Bryhali lotion has been given FDA approval for use with psoriasis.

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Bausch Health announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month.

What is Bryhali Lotion?

• Bryhali Lotion is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if BRYHALI Lotion is safe and effective in children under 18 years of age.
  

Important Safety Information

• Bryhali Lotion is for use on skin only. Do not use bryhali Lotion in your mouth, eyes, or vagina.
  

Before you use Bryhali Lotion, tell your healthcare provider about all your medical conditions, including if you:

• Have had irritation or other skin reaction to a steroid medicine in the past
  
• Have a skin infection
  
• Have diabetes
  
• Have adrenal gland or liver problems
  
• Are pregnant or plan to become pregnant
  
• Are breastfeeding or plan to breastfeed. It is not known if Bryhali Lotion passes into your breast milk. If you do breastfeed, do not apply Bryhali Lotion to your nipple or areola to avoid getting it in your baby's mouth
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroids by mouth or injection, or use other products on your skin that contain corticosteroids.
What are the possible side effects of Bryhali Lotion?
Bryhali Lotion may cause serious side effects, including:

• A condition where your adrenal glands stop working
  
• Cushing's syndrome, a condition caused by too much exposure to the hormone cortisol
  
• High blood sugar (hyperglycemia)
  
• Skin reactions at the treated site
  
• Vision problems such as cataracts and glaucoma. Tell your doctor about any blurred vision or other vision problems during treatment
  
• Effects on growth and weight in children
  

The most common side effects of Bryhali Lotion include: burning, stinging, itching, dryness (application site dermatitis), upper respiratory tract infection, and high blood sugar (hyperglycemia).

Use:

• Apply a thin layer of Bryhali Lotion to the affected areas once daily.
  
• Treatment beyond 8 weeks is not recommended. Discontinue treatment if control is not achieved before 8 weeks.
  
• Do not use with occlusive dressings unless directed by a physician.
  
• Avoid use on the face, groin, or axillae.
  
• Not for oral, ophthalmic, or intravaginal use.
  

I'm about to start Taltz tomorrow. I'm excited after reading a few posts but I have a question. I'm a pretty fat guy with a big ol belly. I always used an autopen with Humira (Did nothing for me) in my leg. I never minded the slight pain. I've got the prefilled syringe for Taltz. Would you old pros still recommend I try to do it in my stomach even though I'm really fat there? Or should I suck it up and try the legs?

Hello from newbie ItchyTeri!!
Just wanted to pop by and say 'Hi' to all fellow sufferers lurking here.
I only found this group today. I've not been one to join groups regarding my skin condition, but thought I might just as well.
I've had Psoriasis for many years now. Always had dry skin even as a teenager, with mild eczema to start with. The Psoriasis kicked in with childbirth, just one weird spot on the leg to start with, which grew and spread and got worse and worse as time went on.
I've used various cremes and ointments over the years. None of which has cleared my skin up. Some worked better than others just to hold it in check, but as one patch starts to clear, many more spots break through. It's an endless cycle.
A few years ago I got sent for Photo Therapy - what a godsend!!  I cleared up and was FREE - but only for a while. A couple of weeks later, and here we go again...Only Worse than before. Nothing I do seems to hit the mark.
I've had three sessions in the light box up to now. Just been referred for another session, but won't get to that one for at least a year due to crappy waiting times. Only one booth here where I live, unless I wanted to travel 60 miles to the next one.
Anyroadup. Here I am saying hallloooooooooo!!
Teri x

This study suggests Women showed higher expectations and rated specific needs in psoriasis treatment higher than men.

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Background:
Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care.

Objective:
This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and SDNTT with respect to treatment choice, age and gender.

Methods:
The German and Swiss psoriasis registries observe patients recruited at first‐time use of systemic drugs. Within 10 years, clinical (Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)) and patient‐reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis dataset includes n=4,894 patients from PsoBest and n=449 from SDNTT with mean follow‐up time of 7.5 months.

