The European Commission (EC) have approved the use of Stelara (ustekinumab) in age 6+ for the treatment of psoriasis.

Quote:

---

Janssen Pharmaceutical today announced that the European Commission (EC) has approved the expanded use of STELARA® (ustekinumab) for the treatment of paediatric patients (ages 6–11) with moderate to severe plaque psoriasis. Ustekinumab was previously approved for use in adolescent and adult patients with plaque psoriasis, aged 12 years and older, and is now the first available biologic treatment in this patient population to selectively address the IL‑23/IL‑12 pathway, an important therapeutic target for the condition.

In one third of the 14 million cases in Europe, psoriasis begins in childhood. Psoriasis is an immune-mediated inflammatory disease that affects the skin, resulting in areas of red or inflamed skin covered with silvery scales, which are known as plaques. The condition can have a profound, long-term impact on the psychological health and overall quality of life for children. The development of paediatric psoriasis is also associated with high incidence of low self-esteem, and it can have long-term ramifications into adulthood and beyond.

“This latest EC approval is a significant milestone for young children struggling to cope with the symptoms of psoriasis,” said Lloyd Miller, Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. “We’re delighted that this therapy, which has a well-established safety and efficacy profile in adults with plaque psoriasis and other immune diseases, is now expanded to children as young as six who are living with this chronic disease.”

The EC approval is based on results from the Phase 3 CADMUS Jr study, building on the prior Phase 3 CADMUS study, which found ustekinumab improved the signs and symptoms of plaque psoriasis, as well as health‑related quality of life (HrQOL), in paediatric patients aged six to 11 years old. The primary endpoint was the proportion of patients who achieved a physician’s global assessment (PGA) score of Cleared (0) or Minimal (1) at week 12. Secondary endpoints included the proportion of patients achieving improvements in psoriasis area and severity index of ≥75% (PASI 75), ≥90% (PASI 90), and change from baseline in Children’s Dermatology Life Quality Index (CDLQI)* at week 12.

In the study, 44 patients (aged 6–11 years) from nine countries were enrolled and treated with at least one injection of ustekinumab. At baseline, the mean duration of psoriasis was 3.5 (standard deviation 2.49) years. At week 12, subjects treated with ustekinumab showed clinically meaningful improvements in their psoriasis and HrQOL. At week 12, 77.3% (95% confidence interval [CI]: 62.2%, 88.5%) achieved PGA 0/1, 84.1% (95% CI: 69.9%, 93.4%) achieved PASI 75, and 63.6% (95% CI: 47.8%, 77.6%) achieved PASI 90. The mean change from baseline in CDLQI was -6.3 (95% CI: -8.29; -4.28, lower is better). All patients were followed for up to 52 weeks after the first administration of ustekinumab. Improvements in PGA 0/1, PASI 75, PASI 90 and CDLQI were maintained through to week 52 (75.6%, 87.7%, 70.7%, and 58.3%, respectively).

Safety data from CADMUS Jr were consistent with the known safety profiles reflected in respective current prescribing information labels and ustekinumab was generally well‑tolerated by paediatric patients with plaque psoriasis. Overall, 34 patients had more than one adverse event (AE; [77.3%]) and three had more than one serious AE (6.8%). One patient had a serious infection (mononucleosis), 29 had infections (65.9%), and 12 had infections requiring treatment (27.3%). In general, the AEs and other safety data reported up to one year in two paediatric patient studies (CADMUS and CADMUS Jr) were similar to those seen in previous studies in adults with plaque psoriasis.

This study suggests the use of Methotrexate for psoriasis was not associated with an enhanced risk for cutaneous malignant melanoma (CMM)

Quote:

---

Background:
Cutaneous malignant melanoma (CMM) is a highly immunogenic tumor. Patients with an impaired immune system have an enhanced risk for CMM and a worse prognosis. Methotrexate (MTX) is an anti‐inflammatory and immunosuppressive drug frequently used for treating patients with psoriasis. An association between MTX and risk of CMM has previously been demonstrated in patients with rheumatoid arthritis.

