i originally joined this forum to ask a simple question, but i guess i may as well join the group.

since adolescence i had really bad dandruff, but after a few years, lesions appeared on my private areas, which made me go to the doctor, leading to my diagnosis of inverse psoriasis. this was about 10 years ago. these days i get lesions on my back and stomach too, and recently my arms and legs have joined in on the fun.

originally i treated with steroid creams, but then discovered protopic, which i used happily for years. however, one day i got incredible side effects - i could not stop scratching. as a sufferer from psoriasis, i know very well what itching can be like - this was 100 times worse, i ran into the bathroom and stayed for 15 min in a cold shower.
despite this experience, i tried again the next night, and went through the same thing again.
so it was back to daivobet for me. see im fortunate enough to have a light case, so no biological or systematic treatment for me.
now ill rant:
this nasty "gel" stains my cloths, so i only use it before going to bed. but see i work really long hours, and i study 2 nights a week ontop of that, not to mention my drinking habit. so by the time i get home im usually starving and exhausted, theres no way im spending 15 minuets rubbing horrible creams into my skin.. even if im a good little boy and i use the cream 4-5 nights in a row (a rare occurrence) theres no way in hell it will happen on the weekend. so i use the "gel" in 2-3 day patches, with a few days interval in between. 
all this to say, im treating my p all wrong, and im very much aware of it.
i went online to find out the the recommended diet is (for me) virtually impossible. i get stressed easily too...  

i may have been diagnosed 10 years ago, but i still feel like a novice, and i simply do not know what to do. i hope to gather some more info (partly from this forum), and go back to my doctor. but im pretty sure he'll just tell me again that for my case, daivobet is my best option...

thanks for the opportunity to let all that out.

hello everyone

and it was really hot too, like 35 degrees Celsius, and it wasnt a new tube either, it was already a few months old anyway. im afraid to use it now, but ofcourse the psoriasis is flaring up right when i least need it, and it will be hell to wait till i can see a doctor.
anyone got any insight? would it be ok to use anyway? whats the worse that can happen?
any help will be greatly appreciated, thanks

It was so hard getting on this site...I forgot I even had psoriasis!!

I've had PPP for about five years and about six months ago it became pretty much unbearable, so I caved in and told my dermatologist I'm ready to try the oral meds. Three months ago I started on Neotigason/Acitretin 25 mg for two weeks and then upped it to 30 mg until I saw the dermatologist again. The worst of the side effects were that my lips were peeling badly and the inside of my nostrils was incredibly sore, but my hand and foot were definitely improving, to the point where I can show my hand without the PPP being obvious.

Wasn't particularly happy with the coating on my palate after eating, some dizzy spells, very dry skin all over, itchy spots appearing on my legs, hair loss - most of the usual side-effects. I was advised to cut back to 25 mg to lessen the side effects, and that's helped. Still get patches on my legs that I never had before and they itch, and spots on my arms itch too, mainly in the evenings. I stuff QV intensive moisturiser up my nose at least twice a day now instead of on my hand and foot which helps the dry and sore nostrils. My lips have improved but still get dry. It's been quite something to see how much skin has peeled off both of my feet, top and bottom, in places I never had PPP. When my skin is wet it becomes disturbingly smooth and sticky, and I have to be careful in the shower that I don't slip on the tiles. My foot hasn't improved as much as my hand, but apparently feet take longer. I'm glad I can walk without a limp now, though!

I could do with some advice: My hair has been thinning and I'm worried enough about that, but it's my eyebrows! Although I'm a brunette, my eyelashes and eyebrows are quite light and the Neotigason seems to have thinned what little I had in the way of eyebrows to the point where they're not obvious at all. I always used an eyebrow pencil to fill them in to make my face look less 'blank', but there's not much left at all anymore. I'm wondering about costmetic tattooing to help my self-esteem but I'm worried that the effect of the Acitretin on my skin may cause more problems. Does anyone have experience in cosmetic tattooing, or general tattooing, while using Neotigason/Acitretin?

Thanks to all for sharing their stories and making us all feel less alone in our struggles with this disease.
M.

Following on from this post Orencia gets FDA approval for psoriatic arthritis Orencia has also received EU approval to treat psoriatic arthritis.  

Quote:

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Bristol-Myers Squibb Company (NYSE: BMY) announced today that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.

