This months poll above asks: What effect has Exercise had on your psoriasis and/or psoriatic arthritis ?

Voting is open to members and guests and our members can also leave a comment if they wish.

I learned the hard way this week.  No matter that I keep the shower stall clean, using a squeegee on the walls and floors, drying with a cloth after showering.  Each time I shower, the moisturizer creams or the coconut oil makes the shower stall floor slick.

I'd forgotten my razor on the bathroom counter and turned off the shower's flow, quickly stepped out of shower to fetch the razor, quickly hopped back into the shower stall to shave my legs.  A sudden loss of balance and nothing to be done for it.

I fell against the stall's built-in bench, striking my side between my ribs and hip on Tuesday.  I was temporarily immobilized by pain and could only call out in agony.  My partner rushed in, assessed the crisis, covered me with a towel, and sat on the floor nearby until I could move.  

The rest of Tuesday was pained with little mobility.  I slept sitting up.  On Wednesday, a trip to "same day" care for doctor and x-rays took three hours.  But nothing was broken. Kidney is okay.  Heart is okay.  I got prescriptions for Tramadol and Lidocaine Patches.  

I'm resting and hoping to be able to work on Saturday.  

So this is my warning to not try gymnastics in the shower or bath if you are also using moisturizers and/or coconut oil.  (And it's my appeal for sympathy since it still hurts, even though it's 70% better than Tuesday.)

I have to say it’s the best one I’ve seen or been in, it’s easy to navigate and welcoming.
I like the non psoriasis boards a lot too, because although at times psoriasis can be a bit all consuming when you are itchy, sore or whatever, there’s much more to life and it really gives shape to those who take part. If it were just about the P I would probably only pop in occasionally.
I wouldn’t feel comfortable giving the information I give here on other forums but I am very happy with Fred’s approach and I know he and others are keeping watch on it all.

In fact the question is: “Why has Psoriasisclub the nature that we see?”

I think there are a lot of factors that play a role in the nature of Psoriasisclub.
I visit other forums some times, of many kinds and types, e.g. photography, motorcycles, sometimes a technical forum though they are hard to understand, etcetera.
They are mostly helpful also, but have a different atmosphere.

Sometimes I visit facebook psoriasis sites, facebook is kind of a fehtherlight streaming forum with a very low span of attention. And over there I read a lot of nonsense and weird idea on psoriasis. There is a forum of the dutch association, where I sometimes post. They are reasonably good, but there is not so much activity.

So that winds back to partly what Forest said about psoriasisclub concerning adverts and integrity. But there is more to psoriasisclub.
There is knowledge and experience over here. The members together have gathered immense experience, without forcing that experience to others. They tell other members with questions about their personal experiences with medication or show the way to members that do have experience.
It is a factor that is greatly missed by industry.  Yes there is scientific research and statistical proof, but to gain real insight you must dive in to personal experiences.

The strong point is that psoriasisclub has grown into a group of knowledged and friendly friends, spread out over the world, who have never met each other, mostly have never seen each other, but still are friends.

The club has, thanks to Fred, a number of simple rules where above all the rule is to respect each other, and for some reason that really works very well with psoriasisclub.

The club also thanks to Fred, has always the newest news facts about psoriasis and Psoriatic Arthritis. I have never seen that anywhere else. I even know that e.g. in the Netherlands the medical inspections (IGJ) has the weird philosophy that this kind of news should not given to patient as not to give them too much hope. Now that is a weird philosophy. 

The club also has a lot of humour and interesse in each other’s life outside the psoriasis life. Half of what is posted is not about psoriasis but about a lot of other things in life, where we all have our opinions about, sometimes very different and the way that we discuss that has already learnt me lot of things and sometimes changed my view to things that I was sure of.

And last but not least the club has a great Staff…    Kind of weird combination… a cow girl from the States, a fossil seeking gentleman from England, an English speaking hermit living unfindable in the country of France and a Dutch motorcycle girl dancing through life.

But…. It all works.    and I bet this is not all that can be said about psoriasisclub.

I'm just going to whine.  The nausea and headaches with oral MTX are bugging me.  I'm seeing my dermatologist on Tuesday and will ask about switching to the injectable, as Dave recommended.  But I also miss sharing a glass of wine with my partner.  And I would like to enjoy a bourbon, now and then.  

