Category Archives: Psoriasis

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Amgen Inc. (NASDAQ: AMGN) recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla for the treatment of adults with mild to moderate plaque psoriasis.

The company also said the FDA had set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 19.

Amgens Otezla is enjoying a lot of publicity, flying high as a potent drug for psoriasis. It is actually one of the top-selling psoriasis oral drugs currently on the market.

According to EvaluatePharma, Otezla sales in 2020 totaled $1.9 billion, with $1.5 billion of the total coming from the U.S. It is forecasted to generate sales of $3.4 billion in 2026, with $2.5 billion coming from the U.S.

The top 10 psoriasis products are expected to generate sales in excess of $32 billion in 2026. As of the end of 2018, Otezla held approximately 35% new-to-brand market share in psoriasis, significantly above the major competitors in this field.

An Effective Treatment Option from Can-Fite

A recent Phase 3 psoriasis study results released by Israel-based clinical-stage biopharmaceutical company Can-Fite BioPharma Ltd. (NYSE AMERICAN: CANF) (TASE: CFBI) for its Piclidenoson drug has changed the narrative. Piclidenoson may instead be a more compelling option to treat psoriasis.

Psoriasis has been on the radar of several pharmaceutical and drug manufacturers for years now because of the debilitating effects it has on people. Companies are racing to find better treatments and medications for it, which is good for patients.

Like many chronic diseases, psoriasis is on the rise globally, and several factors can be blamed. While scientists dont know yet what exactly causes psoriasis, we do know that the immune system and genetics play major roles in its development.

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Additionally, using biologics over the long-term to treat and cope with psoriasis can have dangerous and unfortunate side effects all biologics work by suppressing the patients immune system and can increase the overall risk of infections.

More than 7.5 million American adults currently have the immune-mediated disease psoriasis thats more than 3% of the U.S. adult population.

Unfortunately, psoriasis, a skin disease that causes red, itchy, scaly patches, most commonly on the knees, elbows, trunk and scalp, has no cure. In addition to Otezla, there are a few other drugs such as Humira (adalimumab) from AbbVie Inc. (NYSE: ABBV) and Cosentyx (secukinumab) by Novartis International AG (NYSE: NVS) available on the market that help manage symptoms.

As with other chronic diseases, psoriasis may affect several areas of a person's life in addition to physical health. However, psoriasis can cause social, emotional, and physical distress, especially when its visible on the skin in social settings. Read more about psoriasis here.

Piclidenoson More Effective Than Otezla?

Piclidenoson is a novel, first-in-class A3 adenosine receptor agonist (A3AR), small-molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies in autoimmune diseases. The drug is also currently under development to treat COVID-19. Presenting a $20 billion commercial market opportunity in psoriasis, Piclidenoson has some potential advantages over existing treatment options, including oral dosing, outstanding safety and tolerability, and durability of effect that position the drug for success.

A scientific paper reported results from prior Phase 2/3 studies with graphs showing Piclidenoson being more effective than Otezla with longer-term use.

Piclidenosons excellent safety profile is key because psoriasis is a chronic condition, and medication needs to be taken long term; in contrast, biologics generally used to treat psoriasis can have serious side effects.

Can-Fites Phase 3 study has a positive interim analysis that showed both efficacy and safety based on the Internal Data Monitoring Committee (IDMC) to continue patient enrollment. Topline results from the study are expected Q1 2022.

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Race to Effective Psoriasis Treatment: Can-Fite's Piclidenoson May Edge Over High-Flying Amgen's Otezla. Here's Why - Yahoo Finance

As the COVID-19 pandemic closed hospitals to many non-emergency procedures, the demand for telehealth services and at-home treatments reached new heights. Venture capitalists and other investors have been scrambling to throw their weight behind the development of new software, devices and programs to reach patients in the comfort of their own homes.

Its a trend that shows no signs of slowing down.Investors latest target is Zerigo Health, maker of an FDA-cleared system for self-administering ultraviolet light therapy to treat psoriasis, vitiligo and eczema. The San Diego-based company, known until last October as Clarify Medical, said Thursday that it closed a $43 million funding round led by 7wireVentures.

