Category Archives: Psoriasis

DURECT Corporation (DRRX) has a drug, DUR-928, that is being studied in alcoholic hepatitis (AH), non-alcoholic steatohepatitis (NASH) and psoriasis. There will be two presentations on DUR-928, including one oral late breaker, at November's AASLD meeting on AH, which is an important cause of liver-related morbidity leading to the need for a liver transplant and has no approved therapy. Current pharmacological therapies include corticosteroids (for which a significant percentage are contraindicated due to infection or acute kidney injury) and pentoxyphylline, but these have not been shown to be very effective. A 2015 study published in the Journal of Clinical Gastroentrology concluded that there are 325,000 alcoholic hepatitis-related hospitalizations in the US annually, with 65,000 representing a primary diagnosis. The study further suggested that, as it relates to the primary AH hospitalization, the cost was $46,000 and the in-hospital mortality rate was 5.8%. The study also noted that the thirty day mortality rate for severe alcoholic hepatitis has historically been in the 30-50% range. Liver transplant is indicated for patients who are steroid failures, but its cost can approach $600,000.

The Phase 2a data on DUR-928, as discussed in the abstracts, showed that the drug was safe at all IV doses. Treatment responders, defined by a Lille score of less than 0.45 were 89%, and among the severe AH patients it was 87%. It was noted that these response rates were significantly better than comparative published historic data. A larger Phase 2b trial is being planned for 2020.

NASH has become a leading cause of liver disease and liver transplant paralleling the obesity epidemic. It is estimated that 10-20 million Americans have the disease, though this could increase given that, according to the OECD, the adult obesity rate in the US is forecast to increase from 38% in 2014 to 47% in 2030. There are currently no approved medications, and it has been shown that a 10% weight loss can reduce the disease severity. The first drug, Ocaliva, should be on the market in mid-2020, but its benefit as monotherapy was seen in only about 23% of patients. I have long maintained that, given the complexity of the disease, pharmacologic treatment is likely to involve a polydrug regimen, and I expect Novo's (NYSE:NVO) oral semaglutide, Rybelsus, to be a cornerstone. DUR-928, in an oral formulation, would be very complimentary, given the beneficial effects it has shown in animal studies on fibrosis and ballooning, and on inflammation, bilirubin and liver injury in a Phase 1 human study. A larger 28 day, Phase 1b study is currrently ongoing, and it will assess safety, pharmacokinetics and some efficacy parameters, while laying the groundwork for a future Phase 2b study. The US NASH market is expected to exceed $10 billion annually, and, in my opinion, the most advanced drugs will represent "first generation" treatments, much like PEG-Intron for Hepatitis C.

DUR-928 is also being studied in a topical formulation for mild to moderate psoriasis. A multi-center Phase 2a trial is slated to have topline data by year end.

Over the next year, DURECT will be advancing DUR-928 in AH, NASH and psoriasis. Data on AH will be provided at November's AASLD, and topline data on NASH and psoriasis will follow soon thereafter. DUR-928 acts via several mechanisms to regulate inflammation, improve cell survival, improve insulin sensitivity, decrease lipid biosynthesis and reduce fibrosis. There is no approved drug for AH, and this market should exceed $1 billion in the US. Although several drugs should be on the market to treat NASH over the next three years, none seem likely to serve the majority of patients as monotherapy. It needs to be understood that NASH progresses from fibrosis stage one to four over a period exceeding a decade, and patients with stage one and two are more likely to die of cardiovascular disease, given the association with hypertension, obesity and Type 2 diabetes. Ultimately, the NASH drug market will be extremely large, with a combination of therapies directed at weight loss, insulin sensitivity and fibrosis required.

As I look at DURECT's stock, I find it similar to other small caps that I have designated as being priced for "non-success". Its lead drug is being advanced in three indications, and it has recently formed a partnership with a leading biopharmaceutical company relating to its legacy drug delivery technology that has brought in $35 million and could bring in additional milestone payments and royalties. Furthermore, the unique characteristics of DUR-928 make it a very attractive candidate for the indications being pursued.