Results:
5,343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years±14.5, PASI 14.2±9.7, BSA 22.7±19.7, DLQI 11.3±7.2).The most important patient needs were to “get better skin quickly” and to “be healed of all skin defects”.

Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy.

Conclusion:
Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analyzing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.

This picture happen last year around August 2017  after it rebound and is way much worse then before is almost 90 % cover my body . I have been taking cyclosporine and steriods cream for a year  . So i have decide to stop western medicine since then , and try natural healing ways . My experience is healthy diet do make a difference on my natural healing journey. As per now my face are completely clear compare to the below picture i attached. Sadly was , my other body part has not much improvement.
Until recently i have make up my mind to back to western medicine path, as i really cant endure the pain anymore.. as most of you will understand how i feel if you were a severe one. I went back to my derm specialist , she had advised me on Stelara. Hope to get some good or even bad reviews about this medicine here based on own experience. Yes i do read at other article that someone post about stelara, but i hope some of you response here and i really have questions to ask .

I have rheumatoid psoriasis, I have also had low platelet count which was put in remission with prednisone. The prednisone was horrible but “fixed” both issues (I thought) but it was temporary. Platelets are in normal range but psoriasis it out of control. Humira stopped working after year and a half, stellara never helped, after loading doses and two more shots on consentx I have now developed pustules covering the soles of my feet and palms of my hands and on my scalp.  So, my new doctor going to try embrell but while I wait for insurance approval I’m back on prednisone. Problem is prednisone makes me feel sick, raging angry, messed up dreams and as you can infer from this post depressed.

Hi
my name is Karen, I live in Brisbane, Australia and I am originally from the United Kingdom. I am a single mum of four and I work full time as a truck driver for a large postal company.
My Psoriasis first appeared when I was about ten and I believe was triggered by my dad getting a promotion, us moving house and having to start straight into a new high school. First sign was on my scalp, over the years it has spread around my body and now at the grand old age of fifty two I have Psoriasis  pretty much everywhere in varying degrees.
I find stress aggravates it, certain foods, alcohol and the cold weather. 
I haven't met anyone else locally who suffers from Psoriasis so I am hoping to participate and learn from others on this site,
thanks
 Karen

This small study evaluated the efficacy of Cyclosporine A (CsA) in patients with psoriasis.

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Background:
Psoriasis course involves increased secretion of pro‐inflammatory cytokines, among others, a beta transforming growth factor (TGFβs) and its receptors. Cyclosporine A (CsA), an immunosuppressive medicine with the molecular mechanism of operation connected with the properties of cell cycle suppression, is often used in the treatment of severe forms of psoriasis. The efficacy of therapy is assessed based on the disease clinical progression indexes – Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Dermatology Life Quality Index (DLQI). The aim of the study was the evaluation of the efficacy of the CsA treatment of patients with psoriasis vulgaris, based on the clinical parameters and an assessment of the expression profiles of TGFβs and TGFβRs, depending on the concurrent diabetes and metabolic syndrome.

Methods:
The group under study composed of 32 patients (15 with the metabolic syndrome, seven with diabetes) treated with CsA for 84 days. The molecular analysis included extraction of RNA, assessment of TGβF1‐3, TGFβRI‐III gene expression with the use of the RTqPCR method. The clinical assessment of the effects of this pharmacotherapy involved evaluation of the parameters: PASI, BSA, DLQI before therapy commencement, on the 42nd and 84th days of therapy.

Results:
A statistically significant change in the transcription activity of TGFβ1 in patients with and without diabetes (P = 0.018) and patients with and without metabolic syndrome (P = 0.023) was shown that on the 84th day of therapy.

Conclusions:
TGFb1 may be claimed as the supplementary molecular marker to evaluate the efficacy of CsA therapy. It seems that systemic diseases have an effect on the efficacy of the applied pharmacotherapy and the course of psoriasis.