Objectives:
To investigate if MTX increases the risk of CMM among patients with psoriasis.

Methods:
A nested case‐control investigation from a Swedish cohort of psoriasis patients was conducted. Data were obtained from available Swedish registers and included 395 previously cancer‐free psoriasis patients with a first CMM in the time period January 1, 2010 to December 31, 2016. Ten randomly selected cancer‐free psoriasis patients were matched per case with respect to age (same birth year) and sex. The accumulated MTX‐doses in both groups was obtained. Crude odds ratios (ORs) for the proportion of MTX in the respective group using conditional logistic regression analyses was conducted.

Results:
Of 395 psoriasis patients with CMM, 97 (25%) had filled any prescription of MTX. Among 3950 controls, the corresponding number was 954 (24%). In a conditional logistic regression analysis, no association between MTX‐exposure (ever use) and risk for CMM were observed (OR 1.0 [95% CI, 0.8‐1.3]). Moreover, no indication of a dose‐response association was observed.

Conclusions:
In this Swedish nested case‐control study, the use of MTX was not associated with an enhanced risk for CMM. These findings are reassuring to dermatologists in everyday clinical practice.

Got approved for Cosentyx through my insurance and they have a program where it sounds like I won't have to pay anything... almost unbelievable in the corporate ruled ruthless capitalist USA. I'm sure the time will come when I need to pay for some lawyers second vacation home... but really, anyone have any advice? Tried the creams and salt baths, messed around with the diet but nothing seems to help much. Had some luck with laying out in the sun a lot during the Summer but where I live it rains half the year. What should I do friends?

This study suggests starting with more aggressive protocols and increasing rapidly dosage progression to prevent Adaptation Factor (AF) may increase NB‐UVB response.

Quote:

---

Background:
In the biologic era, Narrow Band Ultraviolet B (NB UVB) phototherapy stillremains a valuable, effective, inexpensive, safe anti‐psoriatic treatment Patients can lose response to NBUVB over time due to photoadaptation.This phenomenon is the tendency of the skin to respond to ultraviolet (UV) exposure by undergoing changes that may result in a decreased future response to an equivalent dose of radiation, thus leading to the need for an increased exposure during phototherapy course.

Aim:
To characterize and quantify the determinants of photoadaptation in NB UVB treated psoriatic patients.

Methods:
We enrolled 57 adult patients with moderate plaque psoriasis. Patients underwent 24 sessions of NB UVB phototherapy delivered thrice a week. Dosing was started with 70% of the Minimal Erythema Dose (MED) with percentage based dose increments every two treatments. MED as well as change in the erythema and Melanin Index (MI) were measured at baseline and at the end of phototherapy course. Moreover, an Adaptation Factor (AF) was calculated for each patient.

Results:
AF was not influenced by both baseline MED and skin type. We found a weak correlation between higher cumulative dosages and the initial MED (Spearman's rho = 0.32, p= 0.0154) as well as with the mean initial MI (Spearman's rho = 0.25, p = 0.0624, statistically borderline). Clearance and mean number of treatments were correlated (Spearman's rho = 0.48, p < 0.001).

Conclusion:
Photoadaptation is a physiological skin response that negatively influence NB‐UVB responsiveness and is not predictable by the baseline MED and skin type. Thus, starting with more aggressive protocols and increasing rapidly dosage progression to prevent AF may increase NB‐UVB response.

This survey explored whether plasma derived EV microRNAs could serve as biomarkers for psoriatic arthritis.

Quote:

---

Background:
Psoriatic arthritis (PsA) develops in ~30% of patients with psoriasis. The diagnosis of PsA is challenging and there are no reliable molecular markers in clinical use. MicroRNAs are short noncoding regulatory RNAs, which can be actively packaged into extracellular vesicles (EVs) and secreted to the circulation.

Objectives:
To explore whether plasma‐derived EV microRNAs may serve as biomarkers for PsA in patients with psoriasis.