Disclosure: I am/we are long DRRX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Durect Corporation: DUR-928 Data In Severe Alcoholic Hepatitis To Be Showcased At Upcoming AASLD Meeting - Seeking Alpha

CRANBURY, N.J.--(BUSINESS WIRE)--The American Journal of Managed Care (AJMC), the leading multimedia peer-reviewed journal dedicated to issues in managed care, presents its most recent Peer Exchange panel discussion, Understanding the Comorbidities: Psoriasis and Metabolic Syndrome. The video series features experts in the field of dermatology discussing psoriasis and metabolic syndrome and dissecting a variety of treatment options.

Led by Dr. Peter L. Salgo, the panel of experts featured in this educational video series will provide an understanding of these comorbid conditions and discuss the causal relation between psoriasis and metabolic syndrome, said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of AJMC.

Here are the four distinguished experts on the panel:

The Peer Exchange begins with a conversation that defines both psoriasis and metabolic syndrome. The experts also discuss the burdens of psoriasis in addition to the role that genetics play in this chronic systemic inflammatory disease. Next the experts shift the conversation to discuss an understanding of the increased risk of developing metabolic syndrome for patients with psoriasis, highlighting their connectivity. The causal relation between the two conditions will be analyzed as the experts dive deeper into the biologics used to treat psoriasis and review their efficacy in patients who also present with metabolic syndrome.

For more information and to view the video series, click here.

AboutThe American Journal of Managed Care

The American Journal of Managed Care(AJMC) is a multimedia peer-reviewed, MEDLINE-indexed journal that keeps industry leaders on the forefront of health policy by sharing digital research relevant to industry decision-makers. Other brands in theAJMCfamily includeThe American Journal of Accountable Care,Evidence-Based Oncology andEvidence-Based Diabetes Management. These comprehensive multimedia brands bring together stakeholder views from payers, providers, policymakers and other industry leaders in managed care. AJMC is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in the U.S. dedicated to delivering trusted health care news across multiple channels.

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The American Journal of Managed Care Launches 'Understanding the Comorbidities: Psoriasis and Metabolic Syndrome' Video Series - Business Wire

Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 24, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced plans to initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.

Frank Watanabe, Arcutis' President and Chief Executive Officer, commented: "We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year."

The Company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.

Howard Welgus, Arcutis' Chief Medical Officer, commented: "Because psoriasis is a chronic disease, it is critical to understand the efficacy, safety and tolerability of any new psoriasis treatment over an extended period. Thus, this long-term safety study is important to our understanding of ARQ-151's potential to address the unmet needs in topical treatment of psoriasis. Furthermore, this strategic clinical development approach to generating long-term safety data allows our Phase 3 studies to be of shorter duration."

The ARQ-151-202 study is a Phase 2, multi-center, open label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.

About ARQ-151

ARQ-151 is a topical cream formulation containing roflumilast, a PDE4 inhibitor, that Arcutis is developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates the production of pro-inflammatory and anti-inflammatory cytokines and cell proliferation. Roflumilast is a potent PDE4 inhibitor that was approved by the FDA for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug's potency) than other PDE4 inhibitors.

About Psoriasis

Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States. About 90% of psoriasis cases are plaque psoriasis, which is characterized by "plaques", or raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

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Arcutis Biotherapeutics Announces Positive End-of-Phase 2 Meeting with FDA and Planned Initiation of Phase 3 Program for ARQ-151 for Plaque Psoriasis...

A drug made by Johnson & Johnson for psoriasis that is one of the biggest revenue generators in its portfolio could be under threat in the future following the success of a new competitor in a Phase III study.

Brussels-based UCB said Thursday that results of its BE VIVID study showed that its antibody, bimekizumab, was superior in its efficacy against J&Js Stelara (ustekinumab) in adult patients with moderate-to-severe chronic plaque psoriasis.

