When logged in and on the front page you will see in the green menu bar "View Unread Posts" beside it you will see two brackets ( ) inside those brackets are the number of posts that you have not read. For example (3) (72) Etc.

Now when you first try this you may need to set it to Zero. To do this go to the front page of the forum, scroll down to the bottom and click "Mark All Forums Read" which you can find on the right hand side of the bottom dark green bar. Now you will see (0) next to View Unread Posts.

When a new post is made by someone it will change once you refresh the front page and will tell you how many posts you have not read, so click the link again and you should now see only a few threads listed. So it's now set and ready to go.

To find the post you have not go to the thread and look for Unread post on the right hand side next to Post: # once you leave the thread the system will assume you have read it and it will no longer show in the brackets.

Tip: When you click "View Unread Posts" there may be some you're not interested in. No problem just click the little box on the left it will change to White and be marked as read, or visit the ones you want then get rid of the others by clicking "Mark all threads read"

If you log out and have not read all posts listed they will show up again when you log back in, so you won't miss any.

Any questions or feedback please post here.

*Thank you to Caroline for this suggestion.

Though not mentioning the products by name in the study I assume it is about treating adolescent scalp psoriasis with Dovobet (Daivobet) and Dovonex (Daivonex) as it was sponsored by LEO Pharma.

Quote:

---

Objectives:
The primary objective was to assess the safety of once-daily application of fixed-combination calcipotriol plus betamethasone dipropionate gel in adolescent scalp psoriasis. Assessment of efficacy was a secondary objective.

Methods:
This phase II, multicentre, single-arm, open-label, 8-week trial included patients aged 12–17 years with moderate-to-very severe scalp psoriasis according to Investigator's Global Assessment (IGA) (≥ 10% of the scalp area affected).

Results:
Seventy-eight patients received treatment. Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin-corrected serum calcium (0·00 mmol L−1), 24-h urinary calcium excretion (−0·03 mmol per 24 h) and urinary calcium-to-creatinine ratio (−0·12 mmol g−1) were not considered clinically relevant. At the end of treatment 66 patients (85%) were clear or almost clear according to IGA. There was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 (96%) had no or mild pruritus compared with 14 (18%) at baseline.

Conclusions:

Once-daily calcipotriol plus betamethasone dipropionate gel is well tolerated and efficacious for scalp psoriasis in adolescents.

Hello all - My name is Cheryl and i live in manchester, I am married with four children (well one teenage girl and 3 younger boys) i was diagnosed with aih about 3 and half years ago and apart from the fatigue have been managing quite well! I just want to make a quick confession first - i think i may have psoriasis - have been to the gp with odd looking lesions on my skin mainly on my legs and she said she didnt think it was anything really to worry about but if it didnt clear up she would refer me to skin specialist - however on showing them to a couple of people they have said psoriasis straight away and i have googled images and found a couple that look exactly like what i have got. The reason for joining is i wanted to ask a couple of questions, I have an appt with the doctor in a couple of weeks but cannot get hold of her on the phone, even after leaving messages, the lesions dont itch themselves but for the past few days i have been itching all over, does anybody suffer with this before the lesions come up and also does anybody get them round their eyes, i have really sore eyes (like when youre really tired?) and i have just got rid of one off my left eye only to notice that there may be another coming up just a little further along. Sorry if i broke any rules here lol just desperate to try and find out what is going on! Thanks for reading and if anybody can offer any advice i would be most grateful

There are a lot of threads here on Psoriasis Club that discus the link with hypertension and psoriasis, and this study from the UK suggests a need for more effective blood pressure management, particularly among patients with severe psoriasis.

Quote:

---

Importance:
Hypertension is prevalent among patients with psoriasis. The effect of psoriasis and its severity on hypertension control is unknown.

Objective:
To determine the association between uncontrolled blood pressure and psoriasis, both overall and according to objectively measured psoriasis severity, among patients with diagnosed hypertension.

