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drshikhaaggarwal · 2 years ago

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Signs And Symptoms Of Psoriasis

Psoriasis is a chronic inflammatory skin illness characterized by the fast accumulation of skin cells on the skin, resulting in dry, itchy, and scaly areas. It happens when the immune system erroneously targets healthy skin cells, causing them to develop and shed more quickly.

According to Dr. Shikha Aggarwal of Bliss Laser Skin Clinic, who provides the best psoriasis treatment in Ludhiana, psoriasis is caused by hereditary and environmental causes. The specific etiology is unknown. However, it is thought to include an aberrant immunological response. Certain triggers, such as stress, infections, skin injuries, smoking, alcohol intake, and certain drugs, might aggravate the problem.

Treatment for Psoriasis

The best dermatologist in Ludhiana provides the biological/newer psoriasis and psoriatic arthritis treatments.

Biologics are medications delivered via injection or intravenous administration derived from living cells grown in a laboratory. These protein-based drugs have been utilized in medical treatment for many years, but their accessibility has increased significantly in the past decade.

When comparing biologics to conventional systemic medications, it is important to note that they target specific immune system components rather than affecting the entire system. In the case of psoriatic conditions, biologics focus on inhibiting the activity of T cells or blocking immune system proteins like TNF-alpha, IL-17A, IL-12, and IL-23. These cells and proteins play a significant role in developing psoriasis and psoriatic arthritis.

One specific biologic, secukinumab (trade name: Scapho), an IL-17 inhibitor, is commonly used after other medications, such as methotrexate or cyclosporine, have been tried. It is administered through a series of ten shots at regular intervals to achieve treatment for psoriatic arthritis and reach a PASI (Psoriasis Area Severity Index) score of 90. Other biologics that have obtained approval are expected to become available soon.

How to Prevent Psoriasis?

It may not be possible to prevent psoriasis completely, but there are several steps that can help control and lessen both its frequency and severity:

Maintain a healthy lifestyle: A balanced diet, consistent exercise, and stress management can all improve general well-being and possibly lessen the likelihood and severity of psoriasis flare-ups.

Regularly moisturize: Emollients or moisturizers can help calm and hydrate the skin, preventing excessive drying and minimizing itching.

Avoid triggers: Be aware of and keep away from irritants that exacerbate psoriasis symptoms. This can entail reducing stress, giving up smoking, consuming less alcohol, and adopting safety measures to avoid skin injuries.

Take care of the skin: Prevent flare-ups by protecting the skin from abrasive environmental conditions like extreme cold or too much sun exposure. Wear suitable clothing, sunscreen, and moisturizers with an SPF when outdoors.

Use gentle soaps: To avoid inflammation, use gentle soaps or cleansers to wash the skin gently. Scrubbing or itching the afflicted regions might aggravate discomfort.

For an accurate diagnosis and treatment plan, consult a dermatologist for the best psoriasis treatment in Ludhiana. Adhering to the specified medication can aid in the successful management of symptoms.

#psoriasis treatment in Ludhiana #best dermatologist in Ludhiana

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biogenericpublishers · 4 years ago

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Latent Crohn’s Disease Uncovered During Treatment with Secukinumab in a Patient with Ankylosing Spondilitis by Moșteanu Elena Ofelia* in Open Access Journal of Biogeneric Science and Research

Keywords: Crohn’s disease, IL-17A Inhibitors, Secukinumab

Introduction

The inflammatory bowel diseases (IBD) are defined as a group of heterogeneous disorders with multifactorial etiology, in which a chronic inflammation of the digestive tract is caused by disturbances in the immune response to the pathogenic low-diversity gut microbiota [1]. IBD includes two major entities: Crohn’s disease (CD) and Ulcerative Colitis (UC). Current data estimates an impressive prevalence of over 0.3% globally [2]. CD is defined as transmural inflammation of any part of the gastrointestinal tract (GTI), from mouth to the perianal area, with a mainly ileal localization, while UC is an autolimited disease, of localization and histology, affecting only the colorectal mucosa. The clinical presentation of CD typically includes non-specific symptoms as abdominal pain, diarrhea, low-grade fever and weightloss, and with a low prevalence, extraintestinal manifestations. Complications of the disease include stricturing with secondary bowel obstruction, penetrating fistulas or abcesses.

Ankylosing spondylitis (AS) is a disease of spondyloarthropathies’ (SpA) class, which includes arthritis of different etiology. AS is a chronic inflammatory rheumatic disease involving primarily the axial skeleton, clinically expressed by back pain. It’s progressive character leads to continuosly increasing stiffnes of the spine, leading to spine fusion in late stages. In the light of epidemiologic studies of SpA associated with IBD, it was found an association of these pathologies in a third of the patients [3,4]. The overexpression and the complex immunoregulation of IL-17/IL-23 axis is of main importance in the interconnection of these entities [5]. Secukinumab is a human monoclonal antibody, a IL-17A inhibitor that was approved on the market in 2015, 20 years after Th-17, and consequently IL-17, was discovered. The novelty of the current case report is the long-term follow-up of a patient with new-onset of CD during treatment with Secukinumab, describing the resolution of the newly-emerged disease.

