimenstrually include acne, psoriasis, atopic eczema and irritant dermatitis, and possibly also erythema multiforme.

Exacerbations occur at the peak levels of progesterone in the menstrual cycle. Underlying mechanisms include reduced immune and barrier functions as a result of cyclical fluctuations in oestrogen and/or progesterone. Autoimmune progesterone and oestrogen dermatitis are the best-characterized examples of perimenstrual cutaneous reactions to hormones produced during the menstrual cycle.

A patch for the treatment of psoriasis containing 0.1% betamethasone valerate has been accepted for review by Health Canada.

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Cipher Pharmaceuticals Inc today announced that the Beteflam Patch (previously called the Betesil® Patch) has been accepted for review by Health Canada. The Beteflam Patch is a novel, patent-protected, self-adhesive medicated plaster containing 0.1% betamethasone valerate, for the treatment of inflammatory skin conditions such as chronic plaque psoriasis ("CPP").

Topical corticosteroids remain the primary treatment for steroid-responsive inflammatory skin diseases, including mild to moderate CPP. Occlusion with plastic film dressings is a widely accepted procedure to enhance their efficacy, especially in the treatment of psoriasis. The Beteflam Patch is applied once-daily to the affected region and may be cut to fit the particular size and shape of the psoriatic lesion thereby reducing potential contact of the steroid with healthy areas of skin. The occlusive format of the Beteflam Patch provides a consistent distribution, delivery and absorption of the active ingredient and enhances the potency of the corticosteroid.  The patch also helps to moisturize the skin, which accelerates healing and provides a protective barrier that reduces local trauma to the lesion due to scratching and prevents transfer of fluids from the lesion onto clothing.

"Chronic plaque psoriasis is the most prevalent form of psoriasis, found in about 90% of subjects with the disease, and can profoundly impact the quality of life for patients," said Shawn O'Brien, President & Chief Executive Officer of Cipher. "If approved, the Beteflam Patch will represent a promising new product in our growing Canadian dermatology portfolio and an attractive treatment option for Canadians who suffer from this disease."

Cipher licensed the Canadian rights to the Beteflam Patch in 2012 from Institut Biochimique SA ("IBSA"), a pharmaceutical company based in Switzerland. The efficacy and safety of the product has been established in two successful phase III trials and one successful phase IV trial conducted by IBSA. IBSA recently published positive results from a large non-inferiority study, which compared the product to Dovobet (betamethasone plus calcipotriol), a commonly prescribed combination product containing a corticosteroid and a vitamin D analogue.

Evening all,

for those in the UK, do you know if you can get coconut oil prescribed from the GP or derm doc please ?

Thanks gang

Happy scratching

GB

Well this is it time to bite the bullet and go onto the poison Methotrxate, I didn't want to do this but I'm left with no option as Stelara has now failed on me. You can read my old threads about using Stelara here: Stelara 16 Months On. and Stelara round two I will still be keeping the latter one going as I'm still using Stelara, but I thought I would start a new one about Methotrexate.

If you look at some of my comments about methotrexate you will see I'm not a fan, but I'm stuck in a place at the moment where the psoriatic arthritis is taking over my life again and it's no fun. There are no other treatments available to me at the moment and even if there was I couldn't take them as I've just taken 90mg of Stelara, so I need something to try and slow down the onslaught of psoriatic arthritis.

Last time I tried methotrexate was around the mid 80s when living in the UK, the way you was treated for psoriatic arthritis in those days was appalling. I was told to take 8 methotrexate pills a week all in one go, they just kept on throwing them at my via repeat prescription and I can only remember having one blood test. After about six months of being as sick as a dog all the time with constant headaches and weird feelings going on that made me feel so grumpy I stopped taking it, I continued with loads of pain killers and ant-inflamatories for years until one day I was completely locked up and couldn't move.

By now I was living in France and was sent to hospital where they put me on the bio's and I got my life back, but now the bio's have failed. so as they know I'm against the use of methotrexate, we are trying a low does 5mg every week for 3 months to see if we can get the psoriatic arthritis down.

So this my journey:

I've had a blood test and all is well, so today the nurse came and made the first injection. I've also been told to take 5mg folic acid tomorrow (I'm not exactly sure what that does as I haven't researched it yet so maybe someone will now?) Friday the nurse will come back for another blood test. From there we are going with 5mg methotrexate every Monday, 5mg folic acid every Tuesday, and blood test every Friday for three months.

