Another new treatment for psoriasis is in the pipeline.

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DURECT Corporation today announced it has commenced patient dosing in a Phase 2a proof-of-concept trial with topical DUR-928 in patients with mild to moderate plaque psoriasis.  DUR-928, the lead investigational product in the Company's Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in chronic hepatic diseases such as nonalcoholic steatohepatitis (NASH), acute organ injuries such as alcoholic hepatitis (AH) and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.

"As topical agents continue to be the mainstay of treatment for patients suffering from mild to moderate plaque psoriasis, especially localized plaque psoriasis, it is important to investigate a topical agent with a novel mechanism of action," stated Dr. Howard Maibach, Professor of Dermatology at the University of California San Francisco.  "Should the results be positive, DUR-928 should be studied in additional inflammatory skin diseases."

"Commencing patient dosing in this proof-of-concept psoriasis trial is an important milestone in line with our focus for DUR-928 in 2019, which is to produce data with the potential to create significant commercial and partnering value," said James E. Brown, President and CEO of DURECT.

In this Phase 2a, randomized, double-blind, vehicle-controlled proof-of-concept clinical trial, DUR-928 will be applied topically once-daily for four weeks in patients with mild to moderate plaque psoriasis. The trial is being conducted at multiple clinical sites in the U.S.  Twenty patients are planned to be enrolled to obtain approximately 15 evaluable patients. Patients will serve as their own controls, applying DUR-928 to the plaque on one arm and the vehicle to a similar plaque on the other arm. After the treatment period, patients will be followed for an additional four weeks. The primary efficacy endpoint will be change in local psoriasis scores from baseline in the DUR-928-treated plaques compared to that in the vehicle-treated plaques. We expect to announce top line data from this study in the second half of 2019.

DURECT previously conducted an exploratory Phase 1b trial in psoriasis patients (9 evaluable patients) in Australia.  The trial was randomized, double-blinded, placebo and self-controlled, using a micro-plaque assay with intralesional injections of DUR-928.  The results were encouraging and warranted advancing into the current proof-of-concept trial with topically applied DUR-928.

Hi everyone,

Thank you so much for the warm welcome, it is great to finally find somewhere I can discuss Psoriasis with people that understand and have been through the same trials and tribulations.

The great news for me is that I have now completed week 5 of my Cosentyx and the result is amazing. I would say I am now almost 85-90% clear and feel so much better for it.

The injection pens are pretty much painless and  after the second go you get completely used to whole process (which takes seconds) and minor pinch/scratching feeling when administering.

I am due to have my first bloods (which are a little late) to ascertain there is nothing of concern internally. I did feel like I had a little chesty cough but that to me is a minor issue which has pretty much gone. I do plan on relaying any side effects to my consultant when I have the check-ups. I think I have some anxiety around having bloods in case my body isn't tolerating the medication but I recognise this is natural (working in mental health is beneficial) so I don't catastrophise about this.

Sorry to blabber, I will up date again in around a month,

Cheers

Leo Pharma announced they will start a clinical trial of microarray patches for the local intradermal treatment of psoriasis.

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Lohmann Therapie-Systeme AG (LTS), a market leader in transdermal therapeutic systems, and LEO Pharma A/S, a global leader in dermatology, today announced that the companies will start the clinical trial of microarray patches for the local intradermal treatment of psoriasis. The study will start in April 2019 with expected completion later this year and the aim of the study is to document safety and efficacy in patients.

A microarray patch (also known as a microneedle patch) is a polymeric, microscopic array which delivers encapsulated drugs by perforating the outer stratum corneum with numerous microneedles. The needles are biodegradable and will dissolve as they release the drug in the skin.

This is the first time that microarray patch technology is applied to psoriasis treatment, representing a novel dosage form with several potential benefits for patients: The microarray patch enables slow release of the drug (betamethasone and calcipotriol), which means that treatment frequency can potentially be reduced from one or more times daily to once weekly. Furthermore the patch may reduce or potentially eliminate the need for application of topicals such as ointments. Application of the patch is precise due to the small size of the micro needles ensuring that only affected skin is treated.