The company did not disclose the full results, which it said would be presented in due course, but stated that the trial met the primary endpoint of showing at least a 90 percent improvement in psoriasis area and severity index or PASI90 and an investigator global assessment score of clear or almost clear after 16 weeks. The safety profile was consistent with the Phase II BE ABLE studies.

BE VIVID randomizes patients to receive bimekizumab for one year, Stelara for one year with placebo at certain time points to maintain blinding or placebo for 16 weeks followed by bimekizumab for the remainder of the study period. Bimekizumab is an IgG1 antibody tat neutralizes IL-17A and IL-17F, two key cytokines that drive inflammation.

These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates in patients, investigator Dr. Mark Lebwohl of New Yorks Icahn School of Medicine said in a statement. Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients.

Stelara, which was approved in 2009, was J&Js second largest product in 2018, accounting for about 6.3 percent of its total sales for the year, with global sales of about $5.2 billion, according to its 2018 annual report. U.S. patents for Stelara are expected to expire in 2023 due to a patent term extension, followed by expiration in Europe the following year. The companys top-selling product is the autoimmune disease drug Remicade (infliximab), which had sales of $5.3 billion and which already has biosimilar competitors.

In the Phase IIb BE ABLE 1 trial, which randomized patients to various dose levels of bimekizumab or placebo, patients treated with the drug showed a statistically significant dose-dependent response for PASI90, with 46.2-79.1 percent of patients achieving it, compared with 0 percent in the placebo arm. In addition, 27.9-60 percent of bimekizumab-treated patients achieved PASI100, also compared with 0 percent in the placebo arm. Treatment-emergent adverse events occurred among 126 of the 208 patients treated with bimekizumab, compared with 15 of 42 who received placebo.

Photo: juststock, Getty Images

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UCB psoriasis drug beats J&J's second top-selling product in Phase III study - MedCity News

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Oregon grape (Mahonia aquifolium) is a flowering herb that has been used for centuries in traditional Chinese medicine to treat numerous conditions, including psoriasis, stomach issues, heartburn, and low mood.

As such, you may wonder whether these benefits are backed by scientific evidence, and whether the plant has any side effects.

This article examines Oregon grape, explaining everything you need to know about its uses and side effects.

Despite its name, Oregon grape does not produce grapes.

Instead, its root and stalk contain active plant compounds, which may combat bacterial and fungal infections, as well as inflammatory and skin conditions (1, 2).

One of these compounds, berberine, has both antimicrobial and anti-inflammatory properties, which may make it effective at treating many diseases (1).

Oregon grape is found in a variety of products intended for oral or topical use, including supplements, extracts, oils, creams, and tinctures. You can look for these products online or in various health stores.

Oregon grape contains berberine, a powerful plant compound that may relieve many health conditions. This herb is available in various supplements, oils, creams, and extracts.

Some evidence suggests that Oregon grape reduces the severity of symptoms associated with psoriasis and atopic dermatitis.

These common, inflammatory skin conditions can be chronic and occur anywhere on your body. Psoriasis is characterized by reddish, scaly patches of skin, whereas atopic dermatitis is a severe form of eczema that causes itchy, dry skin (1).

In a 6-month study in 32 people with psoriasis who applied an Oregon grape topical cream, 63% reported that the product was equal or superior to the standard pharmaceutical treatment (3).

Likewise, in a 12-week study, 39 people who used an Oregon grape cream experienced significantly improved psoriasis symptoms, which remained stable and didnt require any follow-up treatment for 1 month (3).

Furthermore, a 3-month study in 42 people with atopic dermatitis observed improvements in symptoms after having them apply a skin cream containing Oregon grape3 times daily (4).

Though these results are promising, more rigorous research is necessary to determine this herbs ability to treat these conditions.

Small-scale human studies indicate that Oregon grape may treat psoriasis and atopic dermatitis. All the same, more research is needed.

Oregon grape is a versatile plant with numerous other potential benefits.

Berberine, an active compound in Oregon grape, demonstrates strong antimicrobial activity (1, 5).

Its used mainly to treat diarrhea and parasitic infections caused by bacteria (5).