Other participants in the series B financing include Leaps by Bayer, the Big Pharmas VC arm, as well as Cigna Ventures, General Catalyst and a handful of other new and existing investors. In addition to leading the funding, 7wireVentures is also sending managing partner Glen Tullman, the former founder and CEO of Livongo and current CEO of Transcarent, to lead Zerigos board of directors as executive chairman.

The influx of funds, which follows an $18 million series A in October 2019, will help Zerigo up the availability of its phototherapy system and allow it to reach an even greater percentage of the estimated 40 million people in the U.S. living with chronic skin conditions.

RELATED: Luma begins launch of ultraviolet light-based plaque psoriasis treatment

Zerigos system pairs a hand-held device with a connected smartphone app. The device emits narrowband UVB light, which penetrates only the outermost layer of skin to both slow the growth of affected skin cells, clearing psoriasis and eczema flare-ups, and stimulate melanocytes, re-pigmenting skin affected by vitiligo.

The patient applies each dose of phototherapy at home, with the exact dosage amount controlled by their physician and transmitted to the device via Zerigos cloud-connected app. Patients can also use the app to set up their own treatment schedule, track progress and automatically share any updates with their healthcare providers.

The FDA cleared the Zerigo device and app in May 2017, and the companys U.S. rollout began in November of that year.

Legacy methods and therapeutics to treat chronic skin conditions are not only expensivebut time-consuming and inconvenient, which often leads to adherence challenges, Tom Richards, a senior VP and global lead for strategy and business development at Cigna, said in a statement. By combining cutting-edge technology with human coaching and virtual physician connections, Zerigo Health offers convenient options to treat skin conditions in an individuals home, making it easier to stick to regimens and drive better outcomes.

RELATED: Ra Medical sheds its skincare business with sale of Pharos laser to Strata Skin Sciences

Not only does the at-home system eliminate the need for patients to visit the clinic multiple times a week for treatment sessions, but studies have also shown that the self-administered treatment can be just as successful as in-clinic options.

In a 2019 clinical trial, eight plaque psoriasis patients underwent a treatment regimen using only the Zerigo system. By the end of that 10-week period, two patients had achieved total clearance, and the whole group saw an average 58% reduction in the severity of their psoriasis. After that, the participants spent another three weeks combining the phototherapy treatments with prescribed topical corticosteroids, after which 100% of them achieved total clearance.

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Zerigo Health beams up $43M from Bayer, Cigna and more for at-home psoriasis UV light therapy - FierceBiotech

San Diego, CA, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Mindera Health, developers of the ground-breaking Dermal Intelligence platform that is the first realization of personalized medicine in psoriasis, announced the enrollment of the first patient in the MATCH Study. MATCH is a 16-week randomized clinical utility evaluation of the pre-treatment impact of Mind.Px on biologic drug response rates in patients suffering from psoriasis. The 200 patient study will include approximately 20 sites throughout the US.

According to a recent publication reporting data from the largest independent psoriasis registry (CorEvitas),1 real-world patient response rates to hyper-expensive biologics were observed to be approximately 52%. These low response rates often lead to switching of therapies and massive wasted healthcare spending. With Mind.Px, physicians now have a predictive test to improve management of psoriasis patients and can prescribe biologic drugs with more confidence that a patient will achieve a desired outcome. Mind.Px produces a result with >90% positive predictive value (PPV), meaning that when Mind.Px predicts a patient will respond to a specific drug class, they do respond >90% of the time.

Accessing and using an individual psoriasis patients baseline genetic biomarkers to prospectively predict that patients response to specific drugs and drug classes has been needed for many years, says James Wang, MD, MBA, FAAD, Founder Metropolis Dermatology. Being the dermatologist that enrolled the first patient into this important MATCH Study is exciting and we look forward to reporting the results in the near future.

About Mind.Px

Mind.Px is the flagship test of Mindera Health. The Mindera Health platform uses a dermal biomarker patch that takes only minutes to extract vast transcriptomic information. Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera Health scientists to take a genetic and transcriptomic snapshot of the skin. This rich patient-specific data set is then analyzed by machine learning algorithms to predict the appropriate biologic drug for an individual patient prior to therapeutic selection and treatment.

The ability to collect patient molecular data at scale results in a powerful platform that unlocks cost savings for healthcare systems, particularly when applied to the prediction of response to hyper-expensive treatments. Biomarkers captured using the Mindera platform may include DNA, RNA, protein, and small molecules.

