Category Archives: Psoriasis

Coalition of Stakeholder Groups to Collaborate on Development of Tools to Facilitate Important Dialogue

TORONTO and OTTAWA, ON, Sept. 29, 2021 /CNW/ - Significant numbers of Canadian women+ with chronic rheumatic, psoriatic disease and inflammatory arthritis say they need more information and support during different stages of life (including child-bearing years and menopause) in order to better manage their conditions and overall health.

CPN/RCP Logo (CNW Group/Canadian Spondylitis Association)

Today the Canadian Arthritis Patient Alliance (CAPA), the Canadian Association of Psoriasis Patients (CAPP), the Canadian Psoriasis Network (CPN) and the Canadian Spondylitis Association (CSA) released findings from the Women's Sexual and Reproductive Health Survey demonstrating that women+ have varying levels of comfort discussing reproductive and sexual health with their healthcare providers, romantic partners and support networks.

The four stakeholder groups advocate that without enhanced education, support and dialogue from HCPs, partners and support networks, there can be a number of inherent risks to the patient who may struggle to manage their condition. Honest, informative, two-way discussions about issues, such as the impact of medications on fertility/family planning; the risks and challenges of parenting with chronic disease and pain management, are necessary to empower women as they navigate their health concerns.

The onset and diagnosis of inflammatory arthritis, rheumatic and psoriatic diseases commonly affect people in the prime of their lives, most often between the ages of 30 and 50 for most rheumatic conditions and either between the ages of 15 and 30 or 50 and 60 for psoriasis. Often, these individuals have unique reproductive and sexual health concerns related to contraception, menopause, family planning, and parenting.

The full survey report and infographics are available on each organization's website (included below) and demonstrates a general lack of information:

Story continues

More than 60% of survey participants indicated that they did not have enough information about sexual health and the impact of their condition(s).

Less than 45% of survey participants felt that their healthcare providers provided adequate information about the impact of their medication(s) on their ability to conceive, with significant variation by region of Canada.

Less than half (46%) of survey participants received counselling from a doctor about pregnancy risks and medication safety before considering pregnancy.

63% of survey participants had to switch the medications they were taking to ones that were safe to use during pregnancy or while breastfeeding.

More than half of the women+ surveyed have experienced financial hardships associated with paying for their medications.

87% of survey participants worry about the impact of their condition on their mental health yet only 16% have a mental health professional as part of their care team.

About a third of participants (32%) do not feel like their healthcare provider gives them useful and helpful options to deal with their pain.

The report makes four key recommendations:

1. Destigmatize reproductive and sexual health in women+ as its part of a holistic approach to patient care. We recommend that patients, healthcare providers, romantic partners and support networks raise these topics in conversation early and often.

2. Patient education resources must be available to women+ focused on how to communicate effectively about sexual health needs and concerns, how to navigate reproductive and sexual health at different life stages, the impact of medications on sexual and reproductive health and the role of mental health and wellbeing.

3. Specialists including rheumatologist and dermatologists should counsel patients about the impact of medications and treatments on reproductive and sexual health early in their disease journey in order for patients to make informed choices.

4. Researchers should consider the sex and gender impacts on access to care, medication safety, mental health, parenting and aging to ensure that women+ have the best evidence to inform decision-making.

Based on the findings from the survey, CAPA, CAPP, CPN and CSA are committed to developing tools and educational resources to raise awareness of the issues and facilitate dialogue about the reproductive and sexual health experiences and needs of women+ living with rheumatic, inflammatory and psoriatic diseases.

We appreciate the educational grant from UCB Canada to develop the survey and this report.

Quotes:

Canadian Arthritis Patient Alliance, Laurie Proulx, Volunteer Vice-President: "Planning for pregnancy is recognized as critical for people living with these chronic health conditions. We need to better support people to access information and care that supports optimal decision-making. This report sets an important foundation to inform the development of better supports as women+ navigate pregnancy and parenting with success." http://www.arthritispatient.ca

Canadian Association of Psoriasis Patients, Rachael Manion, Executive Director: "Women+ living with rheumatic and psoriatic diseases and inflammatory arthritis need different types of information throughout their lives, including about contraception and family planning, parenting, menopause, how to access treatments, mental health and pain management. This collaboration explores what women+ are facing as they try to navigate these issues and the health systems across Canada, and how everyone can better support them." https://www.canadianpsoriasis.ca/en/