Design, Setting, and Participants:
Population-based cross-sectional study nested in a prospective cohort drawn from The Health Improvement Network (THIN), an electronic medical records database broadly representative of the general population in the United Kingdom. The study population included a random sample of patients with psoriasis (n = 1322) between the ages of 25 and 64 years in THIN who were included in the Incident Health Outcomes and Psoriasis Events prospective cohort and their age- and practice-matched controls without psoriasis (n = 11 977). All included patients had a diagnosis of hypertension; their psoriasis diagnosis was confirmed and disease severity was classified by their general practitioners.

Main Outcomes and Measures:
Uncontrolled hypertension was defined as a systolic blood pressure of 140 mm Hg or higher or a diastolic blood pressure of 90 mm Hg or higher based on the blood pressure recorded closest in time to the assessment of psoriasis severity.

Results:
There was a significant positive dose-response relationship between uncontrolled hypertension and psoriasis severity as objectively determined by the affected body surface area in both unadjusted and adjusted analyses that controlled for age, sex, body mass index, smoking and alcohol use status, presence of comorbid conditions, and current use of antihypertensive medications and nonsteroidal anti-inflammatory drugs (adjusted odds ratio [aOR], 0.97; 95% CI, 0.82-1.14 for mild psoriasis; aOR, 1.20; 95% CI, 0.99-1.45 for moderate psoriasis; and aOR, 1.48; 95% CI, 1.08-2.04 for severe psoriasis; P = .01 for trend). The likelihood of uncontrolled hypertension among psoriasis overall was also increased, although not statistically significantly so (aOR, 1.10; 95% CI, 0.98-1.24).

Conclusions and Relevance:
Among patients with hypertension, psoriasis was associated with a greater likelihood of uncontrolled hypertension in a dose-dependent manner, with the greatest likelihood observed among those with moderate to severe psoriasis defined by 3% or more of the body surface area affected. Our data suggest a need for more effective blood pressure management, particularly among patients with more severe psoriasis.

So, finally after lots of running around, I collect my prescription of Furmederm today. The process will start and I will keep posting, daily if I can, to let you all know how it's going.

Just for reference, I have had psoriasis for 22 years. I have tried uv treatment, steroid creams, methotrexate, tar treatment and loads I have forgotten! I am hopeful that furmederm will, although might be difficult at first, help me with the process of not worrying about my skin anymore.

Fingers crossed!

More soon......

Hi all,
I'm obviously new to this interesting forum.
I've had mild psoriasis for over 30 years.
I got mild PsA 5 years ago but has got worse lately.
I have just started methotrexate last week.
After reading some other posts I don't think I have to much to worry about.
My psoriasis is mild but the PsA is really starting to affect my work (I'm a tradesman with lots of lifting).
Good luck to everyone looking for a pain free life.
Is anyone out there from New Zealand?

Hi everyone,

I'm new to this site after suffering from psoriasis since my teenage years. It is only in the last two years, however, that it turned from a few spots on my fingers when stressed to coverage over all of my body with guttate, scalp and inverse psoriasis after what I was told was a bacterial sinus infection (I now believe that it could have been strep throat).

I did topical treatments, like dovobet, before UVB treatment. I did 27 sessions and while I wasn't compltely cleared, it was almost. This lasted two months before it started to come back.

After a visit with my dermatologist yesterday, I was told that perhaps it was time to start oral treatments. I was given information on Methotrexate and Fumaderm, and told to consider my options. I'm back in 6 weeks so I have to decide by then.

Has anyone had experience with both of these treatments? Any advice would be helpful. I was leaning towards Methotrexate, but my worry is that as I work in a Creche with 2 year olds, who constantly have colds. Furmaderm seems to have a lot of nasty side affects, which makes me wary.

Thanks in advance

Here's an interesting study that suggest that the people treating psoriasis patients may not have the right training to suggest lifestyle behaviour change. I say interesting because my dermatologist has often suggested to me that exercise and alcohol have a large part to play in psoriasis, I've never disbelieved her but there is no way she is going to be able to push me hard enough to make the changes needed.