This approval, which allows for the expanded marketing of ORENCIA as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for ORENCIA in less than a year; in September 2016, the European Commission approved ORENCIA, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which ORENCIA is approved to treat in Europe.

“This EC approval builds on the well-established profile of ORENCIA in Rheumatoid Arthritis and exemplifies our commitment to ongoing clinical research of ORENCIA as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications,” said Brian J. Gavin, Ph.D., Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Despite the current availability of medications, there are many people with active Psoriatic Arthritis who are in need of a new treatment option; the approval of ORENCIA now provides a novel immunotherapy approach that may help these patients.”

The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively. Responses were seen regardless of prior tumor necrosis factor inhibitor (TNFi) treatment in both studies.

So here goes I thought I'll start a new Thread so I can track my new treatment on treating my psoriasis with a biological drug called Stelara. It's my third biological treatment. I was previously on Ebrel which lasted 2 years and Humira which lasted 3 years. I hope his diary will help others who is starting Stelara or thinking of starting Stelara.
My psoriasis is serve... At its worst it's everywhere taking over at least 80% of my body, when they start to go on my hands and feet that's when I know it's a bad flare and eventually on my face but this has only happened a few times, thank goodness. I don't usually get psoriasis on my hands and feet or my face. It only happen a when I get a serious flare.
So this recent trigger which has taken me off humira to Stelara has been rather bad. But I'm lucky it hasn't started on my face so this isn't the worst it's been. Though having psoriasis on my hands and feet have been a pain and I salute anyone who suffers from this. It's not pretty.
Starting Stelara wasn't easy I had gone to see my Dermo noticing that my psoriasis had started to come back Humira wasn't working anyone and my psoriasis was starting to appear on my legs. I had been pretty much 100% clear in Humira for 3 fabulous years. I was told that Humira isn't working anymore and I was to start Stelara which I agreed to. We did all the paper work and I was assigned to a nurse. She told me it would take 2 weeks to process. I went home and waited. During this time my psoriasis decided to come in vengeance it came up hard and fast and it decided to give me arthritis along with it. OMG I did not know pain until my joints stiffed up and I could not walk or move. I went to the GP and was prescribed Naproxen which made walking bearable. 2 weeks went by and I still hadn't heard from the drug company about delivery of Stelara and nurse appointment to inject me I followed up with my assigned nurse who chased up the drugs for me and planned delivery. A lady called to arrange delivery and told me the earliest the drug would be delivered is 5 days from now and then it would take another 5 days for a nurse to come for my first injection. I broke down and cried. I had been off humira for 3 weeks at this point and my psoriasis was getting worst by the day.
Let me tell you how important it is to have a good dermatology team I called my nurse who has been with through me with countless flares and knows my skin well. Within the hour she had the delivery date escalated and a nurse to come do my injection the next day.
I had my injection 3 days ago, it was painless and I have no side effects and in fact I think I already see some improvement. My psoriasis is less red and not as raised. It still not great but as least it looks like its calming itself down.
I hope that my journey here will help others who are about to take Stelara or newly taking Stelara and that we can experience this together and get better together.

Spotless.

 Hello everyone......

Thanks for allowing me onto the group, I stumbled across it last night.......it is great to see that there are so many people on here willing to help/listen and share experiences....

So April this year, completely out of the blue, I started to get pustules on my hands and feet.  I was originally misdiagnosed with pompholyx , was given a steroid cream but it just got worse, went back to the doctors who suspected palmoplantar pustulosis psoriasis  (PPP).  Following consultation with Derm Consultant I was indeed diagnosed with PPP.  I have never had any experience with psoriasis, no family members have ever suffered so feel a bit like i have been hit by a bus to be honest!!  