Methods:
Plasma samples were obtained from patients with cutaneous‐only psoriasis (PsC) and patients with psoriasis and PsA. Plasma EVs were isolated using miRCURYTM Exosome Isolation Kit. RNA sequencing was used to identify differentially expressed EV miRNAs in the discovery phase (PsC, n=15; PsA, n=14). In the validation phase (PsC, n=29; PsA, n=28), 41 selected miRNAs were analysed in plasma EVs by qPCR. The association of the identified miRNAs with PsA was assessed by logistic regression analysis.

Results:
RNA sequencing identified 19 plasma EV miRNAs with significantly different levels between PsA and PsC in the discovery cohort. Significantly lower levels of plasma EV let‐7b‐5p and miR‐30e‐5p in PsA vs. PsC were confirmed in the validation cohort, and their decreased levels were found to be associated with the presence of PsA. ROC analysis revealed an AUC of 0.68 (95% CI 0.53‐0.83) for let‐7b‐5p and 0.69 (95% CI 0.55‐0.84) for miR‐30e‐5p.

Conclusions:
Circulating EV microRNA levels are altered in patients with PsA as compared with PsC. Findings of this exploratory study suggest that circulating EV microRNAs may serve as biomarkers for arthritis in psoriasis patients.

Hey friends, just signed up for the club. Not the happiest thing I've ever done, but it seems there is so much support and knowledge on this site. I've had P for about a year now. Steadily getting worse and worse. It is causing a good amount of stress in addition to the normal everyday stress of studying wars, climate change, ecological collapse, mass extinction, ect... Can'twait to get to know yall more and hopefully I'll be a positive addition to the community. Stay frosty my friends!   

 

so just recently got the diagnosis- 66 years old newly retired Registered Nurse now with flaking scalp & some inverse psoriasis- now my toenails are showing some major issues- had my thyroid removed for cancer about 5 years ago- endocrinologist super conservative- advised me not to take Biotin & limit my intake of Vit D- says it binds to the Synthroid & is crazy about increasing my dose- I can't lose weight and am feel so down - Dermatologist wanted to start me on Taltz but now being on Medicare I have a part D (pharmacy) plan that is not great with coverage- will cost me over $3,000.00 out of pocket- too expensive & don't qualify for the patient assistance program- wanted to see if anyone has had good results from dietary restrictions and supplements 

Thanks all 

Hi I'm curious to hear if anyone else has had the same experience as I have

I was on Fumaderm tablets through the UK national health service ....this was a drug that was not approved by NICE and was prescribed by dermatology departments at their discretion.
I was on Fumaderm for over six years with never a sign of the psoriasis emerging apart from a very small patch (to remind me to take the tablets )
However around six months ago the dermatologist switched me to Skilarence which was not a worry to me as it was basically the same drug. However since transfering I have noticed the psoriasis slowly returning to my scalp to the extent that I now use a topical to reduce the scales when I need a haircut

I was wondering if others have been switched as I have from Fumaderm to Skilarence and what their experience is

Probably not going to get many if any answers, but has anyone tried both Taltz and Cosentyx ?

We have a lot of threads on both, but I'm interested in those that have tried both. Also preferable those that have psoriatic arthritis.

I'm thinking of going for the switch from Cosentyx to Taltz so on the off chance I thought why not ask here first.

Anyone used both ?

This abstract concludes: We need more un‐biased and well‐designed studies to improve our diagnostic procedure in inflammatory skin diseases. In the future, diagnostic decision‐making will most likely be guided by artificial intelligence‐driven image analysis as well as by molecular diagnostics.

Quote:

---

Abstract:

Therapeutic developments have profoundly changed our understanding of the pathogenesis of inflammatory skin diseases, and with it our treatment aims. In particular, the newest generation of biologics in psoriasis, namely antibodies targeting either the IL‐17 or the IL‐23 signalling cascade, comes with a good chance to relieve the patient completely from disease symptoms. However, diagnostic tools have not been co‐developed with these therapeutic options, and our disease classification is partially old‐fashioned and cuts off numerous patients from access to these new therapeutic options. Furthermore, it is currently impossible to predict which patients benefit from a given therapy as well as to stratify patients according to their risk to develop aggravating disease and/or comorbidity.