I will update as I go if there is anything to report.

Psoriasis Score: 9
Psoriatic Arthritis Score: 33
Feeling shit and miserable.

Hi Everyone. I am from the U/K, and i am 74 years old. I have had psoriasis since i was 32. I first went on the coal tar ointment for quite a lot of years. It was messy and stained all your clothes, as well as your body. It looked as though i had been punched black and blue. After years on that prescription i went on Dovobet, that seemed not so bad, but the doctor told me i had been on it to long and that there was a danger of it thining my skin, what ever that meant. Anyway he has now put me on two different options. I have a tube of Betamethason valerate 0.1%W/W cream, and tubes of Dovobet ointment. The diference with the two tubes is one is a cream and the other is an ointment, which means the cream sorts of rubs into the skin, where as the ointment is more thicker, like vasoline, and tends to stay on your body longer. Ivé been on these for about a Month, with just the same outcome as the Dovobet. I don´t have it to severe i can still put a swimming costume on, plus i go to Tenerife for the Winter, so of course the sun helps quite a lot.

Now what i would like to know is the tablets that some of you are taking. Did you have to ask the doctor for these or, did he suggest them to you, and can you get them on prescription in the U/K. Thanks.

EDIT By Fred: This thread has been split from Stelara round two as it was going off topic.

(Fri-06-02-2015, 11:20 AM)Caroline Wrote:

(Fri-06-02-2015, 09:27 AM)D Foster Wrote:

(Fri-06-02-2015, 07:46 AM)Caroline Wrote: I still don't agree with you Dave.    There are still better ways to go.

I took MTX for 9 years ,6 by mouth and 3 by self injection and even though I am on 90mg of Stelara the relief for my PsA was much better on MTX.The side effects were not good towards the end of the tablets then on injection that settled down but built up again so I came off it however for the P it never cleared it but as I said for the PsA yes it was good. I can think of many other treatments that are worse and if you are very careful and monitor it then it is OK , PsA is extremely painful and I am lucky because I am not as bad as Fred.I take Tramadol and would argue that this is as bad as MTX in many ways especially as it only masks the pain leaving the joints alone which MTX does effect. A catch 22 situation prevails so where do you go ,it's just a matter of trying to play it safe as you can to get some relief.

I took MTX for three weeks. After that three weeks, there was only one thing in my mind. "I don't wanna die so young, I must get rid of this stuff"....
So I had the luck to stumble upon DMF, which you have not used , upto now I am very lucky with that.

I recently was prescribed Psoriderm bath additive and found it helped. It is 40% distilled Coal Tar. There is also a cream available. Has anybody else used it as 'Psoriderm' did not find any results in a search.

It is made by Dermal Laboratories in England.

Good afternoon my fellow lepers

Have any of you been prescribed Cocois ?

Because polytar is not available at the moment, i asked my GP for something for my head.

It seems this Cocois has Coal tar 12%, Salicylic acid 2%, Sulphur 4% & coconut oil compound ointment in it's ingredients.

Is it any good ?

Happy scratching

GB

I am pretty certain I have an ear infection. Not trying to self diagnose here, I've just had so many of them over the years and know the symptoms all too well. This is the first time I've had one since being diagnosed with psoriasis, however, and I don't want to do ANYTHING that might cause a flare after being clear on Acitretin 8 months after starting it. I've been tolerating the ear pain, pressure and dizziness for about two weeks now taking only Tylenol and hoping it would clear on its own yet it's getting particularly bothersome when singing - ears are popping. Ugh.

Thoughts?

In the process getting this approved... more later.

I was thinking after Stelara finally giving up on me after almost five years it would be interesting to see if we could find out from our members and guests what has been the longest amount of successful time on one psoriasis treatment, you can vote in the poll above and members can add to this thread if they wish.

For me it's been my latest treatment that has been the most successful, Stelara almost made five years but has let me down a couple of times and now it's failed big time with psoriatic arthritis. So I'm voting 4

Here's some good news about researchers that have found new gene that confirms existence of psoriatic arthritis (PsA). The research has established PsA as a condition in its own right, and it could have major implications in the way that patients are treated and lead to the development of drugs specifically developed for PsA.

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Researchers led by the Arthritis Research UK Centre for Genetics and Genomics at The University of Manchester have identified genetic variants that are associated with psoriatic arthritis (PsA) but not with psoriasis, in the largest study of PsA ever published.