Also in her defence, this study is suggesting that my dermatologist needs better training in lifestyle behaviour. I think she has enough training to understand her job, and her job is not to instruct patients on how to live their life. Advise yes but a dermatologist will never be able to convince me that going without alcohol and doing more exercise will benefit me, I'm stubborn and it's just not her job, she has enough on her workload without trying to convince me to stop drinking or do more exercise.

One wouldn't ask an electrician to fix the plumbing in their house, so why put more pressure on a dermatologist to discuss lifestyle changes with a patient.

I would be interested to what others think after reading the study.

Quote:

---

Background:
Psoriasis is associated with significant comorbidity. Excess alcohol use, smoking and higher body mass index are all associated with psoriasis and may contribute to its onset and/or exacerbation. Lifestyle behaviour change (LBC) can be beneficial in the prevention of psoriasis and/or reduction of its severity. LBC techniques are effective when used properly by healthcare professionals.

Objectives:
It is unknown whether clinicians managing patients with psoriasis are familiar with LBC techniques or are confident to deliver LBC support in routine consultations. This study aimed to elicit the views and attitudes of healthcare professionals in primary and secondary care about addressing LBC for patients with psoriasis.

Methods:
We carried out in-depth semistructured interviews with 23 dermatology specialist and general practitioners in English primary and secondary care settings stratified by discipline. Data were analysed using constant comparison and principles of Framework Analysis.

Results:
Clinicians recognized that lifestyle behaviours were important in psoriasis management, but believed it was not their role to facilitate LBC. Limited knowledge and skills to implement LBC principles and techniques underpinned their beliefs. Participants identified a need for training to enable the incorporation of LBC support activity into psoriasis services.

Conclusions:
Clinicians are not yet trained to support patients with psoriasis with effective LBC methods. Training in these methods is needed to enable healthcare professionals to assess and manage psoriasis better.

Hi All,
just found this forum while researching Fumaric acid esters. Ive been taking Metotrexate for 3 years with good results but my psoarasis has been slowly creeping back and dose cant be increased anymore so my dermatologist wants me to try the a above mentioned treatment. Unfortunatly it would cost 144 eurro a month and I cant afford it so I'm not sure where to go from here.

I am living in Shanghai, and I am trying to get Otezla for my uncle. But Otezla is still not in the market of China. Can I get some suggestions about getting the medicine?

Thanks a lot!
Zach

We've been reporting the progress of Secukinumab for a while now on Psoriasis Club, and soon it looks like we will be reporting it has gained FDA approval for the treatment of psoriasis.

Secukinumab is a first in class, fully human, monoclonal IgG1κ IL17A antibody that selectively binds to the pro inflammatory cytokine interleukin 17A (IL17A) and inhibits
its interaction with the IL17 receptor. IL17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a role in the pathogenesis of plaque psoriasis.

On the 20th October, FDA advisers will be voting whether to recommend it for full approval. And are due to give a final decision on by January 2015.

The general summery of the FDA Briefing Document states:

Quote:

---

The currently available data support a favorable benefit risk assessment for the use of secukinumab for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. No major safety issues associated with secukinumab use have been identified to date.

Recently a "new" medication was released in the Netherlands for treating Multiple Slerose. It is based on the working substance Dimethylfumarate.

The medication draws attention because of its price, and was in a Television transmission compared to a much cheaper medication in reality one of our well known psoriasis medications.
The neurologist that brought this discrepancy to the attention of the public, dr. Bob van Oosten, says in this transmission, that for MS he is only allowed by the protocol to prescribe this new medication to MS patients. (Long live the protocol designed by [old|wise] men).

In the mean time, the minister of Health, mrs. Schippers, is also attached to the case, and she already signaled to the producing pharmacologist that they are way too expensive, which has also been mentioned in an article in the papers.
Unfortunately she at the same time says that it should be dealt with by the European Parliament, which shifts this item to somewhere in the future. The EU does not have the name to be quick on items that are really important for the civilian.
Pharma says that the price is relevant and in balance with all the research that has been done, but:
- Why is the other medication than so much cheaper? And this has 20 years of field experience.
- And where are those studies?

