Category Archives: Psoriasis

Psoriasis and eczema are both common skin conditions. Eczema affects about 31.6 million people in the United States, while as many as 7.5 million suffer from psoriasis. Both cause red, itchy skin, and they can sometimes look so much alike that some doctors, especially general practitioners, may have trouble distinguishing between them though they look quite different to dermatologists.

Both psoriasis and eczema are autoimmune diseases the former being the most prevalent autoimmune disease in the United States. Psoriasis causes the life cycle of skin cells to accelerate. The dead cells build up on the skin instead of being sloughed off. The disease is believed to be caused by overactive T cells and other white blood cells, which both attack healthy skin cells and trigger increased skin cell production.

Eczema is triggered primarily by exposure to bacteria, allergens, or various other irritants, and may be more prevalent in those who have a genetic variation that affects the skins ability to protect itself. The main risk factor for eczema is a family or personal history of asthma, hay fever, allergies, or eczema itself.

Eczema is an umbrella term, describing various related conditions that cause inflamed, itchy skin, according to the National Eczema Association. They recognize six types. The most common kind, and the one that most of us think of as eczema, is correctly called atopic dermatitis. It usually appears in the crooks of the elbows or knees, though it may also affect the back of the neck and the face. The main risk factor for atopic dermatitis is a family or personal history of asthma, hay fever, allergies, or the condition itself.

There are likewise several kinds of psoriasis, seven in all, the most common being plaque psoriasis. This condition causes raised, dry, scaly red lesions, typically on elbows and knees, though the lesions can appear anywhere on the body, including the face and the inside of the mouth.

There is no cure for either atopic dermatitis or psoriasis, and both are chronic conditions, often coming and going. Preventative measures may stave off flare-ups of either one, however. Doctors recommend that those affected try to identify and avoid factors that may set off bouts of the disease. Such factors include stress and obesity. Smoking increases the risk of psoriasis and can make it worse. Infants and children affected with eczema may experience flare-ups from eating potentially allergenic foods.

Both conditions react negatively to cold, dry weather, and both may be partially soothed by keeping the skin well lubricated and by using only gentle soaps. The American Academy of Dermatology also recommends bathing in a well-diluted solution of household bleach to prevent flare-ups of atopic dermatitis.

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Whats the Difference Between Eczema and Psoriasis? - 24/7 Wall St.

Global Tumor Necrosis Factor Inhibitor Drugs Market: Overview

Tumor necrosis factor or TNF refers to a multifunctional protein cytokine that is produced by immune cells. This protein cytokine causes inflammation in body and has an important role to play in many of the cellular functions such as death, survival, differentiation, and cell proliferation. Tumor necrosis factor inhibitors subdue innate response of the body toward tumor necrosis factor. Tumor necrosis factor inhibitors are drugs that assist in stopping inflammation in the body. These drugs are utilized in the treatment of various diseases, such as Crohn's disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, juvenile arthritis, and rheumatoid arthritis. They are also otherwise known as anti-TNF drugs, biologic therapies, and TNF blockers. Food and Drug Administration of the US has approved many TNF inhibitors for use.

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Product, application, sales channel, and region are the four important parameters based on which the classification of the global tumor necrosis factor inhibitor drugs market has been done. Such dissection of the market comes with the purpose to offer stakeholders with a detailed and clear analysis of the global tumor necrosis factor inhibitor drugs market.

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Global Tumor Necrosis Factor Inhibitor Drugs Market: Notable Developments

One of the recent market developments that offers a glimpse of the market dynamics at play in the global tumor necrosis factor inhibitor drugs market is mentioned below:

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Some of the prominent organizations in the global tumor necrosis factor inhibitor drugs market include:

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Global Tumor Necrosis Factor Inhibitor Drugs Market: Key Trends

The global tumor necrosis factor inhibitor drugs market is characterized by the presence of the following restraints, drivers, and opportunities.

Rise of Biosimilars to Pose Serious Internal Challenge to the Growth of the Market

The growth of the global tumor necrosis factor inhibitor drugs market is likely to be influenced by several factors. These growth factors for the market comprise increasing disposable income, augmented spending on healthcare, new product launches, growing geriatric population, increased prevalence of autoimmune disorders, and rise in the awareness level of people about these drugs. In addition, there has been a trend amongst consumers to opt for cost effective drugs with better safety and effectiveness is likely to drive the demand for tumor necrosis factor inhibitor drugs in the years to come.

The biologics prevalent in the global tumor necrosis factor inhibitor drugs market is faced with a direct internal threat from biosimilars. Loss of patent exclusivities across many regions of the world has worked in favor of the use of biosimilars. In addition to that, stiff competition from Interleukin (IL) inhibitors is likely to pose serious challenge to the growth of the global tumor necrosis factor inhibitor drugs market over the period of assessment.

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Cannabidiol, a non-psychoactive compound derived from cannabis, has shown increasing influence in dermatologic research, but this compound currently lacks robust and long-term data to support its use in specific skin disorders. In spite of the lack of these data, several studies have reported the potential therapeutic effects of CBD in certain skin conditions, according to findings in a review article published in Clinical, Cosmetic and Investigational Dermatology.

Cutaneous biology, according to the authors of this review, is modulated by what is known as the human endocannabinoid system (ECS), and receptors from this system are found in the skin. The ECS is involved in maintaining barrier function and skin homeostasis, but system dysregulation may impair skin barrier function and ultimately lead to different skin disorders, such as atopic dermatitis, acne, and even hyperpigmentation and hypopigmentation.

The use of CBD in in vitro studies has been shown to induce HMOX1 expression as well as expression in other NRF2-regulated genes. Researchers theorize that CBD may be beneficial for skin disorders associated with free radical formation and inflammation, due to the anti-inflammatory, antioxidant, and anti-apoptotic properties associated with HMOX1. In another study, CBD was shown to be capable of penetrating cells and balancing oxidative stress induced by ultraviolet B-induced and hydrogen peroxide.

In addition, topical application of CBD in preclinical and clinical studies may target peripheral inflammation and help reduce pain associated with certain conditions. Topical application circumvents the central nervous system, which may reduce the risk for CBD-related side effects, the investigators related. These research findings have not been validated in larger clinical trials.

Wound healing may also be a potential target for topical CBD use, as it may be influenced by ECS signaling. Some small research models suggest cannabinoid analogs can generate a wound healing response via activation of CB1 and/or CB2 receptors, anti-inflammatory upregulation, and activation of epidermal growth factor receptors. Similar to other studies looking at topical CBD for skin conditions, the research on wound healing with topical CBD is scarce, it was noted.

