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.

This study suggests that brodalumab (aka Siliq and Kyntheum) is associated with a higher likelihood of sustained PASI response, including complete clearance, at week 52 than comparators.

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Background:
Patients with moderate‐to‐severe psoriasis require long‐term treatment, yet few trials compare outcomes beyond a short‐term induction period. Quantitative comparisons of long‐term outcomes in patients with psoriasis are limited. To our knowledge, no network meta‐analysis (NMA) of such data has been performed.

Objective:
To compare novel systemic therapies, both biologic and non‐biologic, approved for moderate‐to‐severe psoriasis by conducting a systematic review (SR) and NMA of Psoriasis Area and Severity Index (PASI) outcomes measured at or around one year.

Methods:
An SR was conducted to identify studies reporting PASI 75, 90 and 100 responses. Feasibility of an NMA on maintenance phase endpoints was assessed and sources of heterogeneity considered. Data appropriate for analysis were modelled using a Bayesian multinomial likelihood model with probit link. Wherever possible, data corresponding to an intention‐to‐treat approach with non‐responder imputation was used.

Results:
Twenty‐four studies reporting outcomes at 40–64 weeks were identified, but heterogeneity in study design allowed synthesis of only seventeen. Four 52‐week RCTs comprised the primary analysis, which found brodalumab was significantly more efficacious than secukinumab, ustekinumab and etanercept. Secukinumab was also more efficacious than ustekinumab and both outperformed etanercept. In a secondary analysis, evidence from thirteen additional studies and four further therapies (adalimumab, apremilast, infliximab, ixekizumab) was included by comparing long‐term outcomes from active interventions to placebo outcomes extrapolated from induction. Results were consistent with the primary analysis: brodalumab was most effective, followed by ixekizumab and secukinumab, then ustekinumab, infliximab and adalimumab. Etanercept and apremilast had the lowest expected long‐term efficacy. Results were similar when studies with low prior exposure to biological therapies were excluded.

Conclusion:
Results suggest that brodalumab is associated with a higher likelihood of sustained PASI response, including complete clearance, at week 52 than comparators. Further long‐term active‐comparator RCT data is required to better assess relative efficacy across therapies.

Britain's National Institute for Health and Care Quality (NICE) has recommended Xeljanz (Tofacitinib) for psoriatic arthritis.

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Tofacitinib, with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, only if:

It is used as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis or the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after 12 weeks or TNF‑alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).

Tofacitinib is only recommended if the company provides it according to the commercial arrangement.

Only continue treatment if there is clear evidence of response, defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response but whose PsARC response does not justify continuing treatment should be assessed by a dermatologist, to determine whether continuing treatment is appropriate based on skin response.

When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities or communication difficulties that could affect a person's responses to components of the PsARC and make any adjustments they consider appropriate.

When using the PASI, healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.

These recommendations are not intended to affect treatment with tofacitinib that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Any Enstilar users got any tips to pass on ?

France has finally approved Enstilar and I'm going to be giving it a try for the stubborn little bit of psoriasis and to use as and when I want if I feel a flare up coming.

Obviesly I will be reading the notes, but sometimes it's good to get some reviews or tips from users.

I have noticed it says you shouldn't use it under your arms or on the groin area, that is usualy where I first feel a flare up starting so what do you think ?

Have been reading on a variety of groups about Zudaifu cream, and whether or not this contains steroids.  When I asked my Dermatologist he said all non-regulated creams contain steroids - it's the only way they work.  I've only met my Dermatologist three times and trying to be nice, he doesn't really have a personality and one of the old-school consultants who quite possibly has a god-complex!  So I'm looking for some user experience. 

I'm flummoxed - listed below the ingredients for Zudaifu cream, I can't figure out which is the steroid - can someone enlighten me? 

Ingredients: Sophorae Flavesgentis radix (anti-inflammatory Chinese medicinal herb), Stermonae radix (antibacterial and antifungal Chinese medicinal herb), Cnidii Fructus (Chinese medicinal herb that kills parasites), Kochiae Fructus (Chinese medicinal herb used to clear heat and remove dampness), Menthae Haplocalycis herb (Chinese medicinal herb for rashes), Extracts, Chlorhexidine acetate (skin cleanser for wounds), Stearic Acid, Distilled Monostearate, Glycerol Vineargear, Petrolatum, Purified Water.

Thanks!
Catherine

Hi every one! So I am new here and I wanted to get some feedback on taltz. I just started the injections yesterday and it hurt so bad :( do these injections ever stop hurting? I mean I'll take the pain to get rid of the painful psoriasis but these shots are no joke. Thanks!