PsA is a common form of inflammatory form of arthritis causing pain and stiffness in joints and tendons that can lead to joint damage. Nearly all patients with PsA also have skin psoriasis and, in many cases, the skin disease is present before the arthritis develops. However, only one third of patients with psoriasis will go on to develop PsA.

The researchers, who are part of a European consortium, say that their work, which took three years to complete and is published in Nature Communications, is a breakthrough because genetic changes have been identified that increase the risk of PsA but not psoriasis.

Until recently opinion was divided as to whether psoriatic arthritis was a disease in its own right, or psoriasis combined with rheumatoid arthritis.

The findings could, in future, lead to the identification of people with psoriasis who are at risk of developing psoriatic arthritis.

Dr John Bowes, who led the analysis of the work, said: “Our study is beginning to reveal key insights into the genetics of PsA that explain fundamental differences between psoriasis and PsA. Our findings also highlight that CD8+ cells are likely to be the key drivers of inflammation in PsA. This will help us to focus on how the genetic changes act in those immune cells to cause disease”.

The gene identified by the research team lies on chromosome 5 and is not the first PsA-specific gene to be identified. Patients who carry the HLA-B27 gene are also more likely to develop PsA.

Professor Anne Barton, a rheumatologist and senior author on the study explained: “By identifying genes that predispose people to PsA but not psoriasis, we hope in the future to be able to test patients with psoriasis to find those at high risk of developing PsA. Excitingly, it raises the possibility of introducing treatments to prevent the development of PsA in those individuals in the future”.

Dr Stephen Simpson, director of research at Arthritis Research UK added: "This is a significant finding. Not only does it help establish PsA as a condition in its own right, but it could have major implications in the way that patients with this condition are treated and lead to the development of drugs specifically developed for PsA, which are greatly needed.”

The research was funded by the National Institute for Health Research Manchester Musculoskeletal Biomedical Research Unit.

Nice to see more and more being put into helping us live with psoriasis, it's been a long time coming but these past few years have been encouraging and today the pipeline is still looking healthy. And today we have another positive phase 1 result from Akall for their APK-11 psoriasis topical treatment.

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(Akaal Pharma), an Australian clinical-stage biopharmaceutical company focused on developing new small molecule drugs for the treatment of inflammatory and autoimmune diseases, today announced the positive results from a randomized, double-blind, placebocontrolled Phase-1 clinical trial of AKP-11, a novel and First-in-Class topical Sphingosine 1- Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque psoriasis.

In this study, the topical application of AKP-11 to psoriasis patients for 28 days was found to be safe, well tolerated and resulted in a significant reduction in plaque severity. No detectable plasma levels of AKP-11 were found in the pharmacokinetic analysis, which is
attributable to the large therapeutic index of AKP-11.

Although a variety of therapies are available for treating psoriasis, there exists an underserved need for safer and effective topical treatments for long-term use. The Phase 1 clinical data for AKP-11, a topical First-in-Class S1P1 modulator, is very encouraging and
strongly supports our Phase 2 clinical trial in a larger number of patients said Dale Dhanoa, Ph.D., CEO of Akaal Pharma.

Study Details:
The Phase 1 clinical trial was a randomized, double-blind, and placebo-controlled study that involved 16 subjects. This study was conducted in 2 parts, Phase 1A and Phase 1B. AKP-11 or placebo were administered as an ointment to 4 healthy subjects in PART A and extended to 12 psoriasis patients in PART B. The patients were treated once daily with a topical application of AKP-11 for 28 consecutive days. AKP-11 reduced the local psoriasis severity index (LPSI) and demonstrated significant efficacy when compared to baseline (p=0.0016). The placebo group did not show efficacy. No clinically significant local or systemic adverse events were observed in the study.

About AKP-11
AKP-11 is a novel, potent and highly selective sphingosine 1-phosphate receptor subtype-1 (S1P1) modulator undergoing clinical development for topical treatment of psoriasis and other skin diseases. AKP-11, a novel small molecule, has also shown excellent preclinical pharmacokinetic and pharmacodynamics profile as a potential Best-in-Class oral treatment for autoimmune indications. AKP-11 acts via multimodal actions and significantly reduces the overexpression of pro-inflammatory cytokines and factors including the permeability factor VEGF.

Good afternoon,

My insurance company has approved me for Cosentyx. Ive been on everything and cant wait to try it. I'll be on 300mg Sensoready shots. Now I am looking for a specialty pharmacy that has it available to order. Does anyone know who might have it yet?