Other research has looked into topical CBD for the modulation of hair growth due to major cannabinoid compounds found in hair fibers. Expression of CB1 and CB2 receptors vary within the hair follicle. Models of obese mice show oral ingestion of synthetic antagonist of CB1 promoted hair growth, but there was no similar effect when the antagonist was applied topically. Additional small studies have looked into the potential of topical CBD for hair pigmentation, but the involvement of the ECS in melanogenesis is not yet clearly understood.

The researchers of this study concluded that while the therapeutic potential of CBD for acne, seborrhea, eczema/dermatitis, and skin barrier function is promising, more robust studies are needed to fully validate its efficacy.

Reference

Baswan SM, Klosner AE, Glynn K, et al. Therapeutic potential of cannabidiol (CBD) for skin health and disorders. Clin Cosmet Investig Dermatol. Published online December 8, 2020. doi:10.2147/CCID.S286411

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The Role of Topical CBD in Skin Disorders: Current Knowledge and Future Directions - Dermatology Advisor

Overview for Psoriasis Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Various Dynamics.

Psoriasis Market Data and Acquisition Research Study with Trends and Opportunities 2019-2024The study of Psoriasis market is a compilation of the market of Psoriasis broken down into its entirety on the basis of types, application, trends and opportunities, mergers and acquisitions, drivers and restraints, and a global outreach. The detailed study also offers a board interpretation of the Psoriasis industry from a variety of data points that are collected through reputable and verified sources. Furthermore, the study sheds a lights on a market interpretations on a global scale which is further distributed through distribution channels, generated incomes sources and a marginalized market space where most trade occurs.

Along with a generalized market study, the report also consists of the risks that are often neglected when it comes to the Psoriasis industry in a comprehensive manner. The study is also divided in an analytical space where the forecast is predicted through a primary and secondary research methodologies along with an in-house model.

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Key players in the global Psoriasis market covered in Chapter 12:Amgen Inc.Biogen IdecStiefel Laboratories Inc.Celgene CorporationJohnson and Johnson (Janssen Biotech Inc.)Eli Lilly and CompanyPfizer Inc.Novartis AGTakeda Pharmaceutical Company LimitedAbbVie Inc.

In Chapter 4 and 14.1, on the basis of types, the Psoriasis market from 2015 to 2025 is primarily split into:SystemicPhototherapyTopical TreatmentOthers

In Chapter 5 and 14.2, on the basis of applications, the Psoriasis market from 2015 to 2025 covers:InjectableTropicalOral

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2025) of the following regions are covered in Chapter 6, 7, 8, 9, 10, 11, 14:North America (Covered in Chapter 7 and 14)United StatesCanadaMexicoEurope (Covered in Chapter 8 and 14)GermanyUKFranceItalySpainRussiaOthersAsia-Pacific (Covered in Chapter 9 and 14)ChinaJapanSouth KoreaAustraliaIndiaSoutheast AsiaOthersMiddle East and Africa (Covered in Chapter 10 and 14)Saudi ArabiaUAEEgyptNigeriaSouth AfricaOthersSouth America (Covered in Chapter 11 and 14)BrazilArgentinaColumbiaChileOthersRegional scope can be customized

For a global outreach, the Psoriasis study also classifies the market into a global distribution where key market demographics are established based on the majority of the market share. The following markets that are often considered for establishing a global outreach are North America, Europe, Asia, and the Rest of the World. Depending on the study, the following markets are often interchanged, added, or excluded as certain markets only adhere to certain products and needs.

Here is a short glance at what the study actually encompasses:Study includes strategic developments, latest product launches, regional growth markers and mergers & acquisitionsRevenue, cost price, capacity & utilizations, import/export rates and market shareForecast predictions are generated from analytical data sources and calculated through a series of in-house processes.

However, based on requirements, this report could be customized for specific regions and countries.

Brief about Psoriasis Market Report with [emailprotected]https://hongchunresearch.com/report/psoriasis-market-size-2020-121215

Some Point of Table of Content:

Chapter One: Psoriasis Introduction and Market Overview

Chapter Two: Executive Summary

Chapter Three: Industry Chain Analysis

Chapter Four: Global Psoriasis Market, by Type

Chapter Five: Psoriasis Market, by Application

Chapter Six: Global Psoriasis Market Analysis by Regions

Chapter Seven: North America Psoriasis Market Analysis by Countries

Chapter Eight: Europe Psoriasis Market Analysis by Countries

Chapter Nine: Asia Pacific Psoriasis Market Analysis by Countries

Chapter Ten: Middle East and Africa Psoriasis Market Analysis by Countries

Chapter Eleven: South America Psoriasis Market Analysis by Countries

Chapter Twelve: Competitive Landscape 12.1 Amgen Inc. 12.1.1 Amgen Inc. Basic Information 12.1.2 Psoriasis Product Introduction 12.1.3 Amgen Inc. Production, Value, Price, Gross Margin 2015-2020 12.2 Biogen Idec 12.2.1 Biogen Idec Basic Information 12.2.2 Psoriasis Product Introduction 12.2.3 Biogen Idec Production, Value, Price, Gross Margin 2015-2020 12.3 Stiefel Laboratories Inc. 12.3.1 Stiefel Laboratories Inc. Basic Information 12.3.2 Psoriasis Product Introduction 12.3.3 Stiefel Laboratories Inc. Production, Value, Price, Gross Margin 2015-2020 12.4 Celgene Corporation 12.4.1 Celgene Corporation Basic Information 12.4.2 Psoriasis Product Introduction 12.4.3 Celgene Corporation Production, Value, Price, Gross Margin 2015-2020 12.5 Johnson and Johnson (Janssen Biotech Inc.) 12.5.1 Johnson and Johnson (Janssen Biotech Inc.) Basic Information 12.5.2 Psoriasis Product Introduction 12.5.3 Johnson and Johnson (Janssen Biotech Inc.) Production, Value, Price, Gross Margin 2015-2020 12.6 Eli Lilly and Company 12.6.1 Eli Lilly and Company Basic Information 12.6.2 Psoriasis Product Introduction 12.6.3 Eli Lilly and Company Production, Value, Price, Gross Margin 2015-2020 12.7 Pfizer Inc. 12.7.1 Pfizer Inc. Basic Information 12.7.2 Psoriasis Product Introduction 12.7.3 Pfizer Inc. Production, Value, Price, Gross Margin 2015-2020 12.8 Novartis AG 12.8.1 Novartis AG Basic Information 12.8.2 Psoriasis Product Introduction 12.8.3 Novartis AG Production, Value, Price, Gross Margin 2015-2020 12.9 Takeda Pharmaceutical Company Limited 12.9.1 Takeda Pharmaceutical Company Limited Basic Information 12.9.2 Psoriasis Product Introduction 12.9.3 Takeda Pharmaceutical Company Limited Production, Value, Price, Gross Margin 2015-2020 12.10 AbbVie Inc. 12.10.1 AbbVie Inc. Basic Information 12.10.2 Psoriasis Product Introduction 12.10.3 AbbVie Inc. Production, Value, Price, Gross Margin 2015-2020

