Category Archives: Psoriasis

PN-235 (JNJ-77242113) now expected to advance into multiple Phase 2 clinical studies in 2022, for indications including psoriasis and inflammatory bowel diseases

NEWARK, Calif., Dec. 2, 2021 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") today announced the selection of PN-235 (JNJ-77242113) as the final candidate for all clinical studies in multiple indications based on intervention of the Interleukin-23 (IL-23) pathway, under the Company's collaboration with Janssen Biotech, Inc. (Janssen). In addition to the previously announced Phase 2 clinical study of PN-235 in psoriasis, new Phase 2 clinical studies of PN-235 in inflammatory bowel diseases (IBD) are expected to commence in late 2022. Further development of PN-232 (JNJ-7510586) will be discontinued in favor of PN-235 based on its superior potency, and overall pharmacokinetic and pharmacodynamic profile.

"We are delighted to see PN-235 emerge as the clear focal point going forward, after over four-plus years of a highly productive and ongoing collaboration with Janssen," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "We look forward to exploring the full potential of a highly differentiated, oral targeted therapy like PN-235, thereby potentially addressing persistent unmet needs of patients with immune-mediated diseases like psoriasis and IBD."

Protagonist will earn a $25 million milestone in connection with the initiation of the first Phase 2 study of PN-235 in psoriasis in early 2022. Protagonist is also eligible for a $10 million milestone in connection with the start of the second indication-based Phase 2 study. Protagonist is eligible for up to approximately $900 million in development-related milestone payments, in addition to the $87.5M in milestones already earned. Under the terms of the collaboration, Janssen will conduct all future clinical studies, including these anticipated Phase 2 studies, and will be solely financially responsible for any such studies.

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About Protagonist

Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform.

Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study for hereditary hemochromatosis. The Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development include PN-235, a second-generation oral interleukin-23 receptor antagonist candidate. Under the collaboration with Janssen, PN-235 is expected to advance into Phase 2 studies in psoriasis and new Phase 2 clinical studies in inflammatory bowel diseases.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the Company's collaboration with Janssen, the timing of Janssen's PN-235 trials and the potential benefits of PN-235. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

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Protagonist Therapeutics Announces the Selection of Oral Peptide PN-235 into Phase 2 Clinical Development Program for Multiple Indications - Yahoo...

Most of us might not think twice about using a hand sanitiser, especially since it's an essential item during the pandemic.

However, things aren't as easyfor17-year-old Monissha Nath Kaushal.Kaushal suffers from psoriasis, a skin disorder that causes one's skin cells to multiply up to 10 times faster than normal.

In October, she posted a TikTok recounting an incident in school where she was forced to use hand sanitiser, despite indicatingthat she has a skin condition.

why did you do that ##fyp ##sgtiktok ##skin ##foryoupage ##psoriasis ##psoriasisawareness ##eczema ##pain ##trending ##shopping ##xyzbca

The video has over 5.4 million views and received many comments from other TikTokers with similar experiences.

Speaking with AsiaOne last Saturday (Nov 20), Kaushal saidshe was diagnosed with psoriasis and twenty-nail dystrophy when she was five.

Psoriasiscauses her skin to appear bumpy and covered in white scales. Sometimes,patches ofdry skin appear on her soles and palms and they maytear and bleed.

Her initial motivationfor creating a TikTok account, she shared, was so that she could keep track of her skin's recovery.

"I'm turning17 this year, I wanted to learn how to treat my psoriasis on my own. I made my first TikTok so that I could be committed to tending to my skin every day."

Judgmentalgazes and opinionsdon't seem to faze Kaushal that much anymore, as she's had a fair share of them growing up.

"I've heard plenty insensitive things said to me but thats just how life is. [There are people] who really don't care about what their words do to someone," she said.

"Ive been through so much discrimination in my life, so it'seasy to ignore someones opinion on the internet."

ouch#psoriasis #fyp #psoriasisawareness #foryoupage #fyp #what #eczema #skin #skintok #skincare #ouch #shook #sgtiktok #skincondition #trending #m

That said, she still vividly remembers an incident that happened when she attended a friend's birthday party in primary school.

"When I entered my friend's place, I kept my socks on. Every two minutes, my palms bled and I needed to be taken care of. I remember other kids' parents seeing itand keeping their children away from me. I ended up leavingearly."

It's no exaggeration, she said.

"When itfirst appeared on my skin, the soles of my feet were completely covered in dry, dead skin it was about four centimetres thick. My nails also looked like they were decaying; they curled inwards due to the nail dystrophy."