This study assesses the clinical course after Taltz (ixekizumab) treatment withdrawal and retreatment, as well as the effectiveness of Taltz (ixekizumab) retreatment, in Japanese patients with plaque psoriasis.

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Background:
Long‐term management of moderate‐to‐severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment.

Objective:
To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis.

Methods:
This single‐arm, open‐label study (UNCOVER‐J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160‐mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks [IXE Q4W] until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks.

Results:
At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90, and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment‐emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period.

Conclusion:
In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

This study investigated the molecular mechanism of Methotrexate in the treatment of psoriasis.

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Background:
Methotrexate (MTX) is used to treat psoriasis, a chronic inflammatory skin disease.

Objectives:
To investigate the molecular mechanism of MTX in the treatment of psoriasis.

Methods:
Regulatory T cells (Tregs) and effector T (Teff) cells were isolated from the blood of patients with psoriasis and healthy controls. The proliferation of Teff cells was detected by carboxyfluorescein succinimidyl ester assay. The interferon (IFN)‐γ and interleukin (IL)‐17 levels were analysed by enzyme‐linked immunosorbent assay. The expression of CD73 and FoxP3 were determined by flow cytometry. The expression of proteins in the AMPK/mTOR pathway were detected by Western blot analysis.

Results:
The data suggested that patients with psoriasis have Tregs with decreased immune suppression function and reduced expression of CD73 compared with healthy controls. Moreover, MTX could significantly restore the immunosuppressive function of IL‐17‐secreting Tregs. This, in turn, inhibits aberrant proliferation of Teff cells in patients with psoriasis, reverses downregulation of CD73, upregulates phosphorylated AMPK and inhibits phosphorylated mTOR, and downregulates IL‐17 and IFN‐γ levels.

Conclusions:
We speculate that MTX can restore the immunosuppressive function of Tregs through upregulating CD73, activating AMPK and inactivating the mTOR pathway. These findings may partly explain the mechanism by which MTX treats psoriasis.

Hi,

Been a really long time since i posted last (approx 2 years... )
When I last posted I was on Acitretin and things were not going well.
About a month after my last post I was put on Methotrexate and have been on 15mg /week since then.
I can happily say that after 8-10 weeks all my patches were cleared and I have been cleared for the better part of the last two years.
So far I have had no effects from Methotrexate. Bloodworks getting done every month although that is a real pain as I loose a day's income every month for a 2 min bloodwork. (I can live with that )

I'd just like to say, Psoriasis can be controlled. Just stick with it and you'll get there. It might be a painful, frustrating process but something will work for you.

Results of a pooled analysis of week 16 data from three randomized controlled trials for Cimzea (certolizumab pegol) for the treatment of patients with moderate to severe chronic plaque psoriasis

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Background:
Certolizumab pegol, an Fc‐free, PEGylated, anti‐tumour necrosis factor (TNF) biologic, has demonstrated favourable results in three ongoing, phase 3, randomized, double‐blinded, placebo‐controlled trials in adults with psoriasis.

Objective
Data were pooled from the ongoing trials to investigate efficacy in selected subgroups and add precision to estimates of treatment effects during the initial 16 weeks of treatment.

Methods:
In each trial, patients ≥18 years with moderate‐to‐severe chronic plaque psoriasis for ≥6 months were randomized to receive certolizumab 400 mg, certolizumab 200 mg or placebo every 2 weeks for 16 weeks. Coprimary endpoints for the pooled analysis were responder rates at Week 16, defined as ≥75% reduction in psoriasis area and severity index (PASI 75) and physician global assessment (PGA) of 0/1 (‘clear’/‘almost clear’ with ≥2‐category improvement). Safety was assessed by treatment‐emergent adverse events.