Chapter Thirteen: Industry Outlook continued

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List of tablesList of Tables and Figures Figure Product Picture of Psoriasis Table Product Specification of Psoriasis Table Psoriasis Key Market Segments Table Key Players Psoriasis Covered Figure Global Psoriasis Market Size, 2015 2025 Table Different Types of Psoriasis Figure Global Psoriasis Value ($) Segment by Type from 2015-2020 Figure Global Psoriasis Market Share by Types in 2019 Table Different Applications of Psoriasis Figure Global Psoriasis Value ($) Segment by Applications from 2015-2020 Figure Global Psoriasis Market Share by Applications in 2019 Figure Global Psoriasis Market Share by Regions in 2019 Figure North America Psoriasis Production Value ($) and Growth Rate (2015-2020) Figure Europe Psoriasis Production Value ($) and Growth Rate (2015-2020) Figure Asia Pacific Psoriasis Production Value ($) and Growth Rate (2015-2020) Figure Middle East and Africa Psoriasis Production Value ($) and Growth Rate (2015-2020) Figure South America Psoriasis Production Value ($) and Growth Rate (2015-2020) Table Global COVID-19 Status and Economic Overview Figure Global COVID-19 Status Figure COVID-19 Comparison of Major Countries Figure Industry Chain Analysis of Psoriasis Table Upstream Raw Material Suppliers of Psoriasis with Contact Information Table Major Players Headquarters, and Service Area of Psoriasis Figure Major Players Production Value Market Share of Psoriasis in 2019 Table Major Players Psoriasis Product Types in 2019 Figure Production Process of Psoriasis Figure Manufacturing Cost Structure of Psoriasis Figure Channel Status of Psoriasis Table Major Distributors of Psoriasis with Contact Information Table Major Downstream Buyers of Psoriasis with Contact Information Table Global Psoriasis Value ($) by Type (2015-2020) Table Global Psoriasis Value Share by Type (2015-2020) Figure Global Psoriasis Value Share by Type (2015-2020) Table Global Psoriasis Production by Type (2015-2020) Table Global Psoriasis Production Share by Type (2015-2020) Figure Global Psoriasis Production Share by Type (2015-2020) Figure Global Psoriasis Value ($) and Growth Rate of Systemic (2015-2020) Figure Global Psoriasis Value ($) and Growth Rate of Phototherapy (2015-2020) Figure Global Psoriasis Value ($) and Growth Rate of Topical Treatment (2015-2020) Figure Global Psoriasis Value ($) and Growth Rate of Others (2015-2020) Figure Global Psoriasis Price by Type (2015-2020) Figure Downstream Market Overview Table Global Psoriasis Consumption by Application (2015-2020) Table Global Psoriasis Consumption Market Share by Application (2015-2020) Figure Global Psoriasis Consumption Market Share by Application (2015-2020) Figure Global Psoriasis Consumption and Growth Rate of Injectable (2015-2020) Figure Global Psoriasis Consumption and Growth Rate of Tropical (2015-2020) Figure Global Psoriasis Consumption and Growth Rate of Oral (2015-2020) Figure Global Psoriasis Sales and Growth Rate (2015-2020) Figure Global Psoriasis Revenue (M USD) and Growth (2015-2020) Table Global Psoriasis Sales by Regions (2015-2020) Table Global Psoriasis Sales Market Share by Regions (2015-2020) Table Global Psoriasis Revenue (M USD) by Regions (2015-2020) Table Global Psoriasis Revenue Market Share by Regions (2015-2020) Table Global Psoriasis Revenue Market Share by Regions in 2015 Table Global Psoriasis Revenue Market Share by Regions in 2019 Figure North America Psoriasis Sales and Growth Rate (2015-2020) Figure Europe Psoriasis Sales and Growth Rate (2015-2020) Figure Asia-Pacific Psoriasis Sales and Growth Rate (2015-2020) Figure Middle East and Africa Psoriasis Sales and Growth Rate (2015-2020) Figure South America Psoriasis Sales and Growth Rate (2015-2020) Figure North America COVID-19 Status Figure North America COVID-19 Confirmed Cases Major Distribution Figure North America Psoriasis Revenue (M USD) and Growth (2015-2020) Table North America Psoriasis Sales by Countries (2015-2020) Table North America Psoriasis Sales Market Share by Countries (2015-2020) Table North America Psoriasis Revenue (M USD) by Countries (2015-2020) Table North America Psoriasis Revenue Market Share by Countries (2015-2020) Figure United States Psoriasis Sales and Growth Rate (2015-2020) Figure Canada Psoriasis Sales and Growth Rate (2015-2020) Figure Mexico Psoriasis Sales and Growth (2015-2020) Figure Europe COVID-19 Status Figure Europe COVID-19 Confirmed Cases Major Distribution Figure Europe Psoriasis Revenue (M USD) and Growth (2015-2020) Table Europe Psoriasis Sales by Countries (2015-2020) Table Europe Psoriasis Sales Market Share by Countries (2015-2020) Table Europe Psoriasis Revenue (M USD) by Countries (2015-2020) Table Europe Psoriasis Revenue Market Share by Countries (2015-2020) Figure Germany Psoriasis Sales and Growth Rate (2015-2020) Figure UK Psoriasis Sales and Growth Rate (2015-2020) Figure France Psoriasis Sales and Growth (2015-2020) Figure Italy Psoriasis Sales and Growth (2015-2020) Figure Spain Psoriasis Sales and Growth (2015-2020) Figure Russia Psoriasis Sales and Growth (2015-2020) Figure Asia Pacific COVID-19 Status Figure Asia Pacific Psoriasis Revenue (M USD) and Growth (2015-2020) Table Asia Pacific Psoriasis Sales by Countries (2015-2020) Table Asia Pacific Psoriasis Sales Market Share by Countries (2015-2020) Table Asia Pacific Psoriasis Revenue (M USD) by Countries (2015-2020) Table Asia Pacific Psoriasis Revenue Market Share by Countries (2015-2020) Figure China Psoriasis Sales and Growth Rate (2015-2020) Figure Japan Psoriasis Sales and Growth Rate (2015-2020) Figure South Korea Psoriasis Sales and Growth (2015-2020) Figure India Psoriasis Sales and Growth (2015-2020) Figure Southeast Asia Psoriasis Sales and Growth (2015-2020) Figure Australia Psoriasis Sales and Growth (2015-2020) Figure Middle East Psoriasis Revenue (M USD) and Growth (2015-2020) continued

About HongChun Research: HongChun Research main aim is to assist our clients in order to give a detailed perspective on the current market trends and build long-lasting connections with our clientele. Our studies are designed to provide solid quantitative facts combined with strategic industrial insights that are acquired from proprietary sources and an in-house model.