About Mindera Health

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and Machine Learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera is a CLIA and CAP certified Laboratory and has received ISO 13485:2016 certification. Find out more at http://www.minderahealth.com.

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1 Enos CW, et al. Psoriasis Severity, Comorbidities, and Treatment Response Differ among Geographic Regions in the United States. JID Innovations 2021; 1:100025.

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Mindera Health announces first patient enrolled in the MATCH Study: a clinical utility evaluation of the impact of Mind.Px on response rates of...

Psoriatic arthritis (PsA) is inflammatory arthritis often associated with a skin condition called psoriasis. One PsA symptom is joint pain. It can also cause whole-body (systemic) symptoms such as vertigo and dizziness.

PsA is a chronic condition with no permanent cure. But there are several treatment options to help manage symptoms. Recognizing and treating PsA as soon as possible can help prevent symptoms such as dizziness from worsening or leading to long-term health problems.

In this article, we discuss PsA and dizziness. We also examine whether PsA causes dizziness and vertigo and the potential treatment options.

PsA may cause dizziness in some people.

While people often use the term dizziness interchangeably with vertigo, dizziness is a broad area that includes an array of sensations or feelings, such as:

Other symptoms may accompany dizziness, such as nausea. Sudden movements or walking may make it worse.

There are many potential causes of dizziness, including:

Systemic autoimmune disorders such as PsA may cause dizziness, unsteadiness, and vertigo. An autoimmune disease is when the body cannot differentiate between healthy cells and foreign bodies, so attacks itself.

There is evidence that PsA may cause damage to the inner ear, which could result in dizziness. One study concluded that individuals with PsA are more likely to experience dizziness, tinnitus, vertigo, and unsteadiness than those without the condition.

PsA and vertigo also appear to share a link. Vertigo differs from dizziness in a few ways. Symptoms of vertigo include:

As with dizziness, damage to the inner ear may impair a persons balance, resulting in vertigo. Vertigo typically goes away without treatment. But individuals with PsA who experience vertigo may require treatment to help manage it.

A 2019 study of 60 individuals with PsA and its impact on hearing loss or impairment, dizziness, and vertigo concluded that approximately 23% of the people with PsA had balance problems. In addition, over half of the people with PsA exhibited signs of hearing loss or impairment.

Since PsA may damage the inner ear through immune-related inflammation, this could impact both balance and hearing. These findings are consistent with other research, which found that 60% of individuals with PsA have inner ear damage, balance issues, and significant hearing loss.

There are several treatments for vertigo and dizziness in people with PsA.

Research from 2011 suggests that one option is vestibular rehabilitation, an exercise-based program that aims to improve balance, increase stability, and limit the impact of dizziness in people.

Individuals with vertigo or dizziness may benefit from vestibular rehabilitation, especially when those symptoms result from autoimmune diseases, Mnires disease, stroke, or other conditions. Vestibular rehabilitation is an exercise-based form of treatment to aid balance. The exercises may decrease the severity of vertigo and dizziness but not entirely prevent it.

A doctor may also prescribe certain medications to help treat or manage dizziness or vertigo in people with PsA. Common options include:

Besides treatments a doctor recommends, a few self-care techniques may make it easier to manage PsA. These include:

A person should always consult a doctor to determine the best treatment methods for dizziness and vertigo in PsA.

As an autoimmune disease, PsA commonly attacks the joints, skin, and organs. Besides dizziness and vertigo, other common symptoms of PsA include:

The symptoms of PsA may be either moderate or severe, depending on the individual. Some symptoms may disappear on their own, while others require immediate treatment.

PsA can worsen without treatment. Individuals who have PsA and experience vertigo, dizziness, or other severe symptoms should consult a doctor as soon as possible to help prevent the symptoms from becoming worse.

A person should reach out to a doctor if they experience:

An estimated 10% of all emergency room visits in the United States result from dizziness or vertigo, according to research from 2012.

Individuals with dizziness or vertigo may also be more susceptible to other health conditions such as cardiovascular disease or stroke. Due to these risks, a person should speak with a doctor as soon as possible if they experience dizziness or vertigo to help prevent more significant health risks in the future.