The micro array patch for psoriasis treatment has been developed jointly between LEO Pharma and LTS’ laboratories and has Good Manufacturing Practice (GMP) status. The project is the first result of a partnership agreement which the two companies entered in 2016.

"After a successful preclinical development in the last two years, initiating a human study in corporation with LEO Pharma is the next major milestone. Our Micro Array Patch (MAP) platform allows the active ingredient to be released directly into the skin MAP innovation is driven by a productive and constructive cooperation using core competences of LEO Pharma and LTS," said Stefan Henke, Head of LTS‘s Innovative Injection Systems Unit.

"Our alliance with LTS is a great example of LEO Pharma’s innovative approach to psoriasis treatment and how we collaborate to improve and extend what’s possible for the benefit of patients. The microarray patch represents a new treatment method, which we believe has the potential to improve both treatment compliance and convenience – thus helping even more patients achieve healthy skin," said Kim Kjøller, Executive Vice President, LEO Pharma Research & Development.

This study looked at the three biological treatments available for children with psoriasis.

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Background:
Three biotherapies – etanercept, adalimumab, and ustekinumab – are licensed in childhood psoriasis. The few data available on their efficacy and tolerance are mainly derived from industry trials. However, biological drug survival impacts long‐term performance in real‐life settings.

Objective:
The objective of this study was to evaluate the survival rates of biological therapies in children with psoriasis in real‐life conditions. Secondary objectives were to evaluate the factors associated with the choice of the biological therapy and to report severe adverse events.

Materials and methods:
This study was an observational retrospective study. Data were extracted from the clinical records of 134 children. Kaplan–Meier estimates were used to analyse drug survival overall and in subgroups of plaque psoriasis, bio‐naïve, and non‐naïve patients.

Results:
We analysed 184 treatment courses: 70 with etanercept, 68 with adalimumab, and 46 with ustekinumab. Factors associated with the choice of first‐line biological agent were age at initiation (younger for adalimumab, p<0.0001), age at onset of psoriasis (younger for adalimumab and etanercept, p=0.03), and baseline PASI and PGA (both higher for adalimumab, p<0.001). Drug survival rates were higher for ustekinumab than for adalimumab and etanercept (p<0.0001) for all treatment and all psoriasis types, plaque‐type psoriasis (p=0.0003), patients naïve for biological agents (p=0.0007), and non‐naïve patients (p=0.007). We reported eight SAEs: severe infections (n=3), significant weight gain (n=2), psoriasis flare (n=1), and malaise (n=1). Biological therapy was discontinued in three children (one with psoriasis flare and two with weight gain). Only the two cases of weight gain resulted in an unfavourable outcome.

Conclusions:
Our real‐life comparative study found that UST had the best drug survival outcome. The profile of SAEs in children was comparable to that in adults. These results will assist dermatologists in the decision‐making process when choosing treatment options for children with psoriasis in daily practice.

I'm still waiting for everything to go through but thought I would share my process here in case someone finds it helpful.

So, right after the doctor prescribed Cosentyx, the first step was blood work. Since I had my yearly check up they were able to get most of what they needed from my primary doctor, however they still needed a couple of more tests. So got that done and the doctor prescribed Costenyx.

I am in the United States, and have commercial primary insurance (through my husband's work) which is also where our prescription insurance comes from.

I received a call at the end of last week from a specialty pharmacy (we'll just call them Pharmacy A) letting me know they were handling the prescription. Today they called to tell me that I needed to call Cosentyx and join their co-pay program. I thought uh oh we most likely will not qualify but I called them and they really didn't ask me too many questions, NOTHING about income. So they signed me up and also on a secondary credit type (no, not the kind you have to pay back but the kind that if my insurance plus the co pay doesn't pay it all then the credit one will pay the balance) So, I call back Pharmacy A to give them the information. A very short time later, our prescription insurance company called (we'll just call them PIC for short) and informs me that pharmacy A is not in their network so I have to use specialty pharmacy B. Also, PIC informs me I need to call "save on" and get an exemption. Say what? So I call pharmacy A to make sure they know and yes, they already knew and was preparing to send my information to pharmacy B. So I call Save on and tell them I was told to call and why. They explain that it is part of my insurance perk, basically my co pay is a bit over $1300 per 300 mg and that the Cosentyx co pay program will pay half and that the credit program pays the other half but that the save on ensures that if for some reason there is a problem then Save On will pay meaning my cost will never be over $0.00. I guess it's insurance for my insurance But no matter, as long as they don't expect me to pay out that much!