I think the main thing for me is that i feel totally out of control with all the medications/lotions/potions etc, I understand it is a long process trying to find something that works for you personally but I just feel that everything is out of control......  seems every time i go to the hospital i am told to stop taking this and start taking that.  GP prescribed Calcitriol (didn't see any improvement using that) a Coal Tar lotion and Epaderm (which is disgusting), then a month later the Consultant prescribed Lotriderm and Protopic and Dermol 500 lotion then i am not kidding you 10 days later (last Thursday) i had an appointment with the nurse and she tells me to stop taking Lotriderm and Protopic and instead take ClobaDerm and another Coal Tar treatment which is much stronger.......Not only has this all been confusing, but at £8.60 an item would have cost me around £120 so far for all this medication, luckily i got a pre-payment prescription card very early on....but now I also have a bathroom that resembles a pharmacy

So since i started taking ClobaDerm my feet have become unbearable and feels like i am walking on broken glass and the upshot of this is i have stopped using everything prescribed and am using a normal everyday moisturiser....the next step for me is PUVA which i start next week so fingers crossed that helps the condition somewhat.....Has anyone else had this treatment?

Will definitely be looking for advice on natural lotions and potions available or what helps other people on the group.....

Apologies for the huge ramble but boy does it feels good to blurt all this out.....so thanks for reading  

Hi,
I thought I'll join the club been lurking here for a few days. I start Stelara today and very nervous about yet another biologic that may not work for me. Been on Enbrel and Humira.
I've had psoriasis for as long as I can remember and I've been on everything that's possible to treat psoriasis. Unfortunately after Humira stopped working I have developed arthritis (god hates me) and this is another ball game. When you can't walk that's just a different story.
So here all flared up waiting for the nurse to come inject me. It's taken 3 weeks to process through the NHS here in London I don't know if that's normal but it has been terrible waiting to start.
So here I am and so happy to read really good success stories about Stelara.

Cheers!
A girl who really really wants to be Spotless!

I have had psoriasis for 16 years. I was first diagnosed when I was 34 years old and I believe it was first triggered by a stressful event. It is also partly hereditary – my mother has it and my grandfather was thought to have it.
In the first few years I was treated with a series of medications, including dovonex (useless), light therapy (good but had a flare straight after the treatment was completed, so not long lasting) and dovobet (my lifeline for the last 14 years). My psoriasis covers more than 10% of my body and is mostly on my legs, feet, elbows, scalp and ears. About 2 years ago it began to spread to my torso and flare fairly frequently. I have also developed mild psoriatic arthritis in my hips, knees, feet and hands, including dactylitis in my left thumb. I have had to use dovobet fairly continuously since then.
I wasn’t keen to move on to more aggressive systemic treatments (methotrexate and biologics) because of the side effects. At this point I should mention I am a medical writer by trade, and have written extensively on the use of these treatments across a wide range of immune-related disorders, including psoriasis and psoriatic arthritis. 
I did some research on Removed to see what studies had been carried out on the natural control of symptoms associated with psoriasis. As everyone has probably read, diet is a big factor. So I decided to try diet as a way of controlling my symptoms. I stopped eating gluten, lactose, sugar and limited alcohol to a couple of glasses of wine a week. I managed to follow this for about 6 months and did notice a gradual improvement. I maintained the diet until about 6 months ago, when I was worried I could make myself gluten/lactose intolerant. So I gradually began to reintroduce these to my diet. I also wanted to enjoy life! So I would have sweet stuff and a few more drinks on occasion. One thing I have noticed through this elimination diet was that I definitely had some dietary triggers that resulted in almost immediate flares (same day). These were wheat (bread/pasta/cake) but not necessarily gluten, more than 3 glasses of wine in one sitting and a high dose of sugar (e.g., large slice of cake). All 3 would be a disaster. The flares start in my joints and the skin itching begins after that. I can minimise the impact of the flares by taking ibuprofen and antihistamines (one loratadine and one cetirizine – generic brand) – and obviously not repeating the dietary mistake!
I did some more research to see what evidenced-based natural supplements are out there that could have benefits in an immune-related disorder such as psoriasis. Psoriasis is inflammation – your body attacking itself (in our case our skin). It is also associated with vitamin D deficiency. For many immune-related disorders there has also been the suggestion that gut imbalance is a factor. Basically, our gut bacteria (microbiome) are out of whack. So I focussed my research around anti-inflammatory supplements, supplements good for the skin and probiotics for the gut aspect. I have honed my list of supplements down to the following:
1.    Vitamin D (10,000 IU per day)
2.    Bio-selenium and zinc
3.    Turmeric (curcumin 600 mg with 5 mg organic black pepper)
4.    Astaxanthin (12 mg)
5.    Biotin (10,000 μg)
6.    Omega 3, 6 and 9 (1200 mg) – fish oils
7.    Optibac probiotics extra strength (they have shown the good bacteria in their capsules make it through the stomach acid – many others don’t)
I get 1-6 from Removed and 7 direct from the manufacturer (in the UK).
I take one table of each every day after dinner and have been doing so for 6 weeks now. I have noticed a major improvement in my psoriasis and joint pain. It took about 3 weeks to notice the benefit. I have managed to come off dovobet completely for the first time in over 2 years – I was using it every evening. My plaques have gone from red, scaly, itchy/sore to flat stains in the majority of places. I still have minor raised plaques on my elbow and one on my feet. I am not having any side effects from taking the supplements. I do try and stick to the wheat free, low sugar, sensible alcohol intake diet. I also keep my skin well moisturised by applying an emollient in the morning and at bedtime.
It has made a big difference to the quality of my life, which has been fairly dominated by my condition. I would be interested to see if this has any benefit in anyone else willing to try, as I recognise this is only a case study of one person.