These facts demand progress in the field of inflammatory skin diseases. First, a modern classification of inflammatory skin diseases that is based on molecular events and with it immune response patterns is needed and second, objective biomarkers that improve our diagnostic power have to be identified. Such biomarkers can improve diagnostics, mirror disease severity,4 stratify patients according to the risk of aggravating disease course or developing comorbidities or predict therapeutic response. Numerous efforts are currently undertaken to assess the quantity of target biomarkers in serum or skin. In parallel, the potential of specific genotypes to stratify patients is investigated.

In a landmark paper published in this issue of the JEADV, Vugt and colleagues demonstrated that therapeutic response to IL‐17 inhibitors is not associated with genetic variation in the IL‐17 gene region. Even though reporting negative data, this study underlines how important well‐designed multi‐centre approaches are to prove hypothesized biomarkers. As it is straight forward to investigate the target region itself for the potential to predict therapeutic response, it is also promising. In the field of melanoma and checkpoint inhibitors, levels of PDL‐1 in tissue have been proposed to stratify response to PD‐1 antagonists as they predict overall survival in combination with the quantity of tumour‐infiltrating lymphocytes. Furthermore, while parallel studies confirm there is no association of IL‐17 genetic variants with response to IL‐17 there is also evidence that the genotype predicts therapeutic response in psoriasis. Namely, the PSORT registry recently published that polymorphisms in HLA‐cw6 are associated with therapeutic response to ustekinumab as compared to TNF inhibitors.

The study of Vugt and colleagues also illustrates how difficult it is to identify reliable biomarkers of therapeutic response. Beyond the detection method (nucleic acids or protein in serum or skin versus genotype), choosing the optimal readout is challenging. This refers both to the time point and to the chosen endpoint – is 24 weeks long enough to determine therapeutic response? Is it primary or secondary non‐responders that are more interesting to investigate? Is skin severity/PASI the ideal readout or should it be a patient‐related outcome or rather an indicator of inflammation/comorbidity?

This is why we need more un‐biased and well‐designed studies to improve our diagnostic procedure in inflammatory skin diseases. In the future, diagnostic decision‐making will most likely be guided by artificial intelligence‐driven image analysis as well as by molecular diagnostics. The latter will determine (a combination of) biomarkers ranging from genotype over serum factors to cutaneous determinants. With time, assessment of such objective biomarkers will become more and more easy and minimally invasive. The future starts now, and it will result in true precision medicine in inflammatory skin diseases.

This study evaluated the effects of patient demographic and disease characteristics on Ilumya / Ilumetri (tildrakizumab) efficacy using phase 2b/3 trial data.

Quote:

---

Background:
Tildrakizumab is a high‐affinity, anti–interleukin‐23p19 monoclonal antibody approved for treatment of moderate to severe plaque psoriasis.

Objectives:
To evaluate the effects of patient demographic and disease characteristics on tildrakizumab efficacy using phase 2b/3 trial data.

Methods:
Data from patients who received placebo, or tildrakizumab 100 or 200 mg, in P05495 [NCT01225731], reSURFACE 1 [NCT01722331] and reSURFACE 2 [NCT01729754] were analysed. Patient subgroups were defined by age, sex, race, weight, self‐reported psoriatic arthritis, failure of ≥1 traditional systemic treatment, and prior biologic use. Percentage of Psoriasis Area and Severity Index (PASI) 75 and 90 responders at Week 12 were compared across treatment arms in each subgroup. Absolute PASI at Weeks 0 and 12 were also determined for each subgroup.

Results:
Among patients randomised in P05495 (N = 355), reSURFACE 1 (N = 772) and 2 (N = 1090), percentage of PASI 75 and 90 responders were significantly greater for each tildrakizumab dose vs. placebo (P<0.0001). PASI 75 and 90 responder percentages were numerically greater in patients <65 years of age, body weight ≤90 kg, without psoriatic arthritis, and with no prior biologic exposure (only PASI 90), vs. their counterparts in corresponding subgroups. There were no clear or consistent differences in efficacy between the other subgroups. Absolute PASI scores were generally similar across subgroups.

