Monthly Archives: January 2021

Newswise In a major register-based study, scientists at University of Gothenburg, Sweden, have now demonstrated a connection between inferior physical fitness in young adults and elevated risk of the autoimmune disease psoriasis. For the male recruits to compulsory military training who were rated as the least fit, the risk of developing psoriasis later was 35 percent higher than for the fittest.

The study was based on data on more than 1.2 million men conscripted, aged 18, into the Swedish Armed Forces between the years 1968 and 2005. During the enrollment process, all these young men underwent the same fitness test on an exercise bicycle. The researchers divided the data, according to how fit the men were, into three levels (low, medium, and high fitness). They then merged the data with other registers, using Sweden's National Patient Register to obtain diagnostic codes for psoriasis and the joint disease psoriatic arthritis. The men who had already received one of these diagnoses before conscription were excluded from the study.

Later in life, between the ages of 37 and 51, just over 23,000 of the conscripts developed psoriasis or psoriatic arthritis. In the low-fitness group, 2.5 percent developed one or both of these diseases, while only 1.7 percent in the high-fitness group did so. In calculating this risk differential, the scientists adjusted for other risk factors, such as body mass index (BMI).

Association not causal

Thus, the less fit the men were when they were recruited, the higher the proportion of them who later fell ill with psoriasis or psoriatic arthritis. In the low-fitness group, the risk of developing psoriasis was 35 percent higher, and that of developing psoriatic arthritis 44 percent higher, than in the high-fitness group.

"We show that there's an association between lower fitness and raised risk of developing psoriasis and psoriatic arthritis, but we don't show a causal connection. So we can't say that these health conditions can be prevented by exercising," says the study's first author Marta Laskowski, a doctoral student in dermatology at the University of Gothenburg and resident physician (specialist trainee) at Sahlgrenska University Hospital.

Group in need of monitoring

The group of men who were least fit was also the smallest: just under 48,000 or 3.9 percent of all the conscripts in the study. This is a group that healthcare services should try to monitor regularly.

"Low fitness was already known to boost the risk of incurring cardiovascular disease, and psoriasis as such is linked to raised cardiovascular disease risk, too. The results from our study confirm the reasons for assessing people's fitness early in life, to identify individuals at a higher risk for adverse health outcomes later in life," Laskowski says.

Previous research has indicated that, in general, people with psoriasis are less fit than those without it who engage in an equal amount of physical activity. However, the reasons for this difference have not been fully clarified.

"One weakness of our study is that we weren't been able to monitor the trends of the men's fitness during the intervening years, between their conscription and the disease onset. We're also lacking data on smoking, which is a known risk factor for psoriasis," Laskowski explains.

Scaly skin patches

Some 300,000 Swedes have psoriasis in a mild, moderate, or severe form. It is a chronic, systemic inflammatory disease that affects women as often as men. What triggers its onset is not entirely clear, but heredity is known to play a large part in combination with external factors. The most common type, plaque psoriasis, causes reddened, flaking, and itchy skin lesions ("plaques").

Psoriasis sufferers also often have other diseases. Some 30 percent get the inflammatory joint condition known as psoriatic arthritis. Examples of other known comorbidities are obesity, cardiovascular disease, diabetes, and depression.

In recent years, treatment options have substantially improved. Today, besides ointments with local effects, there are drugs that have systemic effects. Recent years have also seen the emergence of efficacious biological agents that modulate the signaling cascade in the inflammatory process that drives psoriasis.

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Low fitness linked to higher psoriasis risk later in life - Newswise

Psoriasis Drugs Industry Market size and Key Trends in terms of volume and value 2020-2025

The research report of Psoriasis Drugs Industry Market study report covers all main geographical regions and sub-regions in the world and focuses on product sales, cost, and Psoriasis Drugs Industry market size and growth opportunities in these regions. The Psoriasis Drugs Industry market industry provides market research data status categorizes the Psoriasis Drugs Industry market into key dynamics, region, type and application.

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Product spectrum

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Regional analysis

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Psoriasis Drugs Industry Market size and Key Trends in terms of volume and value - Business-newsupdate.com

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Amgen is partnering with Ann Arbor, Michigan-based EVOQ Therapeutics for a license and collaboration deal to discover and develop drugs for autoimmune disorders. Amgen is paying EVOQ $240 million up front in addition to royalties on subsequent sales.