Dizziness or vertigo may be symptoms of PsA because the condition could cause inflammation and damage to the inner ear. Without treatment, these and other symptoms could worsen, leading to other chronic health conditions or a higher mortality rate in individuals.

There is currently no cure for PsA. But vertigo and dizziness often disappear without treatment in a few days or weeks.

Individuals who experience other symptoms such as vision or hearing impairment, chest pain, or difficulty breathing along with vertigo or dizziness should consult a doctor immediately. A doctor may prescribe certain medications or a vestibular rehabilitation plan to help manage PsA symptoms.

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Psoriatic arthritis and dizziness: Link, vertigo, and more - Medical News Today

Psoriatic arthritis (PsA) is a form of arthritis that may affect some people with psoriasis. Increasing evidence indicates that people with PsA have a higher risk of high blood pressure, hypertension, and other potential complications relating to heart health.

PsA is a chronic inflammatory autoimmune condition that affects roughly 30% of people with psoriasis, according to the National Psoriasis Foundation.

It may lead to systemic inflammation, meaning inflammation that affects the whole body. This body-wide inflammation can in turn affect blood vessels and result in high blood pressure, or hypertension.

In this article, we will discuss the association between PsA and high blood pressure. We will also look at how a person can reduce their risk of hypertension and heart disease.

Hypertension is common in people living with PsA. It refers to persistently increased pressure in the blood vessels. As this pressure increases, it causes the heart to pump harder to supply the body with blood.

High blood pressure can lead to heart damage by hardening arteries and decreasing blood and oxygen flow to the heart. High blood pressure is a severe medical condition that can cause health complications and increase the risk of heart disease.

While more research is necessary, existing evidence suggests that high blood pressure is higher in those with PsA than in people with psoriasis or the general public. This may be due to the higher inflammatory burden resulting from PsA that can damage blood vessels and increase blood pressure.

These findings are consistent with a 2019 review highlighting the prevalence of high blood pressure in people with PsA and suggest it may be more common with more severe psoriatic disease.

The authors of a 2021 study also found that high blood pressure was the most common comorbid condition in severe PsA.

Additionally, a 2020 study indicates that high blood pressure is the most prevalent risk factor for cardiovascular disease in people with PsA.

Health experts previously identified that chronic inflammation is a risk factor for heart disease. While researchers were aware of the links between psoriasis and arthritis and heart disease, emerging evidence highlights the association with PsA.

A 2016 meta-analysis notes a 43% increased risk of cardiovascular conditions in those with PsA, compared with the general population.

Moreover, a 2019 study reports that people with PsA were more likely to have other potential risk factors for cardiovascular diseases, such as type 2 diabetes, obesity, and high fat levels in the blood.

According to the American Heart Association (AHA), metabolic syndrome is a group of conditions that may increase the risk of heart disease. An older 2014 study found that these conditions were present in 44% of people with PsA.

The authors of a 2015 meta-analysis also observed a high prevalence of high blood pressure and other features of metabolic syndrome in people with PsA. Furthermore, they note that there is a link between PsA and many markers of cardiovascular risks, such as atherosclerosis. Atherosclerosis is the narrowing of the arteries due to a buildup of plaque.

Learn more about PsA and heart disease here.

Although high blood pressure is common among people with PsA, it is a modifiable risk factor. This means that people can make dietary and lifestyle changes to lower their blood pressure and reduce the risk of heart disease.

Additionally, many of the steps people can take to reduce their blood pressure can also play a key role in managing PsA. Some of these changes could include:

Learn more about ways to quickly and naturally lower blood pressure.

Although high blood pressure does not typically present with symptoms, according to the World Health Organization (WHO), people should check their blood pressure if they notice symptoms such as:

The only way to diagnose high blood pressure is to check blood pressure regularly. For this reason, it is essential for people with PsA to monitor their blood pressure routinely. If a persons blood pressure is consistently above 140/90 millimeters of mercury, it may indicate hypertension.

If a person experiences these symptoms or has high blood pressure readings, they should seek medical help.

High blood pressure is common in people with PsA and is likely due to the condition causing inflammation throughout the body. This inflammation can result in blood pushing harder than normal against the walls of the arteries, increasing blood pressure.