Physical pain wasn't the only problem.Kaushal also had many dietary restrictions no dairy, no gluten, no seafood and no meat.Even chocolate, a well-loved children's treat, was out of bounds.

The physical effects of her conditionweren't the only thing that Kaushal was struggling with.

"Many people think that psoriasis is just a skin condition, but it's more than that. It can alsoaffect one's mental health."

As a child, she never dared look at herself in a mirror. That only changed when she turned 14 andher skin started to show signs of improvement."I thought I was a monster," she said.

Without any peers she could turn to for advice or help, Kaushal spent a lot of time on her own. She confessed that she "didn't feel human" because she "didn't have similar experiences as people my age".

The pandemic in 2020 also brought along new fears and anxieties for the student, who was due to take her O'Level examinations the same year.

"I was incredibly stressed out. My skin started to flare up violently it got so bad I had an anxiety attack."

To protect herself physically and mentally,she took her exams as a private candidate. She said that she wanted to give herself "air to breathe".

With regard to her own journey towards self-acceptance, she said: "I saw myself and psoriasis as two different people, however, now I feel like it's a part of me, and so there's lessto worry about."

She also said that she "became less self-conscious" as time went by and she learntto "look at myself and see myself for who I was".

Addressing netizens' reactions to her TikToks so far, Kaushal saidthat sharing her story online has given her a sense of community, as others with similar conditions have begun reaching out to her.

One of the most memorable messages she received was from someone who had no idea they were suffering from a skin disorder until they came across her TikToks, and it prompted them to visit a dermatologist.

"I felt truly touched, knowing that Im a part of the reason why someone can feel better about their condition."

claudiatan@asiaone.com

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'I can't use hand sanitiser': Meet Monissha, a 17-year-old who suffers from psoriasis - AsiaOne

Dr Ophelia Veraitch, Consultant dermatologist and founder of Dr Ophelia Comsecutical Skin and hair, has shared her top tips to help you on your hair growth journey

Hair loss is completely normal, but when you start noticing more hair in your hair brush or clumps clogging up the shower drain, it can be quite concerning.

Genetics may play a part in hair loss, as can an underlying health condition.

But there are several other influences that may be a factor like stress, weight loss or an iron deficiency.

While we can't always prevent the cause of hair loss or thinning, there are things we can do to minimise it.

We spoke to Dr Ophelia Veraitch, Consultant dermatologist and founder of Dr Ophelia Comsecutical Skin and hair to find out what we could be doing wrong and how to things we can do to boss that hair growth.

For more of the news you care about, straight to your inbox, sign up for one of our daily newsletters here.

The state of your scalp can have a huge impact on the health of your hair.

A dry scalp or a scalp with a lot of product built up can lead to hair loss or thinning. This is because the build up slowly starts to suffocate the hair follicle, which can stunt growth or cause the hair to shed.

Dr Ophelia suggests massaging the scalp with oil, as she says "It's the best way to naturally hydrate your scalp and hair and help both to retain moisture."

"On the days I'm not going out I massage almond oil into my scalp and hair and onto my children's scalp and hair too.

"This ritual comes from my Sikh background where having uncut hair (which I havent stuck to!) and importantly looking after your hair is a sign of respect to personal attributes that are considered god given.

"Its common for Asian and Mediterranean cultures to put oil in the scalp and hair like this as a natural and effective way to moisturise our scalp and hair!"

Massaging almond oil into the scalp and hair like this helps to reduce frizziness of the hair and improve the condition of the scalp too.

"You can use coconut oil but I find this is smellier and harder," she says.

"Alternatively argan oil is thinner so it's better for people with finer hair."

Psoriasis is a skin condition that affects around 2 per cent of people in the UK and it can result in hair problems for women aged 45 and above.

It causes flaky patches of skin that are usually red and crusty with silvery scales and can occur in the scalp, resulting in fine scaling that looks like dandruff, a thick crust, or crusted plaques that cover the entire scalp.

Psoriasis is a chronic disease, this means that it's long-lasting and usually involves periods when you have symptoms and then periods where you don't have any. Whilst there's no cure as such, there are a number of safe and effective treatments that can improve the symptoms and the appearance of the skin and reduce the severity and size of the patches.

Lifestyle measures such as loosing weight, exercise, healthy eating, stopping smoking and reducing alcohol intake can all help psoriasis.

Soaking your scalp in olive oil can help to ease the symptoms of psoriasis, says Dr Ophelia.