EVOQs focus is on autoimmune diseases, although its original intent was targeting oncology. It is a spinoff from the University of Michigan (U of M) in 2016. It was co-founded by James Moon and Anna Schwendeman, both from U of M. Moon is the chief scientific officer and Schwendeman is the vice president of preclinical development. William Brinkerhoff is also a co-founder and acts as the chief executive officer. Their technology platform is called NanoDisc, a high-density lipoprotein platform, that they believe can be used to deliver peptides directly into the lymph nodes.

The two companies will work together to use dendritic cells to develop immune tolerance. The companys in-house pipeline includes two compounds that target MOG antibody disease, a new condition that results in neuro-spinal swelling and is typically misdiagnosed as multiple sclerosis (MS), and type 1 diabetes.

A big driver of Amgens autoimmune portfolio is Otezla (apremilast). Amgen acquired Otezla for moderate-to-severe plaque psoriasis and psoriatic arthritis in November 2019 from Celgene. Bristol Myers Squibb acquired Celgene, but was forced by the U.S. Securities and Exchange Commission (SEC) to divest Otezla because of a competing product in their pipeline, deucravacitinib (BMS-986165). In fact, in November 2020, deucravacitinib beat out Otezla in the POETYK PSO-1 Phase III clinical trial in one of the key secondary endpoints. The drug otherwise hit the co-primary endpoints on psoriasis.

Amgen paid $13.4 billion in cash for access to Otezla, which is approved in the U.S. for moderate-to-severe plaque psoriasis patients who are candidates for phototherapy or systemic therapy; adults with active psoriatic arthritis; and adults with oral ulcers associated with Behcets disease. The drug is approved in more than 50 markets outside the U.S. and has patent protection through at least 2028 in the U.S. In 2018, Otezla sales were $1.6 billion.

In other news, Amgen announced new data from its oncology pipeline in lung cancer will be presented at the 2020 World Conference on Lung Cancer (WCLC) from January 28-31, 2021. That will include Phase II data from the CodeBreaK 100 clinical trial of sotorasib in KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). They will also describe updated Phase I data from AMG 757, a first-in-class BiTE molecule that targets delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC).

We are incredibly excited to present the first complete Phase II non-small cell lung cancer data set for an investigational KRAS G12C inhibitor, including novel biomarker analyses, said David M. Reese, executive vice president of Research and Development at Amgen. This is an historic moment not only for us, but for the scientific community working on the 40-year quest to target KRAS, one of cancer researchs toughest challenges. Additionally, following recent regulatory submissions to the FDA and European Medicines Agency, we remain focused on rapidly bringing this potential foundational KRAS G12C therapy to patients with advanced non-small cell lung cancer harboring this mutation.

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This article was originally published here

J Am Acad Dermatol. 2021 Jan 7:S0190-9622(21)00016-5. doi: 10.1016/j.jaad.2020.12.058. Online ahead of print.

ABSTRACT

OBJECTIVE: To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic.

STUDY DESIGN: The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by non-voting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the NPF. A Delphi process was conducted.

RESULTS: The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus, 14 with moderate consensus.

LIMITATIONS: The evidence behind many guidance statements is variable in quality and/or quantity.

CONCLUSION: These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with SARS-CoV-2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge.

PMID:33422626 | DOI:10.1016/j.jaad.2020.12.058

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National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic: Version 2 - Advances in Psoriatic...

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S a global leader in medical dermatology announced today that the first patient has been screened in the first head-to-head clinical trial to evaluate brodalumab (marketed in the European Union as Kyntheum) compared with guselkumab (marketed globally as Tremfya) in adult patients with moderate-to-severe plaque psoriasis who have an inadequate response to ustekinumab (marketed globally as Stelara) treatment.

The COBRA (COmparing BRodalumab And guselkumab in ustekinumab inadequate responders) clinical trial is a randomized, double-blind, parallel-group, multinational study. The primary study endpoint is the proportion of patients who achieve PASI 100 (100% skin clearance) at week 16. The study further includes several secondary and exploratory endpoints, including the key secondary endpoint of time to PASI 100 response while on treatment for up to 28 weeks. PASI scores are used in clinical trials for psoriasis treatments to measure a change in disease severity.

People with moderate-to-severe psoriasis benefit from complete skin clearance, said Prof. Kristian Reich, Professor for Translational Research in Inflammatory Skin Disease at the University Medical Center Hamburg Eppendorf. We have specifically designed this study to help understand which newer mechanism of action is the best option to help patients potentially achieve complete skin clearance when there is an insufficient response to older-generation biologics.