Results:
A total of 850 patients treated with certolizumab 400 mg (N = 342), certolizumab 200 mg (N = 351) or placebo (N = 157) were included in the pooled analysis. At Week 16, PASI 75 and PGA 0/1 responder rates were 80.1% and 63.7% in the certolizumab 400 mg group, 74.5% and 54.6% in the certolizumab 200 mg group, and 7.5% and 2.8% in the placebo group (P < 0.0001 for each dose versus placebo). In patients with and without prior biologic therapy, both doses of certolizumab resulted in substantially higher responder rates versus placebo. The incidence of adverse events was generally similar between the 400 mg and placebo groups, and somewhat lower in the 200 mg group versus placebo. No new safety signals were identified.

Conclusion:
Certolizumab pegol 400 mg or 200 mg every 2 weeks for 16 weeks was associated with statistically significant and clinically meaningful improvements in signs and symptoms of psoriasis in patients with and without prior biologic therapy, and a safety profile consistent with the anti‐TNF class in psoriasis.

I notice tonight the boys rear end and lower back (areas that have never had sun exposure) are quite red and verging on burnt. We are due to go in for the third treatment of the week tomorrow. I will ask at the dermatologist office but I would appreciate your thoughts on a) do we wait until Monday and only go twice this week or b) go and ask for a lower dose snd less time so he is still getting the 3x uv but not getting a burn. It seems obvious to me to skip tomorrow, but I don’t want to lose and benefits (and time spent)

Hi there

I got my first bout of psoriasis (as I now know it) back when I was pregnant with my first child 22 years ago.  It covered the palms of both hands.  I was told it was stress eczema and to basically change my lifestyle to get rid of stress and cover my hands with greasy ointments (not medicated).  Needless to say that didn't work and I had to put up with it for the next 12 years or so.  I did notice that when I went on holiday with my kids and not my (now ex-) hubby, my palms improved considerably.  Having split from my hubby and moved in with my mother 8 years ago, my hands cleared up over the next 6 months - yay.

Fast forward to 2016 and I noticed a patch on the sole of my left foot.  This just happened to coincide with my blood pressure shooting through the roof.  As it got worse and appeared on my left hand as well, I was referred to a dermatologist, who didn't think it could be psoriasis as it was only in those two area - she tried me on various creams and a tablet to clear up fungal infections - none of which worked.  After about 6 months she decided to send me for a biopsy (which took over 9 months to be done) and I was eventually seen by her again 14 months after our last appointment (she had me just putting E45 on while waiting for the biopsy and results, so you can imagine how much good that did)!

Anyway biopsy came back as psoriasis, so now I can actually (hopefully) get treatment that works. 

So far I have been put on 2 steroid ointments one is dermovate (I can't remember the name of the other one).  I was also put on 10mg of acitretin with fortnightly blood tests as I was/am diabetic (diet controlled) and my triglycerides were a "bit high".  I was a bit surprised by also having to have a pregnancy test every month before I can pick the pills up from the hospital pharmacy (I'm 51, single and can't remember what sex is lol), but the pills seem to be working.  They've just been increased to 20mg.

So far the only side effect I seem to have (and that's only since we went up to 20mg) is that my lips are incredibly dry and cracking - which is how I found this site - a google site for dry lips on acitretin!

Thank you to Craig for pointing out that Tremfya is now indicated for the treatment of adult patients (18 years or older) in Australia with moderate to severe plaque psoriasis.

Guselkumab-Tremfya

Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial.

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Bristol-Myers Squibb Company today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165, with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported.  

“Moderate to severe psoriasis remains undertreated and many patients struggle with insufficient disease control, leaving a significant need for effective and convenient therapies that can provide a positive impact on patients' lives,” said Mary Beth Harler, M.D., head of Innovative Medicines Development, Bristol-Myers Squibb. “BMS-986165 is a novel, oral, selective TYK2 inhibitor with a distinct mechanism of action that has the potential to help psoriasis patients control their disease, and is planned for study in a wide spectrum of immune-mediated diseases.”

“Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,” said Dr. Kim Papp, M.D., Ph.D., of Probity Medical Research in Waterloo, Ontario and lead author of the New England Journal of Medicine publication. “Having a favorable risk-benefit profile and delivering significant skin clearance and improvements in quality of life measures, these data suggest that BMS-986165 may be a promising oral option to help patients control their psoriasis in the future.”

The registrational POETYK (PrOgram to Evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor) PSO Phase 3 program for patients with moderate to severe plaque psoriasis is currently enrolling. Phase 2 trials for patients with systemic lupus erythematosus or Crohn's disease are also ongoing.

A new topical could soon be made available for the treatment of plaque psoriasis.

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Bausch Health Companies and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALI™ (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy. 1 The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI Lotion shortly thereafter, as scheduled, in November 2018.

"Our customers and their patients can benefit from this new treatment option that is expected to provide the efficacy of a high-potency steroid with tolerability and longer duration of use," said Bill Humphries, president, Ortho Dermatologics. "Just as every psoriasis patient's journey is different, so too are their treatment needs, which is why psoriasis is a key therapeutic focus for our business. We look forward to adding BRYHALI Lotion to our growing psoriasis portfolio."

Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events such as epidermal atrophy. Other local adverse reactions from topical corticosteroids may include striae, telangiectasias, hypopigmentation and contact dermatitis, and some local adverse reactions may be irreversible. In clinical trials, BRYHALI Lotion was applied once daily for eight weeks and shown to be generally well-tolerated with no increase in epidermal atrophy.

"Topical steroids are a cornerstone of psoriasis treatment, but the efficacy of a high-potency steroid often comes with an increased risk of adverse events and a duration of use limited to two to four weeks," said Lawrence J. Green, M.D., associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. "In clinical trials BRYHALI Lotion has demonstrated good local tolerability for up to eight weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients."

I tried to post an intro but got a message that
I am not authorized 
Did I do it wrong??

I am not new to this site but have not introduced myself

I am 61 and have had Psoriasis since I was 17 at varying degrees of intensity 
I would only use natural treatments up until about 6 years ago
 when it became unbearable. I think it may have been because of menopause 
but I finally found a Derma I liked who convinced me to try Stelera.
Honestly it was life changing. I still always had some areas 
but I was at about 80% covered before Stelera 
I have since switched to Try?? - sorry I always go blank on the name-
But it is even better. Do I worry about long term effects of these drugs?' Yes
but my quality of life is vastly improved. Anyway
I don't want to forget that I am still a psoriatic and want to be more in
touch with this wonderful community

Enstilar foam for psoriasis.

Active  ingredients: 50  μg/g  calcipotriol  (as  monohydrate)  and  0.5  mg/g betamethasone (as dipropionate)

List of excipients: Liquid paraffin, Polyoxypropylene stearyl ether, All-rac-α-tocopherol, White soft paraffin, Butylhydroxytoluene (E321), Butane, Dimethyl ether.

Shelf life: 2 years. Use within 6 months of first use. Do not store above 30°C.

Caution: Extremely flammable aerosol.

Important information: For skin use only (topical use). Do not get Enstilar in your mouth, eyes or vagina. If you accidentally get Enstilar on the face, in the mouth or in the eyes, wash the area with water right away.

How to use: The can should be shaken for a few seconds before use. Enstilar should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally.

Enstilar should be sprayed directly onto each affected skin area and rubbed in gently. The hands should be washed after using Enstilar (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. It is recommended not to take a shower or bath immediately after application of Enstilar.

Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand.

If using other topical products containing calcipotriol in addition to Enstilar, the total dose of all calcipotriol containing products should not exceed 15 g per day. The total body surface area treated should not exceed 30%.

Notes:

Enstilar is contraindicated in erythrodermic and pustular psoriasis.

Enstilar is contraindicated in the following conditions if present in the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.

Always read the enclosed leaflet and use as prescribed by your doctor.