Conclusions:
Small numerical differences in tildrakizumab efficacy were observed between subgroups defined by patient age and weight, presence of psoriatic arthritis, and prior biologic use. These differences were not clinically meaningful; however, analyses of long‐term data may be of value. Tildrakizumab efficacy did not differ with respect to patient sex or race, or number of prior failed conventional systemic treatments. Overall, these results suggest tildrakizumab may be appropriate for treatment of moderate to severe plaque psoriasis in patients with a range of demographic and disease characteristics.

This study suggests Taltz (Ixekizumab) may help to improve the well-being of patients with genital psoriasis (GenPs)

Quote:

---

Background:
Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient’s sexual health.

Objective:
To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate‐to‐severe genital psoriasis (GenPs) and treatment responses to ixekizumab versus placebo until Week 12.

Methods:
This post‐hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomised, double‐blind, placebo‐controlled study (IXORA‐Q; NCT02718898) in 149 adults with moderate‐to‐severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician‐rated GenPs severity (static Physician’s Global Assessment of Genitalia; sPGA‐G) and patient‐reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs‐SFQ).

Results:
At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA‐G) and pain (GPSS) but not sexual health (GenPs‐SFQ). Complete resolution of these signs was observed in 62% of ixekizumab‐treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.

Conclusion:
Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well‐being of patients with GenPs.

So, this thread is for everybody who wants to follow my new journey with trying to heal psoriasis through diet and supplements. Also for myself; to follow my progress.
After failing on both Humira ( depression, a much reported side-effect ) and Stelara ( floored for a week per month with heavy flu symptoms, not to mention recuperation time )

on the 22th of july 2019 I began leaving out nightshade foods ( tomato, peppers and potatoes ) and gluten ( grains, pasta ).
But I did eat a lot of ricecakes, nuts and seeds )  
This is the Pagano diet; Healing Psoriasis the natural way. Supplements; slippery elm bark tea and Safflower Petal tea.

Lost weight quickly but the psoriasis didn't subside; it just got worse.

on the 25 of september 2019 I've started doing the AIP Paleo diet. That's like Paleo only stricter. All the known allergens are left out ( tho shellfish is allowed ) 
no seeds
no nuts
( no glory )
no nightshades, grains or oils based on seeds and nuts )
Anyway, you can easily look this up. Heaven knows I did just that bordering obsession   

took a standard probiotic, stopped the Slippery Elm but still continuing the Safflower Petal tea. Slippery Elm is supposed to create a muceous barrier on your intestinal walls. The AIP Paleo diet says no to this. 
Other supplements; some Vitamine D, Fish oil capsules and digestive enzymes.

AIP Paleo is all about not letting food particles ( those on the no list ) not slip into your bloodstream. The idea is that you eliminate those foods as it is said that the intestinal walls of a person with a autoimmune disease are compromised. Or you can call it Leaky Gut, or hightnened permeability of the intestinal walls.

This is all in what is called the 'elimination stage'  after which some foods can be reintroduced slowly and properly monitored. I have no idea how to do that yet, because symptoms are not immediately like in painfull autoimmune diseases like Psoriais Arthritis and such. 
In the USA such diets are already being prescribed, albeit slowly and science is only just taking this more seriously.



Also, alcohol is not allowed in the 'elimination stage'  
This was a hard one for me but I've managed not to drink since the first of January this year. And boy do I looooove my wine and cider.

So basically you could say I've begun this journey in earnest as of the first day of 2020.

I'm now down 9,5 kilo, which is nice.

As of today I'm taking an exta supplement; the probiotic Bacillus Coagulens. I read some interesting scientific reports on 'rheumathoid arthritis and this probiotic, where the results reported where mentioned as "borderline statistically improvement" Apparantly it takes care of harmfull intestinal bacterial growth and because it's spore forming will survive stomach acid and manages to do it's magic in your intestines.

Did I mention I lost weight?   Not that I was much overweight but occurance and severity of psoriasis is higher in overweight people, I've read in my googling.