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NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

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Impact Of Covid-19 on Psoriasis Market 2021 Industry Challenges, Business Overview and Forecast Research Study 2026 NeighborWebSJ - NeighborWebSJ

Psoriasis occurs when the immune system mistakenly attacks normal tissues in the body. This reaction leads to swelling and a quicker turnover of skin cells.

With too many cells rising to the surface of skin, the body cant slough them off fast enough. They pile up, forming itchy, red patches.

Psoriasis can develop at any age, but it usually occurs in people between ages 15 and 35 years old. The main symptoms include itchy, red patches of thick skin with silvery scales on the:

Psoriasis can be irritating and stressful. Creams, ointments, medications, and light therapy may help.

However, some research suggests diet might also alleviate symptoms.

So far, research on diet and psoriasis is limited. Still, some small studies have provided clues into how food may affect the disease. As far back as 1969, scientists looked into a potential connection.

Researchers published a study in the journal Archives of Dermatology that showed no link between a low-protein diet and psoriasis flare-ups. More recent studies, however, have found different results.

Some recent research shows that a low-fat, low-calorie diet may reduce the severity of psoriasis.

In a 2013 study published in JAMA Dermatology, researchers gave the people involved in the study a low-energy diet of 800 to 1,000 calories a day for 8 weeks. They then increased it to 1,200 calories a day for another 8 weeks.

The study group not only lost weight, but they also experienced a trend in decreased severity of psoriasis.

Researchers speculated that people who have obesity experience inflammation in the body, making psoriasis worse. Therefore, a diet that increases the chances of weight loss may be helpful.

What about a gluten-free diet? Could it help? According to some studies, it depends on the persons sensitivities. Those with celiac disease or wheat allergies may find relief by avoiding gluten.

A 2001 study found that people with gluten sensitivities on gluten-free diets experienced improvement in psoriasis symptoms. When they returned to their regular diet, the psoriasis worsened.

A 2005 study also found some people with psoriasis had an elevated sensitivity to gluten.

Though fruits and vegetables are an important part of any healthy diet, it may be especially important for patients with psoriasis.

A 1996 study, for instance, found an inverse relationship between an intake of carrots, tomatoes, and fresh fruit and psoriasis. All of these foods are high in healthy antioxidants.

Another study published a few years later found that people with psoriasis had lower blood levels of glutathione.

Glutathione is a powerful antioxidant found in garlic, onions, broccoli, kale, collards, cabbage, and cauliflower. Scientists speculated that a diet rich in antioxidants may help.

According to the Mayo Clinic, a number of studies have shown that fish oil may improve symptoms of psoriasis.

In a 1989 study, participants were put on a low-fat diet supplemented with fish oil for 4 months. Over half experienced moderate or excellent improvement in symptoms.

A 1993 study showed that men who misused alcohol experienced little to no benefit from psoriasis treatments.

A 1990 study compared men with psoriasis to those without the disease. Men who drank about 43 grams of alcohol a day were more likely to have psoriasis, compared with men who drank only 21 grams a day.

Though we need more research on moderate alcohol consumption, cutting back may help ease psoriasis symptoms.

Current treatments focus on managing the symptoms of psoriasis, which tend to come and go.

Creams and ointments help reduce inflammation and skin cell turnover, reducing the appearance of patches. Light therapy has been found to help reduce flare-ups in some people.

For more severe cases, doctors may use medications that suppress the immune system, or block the action of specific immune cells.

However, medications can have side effects. If youre looking for alternative treatments, some studies show promising results with certain types of diets.

Dermatologists have long recommended that a healthy diet is best for those with psoriasis. That means lots of fruits and vegetables, whole grains, and lean proteins.

In addition, maintaining a healthy weight may provide significant relief.

A 2007 study found a strong connection between weight gain and psoriasis. Having a higher waist circumference, hip circumference, and waist-hip ratio were also associated with an increased risk of developing the disease.

Try to eat healthy and keep your weight within a healthy range to help reduce psoriasis flare-ups.

Excerpt from:
Psoriasis Diet: Food Tips to Help Treat Psoriasis

BARCELONA, Jan. 28,2021 /PRNewswire/ --Almirall, S.A. (BME:ALM), a global biopharmaceutical company based in Barcelona,and Happify Health, a leader in digital therapeutics solutions to improve mental and physical health based in New York, will develop a version of its digital platform specifically for people with psoriasis in Spain, UK, Italy and France to be rolled out this year. It is estimated that 20-30% of patients with moderate to severe psoriasis suffer from mental health issues such as anxiety and depression[1]. Happify Health, through evidence-based and clinically validated platforms, delivers mental health solutions targeted to patients with chronic diseases.

The Almirall partnership with Happify Health will focus on a solution called CLARO targeted to addressing the mental health concerns of psoriasis patients. The goal of the CLARO program is to create a solution/service to help psoriasis patients improve their well-being when living with a chronic diseaseproviding a meaningful, dynamic and fun user experience. CLARO will be delivered through the Almirall patient support program.

This new partnership demonstrates Almirall's commitment to deliver digital solutions to patients suffering from psoriasis. "We are so pleased to be joining Happify Health on their mission to improve the lives of patients with chronic conditions. This partnership will allow us to provide patients with psoriasis a solution based on a clinically validated positive psychology platform. We selected Happify as our partner as they have already demonstrated a positive impact on the mental health of patients with chronic conditions, including psoriasis, in published research," saidFrancesca Domenech Wuttke, Chief Digital Officer at Almirall.

"Since mental health events act as stressors that can trigger psoriasis flare ups, Happify is excited to work with a European leader like Almirall in this condition to address the mental and physical health symptoms of these patients," said Chris Wasden, Head of Digital Therapeutics at Happify Health. "Our digital therapeutic solution acts as a complement to Almirall's commitment to psoriasis patients to empower people with psoriasis to live full lives through meaningful behavior change. Together, we can help psoriasis patients, one patient at a time, and at scale."