Moreover, a test-tube study revealed that Oregon grape extracts exhibit antimicrobial activity against certain harmful bacteria, fungi, and protozoa (6).

Multiple studies demonstrate similar results, indicating that berberine may combat MRSA and other bacterial infections, such as those caused by E. coli (7, 8, 9).

The berberine in Oregon grape may ease symptoms of irritable bowel syndrome (IBS), as well as other stomach issues like gut inflammation.

In an 8-week study in 196 people with IBS, those who received a berberine treatment experienced reductions in diarrhea frequency, abdominal pain, and overall IBS symptoms, compared with those on a placebo (10).

Animal studies using this compound have suggested improvements not only in IBS symptoms but also in other stomach conditions like gut inflammation (11, 12).

Still, human research on the effects of Oregon grape and gut inflammation is lacking.

Due to the anti-inflammatory effects of berberine, Oregon grape may help prevent heartburn and related damage to your esophagus (13).

Heartburn is a common symptom of acid reflux, which occurs when stomach acid rises into your esophagus. Heartburn triggers a painful, burning sensation in your throat or chest.

In a study in rats with acid reflux, those treated with berberine had less esophageal damage than those treated with omeprazole, a common pharmaceutical heartburn treatment (13).

Keep in mind that human research is needed.

Some evidence indicates that berberine, an active compound in Oregon grape, may alleviate symptoms of depression and chronic stress (14, 15, 16, 17).

In a 15-day study in mice, a berberine treatment increased levels of serotonin and dopamine by 19% and 52%, respectively (18).

These hormones are known to help regulate your mood.

Yet, human research is needed before Oregon grape can be recommended as a treatment for depression.

Berberine, a powerful plant compound in Oregon grape, may exert strong antimicrobial activity and help improve symptoms of IBS, heartburn, and low mood. However, further research is necessary.

Despite the potential benefits of Oregon grape, there are several concerns associated with its use.

Most studies on this herb have tested it as a topical cream for psoriasis treatment. While its widely recognized as safe in this form, insufficient information exists to determine whether Oregon grape is safe to ingest (1, 3).

Thus, you may want to practice caution or talk to your healthcare provider before taking supplements, tinctures, or other orally administered forms of this herb.

Whats more, children and women who are pregnant or breastfeeding should avoid all preparations of this product due to a lack of safety information.

Notably, berberine, an active compound in Oregon grape, can cross the placenta and cause contractions (19).

Oregon grape is generally safe to use on your skin, but you should practice caution with oral supplements. Children and women who are pregnant or breastfeeding should avoid it due to insufficient data regarding its safety.

Oregon grape is a flowering plant that has been used for centuries in traditional Chinese medicine.

Scientific research suggests it relieves symptoms of psoriasis and other skin conditions, but it may also boost your mood, offer antibacterial activity, and ease IBS and heartburn.

Though generally safe, Oregon grape should not be taken by children or pregnant or breastfeeding women.

If youre interested in trying this herb, it may be best to start by using a topical treatment containing it, such as a skin ointment, and consult a medical professional before taking supplements or other oral formulations.

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What Is Oregon Grape? Uses and Side Effects - Healthline

DUBLIN--(BUSINESS WIRE)--The "Psoriasis Drugs - Market Analysis, Trends, and Forecasts" report has been added to ResearchAndMarkets.com's offering.

The Psoriasis Drugs market worldwide is projected to grow by US$10.8 Billion, driven by a compounded growth of 9%

Tumor Necrosis Factor Inhibitor, one of the segments analyzed and sized in this study, displays the potential to grow at over 9%. The shifting dynamics supporting this growth makes it critical for businesses in this space to keep abreast of the changing pulse of the market. Poised to reach over US$8.1 Billion by the year 2025, Tumor Necrosis Factor Inhibitor will bring in healthy gains adding significant momentum to global growth.