Simply cover the scalp in the oil, wrap it in cling film and leave it for several hours or even overnight.

Another option is to use hair products that target hair thinning and loss that contain ingredients which can help promote hair growth.

For example, the sleep hormone melatonin isn't just to regulate the circadian rhythms, it's also a great antioxidant synthesised in hair follicles.

The expert recommends finding a hair growth tonic like Dr Ophelia Hair Growth Elixirs, to optimise luscious and beautiful looking hair.

A common mistake people make is drying their hair with a cotton towel.

The hair shaft is made of keratin. The outermost layer of the hair shaft is known as the cuticle, and is made of overlapping keratin cells.

The hair cuticle works as a protective layer, but if not looked after, damage to the hair cuticle can make the hair look and feel dry and unhealthy.

Towel drying wet hair can cause damage to the keratin cells in the cuticle.

Instead, either pat your hair dry or use a microfibre cloth or a t-shirt.

There's a common misconception that towel drying your hair before using conditioner makes the product absorb into the hair shaft more easily.

But Dr Ophelia warns against it.

"This argument to me is that it's a bit like using sand paper on your skin to make active ingredients absorb better into the skin.... I don't know why anyone would purposefully damage the cuticle of the hair shaft in order for the conditioner to be 'absorbed'."

If your hair loss is causing your distress, contact your GP for further advice.

Have you got a story to share? We want to hear all about it. Email us at yourmirror@mirror.co.uk

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Expert-approved tips to thicken and grow fine hair and mistakes you are making - Mirror.co.uk

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(WFXR) With the holidays closing in, it also means enduring the colder and drier months. These months can disrupt your skins barrier during the winter.

The American Academy of Dermatology (AAD) Association says that it is especially bad for those who deal with conditions like eczema and psoriasis.

To help make sure your skin is winter-ready, the AAD put together a survival kit to help you get through the winter blues.

You want to look for products that say gentle and moisturizing on the label and avoid products that contain alcohol. The alcohol can dry out your skin.

You want to look for cleansers that are liquid, gel, or mousse. Health officials say that the creamier the body cleanser is the better it is for your skin. If you suffer from eczema, you want to look for products that contain petrolatum, shea butter, and silicones.

When browsing the shelves for a facial moisturizer you want to keep in mind that lighter lotions may not protect your skin from the colder and drier elements.

Instead, doctors suggest you look for products that contain creams, oils, or balms. Doctors say that products containing lactic acid moisturizers can help exfoliate dry, flaky skin while locking in sky hydration.

Doctors suggest that you apply moisturizers to your skin when it is still damp after a shower or bath. They say it will help trap moisture in the skin.

When looking for a body moisturizer you want to find ointments and creams that you squeeze from a tube or scoop from a tub. Doctors suggest that the thicker the formula the more moisture it packs. Other ingredients to look for are glycerin, lanolin, mineral oil, petrolatum, and shea butter.

If you are looking for a rejuvenating product, doctors suggest that you stay away from products containing anti-aging ingredients. Instead, look for products that have a lower concentration of harsh ingredients.

Sunscreen is a product many dermatologists say we should be wearing year-round on areas that are not covered by the sun such as the face, neck, ears, and hands.

When thinking about what products to buy, look for creams instead of lotions or sprays. You also want to make sure your sunscreen has an SPF of at least 30. When you are out and about, always look for shade and wear gloves and sunglasses with UV protection.

Get breaking news, weather, and sports delivered to your smartphone with the WFXR News app available on Apple and Android.

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What to pack in your skins winter survival kit - WFXRtv.com

Many people who have psoriasis will experience the telltale sign of itchiness or burning. But for people with differing skin tones, thats where the similarities may end.

The symptoms of psoriasis, a chronic inflammatory condition, can look different on people with differing skin tones. On lighter skin, plaque psoriasis can appear red; on darker skin, it can be purple or gray-ish.

Unfortunately, many people whove searched Doctor Google for psoriasis images on Black skin havent found very many answers and, given this lack of representation, they can leave with possibly with more questions than they had before.

Heres what you should know about psoriasis including what it looks like, and why it can go underdiagnosed and undertreated in the Black community.

The Internet is flooded with images of white people who have psoriasis, but there arent nearly as many pictures of Black people who have psoriasis. This often leads people to the conclusion that psoriasis mainly develops in people with lighter skin which couldnt be further from the truth.

In fact, about 1.9 percent of Black Americans have psoriasis, according to a study published in the March 2014 issue of the Journal of the American Academy of Dermatology. The same research found that 1.6 Hispanic Americans had psoriasis, and 3.6 percent of white Americans had psoriasis.