References

[1]H.L. Richards, D.G. Fortune, C.E. Griffiths, C.J. Main The contribution of perceptions of stigmatisation to disability in patients with psoriasis

J Psychosom Res., 50 (2001), pp. 11-15.

The prevalence of comorbid depression in patients with psoriasis is estimated at between 20% and 30%, and rates as high as 62% have been reported. E.A. Dowlatshahi, M. Wakkee, L.R. Arends, T. NijstenThe prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: A systematic review and meta-analysis J Invest Dermatol., 134 (2014), pp. 1542-1551.

M. Esposito, R. Saraceno, A. Giunta, M. Maccarone, S. ChimentiAn Italian study on psoriasis and depression Dermatology., 212 (2006), pp. 123-127.

SOURCE Almirall, S.A.

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Almirall and Happify Health enter into strategic partnership to develop evidence-supported digital therapeutics solutions for psoriasis patients -...

NORTH CHICAGO, Ill., Jan. 25, 2021 /PRNewswire/ --AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.1 The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ's efficacy across multiple measures of disease activity.* 4-6

"Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions," saidTom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases."

"Psoriatic arthritis and ankylosing spondylitis are multi-faceted diseases that can cause severe pain, restricted mobility, and lasting structural damage," said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK. "In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases. The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms."

In both Phase 3 clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adults with active PsA who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.4,5RINVOQ also achieved non-inferiority to adalimumab# (40mg, every other week) for ACR 20 at week 12.4Patients receiving RINVOQ experienced greater improvements in physical function (as measured by HAQ-DI at week 12) and skin symptoms (as measured by PASI-75 at week 16), and a greater proportion achieved minimal disease activity (MDA) compared to those receiving placebo at week 24.4,5

RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in adult patients with AS who were nave to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).6 Additionally,RINVOQ achieved statistical significance across several multiplicity adjusted key secondary endpoints versus placebo, including ASAS partial remission (PR) at week 14 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at week 14.6

Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified.3-6 Integrated safety data for SELECT-PsA 1 and SELECT-PsA 2 through week 24 show that Serious Adverse Events occurred in 4.1% of the patients in the RINVOQ 15 mg group compared to 3.7% in the adalimumab group and 2.7% in the placebo group.7,8 The most common adverse events reported with RINVOQ 15 mg were upper respiratory tract infection, nasopharyngitis, increased blood CPK, ALT increase and AST increase.3-5 In SELECT-AXIS 1, Serious Adverse Events were reported in 1% of the patients in both the RINVOQ 15 mg and placebo group. The most common adverse events reported with RINVOQ 15 mg included blood CPK increase, diarrhea, nasopharyngitis, headache and nausea.3,6

The Marketing Authorization means that RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. RINVOQ is already approved for the treatment ofadults with moderate to severe active rheumatoid arthritis.2

About Psoriatic Arthritis and Ankylosing Spondylitis

Psoriatic arthritis and Ankylosing spondylitis are debilitating diseases that can cause severe pain, restricted mobility and lasting structural damage.9-11 Despite treatment advances, many people with AS and PsA often do not achieve their treatment goals.12,13

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including skin and joints.14 In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.10,14

Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility and structural damage.16

About SELECT-PsA 12,4

SELECT-PsA 1is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either RINVOQ 15 mg or RINVOQ 30 mg.

The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or RINVOQ 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity (MDA) at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 1were previously announced in February 2020. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104400).

About SELECT-PsA 22,5

SELECT-PsA 2is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic (bDMARD). Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 2were previously announced in October 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104374).

About SELECT-AXIS 12,6

SELECT-AXIS 1is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with activeankylosing spondylitis who are bDMARD-nave and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

Key ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium ofCanada(SPARCC) score (spine) and Bath Ankylosing Spondylitis Functional Index (BASFI) at week 14. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of RINVOQ in subjects who completed Period 1.

Results from SELECT-AXIS 1were previously announced in November 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03178487).

About RINVOQ(upadacitinib)

Discovered and developed by AbbVie scientists,RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,17-27 InAugust 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. InDecember 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.17, 20-27

Important Safety Information about RINVOQ (upadacitinib)1

RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Use in combination with other potent immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients 65 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count <1000 cells/mm3, absolute lymphocyte count <500cells/mm3, or haemoglobin levels <8g/dL were reported in<1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions (ADRs) were upper respiratory tract infections, bronchitis, nausea, blood creatine phosphokinase (CPK) increased and cough. The most common serious adverse reactions were serious infections.

Psoriatic arthritis: Overall, the safety profile observed in patients with active psoriatic arthritis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. A higher incidence of acne and bronchitis was observed in patients treated with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively). A higher rate of serious infections (2.6 events per 100 patientyears and 1.3 events per 100 patientyears, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with upadacitinib in combination with MTX therapy compared to patients treated with monotherapy. There was a higher rate of serious infections in patients 65 years of age, although data are limited.

Ankylosing spondylitis: Overall, the safety profile observed in patients with active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. No new safety findings were identified.

Please see the full SmPC for complete prescribing information atwww.EMA.europa.eu.

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

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

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, YouTubeand 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, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, 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 of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). 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.

* Key domains include: Patient's global assessment of disease activity; Pain; Function; Inflammation# Superiority for RINVOQ 15 mg to adalimumab could not be demonstratedIn patients with 3% BSA psoriasis at baseline

References

SOURCE AbbVie

abbvie.com

Continued here:
European Commission Approves AbbVie's RINVOQ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis - PRNewswire

Just like the rest of the world, Im excited about the rollout of the new COVID-19 vaccines. When I saw news footage of the first hospital workers getting their immunizations, a sense of relief washed over me. Help is on the way.

The pandemic has upended my life and disrupted my family; my most recent disappointment was not being able to visit my mom in Southern California for her eightieth birthday. With a vaccine I envision being able to see my parents sooner rather than later. My daughter should be able to return to the University of California in Riverside, which announced plans to hold in-person instruction in the fall.

At the same time, Ive wondered if the vaccines are safe for me, a person living with psoriasis taking an immune-modulating biologic, Skyrizi.

Im encouraged that my dermatologist and two national psoriasis organizations agree that its safe for me to receive a COVID-19 vaccine.

At my December teledermatology appointment my doctor advised me to get a vaccine when it becomes available to me. She assured me that the new mRNA (messenger RNA) vaccines produced by Pfizer and Moderna are not live vaccines (that is, the kind made with weakened forms of the coronavirus), which can be an issue for people who take biologics.