High blood pressure is a risk factor for heart disease. People can make lifestyle and dietary changes to manage PsA and high blood pressure, including getting regular exercise, following a balanced diet, and reaching or maintaining a moderate weight.

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Psoriatic arthritis and high blood pressure: Link and more - Medical News Today

When youre dealing with an itchy, flaky, and straight-up unhappy scalp, your mind probably jumps to dandruffnot something like scalp psoriasis. The condition, which can be much more difficult to diagnose and treat than your run-of-the-mill dandruff, can cause scaly skin patches or plaques to develop on the scalp, and you may not even know it because theyre hiding under your hair1. To better understand what you may be dealing with, SELF asked a leading expert to explain what scalp psoriasis looks like, plus the conditions most common triggers and treatments, so you can finally get the relief you deserve.

What is scalp psoriasis?

Scalp psoriasis is not officially recognized as a subtype of psoriasis, but the scalp is a commonly affected2 area for people who struggle with the autoimmune condition. For a person with psoriasis, the immune system goes a bit haywire and mistakenly tells skin cells to grow too quickly3. Because those extra skin cells arent needed by the body, it results in a pile up of skin, forming those telltale psoriasis plaques, according to the American Academy of Dermatology (AAD).

When the condition affects your scalp, which happens in approximately 80% of people with psoriasis, according to a 2016 paper published in the journal Psoriasis: Targets and Therapy4, its commonly known as scalp psoriasis. Some people may have plaques only on their scalps, while others may have them on their scalps and other areas of their bodies, according to Tina Bhutani5, M.D., an associate professor of dermatology and the co-director of the Psoriasis and Skin Treatment Center at the University of California, San Francisco.

What are the most common scalp psoriasis symptoms?

Youre probably wondering, What does scalp psoriasis looks like? Generally, you might notice flaking or scaly patches of raised skin on your scalp first, Dr. Bhutani says. These patches can also be inflamed, thick, and swollen6, and sometimes extend to the forehead, the back of the neck, or behind the ears. On light skin tones, psoriasis plaques on the scalp typically appear pink or red with silvery scales. For people with dark skin, these lesions may range in color and appear salmon-y pink, silvery white, violet, or brown, depending on your specific skin tone7.

But the signs of scalp psoriasis go far beyond the physical effects. Scalp psoriasis, honestly, causes some of the largest impact on quality of life, Dr. Bhutani says. Thats because severe symptoms can interrupt sleep, create feelings of anxiety, and hurt a persons self-esteem, especially if the scalp psoriasis plaques are clearly visible.

In addition to plaques, other scalp psoriasis symptoms include6:

What causes scalp psoriasis?

While we know what causes psoriasis plaques to develop on the scalp (an overactive immune system causes the body to make too many skin cells), experts dont fully understand why someone develops the condition in the first place or what determines where those lesions will appear. Experts suspect there is a genetic component to psoriasis because people who have a family history of the condition are more likely to develop it, but the specific genes that could be linked to psoriasis are unknown8.

More here:
Scalp Psoriasis: Symptoms, Causes, and Treatment Tips - SELF

Let's talk about psoriasis. (Illustration by Franziska Barczyk)

Imagine that the stress of a work-related deadline, the cocktails you drank over the weekend or a chilly fall evening could make you wake up the next day with red, scaly, itchy patches on your skin. This is the reality for an estimated 7.5 million Americans who suffer from psoriasis a chronic inflammatory skin condition.

Psoriasis can literally make you feel uncomfortable in your own skin. But it's more than cosmetic: Psoriasis is associated with an increased risk of cardiovascular disease and has been linked to depression, Dr. Orit Markowitz, a dermatologist at the Icahn School of Medicine at Mount Sinai and founder of OptiSkin in New York City, tells Yahoo Life. In some cases, psoriasis patients can go on to develop psoriatic arthritis, which can cause irreversible joint damage.

Not surprisingly, the skin condition can affect a patient's daily life something Judy Schmidt knows well. The 44-year-old mom of two, who lives in Orlando, Fla., finds that during her psoriasis flare-ups, even moving her hands can be challenging. This makes it difficult for Schmidt to help her young children in the bath or manage their car seat buckles.