P scale; not so good yet. Daily showering, steel wire brush and calcipotriol salve to ease the scaliing.

Anyway, this is the first post, let me know if there are any questions and I'll update here when I get a chance.

Hi everyone
My son (who is 16) was diagnosed with psoriasis over a year ago. After finding our way through many doctors we have finally found a dermatologist that has started him on Stelara. First does was on November 16th and his next injection is scheduled for December 14th.
No sign of immediate improvement as of yet. Scalp is flaking very badly and making it difficult for him to attend school. We struggle with the emotional issues that psoriasis can cause, especially when you are a teenager.

Time for another experiment. I have had a plaque on my right knee in some form for at least 25 years. I would treat it with topical and cover it in band aids, but I invariably develop an irritation to the band aid adhesive before the thing heals. After reading a bit of research relating to b vitamins and psoriasis, I thought I'd try a 5mg a day folic acid supplement along with a b complex supplement. This did bugger all, but a little more reading alerted me to a 1963 paper by some British researchers who claimed a 75% positive response (not sure what they mean) to subcutaneous b12 injections directly into plaques.

I don't have b12 for injections, but I do have injectable b12/folic acid (500micrograms/15mg per ml) and sterile insulin syringes suitable for subcutaneous injections. I have been injecting the plaque on my knee daily since Saturday (30/11/2019), initially with 0.075ml, and 0.15ml from Sunday. Below is an image I took of my knee at the start of treatment.



The response has been positive and quite rapid. I will post an updated pic tomorrow as I want to use natural light.

Cheers

Saw a lovely Dermatologist today. Managed to see him privately though he told he I need to get into the NHS system for dermatology at my local hospital. Anyway he was talking about different ways of trying to manage my psoriasis - topical, injections and oral. He said injections wouldn’t help and then said oral would but comes with a lot of side affects. To be honest, I’m not bothered about the side affects at the moment. Just wondering what oral medication anyone is taking and if it’s been successful or if the side affects have been awful - I’m happy to have good and/or bad stories!  My psoriasis gets so sore due to friction from my clothes plus I have them in all the crevices in the body! I’ve got to wait for a letter from him, then I need to go and see my GP to get referred into the system and I go back and see the chap I saw today on 27/1/20 with my research done and ideas of how I want to move on. After 15 years of suffering today has been the first day where I’ve felt someone may be able to give me help and hope!

hi andrews from india

Hello All .... fellow psoriasis sufferer here … have had it since a teenager – now late forties and it has decided to go crazy  ……..got pityriasis rosea in April which really assisted in kicking things south …

went to a dermatologist who is proposing Skilarence – but not too sure I’ll be up for the side effects ive read so doing the usual and trying every other thing else ...
 
ie this month I’m off wheat / taking iodine drops and Astaxanthin ……………………you have to do something ---
Hello .

Hi everyone,

I've posted before on using fumeric acid esters(fumaderm and skilarence) before. I've had great success with these over the last number of years, however they have stopped working 

Seen my derm last week and I've been put on stelera. Nurse is due to call today to help me with my first dose. I'll try to keep this post updated so you can follow the effects 

Let's hope it's as successful as fumaderm was to begin 

Hello everyone I hope you are all well as can be and had a lovely summertime.   Today at dermatology appointment I was told my treatment is changing because the cosentyx has stopped being as effective after almost three years.   I am due to start stelara in a month or so.  I was told a nurse will come to my home to administer my injection every time! With cosentyx this only happened on the first occasion so I’m a little confused at this.   Anyway I’m looking forward to possibility of having clear skin once more.  I also thought stelara was an older biologic but I guess the dr has good reason for making that choice.   I would be interested to hear how others have done with the same switch in treatment too, along with side effects.  I’m concerned about any potential weight gain as I’m no lightweight but I did lose weight when I started cosentyx.  This is important to me because I have reduced mobility and find exercise more difficult.    Other news is we moved house a few months ago into a bungalow and it was very stressful so I think it probably had an effect on my psoriasis.   Thanks for reading !