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Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Data will be presented at a key medical congress in the second half of 2017. 5 year Phase III data are a recognized milestone for assessing long-term efficacy and safety of innovative treatments.

"Cosentyx has consistently demonstrated sustained efficacy and safety providing psoriasis patients a new standard of long-term care," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "With the first data from a pivotal trial with 5 years of follow up, Cosentyx continues to demonstrate it can provide what psoriasis patients want, a life with clear skin."

4 year Phase III data presented at EADV 2016 showed Cosentyx delivered almost clear or completely clear skin in a majority of patients (PASI 90 - 66%, PASI 100 - 44%) after 4 years of treatment. The data showed that with Cosentyx, 97% of PASI 90 and 99% of PASI 100 response rates were maintained from Year 1 to Year 4.

Recently, new label updates announced for Cosentyx in Europe demonstrated long-term superiority of Cosentyx versus Stelara®* (ustekinumab) in moderate-to-severe plaque psoriasis on the basis of 52 week data from the CLEAR study, and expanded the use of Cosentyx for the treatment of moderate-to-severe scalp psoriasis. Cosentyx was launched in 2015 as the first and only fully-human IL-17A inhibitor to treat psoriasis and is now licenced for the treatment of psoriatic arthritis and ankylosing spondylitis as well. Novartis remains committed to investigating important scientific questions with Cosentyx that address unmet needs and could significantly enhance patients' quality of life.

About the study
The long-term extension study for Cosentyx in patients with moderate-to-severe psoriasis is designed to analyze efficacy and safety over the period of 5 years (Week 260). The current data analysis for Cosentyx includes all patients who reached a PASI 75 response at Week 12 and subsequently received continuous treatment with 300mg secukinumab until the end of Year 5.  The study includes analysis of the PASI 75/90/100 response rates over the extended treatment period from Year 1 (Week 52) to the end of Year 5 (Week 260), analyses of body surface area (BSA) and absolute PASI (i.e. assessments of increasing relevance to the dermatologists), showing how many patients still on study drug had no more than 1% of their BSA covered by psoriasis, mean PASI and BSA improvement, as well as the safety profile of Cosentyx.

This study suggests there is an association between psoriasis and migraine.

Quote:

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Background:
Psoriasis and migraine share several pathogenetic mechanisms due to systemic inflammation, which increase the risk of developing cardiovascular disease.

Objective:
Our aim is to investigate the prevalence of migraine with (MA) and without aura (MO) in the psoriatic population, investigating a possible new comorbidity of the psoriatic disease.

Methods:
We referred 68 psoriatic patients to a 9 questions survey formulated on the basis of the International Headache Society (IHS) diagnostic criteria for migraine. Than, in the case of MA, the mean monthly number of migraine crises was assessed. Data of psoriatic patients were than compared with those of a psoriasis free control group composed of 235 migraine patients (with and without aura).

Results:
A clinical diagnosis of migraine was performed in 32 psoriasis patients with a great prevalence in women (F: 87.50% - M: 12.5%). Moreover we found a much higher prevalence (62.5%) of MA, with the remaining 37.5% diagnosed with MO. Comparing the prevalence of MA between psoriasis + migraine patients and the control group we observed a statistical significative difference (p<0.0001); furthermore the number of MA crises was significantly higher (p<0.0001) in patients with psoriasis with respect to the MA control group.