Despite these statistics, a whopping 93 percent of all main characters who were featured in TV commercials and advertisements about psoriasis, including treatments and products, over a two-week period in 2018 were white, according to a study published in September 2020 in the journal Cutis. Black and Asian main characters only represented about 6 percent and 1 percent. The findings of this study, conducted by Junko Takeshita, MD, PhD, and other researchers, are important because advertisements are a main source of health-related information for the public.

Ultimately, Black people who have psoriasis are less likely to see themselves represented in ads for psoriasis treatments, concluded the study authors which may deter them from seeking treatment or suspect that those treatments arent an option for them. This is something that Corey L. Hartman, MD, a board-certified dermatologist and the founder of Skin Wellness Dermatology, has seen firsthand. Many Black patients are either shocked to learn they have the condition or reluctant to believe certain treatments will be effective for them, says Dr. Hartman.

Although the lesions on all skin types can be painful, itchy, and filled with pus, Hartman points out that psoriasis on white skin usually appears as thick plaques with a silver scale and are most commonly found on the arms, chest, legs, and shoulders.

This isnt necessarily the case for Black patients or individuals with darker pigmented skin, however. People with more melanin in their skin may develop psoriasis lesions that appear violet, dark brown, or gray. Since psoriasis looks different on Black skin and there's not enough education about what this looks like it's often misdiagnosed, says Hartman.

Individuals with darker skin are also more likely to find psoriasis lesions on the scalp, elbows, knees, torso, buttocks, and even nails; the areas affected can also vary in size, although its not exactly known why. In the case of scalp psoriasis, people should work with their dermatologist to create a hair care regimen that works for their specific type of hair.

The after-effects of psoriasis also differ among individuals with heavier pigmented skin. Depending on the severity of the outbreak, Hartman says that lesions from psoriasis can leave spots of discoloration or post-inflammatory dyspigmentation for months after a flare-up resolves. Dermatologists caution Black patients not to confuse this with active psoriasis, and recommend against using topical steroid treatments on the inflamed areas.

Other research published in November 2014 in The Journal of Clinical and Aesthetic Dermatology, shows that Black people who have psoriasis also typically have more severe breakouts compared to white people. Because of this, Hartman tells his patients of color to pay attention to any changes in their skin and consult with a dermatologist if they notice any symptoms. This way, they can be treated before the condition worsens.

While psoriasis medications can help control outbreaks in many people, Black people are often undertreated. Compared to white people, theyre not only less likely to be treated with biologics (a newer type of medication that quiets the immune-system), according to a study published in December 2015 in The Journal of Investigative Dermatology, but they sometimes receive only topical medications or no treatment at all, according to the National Psoriasis Foundation.

Black people who have psoriasis were also less familiar with biologics as a treatment option compared to white people, according to a study published in February 2019 in the Journal of Investigative Dermatology, despite the fact these medications are highly effective at treating the skin condition, regardless of a persons pigmentation.

Dr. Hartman points out that undertreatment among Black patients is not due to a lack of concern or care for their health. Disparities such as a lack of access to quality medical care and healthcare insurance in the Black community have been well documented and contribute significantly to Black patients with psoriasis not being treated adequately.

Other research published by Dr. Takeshita has shown that dermatologists are less confident about diagnosing psoriasis in people with darker skin than those with lighter skin.

Contrary to what has been displayed in the media, psoriasis can affect people of any race. And a growing number of providers agree that we need more diverse representation and information for Black people with psoriasis.

See the article here:
Black Skin and Psoriasis - Everyday Health

- Approval supported by data from two Phase 3 studies evaluating SKYRIZI in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-2[1-3]

- These two Phase 3 studies evaluated SKYRIZI in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)[1-6]

- In KEEPsAKE-1 and KEEPsAKE-2, statistical significance was achieved for the primary endpoint of ACR20 response for efficacy and multiple secondary endpoints, including physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Minimal Disease Activity (MDA)[6]

- The safety profile of SKYRIZI in patients with psoriatic arthritis was consistent with the safety profile of SKYRIZI in plaque psoriasis patients[6]

- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis[7-10]

NORTH CHICAGO, Ill., Nov. 17, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

"People living with psoriatic arthritis struggle with psoriatic lesions and joint inflammation that causes swelling and pain. Reducing these symptoms may give people the ability to resume their daily activities and improve their quality of life," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis."