So for all those thinking (like myself) that they would not be able to get assistance, always check to make sure because it seems you just never know!


I used some Taclonex over the weekend as my scalp was just bothering me too much. One application and a definite improvement, too bad it's a steroid ointment. I REALLY didn't want to use it as I used it prior to Stelara and cleared quite a bit which made it difficult to tell how much Stelara was helping right off. I also didn't want things to get worse but I'm hoping I don't have to continue with the Taclonex while waiting for Cosentyx (which should be soon now)

So things are on track it seems. I'll update when I get the call to set up my first round along with a picture for reference.

I have a question....
I have done numerous searches online but can't seem to find an answer....

I have been on oral mtx for over a year, and I am finding that my finger joints are becoming inflamed and distorted (mostly over the past 6 months or so.) I am also beginning to get skin plaques again after being completely clear for over 10 years.
How long is long enough to know for sure that the dose/medication is not working?

I have an appt with my new rheumy coming up, and I want to get off mtx due to side effects and my belief it isn't working for me but my gp, dermy and rheumy keep urging me to stay on it. Why, when I am obviously haging issues?

So far, I have found online sites saying 3 months, 6 months, one year and 3 years are all acceptable time frames.
Very confusing!

I cannot find an Australian site that gives clear information. How am I supposed to advocate for myself if I don't have the info?

Please help.

Hi! My name is Dani. I am 18 years old and I have Scalp Psoriasis.

I grew up in Yokosuka City, Kanagawa, Japan but I am currently in the Philippines studying. The first time I noticed flaky patches on my scalp was about 8 months ago when I was still in Japan. I had an auntie who works at a derma clinic and provided me topical creams to cure it so I never had to buy one from the drugstore. It worked and everything was okay, until February this year.

The heat's too strong here in the Philippines so I decided to tie my hair up in a bun. My blockmate noticed flaky patches and asked me what they were and I was so embarassed. ?

I did a little google search and found this forum and it looks like everyone here is nice and friendly so I am trying my luck here. 

I never bothered to take note of what cream I was using back when I was still in Japan. I wonder if you guys can help me what name of topical cream to buy here in the Philippines? I'm a student and I don't have extra money to have myself checked more so purchase the oral medicine they'll prescribe.

I am hoping you can help me. Thank you! ??

Hello everyone. I’m from the State of Georgia in the USA. I’m excited to be a part of this fourm. I was first diagnosed with PsA back in 2016. After Methotrexate and Enbrel failed me, my Rhematologist prescribed Cosentyx. I injected 150 mg last Friday. On Saturday out of know where I became so overwhelmed that I was going to pass out. It was so scary. Then I had bad stomach pains and cramps. Then here comes the diarrhea. I started to feel a little better until about 10 minutes later ... this horrible nausea came over me. I projectile threw up  2 times then this extreme fatigue set in that lasted 2 days. I was curious if anyone else has had these side effects? I’m hoping that was a one time thing. Thank you!

Hi Everyone,

So I have suffered with Psoriasis for around 5 years but my diagnosis was made 4 years ago (ish).

I have tried all of the recommended Creams and tablets such as Methotrexate, Cyclosporine, Apremilast and Acitretin.

Some of the above tablets worked a little, my main issue has pretty much been the side effects of the tablets, ranging from dark thoughts on the Apremilast to Nausea and sick feeling on the Methotrexate. (Bear in mind this is just my experience on the tablets and I am sure not everyone will have the same reaction).

I have recently started on Cosentyx and am on Week 3 of the weekly two 150mg injections (you have a weekly two injections for five weeks and then go monthly).

My skin has already started to clear up, Psoriasis fading massively, I take the medication on a Tuesday, yesterday (Wednesday) after my third dosage I did fairly quickly start to have a sore throat, coldy like symptoms and a runny nose. 