Brodalumab is the only biologic treatment that selectively targets the interleukin-17 (IL-17) receptor subunit A.1 The IL-17 cytokines a family of proteins involved in immune responses send signals through the IL-17 receptors, which cause the inflammation associated with psoriasis.2

Guselkumab is a biologic treatment that selectively targets the interleukin 23 (IL-23) cytokine. IL-23 affects the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.3

We look forward to learning how brodalumab, in comparison with a treatment that targets the IL-23 pathway, can offer benefits to patients who no longer respond to less targeted therapies, said Dr. Per Sproegel, Vice President, Medical Sciences, Global Research & Development, LEO Pharma.

#ENDS#

NOTES TO EDITORS

About the pathophysiology of psoriasis

Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.4 The discovery of the central role of the IL-23/type 17 T-cell axis in the development of psoriasis has led to major paradigm shifts in the pathogenic model for this condition.4 Medical research has further confirmed that the expression of IL-17 cytokines is increased in psoriatic lesion tissue.5

About LEO Pharma

The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit http://www.leo-pharma.com.

References

1 Campa M et al. Dermatol Ther 2016;6:112.

2 Armstrong A et al. J Drugs Dermatol 2019;18(8 Suppl 2):s202-208.

3 Tremfya Summary of Product Characteristics January 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf (Accessed September 2020).

4 Hawkes JA et al. J Allergy Clin Immunol. 2017;140:64553.

5 Martin D et al. J Invest Dermatol 2013;133(1):17-26.

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LEO Pharma initiates head-to-head study to evaluate brodalumab vs. guselkumab in adult patients with moderate-to-severe psoriasis who have inadequate...

If you can identify leading companies in growing industries, you'll be well on your way to finding stocks that will bolster your portfolio's value. Beyond that, it helps to pick companies that have investor-friendly policies -- not to mention favorable tailwinds or upcoming catalysts for growth.

In that vein, after an excellent 2020, the pharma company AbbVie (NYSE:ABBV) is positioned for an encore performance in 2021. Its quarterly revenue is growing faster than 52% year over year, and the company is strongly profitable thanks to its collection of in-demand immunology and rheumatology therapies. But despite three green flags for the upcoming year, it also has one looming red flag that future investors absolutely can't miss if they want to make an informed decision about buying shares. Let's dive in and take a look at what's coming up.

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Rinvoq, one of AbbVie's drugs for rheumatoid arthritis, is already on the market. But in 2021, it may be approved for as many as three new indications, thereby increasing its pool of potential patients and its revenue-making potential, too.

AbbVie is currently awaiting regulatory review of its evidence that Rinvoq is effective for psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis. The potential approval for atopic dermatitis is especially important, as it would mean that the company could serve a new market that it currently has no presence in.

Sometime this year, AbbVie will provide an update from Skyrizi's phase 3 clinical trial for Crohn's disease. If this update is favorable, it'll mean that the company is continuing to see success with its efforts to build out its immunology pipeline by seeking new indications of its established assets. Given that the global market for Crohn's disease therapeutics was estimated to be worth $14.1 billion in 2020, the company could potentially look forward to a slice of the market share moving forward.

The bigger picture here is that advancing rapidly with Skyrizi will help AbbVie replace revenue from Humira, the decline of which has loomed for years. Right now, Skyrizi is already approved for psoriasis, and there are ongoing clinical trials to examine its effectiveness for ulcerative colitis and psoriatic arthritis. If it's ultimately approved for those indications, it'd be capable of serving the majority of the markets addressed by Humira.

AbbVie's drug Humira for rheumatoid arthritis is its largest earner, netting the company an estimated $16 billion from its U.S. sales in 2020 alone. And management expects domestic revenue from Humira to keep expanding in 2021, even as it faces rising competition from biosimilars.

Another way of looking at this green flag is that biosimilars haven't eroded Humira's market share as rapidly as many people had expected. Therefore, AbbVie has a bit more time before sales from Humira fall off the cliff. So investors can have a measure of confidence that AbbVie won't need to take defensive financial actions like curbing its dividend anytime soon.

Even though AbbVie is still seeing revenue growth from Humira in the U.S., the same is not true when it comes to international sales. Continuing a trend that started with gusto in 2018 when Humira lost patent exclusivity in Europe, biosimilars will erode Humira's market share throughout 2021 outside the U.S., with management estimating a sharp drop of 45% this year.

In dollar values, this means that after making $3.7 billion in international sales in 2020, this year Humira could make as little as $1.5 billion. That's going to leave a small but noticeable dent in the company's trailing 12-month revenue of $40.65 billion. But if it succeeds in getting its other immunology projects to pick up its market share where Humira leaves off, its stock price could still be secure for the time being.

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3 Green Flags for AbbVie in 2021 and 1 Red Flag - The Motley Fool