In fact, she said there is nothing that would stop me from getting a COVID-19 vaccine, including having psoriasis or taking a biologic.

I asked if my psoriasis put me into a high-priority group that would go to the front of the line for COVID-19 vaccination. She replied it did not, based on the current rollout priorities in our community. People with psoriasis have not been shown to be at higher risk for contracting COVID-19 or having greater complications if infected.

Her recommendation aligned with what I read from the International Psoriasis Council (IPC) and the National Psoriasis Foundation (NPF).

The IPC posted a statement on COVID-19 vaccines and psoriasis, acknowledging that Many people with psoriasis have raised concerns about potential adverse effects of vaccines on their skin disease. In response to those concerns the IPC lists six practical considerations, including that there is no evidence that vaccines affect psoriasis onset or severity.

The NPFs COVID-19 Task Force also issued a statement on COVID-19 vaccines. Joel Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania Perelman School of Medicine in Philadelphia, and cochair of the NPF COVID-19 Task Force, stated, The new mRNA vaccines are an astonishingly 95 percent effective in preventing COVID-19 and are extremely safe. We recommend that patients with psoriatic disease get the vaccine as soon as it is available to them.

Dr. Gelfand also confirmed what my doctor told me about taking the vaccine while being treated with a biologic: Patients may continue their oral or biologic psoriasis or psoriatic arthritis treatment without interruption when receiving these immunizations.

RELATED: How Im Managing My Psoriasis in the Shadow of the Coronavirus

An effective and safe vaccine represents so much more to me than not getting sick with COVID-19. While Ive tried to stay strong and appear unaffected, my excitement at the arrival of the vaccines revealed just how much this crisis has worn on me. I see the vaccine as the beginning of the end to the pandemic.

Of course, I wish that I could immediately go back to life the way it was before the pandemic, but it will take time. Im still not sure when I will be able to get my shot. While initial vaccine shipments have arrived, vaccinations in my county are rolling out more slowly due to limited dose availability. County officials are urging patience, which is something that I know I will continue to need in high supply.

Even after I get vaccinated, theCenters for Disease Control and Prevention (CDC)says that I will still need to follow its safety recommendations including wearing masks, maintaining physical distance of six feet from others, and washing hands.

The Pfizer and Moderna COVID-19 vaccines require two doses spaced three to four weeks apart and take time to build immunity. Until researchers have a clearer understanding of whether its possible for people who are vaccinated to pass the virus to others, I want to stay vigilant in following safety protocols. It will take months for enough people to be vaccinated to halt the spread of the virus.

RELATED: What You Need to Know About the COVID Vaccine

Still, I look forward to a time when the pandemic is not dominating my thoughts and life.

My emotional health would no doubt improve with a COVID-19 vaccine. Viral infections, especially those accompanied by a fever, trigger my psoriasis to flare severely.

My great fear with COVID-19 is not death, but having it greatly worsen my current health conditions. While I cant be certain I wont get a sore arm, a headache, or another common vaccine side effect as outlined by the CDC, I feel its still better than getting COVID-19.

The potential benefits of a COVID-19 vaccine make me optimistic that we will all emerge from the shadow of the coronavirus.

You can read more about my experiences in my blogfor Everyday Health and on my website.

Read more:
Psoriasis and COVID Vaccine Safety - Everyday Health

Like most drugs, Otezla may cause mild or serious side effects. The lists below describe some of the more common side effects that Otezla may cause. These lists dont include all possible side effects.

Your doctor or pharmacist can tell you more about the potential side effects of Otezla. They can also suggest ways to help reduce side effects.

Heres a short list of some of the mild side effects that Otezla can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Otezlas prescribing information.

Mild side effects of Otezla can include:

Mild side effects of many drugs may go away within a few days or a couple of weeks. If they become bothersome, talk with your doctor or pharmacist.

Serious side effects from Otezla can occur, but they arent common. If you have serious side effects from Otezla, call your doctor right away. If you think youre having a medical emergency, you should call 911 or your local emergency number.

Serious side effects can include:

* For more information about this side effect, see the Side effect focus section below.

You can read below to learn more about some of the side effects Otezla may cause.

You may lose your appetite while youre taking Otezla. You may also lose some weight.

Be sure to tell your doctor if you lose three pounds (1.4 kilograms) or more in 7 days or less. Changes that may occur with weight loss include having:

What might help

While youre taking this drug, your doctor may monitor your weight. They might ask you to check your weight at home.

If you notice that youre losing weight without trying, talk with your doctor. Tell your doctor if your weight loss is happening because of severe nausea, vomiting, or diarrhea.

In some cases, your doctor may have you stop taking Otezla. Dont stop taking Otezla without first talking with your doctor.

To help manage weight loss, your doctor may recommend that you eat plenty of nutritious calories every day. To regain weight that youve lost, try to avoid eating unhealthy empty calories. Instead, choose foods that are high in calories and nutrients. If you have trouble choosing nutritious foods to eat, talk with your doctor.

Some people may have changes in mood or depression while taking Otezla. This may be more common in people whove had depression in the past.

If you have depression or youve had it in the past, let your doctor know before you start taking Otezla.

Be sure to monitor your moods while youre taking Otezla. Talk with your doctor right away if you have any changes in mood, feelings of depression, or suicidal thoughts.

What might help

If youve had depression in the past, your doctor will consider the risks and benefits of prescribing Otezla for you. If the benefits of using Otezla outweigh the risks, your doctor will likely prescribe the drug. Theyll monitor your moods regularly.

Its important to identify depression early. Doing so can help reduce the harmful effects of depression.

If you have depression thats related to using Otezla, your doctor may prescribe counseling or medications to treat the depression. If needed, your doctor may have you stop taking Otezla. Dont stop taking Otezla without first talking with your doctor.

If you think someone is at immediate risk of self-harm or hurting another person:

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

You may have diarrhea while youre taking Otezla. In fact, the most common side effect of Otezla is diarrhea. With diarrhea, you may have more frequent, loose, or watery stools.

Some people may have severe diarrhea while taking Otezla. With severe diarrhea, you can have:

Tell your doctor if you have diarrhea, or any of these other symptoms, during treatment.

You may have a higher risk of complications because of severe diarrhea if you:

What might help

If you have diarrhea while youre taking Otezla, youll need to replace fluid and electrolytes that your body is losing. When you lose fluid and electrolytes through diarrhea, you can get dehydrated. (With dehydration, you have a low fluid level in your body.)