I have to say I felt similarly this morning but this afternoon after plenty of water and food I feel loads better. I am happy to keep everyone posted on my progress as my treatment progresses. I am remaining positive this works for me and am keeping my fingers crossed,

Alex

Boehringer Ingelheim present data showing that their "BI 655130" a monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R) showed significantly improved symptoms of generalised pustular psoriasis.

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New data from a Phase I clinical trial showed BI 655130, a first-in-class investigational treatment, significantly improved symptoms of generalised pustular psoriasis (GPP), a rare form of psoriasis.

BI 655130 is a monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system that may play a role in many inflammatory diseases.

The newly published clinical data, indicate that BI 655130 rapidly improved symptoms in seven patients with GPP, who were experiencing acute moderate or severe disease flares.  Five of seven patients in the 20-week, Phase I clinical trial achieved clear or almost clear skin within the first week, following a single dose of treatment, and all patients achieved this outcome after four weeks. The average improvement in patients’ skin symptoms was close to 80 per cent at week four and was maintained until the end of the study (week 20).

“The tailored targeting of the IL-36 pathway is one of the most exciting new areas in dermatology research, and progress in this mechanism has been eagerly anticipated by the scientific community,” commented the trial’s principal investigator, Professor Hervé Bachelez, Hôpital Saint-Louis, Paris, France. “This trial provides long-awaited clinical data that demonstrates the positive effect of blocking IL-36 action as a potential, novel treatment approach. The rapid improvement seen in patients from just a single dose of BI 655130 show strong potential for the future treatment of GPP.”

The rare skin disease, GPP, is a chronic condition that is distinct from the more common condition, plaque psoriasis.  It has a considerable impact on people’s quality of life. The skin becomes red and erupts into numerous blisters of non-infectious pus (pustules), covering wide areas of the body.  People who develop GPP may experience an abrupt onset of fever, chills and painful skin lesions. GPP may be associated with life-threatening organ failure and infectious complications, and, therefore, should be considered a medical emergency. Available treatment options for GPP are extremely limited and lack profound and persistent efficacy. Therefore, there is a strong need for new treatment options for GPP with rapid, strong and persistent efficacy.

“BI 655130 is a novel antibody discovered by Boehringer Ingelheim and is being investigated for the treatment of multiple inflammatory diseases in the hope of transforming the care currently available for these patients,” said Dr Jan Poth, Therapeutic Area Head, CNS and Immunology at Boehringer Ingelheim.

“We are one of the first companies to focus on targeting IL-36 in dermatology, a reflection of our long-term commitment to researching and developing transformative medicines for patients where there is still high unmet need. Due to its potential, we are moving to the next phase of clinical trials, involving larger numbers of patients with GPP. Trials of BI 655130 are also underway in other immune related conditions, such as palmo-plantar pustulosis, ulcerative colitis, Crohn’s disease and atopic dermatitis,” continued Poth.

I found this forum by accident while searching for information and communities on PsA and psoriasis.
I am almost 51 years old and have had plaque psoriasis from the age of 2. Recently sortof diagnosed with psoriatic arthritis within the last 18 months - I say sortof, because I have had various diagnosis from a few different doctors but no definitive dx from any of them.
My skin has been clear of plaques for over 10 years, but I have distal joint deformities, nail issues, slight joint pain, and a whole slew of what I now know are possible comorbidities (early onset osteopenia, anaemia, skin cancer, etc).
I was prescribed sulfasalazine by my dermatologist which did nothing, and have been on methotrexate for over a year which also seems to not be working.
After pushing hard with my GP, I am finally seeing a rheumatologist.
Sadly, it has been a very difficult issue trying to find cohesive and complete information in Australia about psoriatic arthritis..... I have literally been forced to make a chart to connect all the little fragments of info I have found over the past couple of years.

I am hoping that this forum will give me ideas and information that will help me be the best advocate I can be for myself moving forward.
Looking to live my best possible life as I progress!

Thankyou for reading.

fialstar

This large study of psoriasis patients in Italy suggests Pruritus should be evaluated during consultations.