Conclusions:
We showed a significant association between psoriasis and migraine, especially MA, probably due to common pathogenetic mechanisms, but further studies are needed to assess their interplay in developing cardiovascular diseases.

Following on from this thread Janssen seeks approval of Guselkumab for the treatment of psoriasis the FDA have approved Tremfya (Guselkumab)

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Janssen Biotech, Inc. (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has approved TREMFYA™ (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. TREMFYA™ is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher. TREMFYA™ is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. In clinical studies, patients receiving TREMFYA™ experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16. Superior results in skin clearance (PASI 90) were demonstrated with TREMFYA™ compared with Humira® (adalimumab) at weeks 16, 24 and 48.

“TREMFYA™ represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23–specific therapy at week 16 and up to week 48,” said Andrew Blauvelt, M.D., M.B.A., President of Oregon Medical Research Center, and study investigator. “We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of TREMFYA™ is exciting, both as a researcher and a practicing dermatologist.”

I´m sure I´ve read it on here somewhere, but I can´t find it anymore

Which interleukines have a reaction with the DMF?

well started methotrexate today.. fingers crossed, see what happens.

I made the decision to start with Stelara after reading many posts on this forum of others who have gone down this road. My psoriasis is primarily on my lower legs and tops of feet. My first injection was on July 6, 2017. So far the only reaction I've noticed was stinging at the injection site for about 2-3 hours afterwards. Today I feel a little tired but it could be due to having to get up in the middle of the night with our new puppy. My husband wondered if becoming easily irritated was one of the side effects?

Next injection will be in 4 weeks.

My insurance denied the request from my doctor for Stelara treatment and wanted me to use Humira first. Dr. insisted this was the best treatment and Janssen (the manufacturer) approved me for "free" injections through the end of the year...what's the catch? Dr. said many times the manf. will do this, show that this treatment is working and then the insurance provider typically will support the treatment going forward, i.e. not deny a treatment that is working...hopefully!

Hey folks...

After starting Leflunomide 6 weeks or so ago, last monday, i noticed my sense of taste was diminishing.. a few days later, it has all but gone and replaced with a metallic taste. 
after charting my bloods (bi-weekly), my Urea count is up each test and currently at 10 as well as a bit of kidney ache. 

Since last Friday, i have upped my water intake to 4 litres (not easy) to try to help flush my system a bit.

I called my rheumy specialist nurse this morning but she wasn't available, so left a message and am awaiting a call back.

Looks like Leflunomide isn't for me, as was Sulphasalazine... i don't know if they'll swap me to Methotrexate next or maybe try Bioligics ?

the joys of PsA

Orencia previously used to treat rheumatoid arthritis has been given FDA approval to treat psoriatic arthritis.

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Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA), a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. ORENCIA is approved and available in both intravenous and subcutaneous (SC) injection formulations. ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic Rheumatoid Arthritis (RA) therapy, such as anakinra. This approval marks the third autoimmune disease indication for ORENCIA.

“This approval underscores the efficacy of ORENCIA in adult patients with active Psoriatic Arthritis, who have been in need of new treatments,” said Brian J. Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce ORENCIA, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”

The co-stimulation blockade of ORENCIA inhibits T-cell activation and the resulting cascade of events that contribute to inflammation. T-cell activation is involved in the pathogenesis of PsA.

Psoriatic Arthritis can cause joint pain, stiffness and reduced range of motion, potentially affecting the ability to do everyday activities, such as getting dressed and tying shoes. In PsA, the immune system attacks healthy joints and skin.

“Psoriatic Arthritis takes a toll on patients and families over time,7” said Randy Beranek, president and CEO, National Psoriasis Foundation. “We welcome the introduction of an additional treatment option for adults with active Psoriatic Arthritis, because we believe advancements, along with further research, education and support services, are critical to helping improve the lives of those impacted.”

The approval was based on results from two randomized, double-blind, placebo-controlled trials in which ORENCIA improved (or reduced) disease activity in both TNF-naive and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than seven years.