Case Report

We present the case of a 40 years old male, smoker, diagnosed with AS in 2006, for which he was treated with sulphasalazine for 4 years, etoricoxib for the next 2 years and etanercept (a TNFα inhibitor) for 7 years, until 2019, when the treatment with Secukinumab started. In 2016, he started having brief episodes of mesogastric abdominal pain, nausea, diarheea, episodes that didn’t remit with any medication, but did spontaneuosly after aproximately 24 hours. Because of the short duration and the low frequency, one episode every 6 months, the patient was not referred. After only 2 weeks of treatment with Secukinumab, in February 2019, these episodes worsened and became more frequent, almost weekly at the moment of the first gastrointestinal assessment in April. The abdominal ultrasound and the colonoscopy didn’t reveal any pathologic modifications. The symptoms were to be controlled by diet. In November, the patient was admitted again as the symptomatology worsened. Physical evaluation revealed pain at the abdomnial palpation in the right flank. Paraclinical examination show only an elevated C-reactive Protein of 2.88 mg/dl. Stool examination excluded any gastrointestinal infection. Abdominal ultrasound was nomal. A colonoscopy was performed and revealed cecal pseudopolyps, but the terminal ileon could not be inspected. The MRI Enterography revealed an ileal inflammatory stenosis, right next to the ileocecal valve, explaining the impossibility of ileocecal valve intubation (Figures 1&2).

The diagnosis was of ileocecal CD due to the inflammatory stenosis with subsequent upstream bowel dilatation (Figure 3). Secukinumab administration was discontinued and treatment with Adalimumab was indicated. At 3-months follow-up, the patient’s gastrointestinal symptomatology completely remmited, the remission being controlled by maintaining the treatment with Adalimumab, daily administration of inulin and simeticone and diet.

Discussion

It is widely known that there is a close association between IBD and SpA in terms of genetics, microbiota and immunology discorders [3,4]. In the etiopatogenesis of IBD, CD4 Th cells play a major role by starting and maintaining the autoimmune inflammation of the gastrointestinal tract, by producing pro-inflammatory cytokines. Beside CD4 Th cells, another subset of Th cells, Th17 cells, are overexpressed at this level and are positively regulated by IL-23, another proinflammatory cytokine produced by antigen-presenting cells, after the contact with the compounds of the pathological microbiota [6]. The activation of IL-17/IL-23 axis is fundamentally connected to the etiology of both CD and AS, IL-17 being found extensively in the blood, the synovial fluid in AS and in the intestinal lamina propria of CD patients [7,8].

Human interleukin IL-17 was found to be involved in different autoimmune diseases, such as systemic sclerosis, multiple sclerosis, systemic lupus erythematosus, psoriasis, asthma, SpAs and IBD [9-14]. While IL-17 is a pro-inflammatory cytokine, current data suggests a protective role on the gastrointestinal tract in IBD patients [15]. The importance of this paradox is to be seen in patients that benefit of biological treatment with IL-17 inhibitors and might associate a latent IBD.

Studies conducted with the objective of administering Secukinumab on CD animal models studies (2 ref trial) and on one human trial, which had to be completed prematurely because of the diseases’ unfavorable evolution compared to placebo, enforcing so the theory of IL-17 as being, in an unknown manner, a protective factor in the natural inflammatory evolution of CD. It is suggested that this difference may be due to the pathological microbiota found in IBD [16-18]. Using the data of these trials and knowing the statistical association between CD and SpA, the IL-17 molecule being overexpressed and playing different roles in both diseases, it might come handy that by inhibiting the IL-17/IL-23 path in SpA, the inflammation of the gut might worsen.

In Secukinumab’s summary of product characteristics, IBDs are mentioned in the section of special warnings and precautions for use, warning that the patients should be closely monitored. The latest retrospective analysis of pooled data from 21 clinical trials, containing 7355 patients, concluded that the cases of IBD during treatment with Secukinumab were uncommon [19]. The reported incidence of CD among 794 patients treated for SpA was 0,1 per 100 patients/year, with 5 new onset cases of CD (0,63%) and an exacerbation found in 3 out of 5 patients with a history of CD. The question this case raised was whether our patient was having a silent CD that was activated by this treatment or he developed the disease on a normal gastrointestinal tract. Anamnestically, the patient did associate in time the onset of gastrointestinal manifestations with the use of Secukinumab.

Diarrhea is a common side effect of this treatment and the patients should be informed of the possibility of having an inactive IBD that might activate during this treatment and they should be advised to adress a specialist if the gastrointestinal symptoms persist. IL-17 positive cells are not detected in the mucosa of healthy individuals, infectious colitis or ischaemic colitis patients, but IL-17 levels are significantly elevated in active and even in inactive CD [20]. Therefore, we can’t state that a subclinical CD was not present, taking into consideration also the frequency of IBD and SpA associating. Using the patient’s history and the current data available in the literature, we strongly believe that Secukinumab was the trigger of CD in this case.