If you are interested you can watch the transmission at [web]https://www.rtlxl.nl/#!/132237/ce0a02c6-7153-3bba-b11e-c259ef1b9a46[/web]. It is in dutch, but I think it is not so complicated that you would not be able to follow it.
It is on a site called "Transmission missed?", where one can review all kinds of news transmissions.
The item on the medication starts at around 12:45 minutes, you are able to skip to this time.

Following on from Cimzia (certolizumab pegol) getting approval for the treatment of Psoriatic Arthritis (PsA) in USA, UK, & Ireland See Here: Cimzia gets FDA approval for psoriatic arhtritis
Phase 3 clinical trial data has been presented at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV)

Quote:

---

Treatment with certolizumab pegol showed sustained positive effects on dermatological outcomes over 96 weeks in patients with psoriatic arthritis.

Patients' mean Psoriasis Area and Severity Index (PASI) improved from a score of 12.0 at baseline to 2.6 at week 96.

In addition, a 75% improvement in the PASI score (PASI-75) was seen in 53.0% of patients, and a 90% improvement in the PASI score (PASI-90) was seen in 44.0% of patients over the study period.

The RAPID-PsA trial enrolled adult patients with active psoriatic arthritis who had failed ≥1 disease-modifying anti-rheumatic drugs (DMARDs). In addition, while previous use of a tumour necrosis factor (TNF) inhibitor was allowed for any given patient, the percentage of all patients who had received 1 prior TNF inhibitor could not exceed 40%.

In the first 24 weeks of the study, 409 patients were randomised 1:1 to double-blind treatment with certolizumab 200 mg every 2 weeks, certolizumab 400 mg every 4 weeks, or placebo. Both certolizumab groups initially were given a 400 mg loading dose at weeks 0, 2, and 4.

From week 24 to week 48, a dose-blind period followed, in which patients originally randomised to placebo were re-randomised to certolizumab of either dose. Patients originally randomised to certolizumab continued receiving the same dose. Then from week 48 to week 216, all treatment was open-label, with the same doses being continued. Treatment was administered as a subcutaneous injection.

At week 0, the number of patients randomised to both doses of certolizumab was 273. Of these, 91% completed treatment to week 24, 87% to week 48, and 80% to week 96. A total of 166 of them (60.8%) showed a psoriasis-affected body surface area (BSA) of ≥3% at baseline, with a mean BSA at baseline of 24.2%. Results showed that this group's mean BSA fell to 8.1% at week 24 and then to 6.5% at week 96.

Among these 166 patients, mean PASI score at baseline was 12.0 and this was reduced to 2.7 at week 24 and 2.6 at week 96. Treatment response was also assessed by how many of them reached PASI-75 (61.4% at week 24 and 53.0% at week 96) and PASI-90 (41.6% at week 24 and 44.0% at week 96). In addition, 22.9% of these patients received a rating of "clear" on the Physician’s Global Assessment of Psoriasis (PGA) scale at week 24, which improved to 30.7% at week 96.

Among all patients, the Dermatology Life Quality Index (DLQI) score fell by 5.8 points at week 24 and by 6.0 points at week 96 compared with baseline levels, indicating an improvement in the patient's own assessment of their quality of life impaired by their psoriasis.

The safety analysis included all patients treated with ≥1 certolizumab dose to week 96 (n = 393). Treatment-emergent adverse events (AEs) were reported in 87.8% of patients (n = 345; event rate per 100 patient-years: 329.8), including 45 that were severe (11.5%). Serious AEs occurred in 17.0% of patients (n = 67; event rate per 100 patient-years: 14.5).

Thirty-six patients (9.2%) discontinued the study due to AEs. While serious infections were reported in 16 patients (4.1%; event rate per 100 patient-years: 3.3), no cases of tuberculosis were found. Six patients died (1.5%).