The MTX has been working, though.  But the nausea and headaches are not so fun.  Possibly, the headaches would persist with the injectable form, even if the nausea abates.  

I'm going to read up on Interleukins and try to understand them.  My gastroenterologist said that Stelara works for both Crohn's and Psoriasis.  Humira targets TNF-alpha, not the interleukins.  

I'm grateful for the information on these various medications in Psoriasis Club.

Some of us have had psoriasis since childhood, some got it/ realised they had it later on in life.

But can you remember if you knew what it was and were more than vaguely aware of psoriasis before you had it?

This months poll above asks: What effect has Food had on your psoriasis and/or psoriatic arthritis ?

Voting is open to members and guests, you can choose more than one option and our members can also leave a comment if they wish.

Following on from this thread Bimzelx for psoriasis two year data UCB have released phase 3 results ofr treating psoriatic arthritis.

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UCB today announced positive top-line results from the Phase 3 BE COMPLETE study, which evaluated the efficacy and safety of BIMZELX® (bimekizumab) in the treatment of adults with active psoriatic arthritis, who were inadequate responders or intolerant to anti-tumor necrosis  factor-alpha (anti-TNF-α) therapy.

BE COMPLETE met its primary endpoint, demonstrating that significantly more patients treated with bimekizumab achieved 50 percent or greater improvement in signs and symptoms of disease from baseline, compared with placebo, as measured by the American College of Rheumatology (ACR) 50 response at week 16.

The study also met all ranked secondary endpoints. Bimekizumab showed significant improvements over placebo at week 16 in physical function, as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); skin clearance, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI90); physical health status, as measured by the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score; and low disease activity, as measured by the Minimal Disease Activity (MDA) index.

“The BE COMPLETE results mark the latest positive data in a series of four Phase 3 readouts for bimekizumab in the treatment of psoriatic arthritis and axial spondyloarthritis. We believe that these consistent and robust results have the potential to elevate the standard of care for patients, “Both psoriatic arthritis studies in the program used ACR50 as the primary outcome measure. The positive findings in both studies highlight the clinical potential of bimekizumab in psoriatic arthritis for both biologic naïve and anti-TNF therapy experienced patients.”

In BE COMPLETE, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals. The safety and efficacy of bimekizumab in psoriatic arthritis have not been established, and it is not approved for use in psoriatic arthritis by any regulatory authority worldwide.

The top-line results from the BE COMPLETE study build on the positive top-line interim analysis results from the Phase 3 BE OPTIMAL study in adults with active psoriatic arthritis, who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve, reported in November 2021. Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the United States and the European Union in Q3 2022.

I have a bad flare up after stopping Simponi (too much skin cancer to manage). I am sooooooo fatigued and wonder if that is caused by the flare up or the general state of the world. 

Do others experience exhaustion with a flare up? 

J

Glad to find this forum. I recently moved to Oregon and the care protocol is very different than where I lived in California. Here I am seen by a physician’s assistant only. Besides seeing patients for diseases of the skin, the office sees a lot of clients for Botox, cellulite treatment and who knows what else (I delete the ads they send me.)

After being on Simponi for probably 8 years, I started getting a lot of skin cancer ( new ones popping up weekly) and had to have surgery on spots on my legs 4 times in 3 months. My new rheumatologist said that increased skin cancer was a side effect of Simponi. I stopped the Simponi in December and have fewer incidence of skin cancer already (only planning two surgeries next month!)

However, my psoriasis has flared with a vengeance. I have it all over, including places that I haven’t ever had it (in 45 years with PA). Interestingly my psoriatic arthritis hasn’t flares without Simponi.

My dermatologist Physician’s assistant suggested Skyrizi and asked me to consult with my rheumatologist. (In California, the doctors would have talked directly to come up with a plan…)

My rheumatologist said that Skyrizi wasn’t authorized for PA and suggested Otezla, telling me to discuss with my dermatologist. I decided to try Skyrizi but the dermatologist says now it wouldn’t be appropriate since I have PA. (Huh? I wouldn’t have known of the drug if he hadn’t mentioned it). He said we will talk in a month. 

I am frustrated, itching and moisturizing constantly. Daily new spots appear. 