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Background:
Psoriasis (Ps) is a chronic systemic autoimmune disease associated with pruritus in 64‐98% of patients. However, few modestly sized studies assess factors associated with psoriatic pruritus.

Objective:
To investigate factors associated with Ps pruritus intensity.

Methods:
Psoriasis patients 18 years or older seen in one of 155 centers in Italy between September 2005 and 2009 were identified from the Italian PsoCare registry. Patients without cutaneous psoriasis and those with missed information on pruritus were excluded.

Results:
We identified 10,802 patients, with a mean age 48.8±14.3 years. Mild itch was present in 33.2% of patients, moderate in 34.4%, severe in 18.7% and very severe in 13.7%. Higher itch intensity was associated with female gender, lower educational attainment compared to university degree, pustular psoriasis, psoriasis on the head, face, palmoplantar areas, folds and genitalia, more severe disease, disease duration <15 years, and no or few prior systemic treatments.

Limitations:
Effects of specific medication on itch were not assessed.

Conclusions:
Pruritus should be evaluated during psoriasis visits, and physicians should be aware of patients at higher risk for itch. Further studies are needed to assess the effects of medications on itch, and establish therapy for psoriasis patients with persistent itch.

Another good result for Cosentyx (secukinumab).

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Novartis announced today new data in 441 Chinese patients with moderate to severe plaque psoriasis from a Phase III study investigating the efficacy and safety of Cosentyx (secukinumab). The data, part of a broader ongoing 52 week Phase III study in 543 patients, show 97.7% of patients treated with Cosentyx 300mg achieved PASI 75 and 80.9% achieved PASI 90 by week 12, with 87% of patients reaching PASI 90 by week 16. In patients treated with Cosentyx 150mg, 87.8% achieved PASI 75 and 66.4% achieved PASI 90 at week 12.

"Cosentyx continues to deliver what psoriasis patients need - reimagining care to provide clear skin and a complete treatment," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology, and China Region Development Head. "We're excited to report for the first time data for a Chinese population, and to see strong support from the data for Cosentyx."

Cosentyx is backed by a wealth of research with 100 studies and has been proven to offer clear or almost clear skin in 8 out of 10 patients within 16 weeks of treatment. Nearly 100% of response rates are maintained up to 5 years. It is a fully human monoclonal antibody neutralizing IL-17A and has demonstrated rapid, long-lasting efficacy and safety in the treatment of moderate to severe psoriasis, psoriatic arthritis, and the more persistent manifestations of psoriasis, namely scalp, palms, soles and nails.

Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study

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UCB, a global biopharmaceutical company, presented positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. The results are the longest-term data so far investigating bimekizumab and further highlight the potential value of the molecule’s unique dual mechanism of action, which potently and selectively neutralizes IL-17F in addition to IL-17A, two key cytokines driving inflammatory processes.

“The long-term results observed in the BE ABLE 2 Phase 2b study suggest the meaningful difference that IL-17F inhibition, along with IL-17A inhibition, can make for psoriasis patients who need significant, long-term skin clearance,” said Andrew Blauvelt, MD, MBA, an investigator in the trial and President of Oregon Medical Research Center in Portland, Oregon. “The results add to a growing body of evidence supporting the molecule’s unique dual neutralization of both IL-17A and IL-17F cytokines across multiple inflammatory diseases, suggesting exciting potential.”

“Despite recent advances in therapy, psoriasis patients still have profound unmet needs. Many patients do not experience long-term symptom resolution, and they often have limited confidence in long-term treatments. The positive results and rapid development of bimekizumab in psoriasis reflect UCB’s dedication to connecting scientific innovation with greater patient value,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.

In the BE ABLE 1 study, up to 79% of patients achieved at least 90% skin clearance (PASI90) as soon as week 12, based on a dose range of 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, or 480mg, administered every four weeks. Among these BE ABLE 1 responders, defined as achievement of PASI90 at week 12, 80-100% maintained the rigorous PASI90 measure for up to an additional 48 weeks based on a dose range of 160mg or 320mg, administered every 4 weeks, in the BE ABLE 2 extension study. Further, 70-83% and 78-100% of BE ABLE 1 responders maintained PASI100 and the Investigator’s Global Assessment of response, respectively. The safety profile was consistent with previous studies, with no new safety findings observed. The most frequent treatment-emergent adverse events were oral candidiasis and nasopharyngitis. No cases of suicidal ideation/behavior, major adverse cardiac events, or inflammatory bowel disease were reported.