Canadian Psoriasis Network, Antonella Scali, Executive Director: "Living with chronic conditions like inflammatory arthritis, rheumatic and psoriatic diseases can have a significant impact on mental health. Experiences with anxiety, depression and chronic pain are not uncommon and these issues can be particularly significant for women+ at different stages of their lives. The Baring It All report explores these experiences and provides insights and recommendations for how women+ with these conditions can be supported." https://www.canadianpsoriasisnetwork.com

Canadian Spondylitis Association, Wendy Gerhart, Executive Director: "Over half of the women+ surveyed have experienced significant financial hardships associated with paying for their medications. It is critical that governments and insurers reassess their policies looking through a gender-neutral lens to ensure inclusivity for all. It is essential that all Canadians have equitable and timely access to medications and do not suffer financial hardships in receiving the treatment they need to live full and productive lives." http://www.spondylitis.ca

CAPA Logo (CNW Group/Canadian Spondylitis Association)

CAPP/ACPP Logo (CNW Group/Canadian Spondylitis Association)

CSA Logo (CNW Group/Canadian Spondylitis Association)

SOURCE Canadian Spondylitis Association

Cision

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2021/29/c3941.html

More here:
Women with Rheumatic and Psoriatic Diseases and Inflammatory Arthritis Share Experiences Discussing Reproductive and Sexual Health - Yahoo Finance

Topical roflumilast provided significant improvements in severity and burden of itch in Phase 3 plaque psoriasis studies, as well as Phase 2 studies in seborrheic dermatitis and scalp and body psoriasis.

Quality of life improvements were achieved starting as early as week two

Pivotal studies support potential use of roflumilast cream as effective and well-tolerated non-steroidal topical therapy for plaque psoriasis

WESTLAKE VILLAGE, Calif., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced new patient-reported outcome data that show topical roflumilast provides significant reductions in itch, a common and bothersome symptom of multiple dermatologic conditions. Once-daily roflumilast cream reduced both the severity and burden of itch, and improved quality of life, in the DERMIS-1 and DERMIS-2 Phase 3 pivotal studies in chronic plaque psoriasis. In addition, in two separate Phase 2 studies, topical roflumilast foam showed a robust and rapid reduction of itch in scalp and body psoriasis and seborrheic dermatitis. These data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress (Sept 29 Oct 2).

Itch is the most frequently reported symptom associated with dermatologic conditions such as plaque psoriasis, scalp psoriasis and seborrheic dermatitis, severely impacting patients quality of life. These robust and consistent data across multiple indications demonstrate that topical roflumilast significantly improved both the severity and burden of itch, that symptoms improved quickly and continued improving through the course of treatment, said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. Meaningfully impacting symptoms that matter most to patients, such as itch, is at the core of Arcutis mission. Topical roflumilast continues to demonstrate strong efficacy with a safety and tolerability profile that, if approved, should enable chronic use and the ability to use across the body.

Story continues

Dr. Melinda J. Gooderham presented patient-reported outcome data from the DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream that showed the mean reduction in Worst-Itch Numeric Rating Scale (WI-NRS) score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as two weeks (mean change from baseline of -3.7 and -4.0 for roflumilast cream; -1.4 and -1.7 for vehicle; P<0.0001). In addition, more than two-thirds of patients with a WI-NRS of four or greater at baseline achieved a reduction of four-points or more with roflumilast cream compared to less than one-third of individuals using vehicle at week 8 (67.5% and 69.4% of patients using roflumilast cream compared to 26.8% and 35.6% using vehicle; P<0.0001). Overall quality of life was also improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index (DLQI) with an improvement of 65.2% from baseline in the DLQI score for roflumilast cream vs 12.7% vehicle in DERMIS-1 and a 69.4% improvement from baseline DLQI score roflumilast cream vs 9.0% vehicle in DERMIS-2 (P<0.0001).

In a separate poster presentation highlighting results from the Phase 2 randomized, double-blind, vehicle-controlled study of roflumilast foam in patients with plaque psoriasis on the scalp and body, 68.2% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 23.1% of patients using vehicle at week eight. These results are consistent with that observed specifically in the scalp with 71.0% of patients with a baseline Scalp Itch (SI)-NRS of four or greater at baseline achieving a four-point or greater improvement in SI-NRS as compared to 18.5% in the vehicle treated group.

Likewise, data presented in a poster presentation from a Phase 2 study of patients with seborrheic dermatitis showed approximately 64.6% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 34.0% of patients using vehicle at week eight.

In these studies, both roflumilast cream and roflumilast foam met their primary endpoints and were generally well-tolerated.