But it's the psychological toll of psoriasis that can be the hardest to cope with, affecting patients' self-esteem and body image and causing some to try to cover up the skin condition.

Rather than hiding, however, some women are speaking up about psoriasis on social media. They're sharing what led to their diagnosis and how they manage the skin condition, along with posting candid selfies when they have psoriasis flare-ups to break the stigma.

Nisha Shama wants people to know how "life-changing" a chronic skin condition like psoriasis can be. (Photo courtesy of Nisha Shama)

Not all doctors recognize the signs

At 12 years old, Nisha Shama, a student from Hertfordshire, U.K., developed scaly patches on both sides of her face. But no one, including her family doctor, knew what the patches were. While she was waiting for a biopsy, the condition spread across her body.

"I was being sent to specialist after specialist," Shama tells Yahoo Life. "At one point, a doctor said the phrase 'skin cancer,' which terrified me and my family." By the time Shama got her psoriasis diagnosis, several months had gone by. "I later learned that psoriasis could present differently on darker skin, which may have been why specialists struggled to diagnose my condition."

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In fact, it can take seeing as many as six dermatologists before a person of color is correctly diagnosed, according to the National Psoriasis Foundation.

Shama, who is now 21, has found that sharing her psoriasis journey on Instagram has not only helped her but also helps to educate others. "My psoriasis was often viewed as just a skin problem, despite how severe it was," Shama says. "People need to be aware of how life-changing a chronic skin condition can be with someones identity and daily life. It can be debilitating to live with and is more than skin deep."

Shama adds: "Having a chronic skin condition needs to be normalized."

Victoria Voos shares that psoriasis is one of her insecurities but is also part of her self-love journey, which she shares on Instagram. (Photo courtesy of Victoria Voos)

'No matter what kind of treatment I tried, nothing worked'

Being diagnosed with a chronic condition like psoriasis can be overwhelming. Thats how Victoria Voos, a plus-size blogger from San Diego, Calif., felt when she was diagnosed with psoriasis in 2010, after noticing a dry, itchy patch on her scalp that never seemed to get better. "No matter what kind of treatment I tried, nothing worked," Voos tells Yahoo Life.

It took four years for Voos to find a dermatologist who created a treatment regimen that worked for her. "My skin is the clearest it's ever been," she says. But Voos also had to come to terms with the fact that living with a chronic illness made her feel helpless. Sharing what she was going through on social media helped. "My psoriasis is a big part of me and my self-love journey, as it is one of my biggest insecurities," Voos says, "and so I knew I wanted to share more about it."

Voos adds: "I have also found the more I show and talk about my insecurities, the more comfortable and accepting I am of them. It's a little bit of serving my audience and a little bit of healing myself."

Katie Moczygemba, a nurse with psoriasis, has been sharing her fitness journey on social media and decided not to hide her "scaly patches" in photos anymore. (Photo courtesy of Katie Moczygemba)

'When I got the diagnosis, I felt heard and validated'

Katie Moczygemba, a 28-year-old trauma nurse from San Antonio, Texas, had mixed feelings when the "patches" she'd had on her body since she was five years old were diagnosed as psoriasis in her mid-20s. "When I got the diagnosis, I felt heard and validated, but I felt sadness knowing my body was attacking itself," Moczygemba tells Yahoo Life. She also feared that psoriasis would spread to noticeable parts of her body.

But then, Moczygemba had a realization. She had been chronicling her fitness journey on Instagram, learning how to share her insecurities and triumphs along the way. Why couldnt she do the same for her skin? So Moczygemba, who has been able to manage her psoriasis by partnering with her doctor, started angling the camera so that her skin "patches" were more prominent and using more psoriasis-related hashtags on her posts.

"I had been sharing my fitness journey, and realized I was trying to cover up any scaly patches," Moczygemba says. "I enjoy sharing obstacles and insecurities and how I can overcome them."

It's something Schmidt can relate to. "I really believe speaking about this and sharing my journey shows support and community to those who watch, but don't necessarily feel comfortable doing so themselves," she says. "They are the people who need to know they are seen, even if not heard."

Judy Schmidt, pictured with her two children, hopes that sharing her psoriasis journey empowers and supports others with the skin condition. (Photo courtesy of Judy Schmidt)

Breaking the psoriasis stigma

To combat the stigma surrounding psoriasis, Shama shares candid posts of her flare-ups while sharing information and busting myths about the skin condition, which some mistakenly believe is caused by "bad hygiene, contagiousness or a choice," Shama says.