Currently there are treatment guidelines just for IBD and SpA individually, but not any for both IBD and SpA, which would be needed in the near future, as more specific biological therapies emerge, targeting different inflammatory pathways. As written in the summary of product characteristics of Secukinumab, a close follow-up for IBD patients is needed, but, even if the new onset of CD is reported to have a low incidence, a gastroenterological monitoring would be recommended even for healthy individuals, because of the reported prevalence of IBD and SpA association.

Conclusion

A gastroenterological consult before the initiation of the treatment would be beneficial, since SpA may precede the onset of IBD [21,22] or may associate with an underlying asymptomatic intestinal inflammation [23]. This case report is also enforcing the current data of IL-17 having a protective role in IBD, it’s path inhibition leading to exacerbation or to activation of a silent IBD. Of biological therapies, there are safer treatment schemes for a patient with AS and symptomatic or silent CD, which could include Ustekinumab, a human monoclonal antibody that is targeting the IL-12/IL-23 path, Infliximab, a chimeric monoclonal antibody that inhibits tumor necrosis factor alpha (TNFα) or Adalimumab, the first human monoclonal antibody that bind and neutralizez TNFα. The statistics and this case report are underlining the importance of a multi-disciplinary approach when prescribing biological therapy, including rheumatologists and gastroenterologists. Why the IL-17/IL-23 axis is having a „paradoxal” role on the gastrointestinal tract it still a question that’s laking an answer and represents a future research direction.

More information regarding this Article visit: OAJBGSR

https://biogenericpublishers.com/pdf/JBGSR.MS.ID.00156.pdf https://biogenericpublishers.com/jbgsr.ms.id.00156.text/

For more open access journals click on https://biogenericpublishers.com/

#Latent Crohn’s Disease #Secukinumab #Ankylosing Spondilitis #Moșteanu Elena Ofelia*#OAJBGSR #JBGSR #IL-17A Inhibitors

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pranalipawarshinde · 3 years ago

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Psoriatic Arthritis Therapeutics Market Growth Trends, Current Demand, and forecast 2018-2026

Psoriatic Arthritis Therapeutics Market:Overview

Transparency Market Research (TMR) has published a new report titled, “Psoriatic Arthritis Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to the report, the global psoriatic arthritis therapeutics market was valued at US$ 6,011.7 Mn in 2017. It is projected to expand at a CAGR of 11.4% from 2018 to 2026. High prevalence of psoriatic arthritis, large unmet medical needs, and new product approvals are anticipated to drive the global market in the next few years. North America is expected to dominate the global psoriatic arthritis therapeutics market during the forecast period, followed by Europe. Potential unmet medical needs for moderate to severe psoriatic arthritis, increase in adoption of biologic drugs, and approvals of new therapeutic drug classes in the U.S. and Europe are likely to drive the psoriatic arthritis therapeutics market in these regions during the forecast period. The market in Asia Pacific is projected to expand at a high CAGR during the forecast period.

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High prevalence and increase in incidence rate of psoriatic arthritis to drive market

High prevalence and rise in incidence rate of psoriatic arthritis across the globe is a key factor driving the global psoriatic arthritis therapeutics market. Chances of developing psoriatic arthritis among patients with psoriasis is high, and the number of patients with psoriatic arthritis has been increasing significantly in the last few years. According to the International Federation of Psoriasis Association, more than 125 million people were affected with psoriasis, globally, in 2015. It is estimated that between 10% and 30% of patients with psoriasis tend to develop psoriatic arthritis. According to the study published in the Journal of the American Academy of Dermatology, in 2013, Denmark had the highest prevalence rate of psoriatic arthritis, with around 42% prevalence rate, while the lowest prevalence rates were recorded in Canada and Belgium. Thus, the high prevalence and substantial rise in incidence rate of psoriasis and psoriasis-led psoriatic arthritis across globe is a key factor driving the global psoriatic arthritis therapeutics market.

Interleukin inhibitors and PDE4 inhibitors drugs to propel the psoriatic arthritis therapeutics market