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SKYRIZI received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-3,6 In these studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo, and ranked secondary endpoints including, but not limited to, improvements in several clinical manifestations of psoriatic arthritis such as physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1-3,6

Highlights from the pivotal Phase 3 program1-3,6

In KEEPsAKE-1 and KEEPsAKE-2, 57.3 and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 and 26.5 percent receiving placebo (p<0.001).

SKYRIZI-treated patients showed significantly greater improvement from baseline in physical function as measured by HAQ-DI -0.31 and -0.22, compared to placebo -0.11 and -0.05 at week 24 (p<0.001) in KEEPSAKE-1 and KEEPSAKE-2, respectively.

At week 24, 25.0 percent and 25.6 percent of SKYRIZI-treated patients achieved MDA, in KEEPSAKE-1 and KEEPSAKE-2 respectively, compared to 10.2 percent and 11.4 percent of those on placebo (p<0.001).

"Millions of people living with psoriatic arthritis are impacted by psoriatic lesions, joint pain, stiffness and fatigue," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute in Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "As seen in this Phase 3 clinical trial program in psoriatic arthritis, SKYRIZI has the potential to be a valuable new treatment option, helping to improve the signs and symptoms of the disease."

The safety profile of SKYRIZI in psoriatic arthritis was consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.6 Through week 24, serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with SKYRIZI in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 3.7 percent and 5.5 percent on placebo.1-3,6 Rates of serious infections were 1.0 and 0.9 percent in SKYRIZI-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo.1-3,6 The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent of patients treated with SKYRIZI in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent on placebo.1-3,6 In KEEPsAKE-1, there was one death in the SKYRIZI group not related to the study drug per investigator.1,2,6 There were no deaths reported in KEEPsAKE-2.1,3,6

SKYRIZI (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.9,10 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and the presence of psoriatic lesions.9,10

About KEEPsAKE-1 and KEEPsAKE-21-6

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI 150 mg at week 24. Patients randomized to SKYRIZI received four maintenance doses a year, following two initiation doses.

The primary endpoint for both studies was the achievement of ACR20 response at week 24. Ranked secondary endpoints included, but were not limited to, the achievement of MDA as well as the change from baseline in HAQ-DI at week 24. The studies are ongoing, and the long-term extension remains blinded to the original randomization and evaluates the long-term safety, tolerability and efficacy of SKYRIZI in patients who have completed the placebo-controlled period.

More information on these trials can be found at http://www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

About SKYRIZI (risankizumab)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.6,11 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.11 The approved dose for SKYRIZI is 150 mg (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. The SKYRIZI 150 mg formulation was approved by the European Union in May 2021. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.6,12-14

Important EU Indication and Safety Information about SKYRIZI (risankizumab)6

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at http://www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

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References

Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2021 EADV Virtual Congress. D1T01.4A.

Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial.

str, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.

Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). clinicaltrials.gov; 2021. October 25, 2021. https://clinicaltrials.gov/ct2/show/NCT03675308.

Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2). clinicaltrials.gov; 2021. Accessed October 25, 2021. https://clinicaltrials.gov/ct2/show/NCT03671148.

SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on October 25, 2021.

Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on October 25, 2021.

Galezowski, A., et al. Rhumatisme psoriasique en France, du nourrisson la personne ge: donnes de deux tudes transversales multicentriques [Psoriatic arthritis in France, from infants to the elderly: Findings from two cross-sectional, multicenter studies]. Ann Dermatol Venereol. 2018;145(1):13-20. doi:10.1016/j.annder.2017.10.008.

Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.

Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on October 25, 2021.

Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.

A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed October 25, 2021.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on October 25, 2021.

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How psoriasis changes skin lipids. It doesnt take guts to secrete PCSK9. Anchoring NOD2 on the plasma membrane. Read about papers on these topics recently published in the Journal of Lipid Research.

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Psoriasis sends skin cell production into overdrive, causing buildup and sheddingof dead skin cells.

Psoriasis is an inflammatory disease affecting the outer layer of the skin, or epidermis, which serves as a critical barrier against infection, chemicals and loss of nutrients and water. Psoriasis compromises skin barrier function and causes epidermal skin cells to proliferate, forming raised plaques and scales on the skin.

While skin lipids fatty acids, ceramides and cholesterol are essential for maintaining a healthy epidermis, researchers do not yet know the exact composition of skin lipids in healthy and disease states. As the epidermal skin barrier is formed, ceramides must be oxidized by lipoxygenase enzymes, or LOXs. Mutations of these LOX enzymes disrupt the skin barrier so that the skin loses water and becomes dry, red and scaly. Despite this, researchers have not fully characterized the products of LOX oxidation of ceramides and their roles in maintaining the skin barrier.