Roflumilast cream 0.3% met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 42.4% patients compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in the Phase 3 studies DERMIS-1 and DERMIS-2 respectively (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS One and Two)

Roflumilast foam met its primary endpoint in the Phase 2 Scalp and Body study with a Scalp-Investigator Global Assessment success rate of 59.1% patients compared to a vehicle rate of 11.4% (P<0.0001). Of these, 34.3% of patients on roflumilast foam achieved a status of clear.

Roflumilast foam met its primary endpoint in the Phase 2 seborrheic dermatitis study with 73.8% of roflumilast treated patients achieving IGA success at week 8 vs 40.9% of vehicle-treated patients (P<0.0001). Additionally, 35.5% of patients using roflumilast foam achieved an IGA status of clear at week 8 vs 15.2% of vehicle-treated patients.

About Topical Roflumilast Arcutis is developing topical cream and foam formulations of roflumilast a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis dermatology development platform includes a robust pipeline with seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated by the end of 2022. The companys lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit http://www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com

InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com

See the rest here:
New Data Highlighting Itch Reduction with Topical Roflumilast in Multiple Dermatologic Conditions Presented at European Academy of Dermatology and...

AxisBiotix-Ps was described as delivering "tremendous results" for sufferers of the skin condition during a study conducted earlier this year

(, ) said the soft launch of its probiotic food supplement developed to help alleviate the effects of the skin condition psoriasis will take place on October 29, which is also World Psoriasis Day.

Initially, AxisBiotix-Ps will be marketed on a subscription basis and priced per sachet in the US at US$2.00, in the UK 1.50, and in Europe 1.80 and sold in boxes of 28.

Results from a study of self-identified psoriasis sufferers revealed the probiotic helped alleviate itchiness and irritability in around three-quarters of the cases.

The overall positive response from participants who identified as having psoriasis to AxisBiotix-Ps was tremendous, and we are very grateful for their continued interest and subsequent support, including their moving written and video testimonials, said chief executive Stuart Ashman.

"The soft launch aspect of the commercial strategy is a key element. Given the incurable and severe nature of psoriasis and its significant impact on people's lives, we have always said that we would initially release AxisBiotix-Ps on a controlled basis to ensure our distribution systems are robust. We want to ensure a continuous supply to our customers at all times."

The rest is here:
SkinBioTherapeutics to launch psoriasis targeting food supplement on October 29 - Proactive Investors UK

Interleukin (IL) are group of cytokines that are synthesized by lymphocytes, monocytes, macrophages, and other cells. They regulate cell growth, cell differentiation, and cell motility. Fifteen different types of interleukin are present in body. Interleukin inhibitors are immunosuppressive agents that inhibit the action of interleukins. Interleukin inhibitors are used in various conditions including asthma, ankylosing spondylitis, eczema, gout, arthritis (psoriatic and rheumatoid), psoriasis, and systematic sclerosis. Asthma is a chronic and long-term inflammatory disease of the lungs characterized by bronchospasm and airway obstruction. Ankylosing spondylitis is a type of arthritis that affects the spine. It affects about 0.1% to 0.5% of the adult population and can occur at any age. Eczema is a condition where patches of the skin become inflamed, itchy, red, cracked, and rough. It affects 31.6% of people in the U.S. Gout is a common and complex form of arthritis, characterized by severe joint pain. Psoriasis is non-contagious, chronic skin condition characterized by thickened and scaling skin. Systematic sclerosis is a connective tissue disease characterized by atrophy of the skin, vasomotor disturbance, and fibrosis.

Request Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=50718

Increase in the prevalence of chronic inflammatory diseases such as arthritis, psoriasis, and asthma is a major factor fueling the global interleukin inhibitors market. In addition to this, increase in FDA approvals for novel drugs and therapies for chronic inflammatory disease treatment is further boosting the market. For instance, in 2017, Dupixent monoclonal antibody that targets the interleukin 4 became the first biologic approved for atopic dermatitis. Moreover, the presence of a strong product pipeline and rise in awareness among people regarding chronic inflammatory diseases and their treatment in emerging economies are projected to propel the market in the near future. However, side effects and high cost associated with biological therapy are likely to hamper the global interleukin inhibitors market in next few years.

Request for Analysis of COVID-19 Impact on Interleukin Inhibitors Market

https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=50718

The global interleukin inhibitors market can be segmented based on disease condition, distribution channel, and region. Based on disease condition, the global interleukin inhibitors market can be categorized into asthma, ankylosing spondylitis, eczema, gout, arthritis (psoriatic and rheumatoid), psoriasis, systematic sclerosis, and others. In terms of distribution channel, the global market can be categorized into hospital pharmacies, online pharmacies, retail pharmacies, clinics, and research institutes.