I’d like to see a doctor who specializes in psoriasis and skin cancers. Does anyone know of a dermatologist near Ashland or Medford Oregon? I looked at the USA psoriasis site and one doctor is listed. Haven’t heard of her or her practice group, but I’ll call tomorrow to see what her focus is.

Sorry for the long —and whiny— intro. But, I know you guys get it. Thanks.

Another new treatment in the pipeline for treating psoriasis.

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Can-Fite BioPharma a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that pre-clinical studies with skin cells, modeling psoriasis in humans, show that Piclidenoson, the Company’s drug candidate for the treatment of psoriasis, destroys pathological skin cells. The Company’s scientists reported that in a cell culture of human HaCaT cells, incubated with Piclidenoson, cell apoptosis was induced with an increase in the caspase protein, known to mediate apoptotic responses.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

The Company expects to announce topline results during Q1 2022 from its randomized, double blind, active and placebo-controlled study currently being conducted in Europe, Israel, and Canada. The study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla® in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of A3AR, Can-Fite’s therapeutic target.

“The data shown in our lab experiments are important and support the mechanism of action of Piclidenoson and supply additional support for the drug effect. We are encouraged by the positive interim analysis data reported last year based on 200 patients’ data and hope that it will be reproducible and that psoriasis patients will benefit from safety and long term relief from the symptoms of psoriasis,” stated Can-Fite CEO.

The psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.

This study looked at the prevalence and factors associated with sleep disturbance in adult patients with psoriasis.

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Background:
Sleep, which is crucial for restoring of physiological functions and health, is reportedly impaired in psoriasis. The role of different potential sleep confounding factors, including detailed pruritus characteristics, and the complex interplay between psychological variables (anxiety and depression), pruritus and sleep disturbance in psoriasis remain insufficiently investigated.

Objectives:
To investigate sleep characteristics and to identify clinical, demographic, and psychological factors associated with sleep disturbance in psoriasis.

Methods:
This cross-sectional study included 334 psoriasis patients (response rate 86%) and 126 control subjects (response rate 82%). Measures included sleep quality [Pittsburgh Sleep Quality Index (PSQI)], psoriasis severity, pruritus characteristics, including average pruritus intensity [Visual Analogue Scale (VAS)], severity of comorbidities, anxiety and depression (Hospital Anxiety and Depression Scale – HADS), and quality of life (Dermatology Life Quality Index – DLQI, and Short Form 12 – SF12).

Results:
Fifty-nine percent of patients, and 34% of control subjects (P<0.001) suffered from sleep disturbance (PSQI>5). Patients slept 1 hour less than control subjects (median 6 vs. 7 hours, P<0.001). Patients without pruritus had less impaired sleep (global PSQI) than patients with strong (P<0.001) and very strong pruritus (P<0.001). Anxiety (HADS-A) and depression (HADS-D) levels were the strongest predictors of sleep impairment, followed by pruritus exacerbation at night, age, female sex, pruritus exacerbation in the morning, average pruritus intensity (VAS), diagnosed depression and gastroesophageal reflux disease, altogether explaining 32% - 37% of the variance in global sleep quality. Both, anxiety (HADS-A) and depression (HADS-D) were significant mediators explaining the association between pruritus intensity (VAS) and sleep impairment in 42% and 37%, respectively.

Conclusions:
Sleep disturbance in patients with psoriasis is highly prevalent. Patients with psoriasis should be assessed for sleep impairment, pruritus, anxiety, and depression. Reduction of pruritus should be considered as an important therapeutic goal, along with therapies aimed at reducing anxiety and depression.

I thought it would be interesting to get some history from our members about their psoriasis.

Copy and paste the questions and add your answers. *You can also add other comments and replies if you wish and leave questions blank if you don't want to share.

#1 What age did you think something was going wrong:

#2 How many years later was it that you got a diagnoses:

#3 When you got a diagnoses how did it make you feel:

#4 What was your first treatment:

#5 Did you think it was a temporary thing:

#6 How long before you got to see a dermatologist:

#7 What did you think of your first dermatologist:

#8 Have you ever given up on a prescribed treatment:

#9 How do you feel you are being treated today:

#10 What would you say to the younger you at #1:

This is a voluntary recall notice of Taro Clobetasol Propionate Ointment USP.

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Taro Pharmaceuticals U.S.A is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level.

This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022 ”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.

R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment.

If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.

*This recall is being conducted with the knowledge of the US Food and Drug Administration.