Victoria J. Tyrrell and colleagues at Cardiff University used new mass spectrometrybased methods to characterize the LOX pathway ceramides present in the human epidermis and determine how these lipids change in psoriasis. Their results, published in the Journal of Lipid Research, demonstrate that substrates of the LOX ceramide pathway are elevated in psoriatic patient skin, even in the absence of plaque, whereas oxidized ceramide products are reduced. They also found that psoriatic lesions had more oxidized free fatty acids than nonlesion or healthy skin, but the implications of this are unknown. In psoriasis, many genes were upregulated in the LOX ceramide oxidation pathway, which is required to form the epidermal barrier, possibly as an attempt to repair barrier function. Using network analyses, they identified a potential master regulator of these genes as the zinc finger transcription factor ZIC1.

While ZIC1 stimulates proliferation of some tumor cells, it had not been associated previously with skin cell proliferation during psoriasis. The authors state that ZIC1 is a potential new drug target for psoriasis.

Too much low-density lipoprotein, or LDL, cholesterol clogs the arteries so they can no longer pump enough blood. This can cause a heart attack or stroke. LDL cholesterol is cleared out of the bloodstream by the liver LDL receptor unless the receptor has been degraded.

The latest cholesterol-lowering drugs prevent LDL receptor degradation. These drugs target proprotein convertase subtilisin/kexin 9, or PCSK9, a protein that escorts the LDL receptor along the path to degradation. PCSK9 is highly expressed by the liver and intestines, but only the liver is known to secrete PCSK9 into the bloodstream where it controls liver LDL receptor expression. Researchers are debating whether the intestines secrete PCSK9.

In a study in the Journal of Lipid Research, Franois Moreau, Aurlie Thdrez and colleagues at the University of Nantes report that human intestinal explants and mature human intestinal Caco2 cells do not secrete PCSK9. In mice lacking liver PCSK9, they detected no PCSK9 in the portal vein a conduit between the intestines and liver ruling out the possibility that it transports intestinally secreted PCSK9 to the liver LDL receptors. This study emphasizes the role of PCSK9 secreted by the liver in regulating cholesterol homeostasis.

Crohns disease causes chronic inflammation of the digestive tract. Possible triggers include changes in the gut microbiome and genetic factors. One of the strongest risk factors for Crohns disease is mutation of an immune system protein called nucleotide-binding and oligomerization domain protein 2, or NOD2.

Within a cell, NOD2 senses peptidoglycans the basic unit of the bacterial cell wall that bacteria shed during infection. Then, NOD2 activates the host immune response, which requires its attachment to the cell membrane. Two cysteine residues on NOD2 can be linked to the fatty acid palmitate, thus anchoring it to the membrane.

In a new Images in Lipid Research publication in the Journal of Lipid Research providing further evidence for a study published in the journal Science in 2019, Charneal Dixon and Gregory Fairn at the University of Toronto show how they performed metabolic labeling experiments in HCT116 human colon cancer cells and showed that wild-type NOD2, but not a double cysteine mutant, was labeled with a palmitate mimetic. Additionally, the double cysteine mutant failed to reach the cell membrane. Knowing these cysteine residues are linked to palmitate, the researchers inferred that the surface of NOD2 interacts with the cell membrane. Defects in NOD2 membrane recruitment, which is critical for its ability to sense and respond to bacterial pathogens, are associated with inflammatory disorders, including Crohns disease.

Originally posted here:
From the journals: JLR - American Society for Biochemistry and Molecular Biology

PEOPLE with psoriasis know the struggle of finding a treatment that works for them, all too well.

The condition causes red and crusty patches with silvery scales to flare-up on the skin.

1

In more serious cases it can have a crushing impact on a sufferers life.

Roughly two per cent of the population - both men and women - are affected by psoriasis.

Prominent figures that deal with the skin problem are model Cara Delevingne and singer Cyndi Lauper.

TV personality Kim Kardashian has also described psoriasis as her big flaw, always hoping for a cure.

Sadly, there is no cure for psoriasis.

Patients have to learn to deal with the condition by finding a treatment that works for them.

But some have also found that modifying their diet helps.

The NHS does not make specific diet recommendations for people with psoriasis, other than advising a balanced, healthy diet with regular exercise which it would recommend for everyone. It says this can also relieve stress, which may improve psoriasis symptoms.