UCB also presented findings this week from the BE AGILE study of bimekizumab in ankylosing spondylitis and the BE ACTIVE study of bimekizumab in psoriatic arthritis. The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.

Ilumya (tildrakizumab-asmn) has shown long term sustained ski clearance and cost effectiveness.

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Sun Pharma announced that one of its wholly owned subsidiaries presented new ILUMYA TM (tildrakizumab-asmn) clinical insights at the 2019 American Academy of Dermatology (AAD) Annual Meeting, including long-term data showing sustained skin clearance in some patients living with moderate-to-severe plaque psoriasis after three years of ongoing treatment with ILUMYA TM.

These findings from the Phase 3 reSURFACE 1 and reSURFACE 2 studies showed sustained response by some patients over time and ILUMYA TM was well tolerated with low rates of adverse events. After up to 5 years of treatment, all prespecified adverse events were reported at rates <1.6 and <1.3 events per 100 patient-years in reSURFACE 1 and reSURFACE 2, respectively. Of the adverse events of interest, severe infections (1.2 and 1.5 events per 100 patient-years, respectively) and malignancies (1.2 and 0.5 events per 100 patient-years, respectively) were the most frequently reported. 1,2

The U.S. FDA approval of ILUMYA TM for adults with moderate-to-severe plaque psoriasis, who are candidates for systemic or phototherapy, is based on 64-week and 52-week reSURFACE data. “It’s very encouraging to see these effective response rates with ILUMYA TM over a three-year period, because as clinicians we’re often faced with the challenge of finding the right treatment that addresses the chronic nature of plaque psoriasis. We’re also starting to learn more about which patients ILUMYA TM may be a fit for,” said Dr. Andrew Blauvelt, board-certified dermatologist and President of Oregon Medical Research Center. “In a one-year analysis we saw that ILUMYA TM showed similar results of skin clearance in both patients who were new to biologic therapy and those who had previously been treated with another biologic. Furthermore, with its HCP administration model ILUMYA TM supports treatment adherence and may be a good treatment option for patients who are starting their first biologic treatment or those who have failed previous therapy.”

Results from bio-naïve and bio-experienced patients showed that treatment with ILUMYA TM achieved a PASI ≥50 response at Week 28 and was maintained or continued to increase at Week 52, regardless of the patient’s previous exposure to biologic treatment. Furthermore, additional one-year data analyses presented during the 2019 AAD Annual Meeting show that ILUMYA TM is similarly effective and safe for moderate-to-severe plaque psoriasis patients who have the common condition metabolic syndrome and those who do not. 4,5 People with psoriasis are predisposed to metabolic syndrome, and psoriasis has been shown to increase the prevalence of metabolic syndrome by three-fold. 6 Patients with moderate-to-severe plaque psoriasis treated with ILUMYA TM 100 mg who achieved PASI 75 at Week 52 were comparable between those with metabolic syndrome (84% [0.04]) and without (90% [0.02]) and reported similar adverse events, with no reports of cardiovascular events or diabetes worsening by metabolic syndrome status. 4,5 The most common treatment-emergent adverse event was infection, occurring in 50.6% [n=40] of patients with metabolic syndrome and 53.1% [n=154] of patients without. The most commonly reported serious adverse events (>1.5% of patients with ≥1 SAE) in patients with metabolic syndrome were gastrointestinal and cardiac disorders.

“As we expand our knowledge and understanding of the potential ILUMYA TM has for different patients, we’re excited to see the clinically meaningful benefits this treatment option may continue to offer,” said Abhay Gandhi, President and Chief Executive Officer, Sun Pharmaceutical Industries, Inc. “These insights are promising news for patients and clinicians, and we’re committed to helping those with moderate-to-severe psoriasis for whom ILUMYA TM may be a good treatment option.”