The report offers a detailed segmentation of the global psoriatic arthritis therapeutics market based on different therapeutic drug classes approved and commercialized for psoriatic arthritis. Based on drug class, the global market has been segmented into TNF inhibitors, interleukin inhibitors, PDE4 inhibitors, and others. Interleukin inhibitors drugs have evolved as new therapeutic drug class for the treatment of psoriatic arthritis when other therapeutic drugs classes, especially TNF alpha inhibitors, fail to relieve the symptoms of psoriatic arthritis. Interleukin inhibitor drugs, especially IL-17A inhibitor drugs, have shown the highest clinical efficacy, as compared to any other biologic drug available, to relive the symptoms of psoriatic arthritis. Interleukin inhibitors have been recently approved for the treatment of psoriatic arthritis and are increasingly gaining popularity among physicians across the globe. Currently, only four interleukin inhibitors ? Cosentyx (Secukinumab), Stelara (USTEKINUMAB), Tremfya (Guselkumab) and Taltz (Ixekizumab) ? have been approved for the treatment of psoriatic arthritis. Interleukin inhibitors drug sales are estimated to rise about four times by the end of 2026. PDE4 inhibitor is the new therapeutic drug that was approved by the USFDA, in March 2014, for the treatment of psoriatic arthritis. Currently, Otezla (Apremilast) is the only approved PDE4 inhibitor drug for psoriatic arthritis treatment. Within one year of launch, Otezla generated a sale of more than US$ 1 Billion in the year 2016.

Parenteral route of administration to dominate global market

In terms of route of administration, the global psoriatic arthritis therapeutics market has been segmented into oral route, parenteral route, and topical routes. The parenteral route segment dominated the global market in 2017. It is likely to maintain its dominance by the end of 2026. Majority of the therapeutic drugs available for the treatment of moderate to severe psoriatic arthritis are biologics drugs that are administered through the subcutaneous and intravenous routes. The high cost and large volume prescription of biologic drugs contributed to the leading share held by the parenteral route segment in 2017.

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Hospital pharmacies segment to account for high market share

In terms of distribution channel, the global psoriatic arthritis therapeutics market has been segregated into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment is projected to account for a significant share of the market by 2026. Rise in the number of hospital admissions of patients with psoriatic arthritis and high cost of treatment are anticipated to contribute to the high share of the segment by the end of 2026. Promising biologic product pipeline of leading biopharmaceutical companies is likely to receive approval and commercialization in the near future. Biologic drugs are most commonly and easily available at hospital pharmacy stores. Hence, expected launch and commercialization of biologic therapeutic drugs is likely to drive the hospital pharmacies segment during the forecast period.

Asia Pacific offers high incremental opportunity

The psoriatic arthritis therapeutics market in Asia Pacific is projected to expand at a high CAGR during the forecast period. High prevalence of psoriatic arthritis in highly populated countries, such as China and India, rapidly improvement in health care infrastructure, increase in access to health care facilities, and rise in per capita health care expenditure in the region are likely to fuel the market in Asia Pacific during the forecast period. Large base of pharmaceutical companies in countries such as India, Japan, and China also drives the market in the region. High demand and increased adoption of biologic drugs in developed markets, such as Australia & New Zealand, are projected to propel the psoriatic arthritis therapeutics market in Asia Pacific. For instance, in Australia, the number of patients with severe psoriasis receiving treatment under the Pharmaceutical Benefit Scheme (PBS) with biologics has increased by more than 60% between 2014 and 2016.

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Key trend of M&A among leading players to diversify and strengthen psoriatic arthritis product portfolio

The global psoriatic arthritis therapeutics market is highly consolidated, with a few global players accounting for a major share in respective regions. Leading players in psoriatic arthritis therapeutics are engaged in mergers, acquisitions, and strategic collaborations to broaden their psoriatic arthritis therapeutics portfolio. For instance, more than 20 mergers, acquisitions, and strategic collaborations have taken place between 2014 and 2018. Most biopharmaceutical companies have invested significantly in clinical R&D for the development of psoriatic arthritis therapeutics products. Key players operating in the psoriatic arthritis therapeutics market include AbbVie, Inc., Janssen Biotech, Inc., Novartis AG, Amgen, Inc., Celgene Corporation, Pfizer, Inc., Eli Lilly and Company, UCB, Inc., Biogen Inc., and Bristol-Myers and Squibb Company.

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healthcare-market · 3 years ago

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Psoriatic Arthritis Therapeutics Market Report Analysis With Industry Share Insights Shared in Detailed Report

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High prevalence and increase in incidence rate of psoriatic arthritis to drive market

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Interleukin inhibitors and PDE4 inhibitors drugs to propel the psoriatic arthritis therapeutics market

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Parenteral route of administration to dominate global market

Hospital pharmacies segment to account for high market share

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Asia Pacific offers high incremental opportunity

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Key trend of M&A among leading players to diversify and strengthen psoriatic arthritis product portfolio

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fromsciencetopharma · 3 years ago

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Interim trial data for UCB’s bimekizumab shows positive results #psoriasis #psoriasisawareness “Interim data from a trial for UCB’s investigational IL-17A and IL-17F inhibitor bimekizumab in adults with moderate to severe plaque psoriasis have been presented during a presentation at the 2021 American Academy of Dermatology (AAD) summer meeting in the US. According to UCB, this data presented showed that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks or every eight weeks. “These interim results from the BE BRIGHT study highlight the potential of bimekizumab to provide lasting skin clearance to adults living with moderate to severe plaque psoriasis,” said Mark Lebwohl, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai. Bimekizumab is currently under review by the US Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults.” #MSL #FSTP #BCMSLcert #BoardCertifiedMSL #medicalscienceliaison #Medicalaffairs #Pharmacist #PHD https://lnkd.in/eWhXiFc4 https://www.instagram.com/p/CSbG0P9J8cC/?utm_medium=tumblr

#psoriasis #psoriasisawareness #msl #fstp #bcmslcert #boardcertifiedmsl #medicalscienceliaison #medicalaffairs #pharmacist #phd

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pharmaphorumuk · 4 years ago

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MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA.