The Psoriasis Association in the UK says there is not a definite link with food or a diet that works for everybody.

But it says some foods may help to reduce inflammation in the body - which may help psoriasis because it is an inflammatory condition.

Will keeping an eye on your foods help relieve your psoriasis? Maybe, but there is no proof.

Read on to find out psoriasis treatments and food tweaks.

The NHS says: A wide range of treatments are available for psoriasis, but identifying the most effective one can be difficult.

Treatments fall into three categories.

First, topical creams and ointments applied to the skin are usually the first option to help with mild psoriasis.

If the condition has spread to the scalp, there are also shampoos and ointments that can help.

Examples include:

Another category of treatment is phototherapy, which uses natural and artificial light to treat psoriasis.

The skin is exposed to ultraviolet light, which is different from sunbeds.

You may be offered:

For psoriasis patients whose condition is proving difficult to treat, they may be seen by a specialist who can give treatments that target the whole body.

These are either tablets or injections that generally either reduce inflammation in the body or suppress the immune system.

They all have side effects and risks - for example some are harmful to an unborn baby - so its up to the patient to discuss those with their doctor.

Examples of medication include:

Try eating:

Oily fish, nuts and seeds

These foods are abundant in Omega 3s, which are fatty acids that are beneficial for the skin.

The Psoriasis Association says: There has been some research in other inflammatory conditions, such as rheumatoid arthritis, that suggests that eating foods that reduce inflammation in the body (such as those high in Omega 3 fatty acids oily fish, nuts and seeds) may be helpful.

There is no definite evidence to say that this works in psoriasis, but, again, it may be an approach that some people find helps.

Foods like salmon, mackerel, walnuts, chia seeds and flaxseed oil are high in Omega 3.

Fruit and vegetables

The NHS does not recommend a specific psoriasis diet, but it does say its important to have a balanced diet, which includes plenty of healthy fruit and veg.

Eating well and exercising more can relieve stress, which may in turn reduce psoriasis symptoms.

Many fruits and vegetables are high in antioxidants or anti-inflammatory compounds that are good for the skin, namely dark leafy green vegetables, like kale, berries and squashes.

Vitamin D

Vitamin D deficiencies have been linked to psoriasis, Healthline reports.

The sunshine vitamin, which you can get from sitting in the sun (with SPF), is used to topically treat the skin but could help from the inside, too.

One scientific paper explains how vitamin D is crucial for the skin generally, and in those with psoriasis, by regulating inflammation.

Foods that increase vitamin D include cheese, eggs and tuna.

Gluten

Experts say some research suggests a gluten-free diet may help with the skin condition.

Gluten is abundant in the Western diet, found in bread, pasta, biscuits, cakes and even beer.

The National Psoriasis Foundation says: The jury is still out on eliminating gluten a complex protein found in wheat, barley and rye.

In a small number of cases, eliminating gluten can lead to improvements. However, following a gluten-free diet, which is very restrictive, is a major commitment. Its not a step you should take unnecessarily.

The foundation says it can take several months for the effects of cutting gluten to become clear, and warns those that have seen a difference may have already had a gluten intolerance.

Nightshades

Nightshade foods are thought to be behind flare ups of conditions including psoriasis and eczema.

They include tomatoes, potatoes, peppers and aubergine, as well as cigarettes (tobacco).

While there havent been any large trials proving that night-shade foods, which are high in a compound called alkaloids, cause skin flare ups, some people claim to see an improvement when they dont eat them.

A small survey of psoriasis patients' dietary habits, published in the journal Dermatology and Therapy, found more than half of respondents reported skin improvements after reducing their intake of nightshade vegetables.

They arent necessary to completely cut out, but you could talk to your doctor about trialling a period whereby you watch what happens to your symptoms when you eliminate and then eat these foods.

Alcohol

Again, its not proven that alcohol is the sole explanation for the complex condition psoriasis.

But the Psoriasis Association says there are plausible arguments for why drinking might affect psoriasis (alcohol is dehydrating, and therefore could dry skin out even more).

One scientific paper said that patients with psoriasis and alcohol overconsumption tend to have more severe inflammation.

The association says: Some people might find that alcohol does worsen their condition, but if an individual does not find this, and it is safe to combine alcohol with whatever treatment they are undergoing, then moderate alcohol consumption can be one of lifes pleasures.

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Originally posted here:
How to treat psoriasis and the 11 foods that can help soothe flare ups... - The Sun

Treatment of psoriatic arthritis typically involves medications to manage the condition and prevent flare-ups. However, some people may also want to try complementary therapies, such as chiropractic.