Representing the developed world, the United States will maintain a 7.6% growth momentum. Within Europe, which continues to remain an important element in the world economy, Germany will add over US$367.7 Million to the region's size and clout in the next 5 to 6 years. Over US$321.2 Million worth of projected demand in the region will come from the rest of the European markets. In Japan, Tumor Necrosis Factor Inhibitor will reach a market size of US$377.2 Million by the close of the analysis period.

As the world's second largest economy and the new game changer in global markets, China exhibits the potential to grow at 13.2% over the next couple of years and add approximately US$3.1 Billion in terms of addressable opportunity for the picking by aspiring businesses and their astute leaders.

Presented in visually rich graphics are these and many more need-to-know quantitative data important in ensuring quality of strategy decisions, be it entry into new markets or allocation of resources within a portfolio.

Several macroeconomic factors and internal market forces will shape growth and development of demand patterns in emerging countries in Asia-Pacific, Latin America and the Middle East. All research viewpoints presented are based on validated engagements from influencers in the market, whose opinions supersede all other research methodologies.

Competitors identified in this market include:

Key Topics Covered:

1. Market Overview

2. Focus On Select Players

3. Market Trends & Drivers

4. Global Market Perspective

For more information about this report visit https://www.researchandmarkets.com/r/8dk80z

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Psoriasis Drugs Market Analysis, Trends, and Forecasts, 2025 - Global Market is Projected to Grow by $10.8 Billion - ResearchAndMarkets.com - Business...

DetailsCategory: AntibodiesPublished on Thursday, 24 October 2019 09:33Hits: 195

BASEL, Switzerland I October 24, 2019 I Novartis, a leader in rheumatology and immuno-dermatology, announced today that the European Commission (EC) has approved a label update for the up-titration of Cosentyx (secukinumab) to 300 mg for patients with active ankylosing spondylitis (AS).

The approval is based on data from MEASURE 3, a three-year study that explored the tolerability and efficacy of Cosentyx in patients with AS[1]. Response rates were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure, compared with the recommended 150 mg dose. The safety profile was consistent with previous studies[1].

This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment, said Sam Khalil, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS.

About axSpAAxial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain[16]. The axSpA disease spectrum includes ankylosing spondylitis (AS), in which joint damage is visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint damage is not visible on x-ray[16]. Both parts of the disease spectrum have a comparable symptom burden, including nocturnal pain, fatigue, morning stiffness and functional disability[17]. If left untreated, axSpA can impair activity, lead to lost work time, and have a significant impact on quality of life[17].

About Cosentyx (secukinumab)Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS)[18],[19].

Cosentyx is backed by robust clinical evidence, including 5-year data across PsO, PsA and AS, as well as data from real world evidence[3]-[15]. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA, and psoriatic disease, with more than 250,000 patients treated worldwide with Cosentyx since its launcj[20].

About Novartis

Novartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis or follow @NovartisNews for the latest News & Media Updates at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit http://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.

References[1] ClinicalTrials.gov. 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients (MEASURE 3). Available from: https://clinicaltrials.gov/ct2/show/NCT02008916. Last accessed: October 2019.[2] Novartis press release. Novartis Cosentyx positive 16-week PREVENT results advance potential new indication for patients with axial spondyloarthritis. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis. Last accessed: October 2019.[3] ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet recruiting, active, not recruiting, completed, enrolling by invitation studies. Listed results on ClinicalTrials.gov [online]. Available from: https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= [Last accessed: October 2019].[4] ClinicalTrials.gov. Comparison of Secukinumab versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW). NCT03553823. Available from: https://clinicaltrials.gov/ct2/show/NCT03553823 [Last accessed: October 2019].[5] Langley RG, et al. Secukinumab in plaque psoriasisresults of two phase 3 trials. N Engl J Med 2014;371:326338.[6] Bagel J, et al. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther 2018;8:571579.[7] ClinicalTrials.gov. Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as compared to GP2017 (Adalimumab Biosimilar) (SURPASS). NCT03259074. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03259074 [Last accessed: October 2019].[8] Blauvelt A, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:6069.[9] Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th October 2017.[10] Mease PJ, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.[11] MEASURE 2. Novartis data on file.[12] Holdsworth E et al. Real world physician satisfaction with secukinumab in Psoriatic Arthritis and Ankylosing Spondylitis in Europe. Presented at EULAR 2019.[13] Michelsen B et al. Remission and drug retention rates of secukinumab in 1549 patients with psoriatic arthritis treated in routine care pooled data from the observational EuroSpA Research Collaboration Network. Presented at EULAR 2019.[14] Michelsen B et al. Pooled 6-month treatment outcomes and drug retention rates in 1556 patients with axial spondyloarthritis treated with secukinumab in routine clinical practice in 12 European Countries in the EuroSpA Research Collaboration. Presented at EULAR 2019.[15] Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.[16] Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383391.[17] Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661-1670.[18] Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf. Last accessed: October 2019.[19] Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167:717724.[20] Novartis data on file. September 2019.