The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial.

MoonLake has swiftly in-licensed the drug discovered by Sanofi’s Ablynx unit, with plans to develop the drug targeting IL-17A and F.

Based in Switzerland, MoonLake was founded with Series A financing led by BVF Partners with Merck KGaA taking a minority stake.

German Merck also received an undisclosed milestone payment and will be eligible for development and commercial milestone payments as well as “industry standard” royalties on net sales.

Sonelokimab is a single-domain antibody – a fragment of an antibody that can bind specifically to an antigen with high affinity.

It is a potential competitor to Novartis’ blockbuster Cosentyx (secukinumab) and clinical evidence for its use in dermatology and rheumatology is already stacking up.

There was little indication why Merck considered the drug to be surplus to requirements.

Spike Loy, managing director of BVF Partners said MoonLake’s “expert immunology team…has the depth and breadth of experience to ensure sonelokimab achieves its full potential in a range of inflammatory skin and joint diseases.”

Moonlake described sonelokimab as a tri-specific, balanced IL-17A/F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints.

The company noted that it numerically outperformed Cosentyx in a phase 2b clinical trial in moderate-to-severe psoriasis patients.

Sonelokimab’s mechanism of action could open up indications in diseases such as psoriatic arthritis, ankylosing spondylitis and hidraenitis suppurativa.

Other potential disease targets include palmoplantar pustulosis, generalised pustular psoriasis and pyoderma gangrenosum.

Several further phase 2 trials are planned soon, the company said.

The CEO has not yet been announced but chief operating officer Arnout Ploos van Amstel has been announced as co-founder and chief operating officer.

This follows a long career in biopharma including at Novartis, where he headed the firm’s global immunology, hepatology and dermatology business unit.

He also held several positions during a 17-year stint at Wyeth before moving on following its acquisition by Pfizer.

Professor Kristian Reich is the other co-founder and will be chief scientific officer, with more than 25 years of experience in dermatology and immunology.

The post MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab appeared first on .

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factmrresearch1 · 4 years ago

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U.S. NON-ONCOLOGY BIOPHARMACEUTICALS MARKET

Biologics can be defined as molecules derived from living cells such as microorganisms, plants or animal cells and used in the treatment, diagnosis or prevention of diseases. Most of the biologic molecules are very large, complex molecules or mixture of molecules.

Biopharmaceuticals are part of a wider category of therapeutic agents called biologics. Biopharmaceuticals are the substances developed in living systems with the help of biotechnology and are used in therapeutic and diagnostic applications. Non-oncology biopharmaceuticals are the drugs that are used in the treatment of various diseases rather than cancer such as rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, hemophilia, age-related macular degeneration, osteoporosis, and others.

Increasing launches, approvals, and robust pipeline of novel biopharmaceuticals for non-oncology indications

Frequent approvals, launches, and robust pipeline of novel non-oncology biopharmaceuticals for various indications in the U.S. market is expected to significantly support the U.S. non-oncology biopharmaceuticals market growth.

For instance, in September 2018, Eli Lilly and Company received the U.S. Food and Drug Administration (FDA) approval for its Emgality (galcanezumab-gnlm) 120 mg injection, for the preventive treatment of migraine in adults.

In February 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) approved a label update for its Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis.

In July 2018, Amgen Inc. and UCB Inc. resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

The U.S. non-oncology biopharmaceuticals market size was valued at US$ 116.0 Bn in 2018 and is expected to witness a CAGR of 10.2% during the forecast period (2018 – 2026).

Figure 1. U.S. Non-oncology Biopharmaceuticals Market Share (%), By Product Type, 2018-2026

Source: Coherent Market Insights Analysis (2018)

Increasing mergers and collaborations among key players for development of novel non-oncology biopharmaceuticals is expected to support the market growth

Key players in the market are involved in strategic mergers and collaborations for the development of new biopharmaceutical products and to market them in the U.S. Such strategic mergers and collaborations between key players is expected to support the development of novel products, which in turn is expected to fuel the U.S. non-oncology biopharmaceuticals market growth over the forecast period.

For instance, in 2017, Sanofi S.A. and its vaccines business unit Sanofi Pasteur collaborated with MedImmune, the global biologics research and development arm of AstraZeneca Plc., for the development and commercialization of a monoclonal antibody, namely MEDI8897, for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.