ORENCIA PsA IV and SC Studies Demonstrated Improved Disease Response

The efficacy of ORENCIA was assessed in two randomized, double-blind, placebo-controlled studies (Studies PsA-I and PsA-II) in 594 adult patients with disease duration more than seven years. Patients had active Psoriatic Arthritis (≥  swollen joints and ≥  tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter. In PsA-I and PsA-II, 37% and 61% of patients, respectively, were treated with TNF inhibitors (TNFi) previously. The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (Day 169).

In PsA-I, a dose-ranging study, 170 patients received study drug IV at Days 1, 15, 29, and then every 28 days thereafter in a double-blind manner for 24 weeks, followed by open-label ORENCIA every 28 days. Patients were randomized to receive placebo or ORENCIA 3 mg/kg, 10 mg/kg (weight range-based dosing: 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1000 mg for patients weighing greater than 100 kg), or two doses of 30 mg/kg followed by weight range-based dosing of 10 mg/kg without escape for 24 weeks. Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At enrollment, approximately 60% of patients were receiving methotrexate.

Cosentyx has received approval from the EU for two label updates including scalp psoriasis.

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Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® * (ustekinumab) in psoriasis]. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis - one of the most difficult-to-treat forms of psoriasis, which affects approximately 60 million people worldwide[. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx.

The addition of the CLEAR study data in the European product label reflects the benefit of Cosentyx for people living with this chronic and often distressing condition. The 52 week data show that Cosentyx is superior to Stelara in delivering long-lasting clear or almost clear skin over one year of treatment in adults with moderate-to-severe psoriasis. Cosentyx remained consistently superior to Stelara in achieving and sustaining a PASI 90 response (76% versus 61%) and significantly better in achieving a PASI 100 (clear skin) response (46% versus 36%) at Week 52.

The updated label for Cosentyx on scalp psoriasis, in a difficult-to-treat area of the body, addresses an important unmet need. Many patients with scalp psoriasis do not achieve an adequate response from currently available treatments. Also, scalp psoriasis can be particularly challenging to treat as disease activity is often maintained through hair care, scratching, and shampooing of the scalp, adding to the fact that the application of topical treatments is challenging. Approximately half of all 125 million patients with psoriasis worldwide suffer from scalp psoriasis.

"We are happy to see these two important label updates for our IL-17A-inhibitor, Cosentyx, the first IL-17A inhibitor approved to treat psoriasis. We are continually investigating new areas for Cosentyx to significantly enhance patients' quality of life, such as scalp psoriasis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Cosentyx is an innovative, groundbreaking treatment for people living with auto-inflammatory diseases, and we're proud to continuously expand treatment possibilities for an even greater number of patients."

Cosentyx is currently the only fully human IL-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase III study of scalp psoriasis. The CHMP approval is based on results from the 24 week study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo. Psoriasis Scalp Severity Index (PSSI) 90 responses were achieved by a significantly greater percentage of patients receiving Cosentyx 300 mg (53%) than placebo (2%) at Week 12 (P<0.001).

The label update is applicable to all European Union and European Economic Area countries. Cosentyx is approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis. Cosentyx is also approved in more than 70 countries for the treatment of active PsA and AS.

This study suggests that targeting IL-23 alone could be a potential treatment for psoriasis.

Quote:

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Background:
The development of monoclonal antibodies targeting IL-12 and IL-23 has enhanced the therapeutic options available for psoriasis patients. Recent research suggests that IL-23 alone plays a role in the pathogenesis of psoriasis.

Objective:
The objective was to review the phase III clinical trial data for the anti-IL-23 agents in order to evaluate the safety and efficacy profile of each agent.

Methods:
We reviewed the results of the phase III clinical trials for the anti-IL-23 agents tildrakizumab and guselkumab. The results of phase III trials on risankizumab have not yet been reported.

Results:
By week 12, the proportion of patients reaching Psoriasis Area and Severity Index (PASI 75) was greater than 60% among the most efficacious dose of each agent. The percentage of patients achieving PASI 90 at week 16 was the primary endpoint for the phase III trials for guselkumab, which was above 70%. The safety profiles of the agents were comparable, with the most commonly reported adverse events of nasopharyngitis and upper respiratory tract infections.

Conclusion:
The anti-IL-23 agents demonstrated a rapid clinical improvement that is similar or superior to the improvement seen with currently marketed IL-17 inhibitors with a favorable short-term safety profile. The results of the phase III trials support the notion that IL-23 is a potential target in psoriasis treatment.