Since Shama's psoriasis first appeared, I used to think I was disgusting and 'ugly' and would compare myself to others," she shares. "I know that the issue wasn't myself, but cultural ideals and standards of beauty, which need to be challenged in every way."

Shama adds: "Of course, I still have my bad days, particularly when my psoriasis is painful or flares up, but compared to a year ago, I never would have thought I'd post a makeup-free selfie with my psoriasis patches uncovered. The fact that I have and continue to do so is a major sign that I'm on an emotional healing journey."

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I never would have thought Id post a makeup-free selfie: Women on breaking the stigma of psoriasis - Yahoo Life

- CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2[1],[2]

- If approved, this will mark the second indication for risankizumab in the EU[3]

- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis[4],[5],[6],[7]

NORTH CHICAGO, Ill., Oct. 15, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI, 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 antirheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union.

This CHMP positive opinion was supported by data from two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated risankizumab in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).1,2 Additionally, the efficacy and safety profile of risankizumab with up to 52 weeks of exposure was consistent with the profile observed up to 24 weeks.8

"Many patients with psoriatic arthritis experience uncontrolled skin and joint symptoms despite the availability of existing therapies. For this reason, it is important to have multiple treatment options available for physicians to effectively manage their patients' condition," said Thomas Hudson, senior vice president, research and development, AbbVie. "The CHMP's recommendation to approve risankizumab in psoriatic arthritis is an important step in bringing treatment to more patients in need."

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Across the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 clinical studies, risankizumab met the primary endpoint of ACR20 response at week 24 versus placebo.1,2 In both studies, risankizumab also met ranked secondary endpoints including, but not limited to improvements in several clinical manifestations of psoriatic arthritis such as skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24. In both KEEPsAKE-1 and KEEPsAKE-2, the most common adverse reactions associated with risankizumab were upper respiratory infections, headache, fatigue, injection site reactions and tinea infections.1,2

If the CHMP recommendation is accepted by the European Commission, this will mark the second indication for risankizumab in the European Union, which was approved in 2019 for the treatment of adult plaque psoriasis. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

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

Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.5,6 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.5,6

About KEEPsAKE-1 and KEEPsAKE-21,2,3,8

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24. Patients randomized to risankizumab 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, change from baseline in HAQ-DI, as well as the achievement of PASI 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab 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)3

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.3,9 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.9 The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.10,11,12,13

Important EU Indication and Safety Information about SKYRIZI (risankizumab)3

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

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 past 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, which occurred in 13 percent of patients. 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

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References1 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. 2 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.3 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 7, 2021.4 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.2017.10.008.5 Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.6 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 7, 2021.7 Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on October 7, 2021.8 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.9 Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.10 A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on October 7, 2021. 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 on October 7, 2021.12 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/NCT03398148. October 7, 2021.13 Pipeline Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on October 7, 2021.

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AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI) for the Treatment of Adults with Active Psoriatic Arthritis in the European Union...

Although on the surface it seems that Kim has flawless skin, in actuality the star has a condition that causes scaly patches around her scalp, elbows and knees. The star inherited the condition known as psoriasis from "momager" Kris Jenner, and only discovered that she had the condition herself when it flared up at the age of 25.

Writing in Poosh magazine she said: When I was 25, I had my first psoriasis flare-up. I got a common cold, and since psoriasis is an autoimmune condition, this triggered it. It was all over my stomach and legs.

After consulting a dermatologist the star's condition cleared up. Thinking that she was cured, the star didnt experience another flare up until hitting her early thirties.

Unsure that the condition was actually psoriasis, she consulted her mum Kris, who recognised the distinctive patches of irritated skin from her own experience and broke the news to her daughter.

Kim said: This is when my real psoriasis journey began. For the past eight years, although the spots are unpredictable, I can always count on my main spot on my right lower leg, which consistently stays flared up. I have learned to live with this spot without using any creams or medicationI just deal.

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The NHS explains that psoriasis is a skin condition that only affects small patches of skin but these patches can become extremely sore and itchy.