Pre book Interleukin Inhibitors Market Report at https://www.transparencymarketresearch.com/checkout.php?rep_id=50718&ltype=S

In terms of region, the global interleukin inhibitors market can be divided into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. North America is expected to hold a prominent share of the global market, due to rise in the patient pool suffering from psoriasis, arthritis, asthma, and other chronic inflammatory diseases. The presence of well-established drugs makers in North America is further expected to boost the market in the region. Additionally, according to the International Federation of Psoriasis Associations (IFPA), there are about 150,000 new cases of psoriasis every year in the U.S. According to a Centers for Disease Control and Prevention (CDC) report, in 2016, about 26,515 people lived with asthma in the U.S. Europe currently holds a strong position in the global interleukin inhibitors market. However, demand for interleukin inhibitors in the region is likely to decline due to intense competition among key players in the market in Europe. The market in Asia Pacific and Latin America is anticipated to expand at a rapid pace over the next few years due to rise in awareness regarding chronic inflammatory diseases, rapidly developing health care infrastructure, and increase in adoption of technology in these regions.

Read More Information: Top of Form

ReaRR

https://www.transparencymarketresearch.com/interleukin-inhibitors-market.html

Key players operating in the global Interleukin inhibitors market are Regeneron Pharmaceuticals, Inc. Novartis AG, Valeant Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Johnson & Johnson., Genentech, Inc. (Roche), Eli Lilly and Company, GlaxoSmithKline plc, Sanofi S.A., and AstraZeneca plc.

Browse More Trending Reports by Transparency Market Research:

Healthcare Facilities Management Market:

The demand within the healthcare facilities management market is increasing at a boisterous pace in recent times. The healthcare industry has gradually shifted from being an absolutist focused on medical procedures to a more diverse industry that prioritises patient safety, utility, and wellness. For this reason, healthcare facilities do not just focus on inducting the latest medical device or technology, going an extra mile to ensure state-of-the-art rooms, beds, and storage systems. Healthcare facilities management is a broad area that covers several services provided across hospitals wards, waiting areas, and other zones. In this context, the growth of the global healthcare facilities management market is expected to attract huge-scale revenues.

Prosthetics Market:

Since powered prosthetic devices require a great deal of electricity to function efficiently, researchers are developing innovative skin that stores electricity. For instance, researchers at the University of Glasgow have developed a combination electronic skin to generate and store electricity for prosthetic devices. Thus, manufacturers in the prosthetics market should collaborate with researchers to gain expertise in electrically powered prosthetics.

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

Contact

Mr. Rohit BhiseyTransparency Market Research

State Tower,

90 State Street,

Suite 700,

Albany NY - 12207

United States

USA - Canada Toll Free: 866-552-3453

Email: sales@transparencymarketresearch.com

Website: https://www.transparencymarketresearch.com/

Read the original:
Interleukin Inhibitors Market: Increase in the prevalence of chronic inflammatory diseases to drive the market - BioSpace

Earlier this year, MC2 Therapeutics entered a partnership with Almirall S.A. (ALM), a global biopharmaceutical company, granting Almirall exclusive European rights to commercialize Wynzora Cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate).

Wynzora Cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) is approved in Europe through a decentralized procedure for the treatment of mild to moderate psoriasis vulgaris in adults, including scalp psoriasis.

"We are excited to present new clinical research data to the European dermatology community at EADV 2021. Sharing of clinical data and continued development of our exciting pipeline are part of our commitment to address unmet needs for people living with chronic inflammatory diseases," says Dr. Morten Praestegaard, Ph.D., COO at MC2 Therapeutics.

About PsoriasisVulgaris

Psoriasis is a common, non-contagious, chronic skin disease with no clear cause or cure. The negative impact of psoriasis on people's lives can be immense as it affects the appearance of the skin with red, scaly plaques. Psoriasis affects people of all ages and in all countries. The reported prevalence of psoriasis in Europe is approximately 3% of the population1,2, making psoriasis a severe health problem with more than 100 million individuals affected worldwide.3The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease, and depression.3

About topical treatment of mild to moderate psoriasis vulgaris in adults

The combination of 50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate is a well-established topical treatment for mild to moderate psoriasis in adults. An aqueous cream formulation of calcipotriol and betamethasone dipropionate, based on the proprietary PAD Technology, allows for favorable delivery of the active ingredients to the target tissue. Wynzora Cream was also approved in the US by the FDA in July 2020 and launched in that market.4

About MC2 Therapeutics

MC2 Therapeutics is a privately held commercial-stage pharmaceutical company committed to building leadership in topicals and treatments for autoimmune and chronic inflammatory conditions. Our focus is to develop and advance best-in-class or first-in-class therapies by understanding the pathophysiology and researching novel compounds. Our goal is to minimize the burden of disease for people living with inflammatory or autoimmune diseases by addressing significant unmet needs. Using our patented PAD Technology we are introducing a new standard of topical treatment for the benefit of people living with psoriasis, the healthcare community, and society. Our innovative pipeline is comprised of drug candidates within CKD-ap (uremic pruritus), lichen sclerosis, Sjgren's syndrome dry eye, and atopic dermatitis.