SOURCE: Novartis

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Novartis receives approval for Cosentyx label update in Europe to include dosing flexibility in ankylosing spondylitis | Antibodies | News Channels -...

Published on October 24, 2019

Contributed by Dr. Sravya Chowdary Tipirneni, Consultant Dermatologist, Columbia Asia Hospital Whitefield

Nutrition affects every aspect of health. Psoriasis, an autoimmune condition that features dry, itchy, and scaly skin, may be one condition to which diet can make a difference.

When you have psoriasis, reducing triggers is an important part of managing your condition and avoiding flare-ups. Psoriasis flare-ups can be caused by a variety of triggers. These triggers may include bad weather, excess stress, and also watching whats on your plate!

A healthy diet lots of fruits and veggies, lean protein, and whole grains is a good idea for just about everyone. But some people who have psoriasis say their eating habits can affect their skin.

Limit Alcohol

The link between alcohol and psoriasis isnt clear, butif you drink, be moderate. For men, that means no more than two drinks a day, and for women no more than one.

Studies show that men who drink heavily dont respond to psoriasis treatments as well. And some research suggests that people who have psoriasis and drink heavily may find that their skin gets better when they stop.

If your condition is especially severe or you take certain medications, like methotrexate and acitretin, your dermatologist may tell you to stay away from alcoholcompletely.

Food that fight inflammation

Some studies suggest that antioxidants, like vitamin C, vitamin E, beta-carotene, and selenium, may make a difference. And some research suggests fatty acids from fish oil can be helpful.

Anti-inflammatory foods are generally healthy, so it shouldnt hurt to give them a try.

They include:

Fatty fish

A diet high in fatty fish can provide the body with anti-inflammatory omega-3s. The intake of omega-3s has been linked to a decrease of inflammatory substances and overall inflammation.

Fish to eat include:

Heart-healthy oils

Like fatty fish, certain vegetable oils also contain anti-inflammatory fatty acids. Its important to focus on oils that have a higher ratio of omega-3 to omega-6 fatty acids.

Oils to eat include:

Processed foods

Eating too many processed, high-calorie foods can lead to obesity, metabolic syndrome, and a variety of chronic health conditions. Certain conditions such as these cause chronic inflammation in the body, which may be linked to psoriasis flare-ups.

Foods to avoid include:

Nightshades

One of the most commonly reported triggers for psoriasis flare-ups is the consumption of nightshades. Nightshade plants contain solanine, which has been known to affect digestion in humans and may be a cause of inflammation.

Foods to avoid include:

Nutritional supplements

Fish oil, vitamin D, vitamin B-12, and selenium have all been researched for psoriasis.

Benefits of supplementation with these nutrients may include a decrease in the frequency and severity of flare-ups.

Lose Weight

People who are overweight or obese have a greater chance of getting psoriasis, and their symptoms tend to be worse. Studies suggest that your skin may get better if you shed extra pounds. This may be because fat cells make certain proteins that can trigger inflammation and make the condition worse.

Gluten-Free Diet

You may wonder whether your psoriasis would get better if you ate a gluten-free diet. Although you may hear about success stories from others who have tried it, so far studies arent clear that it helps. More research is needed.