High price of branded biologic products is expected to be a major factor negatively affecting its adoption

According to the report published by the Association for Accessible Medicines in 2018, the annual treatment with Humira comes with a list price of US$ 38,000, and according to the report published by I-Mak.org, between 2012 and 2016, the average spending on Humira per person in U.S. increased from US$ 16,000 to US$ 33,000.

Table 1. Revenue of Top Non-oncology Biopharmaceutical Brands in the U.S.

Source: Coherent Market Insights Analysis (2018)

Market Opportunity

In the recent past, various blockbuster biologics such as Humira and Remicade lost patent in the U.S. market. Furthermore, various other high revenue generating biologics are expected to lose their patents in the near future.

Loss of patent in the U.S. market offers lucrative opportunity to other players for development of its biosimilars. Hence, key players in the market are focused on launch and development of biosimilars of biologic products in the market at affordable price.

For instance, in 2017, Merck & Co., Inc. launched RENFLEXIS (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab) by Janssen Biotech, Inc. As per the company, RENFLEXIS is introduced in the U.S. at a list price (wholesaler acquisition cost) of US$ 753.39, representing a 35% discount to the current list price of Remicade, which is its reference product.

Market Challenges

High R&D Investments: Developing an IV/injectable biopharmaceutical requires sophisticated infrastructure, skilled scientists, and significant resource investment. Development of a biopharmaceutical product requires extensive clinical research and multiple phases of trials, which is a lengthy and expensive process. These factors are significant barriers for the new players to enter the market.

Sales and Marketing: The U.S. non-oncology biopharmaceuticals market has established market players with strong sales and marketing team. Presence of such strong players in the country creates a big challenge for new players to enter the market and to sustain against such big players.

Physician Acceptance: Physician acceptance of substitutes for well-established products may be a challenge, particularly among indications for which numerous products are available and substitutes do not exhibit high/ better safety profile and/or lower cost.

Key players operating in the U.S. non-oncology biopharmaceuticals market include Sanofi S.A., Pfizer, Inc., Johnson & Johnson, Novartis International AG, Amgen, Inc., Eli Lilly and Company, AbbVie Inc., Bristol-Myers Squibb Company, F. Hoffmann-La Roche AG, Novo Nordisk A/S, GlaxoSmithKline plc., UCB Pharma, Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company Ltd, AstraZeneca Plc, Mylan N.V., LEO Pharma A/S, Boehringer Ingelheim GmbH, Alexion Pharmaceuticals Inc., Merck & Co., Inc., Elusys Therapeutics, Inc., Swedish Orphan Biovitrum AB, Samsung Bioepis NL B.V., Biogen Inc., and Theratechnologies Inc.

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sriramnanda-blog · 4 years ago

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U.S. NON-ONCOLOGY BIOPHARMACEUTICALS MARKET ANALYSIS

Increasing launches, approvals, and robust pipeline of novel biopharmaceuticals for non-oncology indications .

The U.S. non-oncology biopharmaceuticals market size was valued at US$ 116.0 Bn in 2018 and is expected to witness a CAGR of 10.2% during the forecast period (2018 – 2026).

Figure 1. U.S. Non-oncology Biopharmaceuticals Market Share (%), By Product Type, 2018-2026

Source: Coherent Market Insights Analysis (2018)

Increasing mergers and collaborations among key players for development of novel non-oncology biopharmaceuticals is expected to support the market growth

High price of branded biologic products is expected to be a major factor negatively affecting its adoption

Table 1. Revenue of Top Non-oncology Biopharmaceutical Brands in the U.S.

Source: Coherent Market Insights Analysis (2018)

Market Opportunity

Market Challenges

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#U.S. NON-ONCOLOGY BIOPHARMACEUTICALS MARKET ANALYSIS #GLOBAL U.S. NON-ONCOLOGY BIOPHARMACEUTICALS MARKET ANALYSIS #non-oncology biopharmaceuticals #US biopharmaceuticals market

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daniablub · 4 years ago

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Results From Two Phase 3 Trials of Bimekizumab Unveiled

Most patients with moderate to severe psoriasis achieve clearance with the investigational interleukin-17A and IL-17F inhibitor, results from two phase 3 trials show. Medscape Medical News from Medscape Medical News Headlines https://ift.tt/2BAYotd via IFTTT

#IFTTT #Medscape Medical News Headlines

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rohinic123-blog · 5 years ago

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Psoriatic Arthritis Therapeutics Market Projected to Garner Significant Revenues by 2026

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High prevalence and increase in incidence rate of psoriatic arthritis to drive market

Interleukin inhibitors and PDE4 inhibitors drugs to propel the psoriatic arthritis therapeutics market

Interleukin inhibitors have been recently approved for the treatment of psoriatic arthritis and are increasingly gaining popularity among physicians across the globe. Currently, only four interleukin inhibitors ? Cosentyx (Secukinumab), Stelara (USTEKINUMAB), Tremfya (Guselkumab) and Taltz (Ixekizumab) ? have been approved for the treatment of psoriatic arthritis. Interleukin inhibitors drug sales are estimated to rise about four times by the end of 2026. PDE4 inhibitor is the new therapeutic drug that was approved by the USFDA, in March 2014, for the treatment of psoriatic arthritis. Currently, Otezla (Apremilast) is the only approved PDE4 inhibitor drug for psoriatic arthritis treatment. Within one year of launch, Otezla generated a sale of more than US$ 1 Billion in the year 2016.