Hello,
I've been reading posts on here for maybe a couple months and am finally doing my introduction.
I was born w/psoriasis. I turned 50 yesterday. I've had psoriatic arthritis about 10 yrs but didn't realize that's what it was. 
I've been trying to manage it all with diet and lifestyle, also tanning beds. However, the progression of symptoms made me realize I could no longer manage this horrible disease on my own.
Skipping ahead, my dermatologist got me samples of Cosentyx in hopes it would be approved by my insurance but they want me to try Humira first.
My first loading does of Cosentyx began on 8/24/18 and did all 5 weeks before the insurance denial. I did just 150 mg instead of 300 mg.
My psoriasis started clearing so quickly. It was amazing. It didn't do anything noticeable for the psoriatic arthritis. No noticeable side effects.
I will be starting Humira, assuming all goes as planned. I hear Humira works pretty well for psoriatic arthritis and I'm trying to ignore the negative stuff I read about it.
This forum seems amazing. 
Nancy Mullendore

My sons neck has been stiff for months. Our doctor said he guaranteed it was not related to psoriatic arthritis, and the dermatologist said yesterday that psoriatic arthritis is usually in the hands so its unlikely related. Anyone here ever had issues with the neck and arthritis?

hi im yato, 13 had psoriasis since i was like 6?? it started on my scalp and gradually went down into my eyebrows but never progressed further until about 5 years later. now its all over my body (at least 50-60%) and i have no pill/shot i can take since i'm not 18 yet. 

the only medicated thing i can use is one of those weak steroid creams, but those have proven ineffective as there isn't enough for me to use it on a regular basis. 

has anyone ever tried regular gold bond lotion (the healing kind), for me it's pretty effective. though it doesnt make it go away super fast, it lessens the impact on my daily life + it doesn't cling to my skin like some other medicated creams. 

okay im going on a tangent but hello!!

Had a few days where we basically pretended Psoriasis was a not a thing in our lives.  It was blissful but now I am crashing. The face P is the most crushing. Getting closer to going the Stelera route but he is just so young ? I been looking for info on Elidel as a doctor friend told me it could be be good. I can’t  find anything on here.  Has anyone here tried it?

Hi All-

Have had severe psoriasis for about 15 years.  Started around the age of 35 or so.  Tried a bunch of steroid ointments which helps minimally.  I was my derms first patient for biologics many years ago.  I believe it was Enbrel.  Can't remember I've gone through so many.  Most of them work for me for a couple of years, then start to lose their effects.  Start to see positive results in a few weeks, then about 4 months for about 80-90% clearances.

After Enbrel, started Humira, then Stelara, then Cosentyx.  Cosentyx worked for about 3 years until the beginning of this year.  Was about to start Taltz, but my derm said I could try Humira again since Taltz doesn't work too well, from his experience.  Went back on Humira for a couple of months, but didn't see any improvement this time around.

My derm suggested I try giving my body a break from the biologics.  So after a few weeks of weening myself from those, and my psoriasis flaring up like crazy...worst I've ever experienced because I've always had the various drug treatments, I started on Otezla(oral pill). 

Well, about 4 weeks into Otezla, I became severely allergic.  I mean, rashes and bumps all over my body.  The itchiest experience you can imagine.  Many, many times worse than any psoriasis itchiness I've experienced.  

I ended taking over 100mg of Claritin a day for 3 weeks.  And of course, immediately stopped taking the Otezla.  Had to rid my system of all traces, so went cold turkey without any psoriasis meds for another couple of months, so you can imagine how bad the psoriasis became.

Anyhow, started on Siliq about a month ago and the results are promising.  Truth be told, other than the Humira on the 2nd round, all the injection treatments have worked pretty well.  I just hope Siliq works as well as the others in clearing up my condition.  And, that it continues to work for years to come or until another (or better) solution is developed.

Thanks for reading and letting me share my experience.

day one on shooting the med up. How long before it works if it works.Thanks

Doc proscribed CLobex foam for a few days on the scalp. Pharmacist (Chemist to most of you) said there isn't a foam, so I have to choose between shampoo and spray. Whats the difference? Is there one more terrible than the other, or more effective?

Hi,

I registered On Friday and activated my account through email. It's not letting me access my own profile saying I don't have permission. Does it just take a while or should I be doing something?

Many thanks,

Kath

Had an appointment with the GP today. He suggests trying a round of phototherapy before trying Stelera.  A gentler treatment and if it works and the P doesn’t come back- awesome! If it does come back, nothing lost and THEN we try Stelera. Makes good sense I think.  What are your experiences with phototherapy?

Hi. So great to hear about this group and to read the various threads-they are of great comfort to me and are also so informative. Thank you. 

 My daughter (18) has extensive guttate P on her body, legs and arms and plaque P on her scalp. 

She has been on treatment for the last 18 months with no change at all to her P-in fact it has become worse. 
She is on the maximum dosage of methotrexate that our doctor is comfortable with and also has topical creams-  dovobet,diprosalic, various tar products, clobex shampoo(which gives her painful hairline acne if used for too long. ) I am probably forgetting a host of other potions and lotions. 

The reason I am posting is that I feel that this way of treatment has gone on too long and it's time for a change. Our dermatologist agreed and has given us various options: acitretin, cylocsporin, phototherapy or one of the Biologics. He is getting back to me on more information about each drug. 
Any advice? I have read some of the threads on Stelera and it seems very positive. 

My question I guess is:-what would the recommendation be from anyone who has walked this road before?
I find it really hard making a decision for my child when all of the drugs have such serious side effects. 
I look forward to any thoughts or suggestions. Many thanks.