For diarrhea thats not severe, you can rehydrate by drinking diluted fruit juice or electrolyte drinks. Eating foods that are low in fiber may help. Some foods that may help improve diarrhea include:

Certain over-the-counter medications may also help treat diarrhea. Be sure to talk with your doctor before taking any medications with Otezla.

If you have severe diarrhea with Otezla, call your doctor. They may lower your dosage of the drug. If needed, your doctor may even have you stop taking Otezla. Dont stop taking the medication without first talking with your doctor.

Sometimes, for severe diarrhea, you may need intravenous (IV) fluids and electrolytes. (Youll get IV fluids as an injection into your vein thats given over a period of time.)

Some people may be allergic to apremilast or any of the other ingredients in Otezla.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Otezla. If you think youre having a medical emergency, call 911 or your local emergency number.

View original post here:
Otezla: Side Effects, Cost, Uses, What to Consider, and More - Healthline

Introduction

Psoriasis is a chronic, immune-mediated disease that affects the skin and exerts multiple systemic effects.1 Increasing evidence suggests that disturbances within the gut microbial composition, their metabolic products and intestinal permeability may exacerbate pathophysiologic pathways in a number of inflammatory disorders.2,3 An altered gut barrier allows the translocation of luminal contents into the underlying tissues and then into the circulation.4 An increased passage of bacterial components (lipopolysaccharide, DNA, toxins), which are potent pro-inflammatory triggers, results in local and (or) systemic immune response with potential clinical implications.5 Emerging data indicated that such a chronic low-grade inflammation was the hallmark of psoriasis and its related comorbidities, such as obesity, insulin resistance, atherosclerosis and nonalcoholic fatty liver disease.6,7

Gut microbiota profiling in psoriasis confirmed significant alterations in its biodiversity and composition.8 Several studies assessed the intestinal barrier in psoriasis by measuring the plasma concentrations of intestinal fatty acid-binding protein (a marker of enterocyte damage),9,10 zonulin (a protein that specifically and reversibly regulates intestinal permeability),11,12 claudin-3 (a component of tight junctions),13,14 lipopolysaccharide (a bacterial endotoxin)12,15 and bacterial DNA.16,17 However, the results were heterogeneous, with some patients presenting significantly affected intestinal integrity, and others showing a properly functioning gut barrier.

Therefore, the aim of our study was to compare those two groups of patients in order to establish the clinical significance of altered intestinal barrier in psoriasis. The specific objectives were as follows: (a) to determine whether there are differences in disease activity between psoriatic patients with a normal and damaged intestinal barrier, (b) to investigate the presence and severity of gastrointestinal symptoms among psoriatic patients with altered gut integrity, (c) to evaluate the blood concentration of trimethylamine N-oxide (TMAO), a gut microbiota-associated metabolite, depending on the function of the intestinal barrier.

A prospective cohort of 120 patients between 18 and 60 years of age, with chronic plaque psoriasis qualified for systemic treatment or phototherapy, was enrolled in the study between January 2018 and December 2018 in a tertiary referral dermatological center (Department of Dermatology, Medical University of Warsaw, Warsaw, Poland). The exclusion criteria were as follows:

The patients underwent a thorough physical examination, whole blood count, C-reactive protein, lipid profile, liver and kidney function tests. Disease severity was determined with the Psoriasis Area Severity Index score (PASI).

Endoscopy, abdominal ultrasonography, computed tomography, serum or fecal analyses were performed to exclude an organic disease of the gastrointestinal tract, if indicated.

The blood was collected once after an overnight fast. Blood samples were centrifuged at 4000 rpm (1500 g) for 10 min. within 15 min. of sample collection. The plasma was subsequently collected and frozen at 80C to be analyzed later.

Gastrointestinal barrier integrity was assessed via the measurement of serum claudin-3 (CLDN-3) and intestinal fatty acid-binding protein (I-FABP) with the use of the commercially available enzyme-linked immunosorbent assay (ELISA) kits (EIAab, Wuhan, China).9,13,14

Based on biomarker concentrations, the participants were allocated into two groups: with disrupted gut barrier and with properly functioning gut barrier. Patients were considered as having a disrupted gut barrier with CLDN-3 over 49.4 ng/mL and I-FABP over 412.3 pg/mL. Those cut-off values were defined as the mean concentration with two standard deviations and based on the results of healthy subjects published in our previous studies.9,13,14

The blood plasma concentration of TMAO was determined using liquid chromatography coupled with triple-quadrupole mass spectrometry as previously described.36,37 The limit of quantification for TMAO was 20.3 ng/mL.

The occurrence of gastrointestinal symptoms was evaluated with the Gastrointestinal Symptoms Rating Scale (GSRS). The GSRS is a reliable and validated questionnaire that utilizes a seven-level Likert scale (17), depending on the intensity and frequency of symptoms experienced during the previous week. A higher score mainly indicates inconvenient symptoms. Sixteen questions are clustered into five domains: reflux, abdominal pain, indigestion, diarrhea and constipation.38,39 Patients completed the questionnaire before blood collection. By the time of the final analysis, the results of the questionnaire were blinded to the investigators.

All participants gave their written informed consent before entering the study. The study was conducted in accordance with the Helsinki declaration and the protocol approved by the institutional Ethics Committee (Medical University of Warsaw, Warsaw, Poland).

The ShapiroWilk test was used to assess the normality of distribution. The categorical variables were summarized as frequencies and percentages and were compared with a chi-square test. The continuous variables were not normally distributed. Therefore, they were presented as medians with interquartile ranges (IQR). The non-parametric MannWhitney U-test was applied to compare differences between the groups.

All statistical analyses were performed with STATISTICA 13 software (StatSoft, Inc., USA). The p value of <0.05 was considered statistically significant.

One hundred and fifty patients with psoriasis were initially included in the study. According to the exclusion criteria, 24 of them could not participate. The subjects were 20- to 60-year-old (mean age 43.714.1) men (n=87) and women (n=39) with the disease duration ranging from 6 months to 35 years. Based on the adopted cut-off values for CLDN-3 and I-FABP, 68 patients were qualified to the group with an altered intestinal barrier and 46 to the group with a properly functioning intestinal barrier. Twelve patients were excluded due to the inconsistent result of gut integrity biomarkers.

Table 1 describes the anthropometric characteristics, clinical data and laboratory findings of the psoriatic patients with an altered and normal gut barrier. No statistically significant differences were observed for age, sex and BMI between the groups. The patients with psoriasis and an altered intestinal barrier demonstrated a higher disease activity assessed with the PASI score (19.7 [16.721.1] vs 10.3 [6.312.7]; p<0.001). Compared to the patients with a normal barrier, those with altered intestinal integrity also had the higher values of systemic inflammation biomarkers, i.e. neutrophil-to-lymphocyte ratio; NLR (2.86 [2.204.42] vs 1.71 [1.472.04]; p<0.001) and C-reactive protein (CRP) concentration (3.76 [2.355.67] vs 1.92 [0.703.60]; p<0.05).