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Parenteral route of administration to dominate global market

Hospital pharmacies segment to account for high market share

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Asia Pacific offers high incremental opportunity

Key trend of M&A among leading players to diversify and strengthen psoriatic arthritis product portfolio

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chriscellman · 5 years ago

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Lilly Presents Positive Results for TaltzÂ® (ixekizumab) in Pediatric ...

Taltz is the first and only IL-17A inhibitor with published clinical trial results in pediatric patients with moderate to severe plaque psoriasis Indianapolis, Oct. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant... This story is related to the following: Health, Medical, & Dental Supplies and Equipment Search for suppliers of: Pharmaceuticals from HVAC /companystory/lilly-presents-positive-results-for-taltz-ixekizumab-in-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-at-the-28th-annual-european-academy-of-dermatology-and-venereology-eadv-congress-40030288 via http://www.rssmix.com/

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pharmaphorumuk · 4 years ago

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Avillion/Merck psoriasis nanobody hits the mark in phase 2

UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx.

The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was significantly more effective than placebo at clearing up skin lesions in patients with moderate to severe plaque psoriasis.

The phase 2 study included a range of doses, but at the highest achieved a 90% improvement in Psoriasis Area and Severity Index (PASI) scores in around 80% of patients after 12 weeks, and 100% improvement – i.e. clear skin – in half of patients at week 24.

Merck licensed sonelokimab (M1095) from Ablynx in 2013, and four years later formed a partnership with Avillion to carry out phase 2 and 3 testing of the drug.

The drug is a nanobody, a molecule around one-tenth the size of a regular antibody derived from camelid species such as the llama. Proponents say they can offer greater stability, smaller size, higher potency, and lower production or synthesis costs compared to conventional monoclonal antibodies.

There are already three IL-17 inhibitors on the market, which mainly target IL-17A, Cosentyx (secukinumab) first to get approval for psoriasis in 2015, with Eli Lilly reaching the market in 2016 with Taltz (ixekizumab) followed by Bausch Health’s Siliq (brodalumab) the following year.

Since then Novartis’ drug has grown into a $4 billion brand, while Taltz has also achieved blockbuster status, racking up $1.36 billion in sales last year.

There are plenty of other biologics available for psoriasis however, and Avillion and Merck will need stellar data to differentiate their drug in the market.

In particular, recently launched IL-23 inhibitors like Johnson & Johnson’s Tremfya (guselkumab), AbbVie’s Skyrizi (risankizumab) and Sun Pharma’s Ilumya (tildrakizumab) are growing quickly, fuelled by emerging data that suggests they may be more effective at clearing psoriasis skin lesions than the IL-17 drugs.

Analysts at GlobalData have suggested that IL-23 inhibitors will outsell the IL-17 class in psoriasis within the next few years, and there are a slew of other drugs coming through the pipeline, including orally-active TYK2 inhibitors from Bristol Myers Squibb, Pfizer and Nimbus Therapeutics.

Avillion and Merck hope that IL-17A/IL-17F could represent another step forward in terms of efficacy, particularly when it comes to the speed of response and the durability of the effect.

They have some direct competition as well however from UCB, which has already filed for regulatory approval of its IL-17A/IL-17F candidate bimekizumab in the US, with an FDA verdict due later this year.

UCB already has head-to-head data for bimekizumab versus Cosentyx showing superior skin clearance, as well as against J&J’s older psoriasis therapy Stelara (ustekinumab), an IL-4/IL-23 inhibitor.

The post Avillion/Merck psoriasis nanobody hits the mark in phase 2 appeared first on .

from https://pharmaphorum.com/news/avillion-merck-psoriasis-nanobody-hits-the-mark-in-phase-2/

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lynleyblake · 5 years ago

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Lilly Presents Positive Results for TaltzÂ® (ixekizumab) in Pediatric ...

Taltz is the first and only IL-17A inhibitor with published clinical trial results in pediatric patients with moderate to severe plaque psoriasis Indianapolis, Oct. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant... This story is related to the following: Health, Medical, & Dental Supplies and Equipment Search for suppliers of: Pharmaceuticals from Air Conditioning /companystory/lilly-presents-positive-results-for-taltz-ixekizumab-in-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-at-the-28th-annual-european-academy-of-dermatology-and-venereology-eadv-congress-40030288 via http://www.rssmix.com/

#hvac #air conditioning

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azveille · 5 years ago

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Eli Lilly's Taltz tops J&J's Tremfya with 41% skin clearance in head-to-head tussle

Eli Lilly knows it has a tough fight ahead for IL-17A med Taltz with challengers from Novartis and Johnson & Johnson on the march. But in a head-to-head battle with one—J&J’s Tremfya—Taltz has taken the day in clearing patients’ skin.