So I know that those red scaly patches itch. And I know moisturizing helps. I know scratching is to be avoided if at all possible. BUT... I admit that I scratch way more often than I should. So I was wondering, what do you do to ignore that itch??

I've found I can refrain from scratching if I'm out in public or around people, at least not that satisfying digging in scratching. Although there have been times I've excused myself to go find a secluded spot to scratch.

I've also found that with scalp psoriasis I can go outside in the sun and since I have long hair I can shake my head and watch the specks that fall shimmer in the sunlight as they blow away, a bit like a snow globe! I'm easily amused at times. But that only lasts a few seconds so isn't really helpful. Actually it might even be a little bit weird.

So how do you ignore the itch?

This months poll above asks: What effect has Alcohol had on your psoriasis and/or psoriatic arthritis ?

Voting is open to members and guests, our members can also leave a comment if they wish.

Around January 2021, a persistent but calm and subtle rash on my ankle bloomed into a troublesome, painful, patch.  A primary care doctor referred me to a dermatologist who took two punch biopsies.  

Before I found Psoriasis Club:

This first dermatologist told me incorrect information regarding Humira and Psoriasis.  He prescribed Betamethasone 0.05% for the legs, a similar formula lotion for the scalp, and Desonide Ointment 0.05% for sensitive areas and skin folds.   

His manner was arrogant and rushed.  He provided little information.  Patches continued to spread upon my lower legs and appear on my torso, arms, genitals, and more across my scalp.

I finally searched for support online when my fingertips and the insteps of my feet began bleeding.  I had developed thinning skin from the topical steroids.

When I found Psoriasis Club:

I learned about overusing topical steroids.  I learned about different medical therapies.  I read that a couple members had managed their skin through diet alone.   This club offered me information that the first dermatologist failed to provide.  This club inspired me to find a better doctor.  

While the dietary changes didn't affect my skin, I did reduce my sugar intake significantly and feel better for it, overall.  I rely less on wheats, also.  My overall diet has improved.  

My current dermatologist: 

I'm receiving good, compassionate, intelligent care, now.  My current dermatologist has provided information on how to use topical steroids, changed the ointments, added a Vitamin D derivative, provided a schedule for usage.  She's offered light therapy, Methotrexate, and Folic Acid.  She provided printed information on this condition and assurance that there are other medications to try.  

Best of all:

I understood the options discussed by this doctor because I read about prescribed treatments here.  Psoriasis Club has helped me to be informed about my condition and the treatments.  

I'm finally, finally, finally . . . finally! . . . feeling some relief.

On this last day of 2021, I feel contemplative, looking back over the year.  I'm hopeful, looking forward to skin improvement and the continued sense of belonging in a community of patchy people from all around the world here at Psoriasis Club.

The Medicines and Healthcare products Regulatory Agency (MHRA) UK are advising anyone using Dermaved cream stop using it immediately.

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Individuals who have purchased Dermaved Sensitive Cream via the company’s website are today being asked to stop using it and return the product after it was found to contain a potent steroid.

The MHRA, who issued the recall, has worked to ensure that Dermaved Sensitive Cream is removed from sale.

Dermaved Sensitive Cream is not a licensed medicine and has been marketed in the UK as a natural Ayurvedic product for sensitive skin.

The MHRA’s analysis of the product found the presence of the steroid clobetasol propionate. This is the active ingredient in topical (on the skin) Prescription-Only medicines used for the treatment of a range skin conditions such as psoriasis and eczema.

Creams containing steroids should be used sparingly and as directed by the prescriber. They should also not be used on children under 1 year of age. Long-term use can rarely cause local complications such as skin thinning and if inappropriately used, can worsen conditions such as eczema.

MHRA has previously issued warnings for products called Zudaifu cream and Yiganerjing Cream which contained the same steroid ingredient.

This could be good news for those with pustular psoriasis.

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Boehringer Ingelheim announced today new data from the pivotal Phase II EffisayilTM trial, which showed spesolimab, a first-in-class investigational treatment, significantly improved signs and symptoms of generalized pustular psoriasis (GPP) in patients experiencing a flare.

GPP is a rare, life-threatening neutrophilic skin disease, which is distinct from plaque psoriasis. It is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus). There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life5 and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure and sepsis and even death.