Psoriasis patients in the UK are being let down when going onto the bio treatments according to a new study which shows 54 percent of patients who failed to achieve effective control with a bio had no treatment change six months later, and almost all (92 percent) of patients who lost effective control had no treatment change six months later.

Quote:

---

New UK data from the PICTURE study released at the European Academy of Dermatology and Venereology (EADV) annual congress in Amsterdam show that two thirds of UK moderate to severe psoriasis patients treated with biologic therapies are failing to reach or maintain effective control of their symptoms. These data show one third failed to reach a 75 percent reduction in symptoms, (known as PASI 75), and an additional one third failed to maintain this response.

Additionally, the PICTURE study demonstrated that 54 percent of patients who failed to achieve effective control had no treatment change six months later. Furthermore, almost all (92 percent) of patients who lost effective control had no treatment change six months later. These data suggest UK clinicians may be maintaining patients on initial biologic treatment even though a response has not been achieved, or is not sustained.

Commenting on the results, chief investigator Dr Anthony Bewley, Whipps Cross University Hospital, London said, "These results demonstrate that many patients are failing to achieve optimal treatment for their psoriasis and remain on inadequate therapies. We must be aware of patients who are failing to respond and work with them to ensure they are on the most appropriate treatment so we can make the most of our resources."

In the UK, approximately 1.8 million people live with psoriasis and 20 percent are thought to have moderate to severe psoriasis. Poorly controlled moderate to severe psoriasis patients could cost the NHS up to approximately £6million per year. In addition to the cost burden, psoriasis has been shown to be associated with depression, anxiety and tendency to suicide (350 cases per year) as well as reduced levels of employment and income.

Obvious symptoms of psoriasis include red, itchy skin with scaly patches (plaques). People with moderate to severe psoriasis may have an increased risk of comorbidities, including psoriatic arthritis, obesity, metabolic syndrome, cardiovascular disease, psychiatric illness and cancer.

About the PICTURE study:
The PICTURE study primarily aimed to describe current treatment pathways with biologic therapies used in the management of psoriasis in UK NHS clinical practice.

PICTURE was a retrospective observational study of 221 UK patients with chronic plaque psoriasis aged >18 years at initiation of first biologic therapy. Data were collected from 10 NHS Trust sites across the UK (England, Wales and Scotland).

A novel new drug for the treatment of psoriasis is about to start Phase 1B clinical trials, ShK-186 is Kineta's® lead clinical stage drug candidate in its Autoimmune program. Originally derived from Stichodactyla helianthus, a Caribbean sea anemone. Kineta’s drug product is manufactured synthetically. Preclinical research demonstrated that ShK-186 is effective in animal models of eight autoimmune diseases including multiple sclerosis and rheumatoid arthritis.

Quote:

---

Kineta, Inc., a biotechnology company focused on the development of immune modulating drugs for critical diseases, announced today that the company has opened a Phase 1B proof-of-concept clinical trial for psoriasis using its drug candidate, ShK-186. ShK-186 is a novel, immune-sparing therapeutic in development for a variety of autoimmune diseases. Kineta is planning on initiating an additional clinical trial in patients with psoriatic arthritis in the coming months.

The psoriasis trial is designed to evaluate the effects of biweekly injections of ShK-186 for four weeks in patients with active plaque psoriasis. Patients will be monitored for safety endpoints, assessment of redness, scaling, and lesion thickness, as well as inflammatory biomarker activity in blood and skin biopsy tissue.

“Initiating this trial is another milestone in the clinical development of this novel compound,” said Charles Magness, Kineta’s CEO and President. “Patients with autoimmune diseases desperately need new treatments that effectively address the disease without harmful side effects.”

More good news for New psoriasis tablet Otezla (Apremilast) has been announced at the European Academy of Dermatology and Venereology congress in Amsterdam.

Quote:

---

New analysis of the ESTEEM 2 trial, demonstrated that more than 70% of patients who received treatment with Otezla (apremilast) twice-daily after 16 weeks achieved clinically meaningful improvement when rated by the Dermatology Quality of Life Index.

Pooled analyses of ESTEEM 1 and 2 from 1,250 patients was also presented, showing that Otezla significantly increased work productivity and improved work limitations compared with placebo at week 16. Other data, from ESTEEM 2, demonstrated that the phosphodieasterase-4 (PDE-4) inhibitor significantly improved psoriasis in difficult-to-treat areas such as the palms of the hands and feet, nails and scalp.

Otezla is competing with the injectable tumour necrosis factor (TNF) inhibitors, notably AbbVie's Humira (adalimumab) and Pfizer/Amgen's Enbrel (etanercept). Many observers believe the fact that it does not require routine lab monitoring is a significant plus, while Lluis Puig of Hospital de la Santa Creu i Sant Pau in Barcelona, speaking at an event outside EADV, said oral treatments could be a better long-term option.

Hi guys
I'm new to the club and wish I'd found you years ago.
I am 35 years old mother of 3 boys. I live in Ireland.  I have had psoriasis for 30years. I was on methotrexate for over 2 years but I changed over to Fumaderm 12weeks ago. I am taking 2tabs twice a day.
Since starting the treatment I have not experienced too much cramping thank God but I have been very flushed a lot of the time. I have had a very bad kidney infection, a bout of gastroenteritis and yesterday I developed a middle ear infection.
After my last blood test the dr rang me and asked me to return for another blood test as there was something abnormal with my white blood cell count, she didn't elaborate but I am getting a bit worried. I had the second test this week and am waiting to hear from them.
Does anyone know what might be going on?
Also can Fumaderm cause a person to have interrupted sleep?? I keep waking after only an hour or two and don't sleep properly for the rest of the night.
If anyone can help I would really appreciate it as I am really anxious about this.
Cheers
Shadie xxx

This study looked at personal history of gallstones and risk of incident psoriasis and psoriatic arthritis in U.S. women.

Quote:

---

Background:
Metabolic syndrome has been associated with both gallstones and psoriasis, suggesting a potential biological linkage between gallstones and psoriasis. However, the association between gallstones and psoriasis has not yet been studied.

Objective:
To investigate the association between gallstones and psoriasis.

Design:
Prospective cohort study.

Setting:
Nurses’ Health Study II (1991-2005).

Participants:
89,230 women aged 25 to 42 years who were free of psoriasis at baseline and responded to a 2005 follow-up questionnaire regarding their diagnosis of psoriasis.

Main Outcomes and Measures:
Relative risk (RR) of developing psoriasis or psoriatic arthritis (PsA), which were self-reported and validated by supplemental questionnaires.

Results:
In this population of women, 2,206 participants had gallstones confirmed by a history of cholecystectomy at baseline. A total of 642 individuals had a diagnosis of incident psoriasis, of which 157 had concomitant PsA. After adjusting for known risk factors of psoriasis besides body mass index (BMI), a baseline history of cholecystectomy-confirmed gallstones was associated with increased risk of psoriasis (multivariate-adjusted RR = 2.20, 95% CI: 1.56, 3.10) and concomitant PsA (multivariate-adjusted RR = 4.41, 95% CI: 2.70, 7.18). After additionally adjusting for BMI, the fully-adjusted RRs associated with a history of cholecystectomy-confirmed gallstones were 1.70 (95% CI: 1.20,2.41) for psoriasis and 2.96 (95% CI: 1.80, 4.89) for PsA.

Conclusions and Relevance:
Personal history of gallstones was associated with an increased risk of psoriasis and PsA, independent of obesity in a cohort of US women.

Janssen the makers of Stelara (ustekinumab) are looking for EU approval to treat 12 to 17 year old psoriasis patients that are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Quote:

---

Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.

"Janssen is committed to the continued development of STELARA, especially in this underserved pediatric population," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from STELARA."

The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving STELARA compared with patients receiving placebo.

About CADMUS:
CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients ages 12 to 17 years with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed more than six months prior to first study agent administration with a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.

Patients were randomized 1:1:1 to receive subcutaneous placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].