Additional analyses presented today used the 10-year Markov model to demonstrate the cost- effectiveness of ILUMYA TM as a first-line treatment. The data results demonstrated that ILUMYA TM is among the most cost-effective options compared to other biologic options including secukinumab,
guselkumab, ixekizumab, adalimumab, ustekinumab, and etanercept.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Skyrizi (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

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AbbVie a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI™ (risankizumab), an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

The CHMP positive opinion is supported by data from the global Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies.1-3 Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, all co-primary and ranked secondary endpoints were met, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 (depending on study design). The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.5 Most reported adverse reactions were mild or moderate in severity.

"Plaque psoriasis can have a significant physical, psychological and social burden on people living with the condition," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited that the CHMP has recognized risankizumab's potential to significantly reduce the signs and symptoms of psoriasis and provide an improved quality of life. In clinical studies, risankizumab demonstrated consistently high rates of skin clearance with a favorable benefit/risk profile. At one year, more than 50 percent of patients receiving risankizumab achieved completely clear skin. This is an important regulatory milestone in our relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions."

The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision, valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. The Commission decision is anticipated within 67 days following the CHMP opinion.

Hi, i thought it was worth a quick update as I have learnt a lot from reading other peoples experience on the site.
After 9 months on Otzela and finding it not having much effect I was prescribed Cosentyx. In the uK this is provided by a company called Healthcare At Home, who send a nurse out to show you how to inject yourself etc.
The first month is a loading dose of one dose (2 syringes) a week. By the end of this month my hands and nails had cleared and everything else was fading. You then go onto a monthly dose. Things improved up to 12 weeks and I was almost completely clear, brilliant! However at 16 weeks I have now got one or two patches coming back on my shins.
I have concluded that it works really well but maybe the maintenance dose is too low. This is possibly because the dose is not adjusted for body mass and I am over 100kg.
After seeing my consultant I am going to try Stelara as this allows an increased dose if over 100kg.
I'm still better than I have been for years and back to where I was on Fumiderm but without the side effects.
I'll try and update on the Stelara.

Hi, just an update from my intro. I was on Otzela for 9 months. No side effects to speak of but didn't do much for the Psoriasis so moved onto Cosentyx.

Last week I received a letter through the post inviting me to help rid the world of Psoriasis. Now as far as I am concerned this lot are a bunch of charlatans and no way would I end up in their clutches. How they got my details and the fact that I have psoriasis isn't something I want to discuss on an open forum.

But it got me thinking what would it take for you to join a trial.

For me nothing less than a recommendation by my Dermy Consultant and their assurances to the efficacy of the trial would suffice.

New guidelines are out for the treatment of psoriasis in France. It's very long so I will try and pick the bones out of it by making two posts.

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These guidelines were developed by the psoriasis research group of the French Society of Dermatology with the aim of providing updated decision‐making algorithms for the systemic treatment of adult patients with moderate‐to‐severe psoriasis.

The initial working group was made up of three dermatologists, without any conflict of interest with the pharmaceutical industry. The first version of the manuscript was reviewed by nine dermatologists, all of whom were experts in the field of psoriasis management. The final document was then reviewed by public and private practice practitioners involved in psoriasis treatment. Thirty four practitioners and two patients were also involved.

The guidelines recommend that systemic therapy, including phototherapy, should be proposed to patients with any form of psoriasis meeting one of the following criteria:

• The disease is considered to be moderate‐to‐severe, defined as psoriasis covering over 10% of the body surface area (BSA), or resulting in a psoriasis area severity index (PASI) score >10 and/or a dermatology life quality index (DLQI) score >10;
  
• The disease has a significant impact on physical and social well‐being, or on psychological well‐being resulting in disease‐related clinically relevant depression or anxiety;
  
• The disease is localized but cannot be controlled with topical therapy and is associated with significant functional impairment and/or high levels of distress, e.g. severe nail disease or involvement at high‐impact sites (such as the palms and soles, genitals, scalp, face and flexures).
  