Table 1 Anthropometric, Clinical and Laboratory Data of Patients with Psoriasis According to Normal and Altered Intestinal Barrier

As for the GSRS scores, both groups showed significant differences (Table 2). The patients with an altered gut barrier had a higher total score in the GSRS (3.20 [2.533.67] vs 1.46 [1.071.67]; p<0.001), as well as in individual values for particular sections.

Table 2 Gastrointestinal Symptom Rating Scale (GSRS) in Patients with Psoriasis According to Normal and Altered Intestinal Barrier

Figure 1 presents TMAO concentration in the serum of psoriatic patients with a normal and altered gut barrier. The latter group had a significantly higher circulating level of this bacterial metabolite (375.751.9 vs 119.427.5 ng/mL; p<0.05).

Figure 1 Plasma concentration of trimethylamine N-Oxide (TMAO) in psoriatic patients with normal and altered gut barrier (*p<0.05).

Several studies previously revealed increased intestinal permeability in patients with psoriasis.12,14 However, the clinical significance of this phenomenon still remains unclear. To our knowledge, it is the first study that evaluates disease activity, self-reported gastrointestinal symptoms and TMAO concentration in patients with psoriasis according to the presence of a normal or altered gut barrier.

We found that psoriatic patients with an altered gut barrier experienced gastrointestinal symptoms much more frequently and intensely. Their results obtained in the GSRS were significantly higher in the total score as well as for individual symptom domains. Gastrointestinal symptoms are quite common among patients with psoriasis. Feldman et al conducted an online-based survey and found that several gastrointestinal signs and symptoms (pain, abdominal bloating, diarrhea, mucus in stool, blood in stool, and unintentional weight loss) were more prevalent in the respondents with moderate-to-severe psoriasis.18 However, literature sources regarding the relationship between gastrointestinal symptoms and increased gut permeability are scarce. So far, gastrointestinal symptoms have been found to be associated with the biomarkers of a disrupted gut barrier in the elderly,19 after intensive exercise20 and in patients with irritable bowel syndrome.21 Impaired gut integrity may facilitate the translocation of luminal content to the inner layers of the intestinal wall and lead to a local immune response. The low-grade inflammation in the intestinal mucosa alters gastrointestinal reflexes and activates the visceral sensory system, subsequently promoting the occurrence of gastrointestinal symptoms.22 Patients with psoriasis and psoriatic arthritis presented the signs of subclinical gut inflammation reflected by an increased fecal calprotectin concentration, without the clinical and endoscopic features of inflammatory bowel diseases.23

A higher disease activity and systemic inflammation are other characteristic features of an altered intestinal barrier in patients with psoriasis. It is unknown whether increased gut permeability is an early event in the pathogenesis of psoriasis or the consequence of the disease. Previous findings indicated a correlation between intestinal integrity biomarkers and the PASI score or an inflammatory state, reflected by an increased CRP concentration and neutrophil-to-lymphocyte ratio.9,13 The loss of barrier function allows the translocation of bacterial antigens into the circulation, where they may contribute to immune activation and act as a trigger of psoriasis exacerbation. The increased blood concentration of lipopolysaccharide, an endotoxin derived from Gram-negative bacterial cell walls and a strong proinflammatory molecule, was confirmed in psoriatic patients.12,15 Cell-free bacterial DNA was also identified in the blood of patients with psoriasis.16,17 Nucleotide sequencing indicates that the detected DNA fragments correspond to the microbiota commonly found in the gastrointestinal tract.

Not only antigens but also bacterial metabolites translocating to the systemic circulation might be crucial in the interactions between gut microbiota, a compromised intestinal barrier, gastrointestinal symptoms and psoriasis activity. Trimethylamine N-oxide is one of the most intensively studied gut-microbiome-derived metabolite in the recent years.24 Dietary L-carnitine, choline and lecithin are metabolized by the intestinal microbiome to trimethylamine (TMA), which is subsequently absorbed and converted into TMAO in the liver by flavin-containing monooxygenase 3.25 An increased circulating TMAO concentration was demonstrated to activate pro-inflammatory signaling pathways and positively correlate with cardiovascular risks.26,27 A high TMAO concentration was linked to several psoriasis comorbidities, i.e. obesity,28 hypertension,29 metabolic syndrome,30 nonalcoholic fatty liver disease31 and insulin resistance.32 Before our study was conducted, TMAO levels had not been assessed in psoriasis, although its concentration correlates significantly with skin and joint involvement in patients with psoriatic arthritis.33 According to some authors, it was not TMAO itself, but rather its precursor TMA which was responsible for the observed disorders and TMAO as the product of oxygenation was a biomarker of the increased intestinal translocation of TMA.34,35

We hypothesize that TMAO or TMA translocation in the presence of an altered intestinal barrier is a potential mechanism linking gut dysbiosis to the immune activation, influence on disease activity and/or the development of psoriasis comorbidities. The modulation of the gut microbiota, the reinforcement of the intestinal barrier or direct TMAO inactivation may thus become an important target in the prevention and treatment of psoriasis.

In the present paper, we demonstrated that an altered gut barrier in psoriasis is associated with gastrointestinal symptoms, systemic inflammatory profile and the increased blood concentration of gut microbiota-derived metabolite TMAO. The findings provide an important basis for future studies to investigate how to optimally modify the gut microbiome and intestinal barrier in order to beneficially influence psoriasis with its comorbidities.

TMAO, trimethylamine N-oxide; PASI, Psoriasis Area Severity Index score; CLDN-3, claudin-3; I-FABP, intestinal fatty acid-binding protein; ELISA, enzyme-linked immunosorbent assay; GSRS, Gastrointestinal Symptoms Rating Scale; IQR, interquartile ranges; BMI, Body Mass Index; NLR, neutrophil-to-lymphocyte ratio; CRP, C-reactive protein; TMA, trimethylamine.

The data that support the findings of this study are available from the corresponding author upon reasonable request.

The authors thank Prof. Robert Gniadecki for his critical comments on the manuscript. The authors would also like to thank AstraZeneca for permission to use Polish adaptation of the Gastrointestinal Symptom Rating Scale.

This research was funded by the Polish Ministry of Science and Higher Education, grant number MNiSW/2020/220/DIR/NN4.

The authors report no conflicts of interest in this work.

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