Psoriatic arthritis (PsA) is a type of arthritis that affects some people with the inflammatory skin condition called psoriasis. As with other forms of arthritis, PsA causes the joints to become stiff, swollen, and painful. It may also affect the skin and nails.

PsA is an autoimmune condition. In PsA, the immune system is overactive and triggers an inflammatory response in the joints and other body tissues. Without treatment, this inflammation can lead to permanent joint damage and deformities.

This article outlines whether chiropractic is a safe and effective complementary treatment for PsA and what to expect during a chiropractic session. We also list some other treatment options for PsA, including medical and dietary options, and home remedies.

Chiropractic is a type of complementary therapy that involves adjusting or manipulating the spine, joints, and muscles to alleviate problems in these areas.

Chiropractic may be beneficial for people with PsA. Claimed benefits include:

These benefits can improve the function of the musculoskeletal system, making it easier and more comfortable for a person to perform their daily activities.

Available research into the benefits of chiropractic focuses on its impact on back pain. A 2017 review of existing research reported that the use of spinal manipulation in patients with lower back pain was associated with improvements in pain and back function. The researchers noted, however, that the quality of the available research was limited.

It is also worth noting that people with forms of arthritis related to inflammation such as PsA should be cautious when it comes to chiropractic. If someone is experiencing a flare-up of symptoms, experts advise that they should avoid chiropractic, as the practice could be harmful.

Below are some indications of what to expect before and during chiropractic treatment.

During the first chiropractic appointment, the chiropractor will gather information that will help them develop an appropriate treatment plan. The chiropractor will likely:

A chiropractor will use their hands or specialized tools to manipulate the spine, joints, or muscles. The treatment may cause mild discomfort, but it should not be painful.

Chiropractic for PsA may involve the following:

Before starting chiropractic treatment, a person should talk with their healthcare professional to make sure the therapy is safe and appropriate for them.

A person must use caution when using chiropractic to treat PsA or other inflammatory conditions. Treatment should not involve high-velocity spinal manipulation. However, the following chiropractic techniques are usually safe:

Medical professionals do not recommend chiropractic for people who have any of the following:

A person should discuss their symptoms and any changes to their health at each chiropractic visit, as these factors can affect the treatment they receive on that day.

Chiropractic may cause mild side effects, but these tend to pass within a few days. Examples include:

Spinal manipulation carries a risk of more serious side effects, such as a slipped disk and stroke.

The main causes of arthritis are:

There is no evidence to suggest that chiropractic causes arthritis. On the contrary, chiropractic may help with the management of some forms of arthritis. It involves manipulation of the spine, joints, and muscles, which may help to alleviate pain and improve mobility.

Massage may also be beneficial for PsA. Massage can help alleviate pain and stiffness in areas that are prone to inflammation but not actively inflamed at the time of treatment. It can also help to reduce stress levels, which can otherwise trigger PsA flare-ups.

A person with PsA should talk with their healthcare professional to determine if chiropractic or massage are suitable to treat their symptoms. Some health insurance plans will cover the cost of these therapies.

Conventional and complementary therapies for PsA may help to alleviate symptoms and lower the risk of complications. A person with PsA may seek treatment from various sources, including:

Some additional treatment options for PsA are outlined below.

Chiropractors may recommend the following adjunctive therapies for a person with active inflammation:

Medications to treat PsA include:

A person who has PsA should aim to eat a diet that is rich in fresh fruits, vegetables, and fiber.

The following foods may be particularly beneficial due to their anti-inflammatory properties:

People should try to avoid foods that may trigger inflammation. Examples include:

The following home remedies may help to reduce PsA flare-ups or alleviate PsA symptoms:

Chiropractic is a complementary treatment that may be effective in reducing PsA. However, a person should talk with their doctor before receiving chiropractic to ensure that the therapy will be safe for them.

Chiropractic involves a chiropractor manipulating a persons spine, joints, and body tissues using the hands or specialized instruments.

The treatment may help to correct spinal misalignment, reduce inflammation, and alleviate joint pain. However, more research is needed to confirm its potential benefits among people with PsA.

Chiropractic can be a safe treatment for PsA. However, a person should not receive the therapy during an active flare-up. People should also make sure to inform their chiropractor of their current symptoms and health status at each visit, as this will have an impact on the treatment the person receives.

Read the rest here:
Chiropractor for psoriatic arthritis: Do they help, and is it safe? - Medical News Today