Foods to avoid include:

The vegan diet:

This may also benefit people with psoriasis. This diet is naturally low in inflammatory foods such as red meat and dairy. Its high in anti-inflammatory foods such as fruits, vegetables, and healthy oils.

The Mediterranean diet:

This diet is well known for its numerous health benefits, including a reduced risk of certain chronic diseases. This diet focuses on foods that are high in antioxidants and healthy fats. It limits foods that are often considered to be pro-inflammatory.

The Paleo diet:

This diet places an emphasis on eating whole foods and avoiding processed foods. Since many whole foods contain anti-inflammatory compounds, this diet may prove to be beneficial for people with psoriasis.

Psoriasis is a life-long condition, and its severity can fluctuate. Medical treatment often aims to reduce skin cell production in order to minimize flares, or the periodic worsening of symptoms. Some lifestyle changes may also help.

In combination with medicine, nutrition may be a potent player in the fight against psoriasis.

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Foods to eat and avoid if you are suffering from Psoriasis - APN News

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The drugmaker Eli Lilly has struggled this year, with the stock down 6.7% in 2019. That is well behind the broader S&P 500 health-care sector, which is up 6%, and the broader S&P 500, which is up 19.9% since the start of the year.

The company will make its case on Wednesday morning when it unveils its third-quarter earnings. Lilly has scheduled a conference call for 9 a.m. ET.

The earnings report comes weeks after a double-dose of good news for Eli Lilly (ticker: LLY). Earlier this month, the Food and Drug Administration approved the companys migraine drug Reyvow, and the company unveiled positive data on its drug Taltz in pediatric patients with plaque psoriasis, all in the space of two days.

Eli Lilly stock trades at 16.9 times its estimated earnings over the next 12 months, slightly below its five-year average of 19.8 times earnings.

Heres a snapshot of investors expectations and recent history.

Wall Street analysts expect earnings of $1.39 per share in the third quarter, according to FactSet, and sales of $5.5 billion.

In a note out October 18, J.P. Morgan analyst Chris Schott wrote that he expected growth on the sale of core products. Strong product trends continue despite competition, Schott wrote.

The companys anti-inflammatory drug Taltz is facing an increasingly crowded field, including AbbVies (ABBV) new drug Skyrizi and other drugs from Novartis (NVS), Celgene (CELG). Still, Schott wrote that Taltz has shown relatively healthy performance despite the Skyrizi launch.

On October 16, Bank of America Merrill Lynch analyst Geoff Meacham issued a Buy rating on Lilly, writing that he viewed the risk/reward profile in Lilly as compelling, and setting a $133 price target on the stock.

The company has reported some promising data in recent months, including a strong response rate for its drug LOXO-292 in some lung cancer patients, and the data on Taltz in pediatric patients with plaque psoriasis.

In July, Lilly reported earnings per share of $1.50, beating Wall Street expectations of $1.45 just slightly. The company attributed the beat to an increase in volume.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Eli Lilly Reports Earnings Tomorrow. Heres What to Expect. - Barron's

havinPsoriasis is associated with jokeIf there is an increased risk of cancer, a new overview of the studies is available.

Researchers writing in JAMA Dermatology combined data from 58 studies and found that psoriasis levels of all severity increased by 18 percent, and 22 percent were associated with severe psoriasis, compared to those without disease. Cancer mortality was increased in all cases of severe psoriasis.

For some specific cancers, the risk was even higher. For example, they found that severe psoriasis was associated with a more than eleven-fold risk of squamous cell carcinoma (skin cancer), such as twice the risk of oesophageal and liver cancer and a 45 percent increased risk of pancreatic cancer.

Any degree of psoriasis, whether severe or not, was significantly associated with, inter alia, colon cancer, non-Hodgkin's lymphoma and cancers of the kidney and pancreas.

The reason for the association is unclear, but there is a known link between chronic inflammation and cancer and this may help explain the relationship.

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Psoriasis associated with increased cancer risk - asume tech