In the 12-week trial, 53 patients experiencing a GPP flare were treated with a single intravenous dose of spesolimab or placebo. Most patients at the outset of the trial had a high or very high density of pustules and impaired quality of life. Results after one week demonstrated that:

54% of patients treated with spesolimab showed no visible pustules compared to 6% of those treated with placebo;
43% of patients treated with spesolimab showed clear/almost clear skin compared to 11% of those in the placebo group.

Pustular and skin clearance continued for the duration of the study. This clearance was accompanied by clinically significant improvements in quality of life and symptoms such as pain and fatigue, compared to placebo.
Over the 12-week duration of the study, non-serious infections rates were higher in the spesolimab group compared with placebo, with no pattern regarding pathogen and affected organs. Two patients reported to have drug reactions with eosinophilia and systemic symptoms.

“With no approved treatments in the U.S. or E.U. for GPP flares, there is a significant unmet need for people with this distressing and painful skin condition, that often requires emergency care,” said Mark Lebwohl, MD, lead investigator and publication author, and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, New York. “These clinical trial results show that spesolimab has the potential to completely clear the skin of the signs and symptoms of a GPP flare after only one week, with sustained effect observed for up to 12 weeks.”

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the treatment of GPP, and Breakthrough Therapy Designation for spesolimab for the treatment of GPP flares. This designation is for therapies treating serious or life-threatening conditions where early clinical evidence suggests a substantial improvement compared to existing treatments. The Chinese Regulatory Authority Centre for Drug Evaluation (CDE) also recently granted Breakthrough Therapy Designation for spesolimab for the treatment of GPP flares.

“At Boehringer Ingelheim, we are committed to finding transformative therapies to help advance treatment for people who urgently need them,” said Dr Emmanuelle Clerisme-Beaty, Head of Clinical Development and Medical Affairs, Dermatology, Boehringer Ingelheim. “The findings indicate that spesolimab may have a significant and positive impact on patients experiencing a GPP flare.”

The clinical program for spesolimab includes two other trials that are currently underway. First, the Effisayil-2 trial is designed to investigate spesolimab as a maintenance treatment to prevent the occurrence of GPP flares. The Effisayil-ON trial is an open label five-year extension study to investigate the longer term efficacy and safety of spesolimab in patents with GPP.

About spesolimab
Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in several autoimmune diseases pathogeneses, including GPP.  It is the first investigational treatment to specifically target the IL-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial. Spesolimab is also under investigation for the prevention of GPP flares and for the treatment of other neutrophilic skin diseases, such as palmoplantar pustulosis (PPP) and hidradenitis suppurativa (HS).

About the EffisayilTM 1 clinical trial
Effisayil™ 1 (NCT03782792) was a 12-week Phase II trial investigating patients with a GPP flare (N=53), randomly assigned 2:1 to a single 900 mg intravenous dose of spesolimab or placebo. The primary endpoint was a GPP Physician Global Assessment (GPPGA) pustulation subscore of 0 (no visible pustules) at week one. The key secondary endpoint was a GPPGA score of 0/1 (clear/almost clear skin) at week one.

After one week, 54% of patients (19 out of 35) treated with spesolimab showed no visible pustules (GPPGA score of 0), compared to 6% of patients (1 out of 18) treated with placebo ( P<0.001). In addition, 43% of patients (15 out of 35) treated with spesolimab showed clear/almost clear skin (GPPGA score of 0/1), compared to 11% of patients (2 out of 18) in the placebo group ( P=0.024).

After one week, adverse events were reported in 66% of patients treated with spesolimab and 56% of those receiving placebo. Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively. Serious adverse events were reported in 6% of patients treated with spesolimab.

Cosentyx (secukinumab) has been approved by the Food and Drug Administration (FDA) for use in juvenile psoriatic arthritis (JPsA)

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Novartis, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, M.D., Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”

ERA and JPsA, subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative. If left untreated, they can lead to high levels of pain and disability.

“This marks the second and third US pediatric approval this year for Cosentyx, following pediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy. With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “Furthermore, we are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need.”

The approved pediatric dosing for Cosentyx in children and adolescents is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more). It is administered as a subcutaneous injection by a pre-filled syringe or Sensoready® pen every 4 weeks after initial loading doses. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready® pen.

The approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104). In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare (P<0.001) versus placebo. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis.