Leo Pharma have announce that their Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% (Enstilar) has been accpeted by the FDA for the treatment of Plaque Psoriasis.

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LEO Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) Foam for the treatment of psoriasis vulgaris in patients 18 years of age or older in the United States.1 Enstilar® is a once-daily, alcohol-free topical treatment.

“We are very pleased by the U.S. approval of Enstilar® and believe it will provide patients with the type of treatment option that they are looking for,” said Gitte Aabo, President and CEO of LEO Pharma.  “At LEO Pharma, we are committed to providing patients with innovative, new solutions and we believe the foam formulation of Enstilar® can help patients living with psoriasis.”

Enstilar® was developed to treat patients with psoriasis vulgaris – the most common clinical form of psoriasis.

The U.S. approval of Enstilar® was based on the Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,5 and the Phase 2 MUSE safety profile study.6  In the pivotal Phase 3 PSO-FAST clinical trial, over half of patients treated with Enstilar® were “Clear” or “Almost Clear” by Week 4 as measured by the 2-step Investigator Global Assessment (IGA) improvement score.1 Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.

In March 2015, LEO Pharma submitted Marketing Authorisation Applications to 30 European Health Authorities for Enstilar®; however, the product is currently only approved for use in the U.S.  

Enstilar® combines a vitamin D analogue (calcipotriol) with a potent corticosteroid (betamethasone dipropionate) to achieve a normalizing result on the affected skin cells and promote a greater anti-inflammatory response than the monotherapy components alone in patients suffering from psoriasis vulgaris.

Apply Enstilar® to affected areas once daily for up to 4 weeks. Patients should discontinue use when control is achieved. Instruct patients not to use more than 60 g every 4 days.

INDICATION AND USAGE
Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Apply Enstilar® to affected areas once daily for up to 4 weeks. Patients should discontinue use when control is achieved. Instruct patients not to use more than 60 g every 4 days.

IMPORTANT SAFETY INFORMATION
For topical use only. Enstilar® is not for oral, ophthalmic, or intravaginal use. Instruct patients to avoid use on the face, groin, or axillae, or if atrophy is present at the treatment site, and not to use with occlusive dressings, unless directed by a physician.

The propellants in Enstilar® are flammable. Instruct patients to avoid fire, flame, or smoking during and immediately after using this product.

Hypercalcemia and hypercalciuria have been observed with use of Enstilar® Foam. If hypercalcemia or hypercalciuria develop, patients should discontinue treatment until parameters of calcium metabolism have normalized.

Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Risk factors include use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

Adverse reactions reported in <1% of subjects treated with Enstilar® in clinical trials included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.

Patients who apply Enstilar® to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. You may wish to limit or avoid use of phototherapy in patients who use Enstilar®.

There are no adequate and well-controlled studies of Enstilar® in pregnant women. Enstilar® should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Enstilar® is administered to a nursing woman. Do not use Enstilar® on the breast when nursing.

The safety and effectiveness of Enstilar® in pediatric patients have not been studied.

This study looked at drug survival rates of different biologic agents in a cohort of psoriasis patients. I concludes the overall efficacy of biologic agents is reduced with time. And patients with the comorbidity of metabolic syndrome demonstrate a loss of adherence to biologic treatment.

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Background:
Psoriasis often requires lifelong therapy, and adherence to treatment is considered a marker for treatment success. Data on the drug survival of biologics in psoriasis patients with comorbidities are lacking.

Objectives:
This study was designed to estimate the long-term drug survival rates of different biologic agents in a cohort of psoriasis patients and to evaluate reasons and predictors for treatment adherence.

Methods:
Drug survival rates and outcome parameters in psoriasis patients treated with biologic agents were analyzed.

Results:
A total of 125 treatment periods with adalimumab (n = 37), efalizumab (n = 9), etanercept (n = 55), infliximab (n = 13), and ustekinumab (n = 11) were administered to 67 psoriasis patients. Patients with psoriatic arthritis (P = 0.010) and without comorbidity (P = 0.033) demonstrated significantly greater rates of drug survival.

Conclusions:
The overall efficacy of biologic agents is reduced with time. Patients with the comorbidity of metabolic syndrome demonstrate a loss of adherence to biologic treatment.

I thought I would share this little study that suggests El Niño decreases the occurrence of psoriasis.

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The El Niño Southern Oscillation (ENSO) is a complex climate phenomenon occurring in the Pacific Ocean at intervals of 2–7 years. The term refers to fluctuations in ocean temperatures in the tropical eastern Pacific Ocean (El Niño [the warm phase of ENSO] and La Niña [the cool phase of ENSO]) and in atmospheric pressure across the Pacific basin (Southern Oscillation).

This weather pattern is attributed with causing climate change in certain parts of the world and is associated with disease outbreaks. The question of how ENSO affects skin and skin-related disease is relatively unanswered.

We aimed to review the literature describing the effects of this complex weather pattern on skin.

El Niño has been associated with increases in the occurrence of actinic keratosis, tinea, pityriasis versicolor, miliaria, folliculitis, rosacea, dermatitis by Paederus irritans and Paederus sabaeus, and certain vector-borne and waterborne diseases, such as dengue fever, leishmaniasis, Chagas' disease, Barmah Forest virus, and leptospirosis, and with decreases in the occurrence of dermatitis, scabies, psoriasis, and papular urticaria.

La Niña has been associated with increases in the occurrence of varicella, hand, foot, and mouth disease, and Ross River virus (in certain areas), and decreases in viral warts and leishmaniasis.

Reports on the effects of ENSO on skin and skin-related disease are limited, and more studies could be helpful in the future.

Stumbled on this website when researching the new drug my dermatologist has given me (Soriatane, 10 mg).  Have very severe ps on palms of hands, bottoms of feet.  Have been hospitalized four times because of the infections  (sepsis, I think they called it?).  Believe me, I am VIGILANT about using antibiotic ointment and keeping clean, doesn't seem to matter; my hands and feet are like giant open wounds all the time.  I try covering them with a very large band-aid, but my skin is so sensitive to the glue in the bandaid that I have to be extremely careful.  I can't take oral antibiotics, so they usually only keep me overnight, or 2 days, put me on massive doses of IV antibiotics, put in a stent (or whtever its called) and I go back and get the drug at the hospital every day for 10 days.  This has happened at least once a year for the last 3 years.  Arrrrghhhh.  

Both hands and feet are constantly shedding, cracking, bleeding, itching, etc.  Pain is sometimes unbearable.

Am 59 years old, and have taken an early retirement because the stress and pain of the ps was just getting to be too much.  I miss my work, but have much to keep me busy. 

Grew up in Ohio, hated the cold, so did my post-grad studies in California and Florida, finally settling on Florida in 1983.  Met the love of my life in 1999 and moved, of all places, to CANADA...where my first year I discovered four feet of snow in my yard was to be a "typical" winter.  Sigh.  Never had psoriasis before coming to Canada, but within a year of being here, my hands started developing it.  Finally became so bad that I sought help.  Have seen at least eight dermatologists, tried every topical (and I do mean, EVERY - at last count, I had tried over 48 different prescription ointments/creams.  

Have a history of proliferative glomerial nephritis (kidney disease) and some liver issues do to the treatments for the kidney, so docs have always been reluctant to try oral meds.  I have finally gotten my liver function to a healthier state and my new derm is allowing me to try this Soriatane.  I am hoping for a miracle, because I believe in miracles!! 

Thanks for being here.

Kersty

Merck's Tildrakizumab treatment for psoriasis came out superior to placebo, maintained for 52 weeks of treatment, and persisted for 20 weeks after cessation, and was generally safe and well tolerated. Results of phase llb

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Background:
Tildrakizumab is a high-affinity, humanized, IgG1/κ, anti-interleukin (IL)-23p19 monoclonal antibody that does not bind human IL-12 or p40 is being developed for the treatment of chronic plaque psoriasis.

Objectives:
To evaluate the safety and efficacy of subcutaneous tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis.

Methods:
A three-part, randomized, double-blind, phase IIb trial was conducted in 355 adults with chronic plaque psoriasis. Participants were randomized to receive subcutaneous tildrakizumab (5, 25, 100, 200 mg) or placebo at weeks 0 and 4 (part I) and every 12 weeks thereafter until week 52 (part II). Study drug was discontinued at week 52 and participants were followed through week 72 (part III). Primary efficacy end point was Psoriasis Area and Severity Index (PASI) 75 response at week 16. Adverse events (AEs) and vital signs were monitored throughout the study.

Results:
At week 16, PASI 75 responses were 33·3% (n = 14), 64·4% (n = 58), 66·3% (n = 59), 74·4% (n = 64) and 4·4% (n = 2) in the 5-, 25-, 100- and 200-mg tildrakizumab and placebo groups, respectively (P ≤ 0·001 for each tildrakizumab dose vs. placebo). PASI 75 response was generally maintained through week 52; only eight of 222 participants who achieved PASI 75 response at week 52 and continued to part III relapsed following discontinuation up to week 72. Possible drug-related serious AEs included bacterial arthritis and lymphoedema (part I), and melanoma, stroke, epiglottitis and knee infection (part II).

Conclusions:
Tildrakizumab had treatment effects that were superior to placebo, maintained for 52 weeks of treatment, and persisted for 20 weeks after cessation. Tildrakizumab was generally safe and well tolerated. These results suggest that IL-23p19 is a key target for suppressing psoriasis.

The FDA have turned down XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The US regulator sent Pfizer a Complete Response Letter stating that it would be unable to approve Xeljanz (tofacitinib) for psoriasis without additional information. It is thought to relate to the safety of the drug, and Pfizer have responded on their website.

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Pfizer Inc. announced it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication.

“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis.”

Hi all,

I've got a a patch of psoriasis on my forehead. My doctor has perscribed Hydrocortisone- it takes the redness and dryness down for a while, but after a couple of days without H/C, the psoriasis thickens and reddens. Could anyone recommend a good treatment for my problem?

Thanks,
Mark

This small study looked at he features of circulating CD4+ CD28null cells in patients with psoriasis.

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Background:
Psoriasis is a chronic inflammatory disease that affects the skin. CD4+ CD28null cells are a subset of T lymphocytes associated with systemic inflammation and increased cardiovascular disease risk, and may be involved in the pathogenesis of psoriasis.

Objectives:
To study the features of circulating CD4+ CD28null cells in patients with psoriasis, adjusted for the influence of known cardiovascular disease risk factors.

Methods:
Forty-two patients with psoriasis and 42 controls entered the study. Peripheral blood mononuclear cells were analysed for the frequency of CD4+ CD28null T lymphocytes and their expression of cytotoxic granules and homing receptors. Immunostaining for cutaneous cytotoxic granules was assessed in skin biopsies from 11 patients.

Results:
There were no differences in the frequency of CD4+ CD28null T cells between groups in all situations analysed. However, there was an increased number of cells expressing cytotoxic granules and a decreased number expressing CXCR3 in ex vivo samples of patients with psoriasis. A negative correlation was observed between the frequency of ex vivo CD4+ CD28null cells and psoriasis severity. After clinical remission in nine patients, ex vivo CD4+ CD28null lymphocytes expressing cytotoxic granules decreased. Perforin-, granzyme B- and granulysin-containing cells were found in skin lesions. Patients with psoriasis also had increased plasma levels of C-reactive protein.

Conclusions:
These data suggest that cytotoxic cells, such as CD4+ CD28null lymphocytes, within an inflammatory environment may play a role in the pathogenesis of psoriasis.

More good news for Cosentyx (secukinumab) after Novartis present new data showing that the majority of patients are able to maintain clear or almost clear skin with Cosentyx across 3 years.

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Novartis announced today new late-breaking data demonstrating that Cosentyx (secukinumab) provides high levels of skin clearance and sustained efficacy in patients with moderate-to-severe plaque psoriasis while maintaining a favorable safety profile across three years. The results of this study - the longest Phase III Cosentyx trial conducted to-date - were presented at the 24th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen, Denmark. Cosentyx is the first fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis.

In this extension study, 320 patients received Cosentyx in a fixed dosing schedule for three years. 69% achieved clear or almost clear skin (PASI 90) at year one. This response was extremely well maintained after three years with 64% of patients continuing to have a PASI 90 response. In addition, 43% of patients maintained completely clear skin (PASI 100) at year three (from 44% at year one). 83% achieved the standard treatment goal of PASI 75 skin clearance at three years.

"Psoriasis patients want therapies that maintain high levels of skin clearance over the long-term given the impact of the disease on their physical and psychological wellbeing," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "In these new data from our longest Phase III trial to date with Cosentyx, we are pleased to show patients were able to maintain clear or almost clear skin for up to three years."

The PASI score assesses the reduction from baseline in the redness, scaling and thickness of psoriatic plaques and to what extent it affects each area of the body. PASI 75 has historically been considered the goal for psoriasis treatment. However, with newer treatments with increased efficacy, there is now a focus on PASI 90 (clear or almost clear skin) and PASI 100 (clear skin) as the ultimate goal for treatment, as recommended by clinical guidelines and regulatory authorities.

In this study, Cosentyx had a favorable safety profile consistent with that observed in previous Phase III studies.

I have some feedback about your office staff. I have tried for a month to contact the director of this website 4 times now and have not received an answer. I think your office staff should have answered me or at the very least let me know they have passed my email on to the director whom I had addressed it to. I am very disappointed that I have had to register as a member to try and speak to the director. So will someone please get in tough with the director and tell him or her that I wish to discuss advertising my website on this forum. I manufacture and sell my own psoriasis and eczema cream that can help all of your members.

In exchange for an article on this forum and a link on your links page I would be prepared to offer all of your members a generous 30% discount. I am also prepared to offer an annual payment of $100 to your donations page.

You can contact me via the email address I used to register. This is the same email I used to try and contact the director that your staff did not pass on.

Disappointed.

Following on from the report last year about BI 655066 achieving psoriasis clearance for 66 months, Boehringer Ingelheim said today it had also cleared skin better, faster and for longer than Stelara (ustekinumab)

Last years report: Psoriasis clear 66 months after one subcutaneous injection of trial drug BI 655066

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New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab.1 Patients also achieved this skin clearance significantly faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer (≥ 32 weeks versus 24 weeks) than those on ustekinumab.  In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43 percent versus 15 percent).

"These results are striking. They further strengthen our understanding of the potential skin improvement that can be achieved with BI 655066, in moderate-to-severe plaque psoriasis. We saw a third more patients achieve clearer skin in a short time period. And this clearance was maintained longer compared to the commonly used treatment ustekinumab,” commented Kim A. Papp, MD, PhD, President of Probity Medical Research, Waterloo, Ontario, Canada. “Achieving clear skin quickly and maintaining clearance is an important goal for patients that have to deal with the daily impact of psoriasis.” These meaningful 24-week findings from a Phase II study in psoriasis were presented today in an oral presentation by Dr. Kim A. Papp  at the 24th European Academy of Dermatology and Venereology (EADV) congress in Copenhagen.

The study (NCT02054481) investigated the efficacy and safety of BI 655066 versus ustekinumab in 166 patients.1 These data build on Phase II data presented earlier this year at the Annual Meeting of the American Academy of Dermatology (AAD). Primary endpoint results showed nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (PASI 90) after 12 weeks of treatment with BI 655066, compared to ustekinumab (77.1 percent versus 40 percent of patients). The new data further demonstrate that BI 655066 has similar safety and tolerability to ustekinumab, regardless of dose, with no serious drug-related side-effects.1 The most common side effects were runny nose, sore throat, and headache.

“The results are an exciting milestone in Boehringer Ingelheim’s growing immunology pipeline. These Phase II study results represent a major step towards our vision of transforming the treatment of immune diseases and the patients affected by it,” said Dr. Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim. “We look forward to continued research and are currently planning multiple Phase III studies.”

Additional trial information
The data discussed in this press release represent results for BI 655066 180mg (n=42) injection under the skin, delivered at weeks zero, four and 16.

The BI 655066 90mg (n=41) dose also showed superior efficacy, onset and duration of action over ustekinumab after nine months.

More patients with moderate-to-severe psoriasis maintained almost clear skin (PASI 90) with BI 655066 compared to those on ustekinumab (81 percent versus 30 percent)
 
More patients on BI 655066 had completely clear skin (PASI 100) compared with ustekinumab (54 percent versus 15 percent)

An exploratory single dose of BI 655066 18mg (n=43) was also studied.

Ustekinumab 45mg/90mg (n=40) was delivered as an injection under the skin at weeks zero, four and 16.

Hello all, 

My name is Jessica and my main concern is my facial P.  All I ever hear is how rare it is and no solution.  I have tried over the counter cortisol creams to maintain it but I don't won't to keep using the steroids. There's got to be a better and safer.

Hi I'm new to this site and in of help.  I have plaque psoriasis on my face, scalp, outer and inner ears, elbows, and knees.  I don't care about all the areas except for my face and I can't find help to stop it or control it.  The only product that works so far is over the counter cortisol cream but it's a steroids.  Anyone have this on their face?

this is a trial and I may be one of 15 in the UK and 300 world wide.

HI I'm richard and I've psoriasis

I'm freaking out fellow flakers!! After almost a year of clear skin I noticed a few new spots today. Granted they are really small and maybe only six or eight total but I'm at a loss as to why. My stress is at an all time low and I'm eating and drinking the same bad stuff I always do. I want to put a stop to this pronto, without topical steroids. HELP!! And please don't say it's from eating a nightshade or drinking. I have been eating and drinking all of the wrong things for a year with zero flare ups.

Hi all, 
I am Joanne. New to this site and posting , as well. Lived with psoriasis for 40 years now. Completely clear due to Stelara, but now facing major dental issues. Saw a few threads on subject. Is anyone else suffering from this ?  Thank you.

How long to leave a cold before asking advice? And (in UK) would you approach GP or derm about it?
I have a sneezy runny nose, sore throat and cough - classic cold.

was talking to my boyfriends mum today and she was telling me her boyfriend is going into hospital next week for a week to do tar treatment and will then have light treatment after to keep him clear. I didn't even know they still done this! I used to get this done about 20 years ago when I was a little girl! Anyone else tried this in recent years?