We recommend that if the patient meets one of the criteria for initiating a systemic treatment, then methotrexate should be proposed as the preferred therapeutic option (Expert opinion). Exceptions to this recommendation include:

• Patients for which there is a contraindication to the use of methotrexate (Expert opinion);
  
• Patients that are pregnant, breastfeeding, or plan to have child in the near future (men and women); we recommend that cyclosporin is used instead of methotrexate for treatment of these patients (Grade A);
  
• Patients for whom there is a need for short‐term disease control; we recommend that cyclosporin is used instead of methotrexate for treatment of these patients (Grade B).
  

Narrowband UVB phototherapy (NBUVB) can also be prescribed as a first‐line treatment (Grade A). Home‐based NBUVB is not currently available for use in France; however, where it is available we recommend that it is offered to compliant and adherent patients who are unable to follow a clinic‐based phototherapy schedule (Grade B). For patients with large thick plaques, we recommend the use of psoralen UVA phototherapy (PUVA) or re‐PUVA therapy rather than NBUVB, except in young female patients (Grade C). The addition of acitretin to PUVA therapy is an option in case of failure to respond to PUVA alone (Grade A).

As a result of its lower efficacy compared to other available treatments, acitretin should not be recommended as a monotherapy in the systemic treatment strategy for plaque psoriasis. However, we concluded that it may be beneficial to propose acitretin as a treatment option for some patients with methotrexate and cyclosporin contraindications (Expert opinion).

Biologic agents are not labelled in France as first line therapies, but as a treatment options for adults with moderate‐to‐severe psoriasis who have not responded to at least two standard systemic therapies, or if the patient is intolerant or has a contraindication to these treatments. Thus, biologic agents could not be proposed as first line therapies in the present algorithm.

We recommend that biological agents and apremilast are prescribed only after the contraindication of, intolerance to or failure of two systemic treatments, such as methotrexate, cyclosporin, or phototherapy. No consensus was reached as to whether or not acitretin should be included with methotrexate, cyclosporin and phototherapy in the list of the two failed or contraindicated systemic treatments.

Given the low efficacy of apremilast compared to biological agents and the risk of some potentially severe adverse events associated with apremilast therapy, we recommend that therapeutic strategies using biological agents are explored prior to initiating systemic treatment with apremilast (Expert opinion). Further studies are required to establish a place for apremilast in the therapeutic armamentarium.

Taking into consideration the short‐term and long‐term efficacies, the long‐term safety and tolerability assessments, the administration regimens and the drug survival rates of the available biological agents, we suggest that adalimumab or ustekinumab should be the preferred first‐line biological agents (Expert opinion). If treatment goals are not achieved, switching between these agents (i.e. from ustekinumab to adalimumab or another TNF inhibitor, or vice versa) or initiation of IL‐17 inhibitor therapy should be considered (Expert opinion).

It should be noted that the initiation of a biosimilar should be based on existing national guidelines, such as those published in France on the status of biosimilar medicines.

New recommendations for patients with comorbidities or special circumstances, such as patients with an alcohol addiction or breastfeeding mothers have also been generated.

New recommendations are also generated for patients with psoriatic arthritis: We propose categorizing patients according to two major clinical profiles. The first clinical profile would include psoriasis patients for whom skin involvement predominates over PsA. In such patients, we recommend that adalimumab or ustekinumab are used as first‐line biological agents, similarly to patients with plaque psoriasis. The second clinical profile would include patients for whom PsA predominates over cutaneous involvement. In such patients, we recommend that a TNF inhibitor is used as a first‐line biological agent.

Unmet needs in the French psoriasis guidelines
Several questions could not be addressed in the present recommendations as a result of a lack of evidence‐based data. Notably, we were not able to provide satisfactory answers to the following questions.

• What is the exact place of apremilast in the therapeutic armamentarium?
  
• How long before and after surgery should apremilast be tapered?
  
• Should methotrexate be prescribed in association with biologic agents?
  
• In patients treated with biological agents who experience complete clearing, is it possible to adjust or stop the treatment? What would be the best strategy; a gradual or immediate stop?
  

*Further studies are necessary to provide clear answers to these questions.