The condition affects around two percent of people in the UK and can start at any age. Most typically psoriasis is a long-lasting (chronic) disease that usually involves periods when you have no symptoms or mild symptoms, followed by periods when symptoms are more severe.

Unusually for Kim, what she thought was just psoriasis turned out to be psoriatic arthritis. This is a type of arthritis that affects only people with the skin condition and can cause joints to become swollen, stiff and painful.

Kim recalled when she found out she had the condition: One night, I woke up to use the restroom and I physically couldnt pick up my phone. I thought it was strange but maybe I just slept on my hands weird and I was so tired.

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I woke up that morning and I still couldnt pick up my phone. I was freaking outI couldnt even pick up a toothbrush, my hands hurt so badly. I had worked out the day before and we did an arm day, so I thought maybe one of the exercises strained my hand. It didnt cross my mind that it could be anything serious. As the day went on, I got a bit more movement in my hands, but they really hurt from the insideI felt it in my bones.

After I flew home I went to the doctor. I had my blood tested for all possibilities, and it came back positive for rheumatoid arthritis and lupus. I immediately started to cry and felt so lost.

I went back three days later, which felt like the longest three days of my life! It turns out those tests were a false positive and I did not have rheumatoid arthritis or lupus. I had psoriatic arthritis.

Its still painful and scary, but I was happy to have a diagnosis. No matter what autoimmune condition I had, I was going to get through it, and they are all manageable with proper care.

The severity of the condition can vary from person to person and similar to normal psoriasis, individuals can experience flare-ups when symptoms get worse and periods of remission when symptoms improve.

It tends to develop five to 10 years after psoriasis is diagnosed, although some people may have problems with their joints before they notice any skin-related symptoms.

Like psoriasis, psoriatic arthritis is thought to happen as a result of the immune system mistakenly attacking healthy tissue. However it is unclear why some people with psoriasis develop arthritis and some do not.

Now 40 years old Kim has been able to deal with her autoimmune conditions. She added: Ive become extremely comfortable with my psoriasis. No matter where it is on my body, sometimes I am fine with showing it off and other times I dont want it to be a distraction, so I cover it up with body makeup.

If you have psoriasis, you cant let it ruin your life or get the best of you. You have to do what you can to make sure you are comfortable but not let it take over.

Treatments for psoriatic arthritis aims to do the following:

To do this, treatments usually involve a number of different medicines, some of which also treat psoriasis.

The NHS recommends if possible that individuals should take one medicine to treat both your psoriasis and psoriatic arthritis. The main medicines used to treat the condition include the anti-inflammatory drugs and drugs that help to reduce pain and swelling.

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Kim Kardashian health: The icon's 'unpredictable' and irritable skin condition - symptoms - Daily Express

Topical application of imiquimod (IMQ), a TLR7/8 ligand and potent immune activator, can induce and exacerbate psoriasis, a chronic inflammatory skin disorder. Recently, a crucial role was proposed for the IL-23/IL-17 axis in psoriasis. We hypothesized that IMQ-induced dermatitis in mice can serve as a model for the analysis of pathogenic mechanisms in psoriasis-like dermatitis and assessed its IL-23/IL-17 axis dependency. Daily application of IMQ on mouse back skin induced inflamed scaly skin lesions resembling plaque type psoriasis. These lesions showed increased epidermal proliferation, abnormal differentiation, epidermal accumulation of neutrophils in microabcesses, neoangiogenesis, and infiltrates consisting of CD4(+) T cells, CD11c(+) dendritic cells, and plasmacytoid dendritic cells. IMQ induced epidermal expression of IL-23, IL-17A, and IL-17F, as well as an increase in splenic Th17 cells. IMQ-induced dermatitis was partially dependent on the presence of T cells, whereas disease development was almost completely blocked in mice deficient for IL-23 or the IL-17 receptor, demonstrating a pivotal role of the IL-23/IL-17 axis. In conclusion, the sole application of the innate TLR7/8 ligand IMQ rapidly induces a dermatitis closely resembling human psoriasis, critically dependent on the IL-23/IL-17 axis. This rapid and convenient model allows further elucidation of pathogenic mechanisms and evaluation of new therapies in psoriasis.

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Imiquimod-induced psoriasis-like skin inflammation in mice ...