Taltz beat out Tremfya in a head-to-head phase 4 study, completely clearing 41.3% of moderate to severe plaque psoriasis patients’ skin at 12 weeks compared with 24.9% for the latter. That top-line data from Lilly’s Ixora-R study was presented Thursday at the Maui Derm NP+PA meeting in Asheville, North Carolina.

Not only did Taltz best its rival at the 12-week primary endpoint, the drug also topped Tremyfa in completely and partially clearing skin at a range of weekly markers, Lilly said. The study is ongoing, with a final marker at 24 weeks.

Ixora-R is the first head-to-head study between an IL-17A inhibitor such as Taltz and an IL-23 inhibitor with full skin clearance as a primary endpoint, and it could translate into a leg up for Lilly's in-class competitor Cosentyx from Novartis.

Lilly is hoping to improve on the $606.3 million in global sales that Taltz pulled in through the first half of the year—a performance that puts it well on track to break the blockbuster barrier. The therapy came just short of it last year, generating $937.5 million.

Cosentyx, by contrast, hit $1.6 billion in the first half, making the first-to-market drug the clear leader in the class.

One area where Taltz has held the lead is in spondyloarthritis, where it could get a head start over its older rival. It put up positive phase 3 results in April, while Cosentyx just Thursday posted the positive data

Tremfya, meanwhile, has a case of its own over Cosentyx after posting head-to-head data in December showing that it helpled more patients achieve clear skin than Tremfya did. At the 48-week mark, 84.5% of Tremfya patients in a phase 3 study achieved a score of 90 on the Psoriasis Area Severity Index (PASI), a commonly used metric for measuring response to psoriasis drugs—and only 70% of patients taking the Novartis blockbuster could say the same.

Tremfya also scored a convenience win in March with an FDA approval for One-Press, a single-dose injector that adults with plaque psoriasis can use to administer the drug at home.

With Tremfya and Taltz on the rise, an already packed psoriasis field got even more competitive with the approval of AbbVie's much-hyped Skryizi in April. The IL-23 med launched with an $88,500 first-year price—inclusive of two starter doses—and a $59,000 maintenance-dose price, pledging to offer “broad and rapid access for patients.”

Editor's Note: This story has been updated to correct a figure. Taltz cleared skin in 41.3% of patients in its study.

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cancersfakianakis1 · 6 years ago

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Tumor-associated neutrophils induce EMT by IL-17a to promote migration and invasion in gastric cancer cells

Abstract

Purpose

Epithelial to mesenchymal transition (EMT) can contribute to gastric cancer (GC) progression and recurrence following therapy. Tumor-associated neutrophils (TANs) are associated with poor outcomes in a variety of cancers. However, it is not clear whether TANs interact with the EMT process during GC development.

Methods

Immunohistochemistry was performed to examine the distribution and levels of CD66 + neutrophils in samples from 327 patients with GC. CD66b + TANs were isolated either directly from GC cell suspensions or were conditioned from healthy donor peripheral blood polymorphonuclear neutrophils (PMNs) stimulated with tumor tissue culture supernatants (TTCS) and placed into co-culture with MKN45 or MKN74 cells, after which migration, invasion and EMT were measured. Interleukin-17a (IL-17a) was blocked with a polyclonal antibody, and the STAT3 pathway was blocked with the specific inhibitor AG490.

Results

Neutrophils were widely distributed in gastric tissues of patients with GC and were enriched predominantly at the invasion margin. Neutrophil levels at the invasion margin were an independent predictor of poor disease-free survival (DFS) and disease-specific survival (DSS). IL-17a + neutrophils constituted a large portion of IL-17a-producing cells in GC, and IL-17a was produced at the highest levels in co-culture compared with that in TANs not undergoing co-culture. TANs enhanced the migration, invasion and EMT of GC cells through the secretion of IL-17a, which activated the Janus kinase 2/signal transducers and activators of transcription (JAK2/STAT3) pathway in GC cells, while deprivation of IL-17a using a neutralizing antibody or inhibition of the JAK2/STAT3 pathway with AG490 markedly reversed these TAN-induced phenotypes in GC cells induced by TANs.

Conclusions

Neutrophils correlate with tumor stage and predict poor prognosis in GC. TANs produce IL-17a, which promotes EMT of GC cells through JAK2/STAT3 signalling. Blockade of IL-17a signalling with a neutralizing antibody inhibits TAN-stimulated activity in GC cells. Therefore, IL-17a-targeted therapy might be used to treat patients with GC.

http://bit.ly/2RdGd3B

#Oncology-Sfakianakis

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