For more information, please visit http://www.mc2therapeutics.com

References:

1Chandran, V., and S.P. Raychaudhuri. 2010. 'Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis', J. Autoimmune, 34: J314-J21

2Schafer, T. 2006. 'Epidemiology of psoriasis. Review and the German perspective', Dermatology, 212: 327-37

3WHO Global report on Psoriasis 2016

4USPI http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213422s000lbl.pdf

Logo: https://mma.prnewswire.com/media/1557753/MC2.jpg

Home

SOURCE MC2 Therapeutics

Go here to read the rest:
MC2 Therapeutics' clinical research to be presented in four poster presentations at the European Academy of Dermatology and Venereology conference -...

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to increase through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis

Deucravacitinib demonstrated efficacy regardless of baseline characteristics, including body weight, disease severity and previous treatment with biologic or non-biologic therapies

Patients on deucravacitinib demonstrated significantly greater improvements from baseline in psoriasis signs and symptoms compared with placebo and Otezla (apremilast) at Week 16, with the greatest improvement in symptoms reported for itch and skin tightness

No clinically meaningful changes from baseline levels in laboratory parameters compared to placebo or Otezla, consistent with data previously presented, with findings confirming no cumulative trends

PRINCETON, N.J., September 30, 2021--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021. The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the companys data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, as well as the emerging dermatology pipeline.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210930005581/en/

(Graphic: Bristol Myers Squibb)

Clinical research being presented at the meeting includes findings from new analyses of the global pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials in moderate to severe plaque psoriasis showing deucravacitinib demonstrated:

Durable efficacy through one year of treatment, with maximum response rates achieved by Week 24 [as measured by Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) and sPGA 0] and maintained through Week 52 (POETYK PSO-1). These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 4:45 p.m. CEST. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).

Efficacy across a broad range of patient subgroups, with a consistently higher percentage of patients receiving deucravacitinib versus placebo and Otezla (apremilast) achieving PASI 75 and sPGA 0/1 response at Week 16 regardless of prior psoriasis treatment, baseline disease characteristics and baseline demographic factors. Data on the efficacy of deucravacitinib, regardless of prior psoriasis treatment (Presentation FC03.06), were featured as an oral presentation today from 2:30 3:30 p.m. CEST.

Significantly greater improvements from baseline of signs and symptoms of psoriasis compared with placebo and Otezla in all individual psoriasis symptom and sign scores at Week 16 as measured by the Psoriasis Symptoms and Signs Diary (PSSD). The greatest improvements in psoriasis symptoms were reported for itch and skin tightness, and the greatest improvements in psoriasis signs were reported for dryness, scaling and shedding or flaking (Poster Number: P1473).

As previously presented in the initial readout of the POETYK PSO-1 and POETYK PSO-2 results, deucravacitinib was well-tolerated and had a similar safety profile in both trials, with no new safety signals identified through 52 weeks of data. Laboratory data now shown from the trials for Weeks 0 to 52 (beyond what was initially presented for Weeks 0 to 16) confirmed no clinically meaningful changes from baseline levels observed in any laboratory parameters, including total cholesterol, creatine phosphokinase, neutrophils and platelets, which are four parameters that are known to change with Janus kinase (JAK) 1, 2 and 3 inhibition, and confirmed no cumulative trends (Poster Number: P1407).

Story continues

"In clinical practice, dermatologists treat a wide range of people living with moderate to severe plaque psoriasis, many of whom remain undertreated or even untreated and are in need of safe and well-tolerated oral therapies that provide durable efficacy," said Professor Richard B. Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust and Professor at The University of Manchester. "These new data show that deucravacitinib is efficacious, regardless of prior treatment and across patient subgroups, and that the strong response rates achieved in the pivotal studies at Week 16 improved to Week 24 and were maintained from Week 24 through one year. The results provide further evidence that deucravacitinib has the potential to become an important new oral treatment for those who require systemic therapy."

Additional data from Bristol Myers Squibbs dermatology pipeline being presented at the meeting include translational research assessing a potential therapy target for alopecia areata, for which there is currently no approved therapy; preclinical research on a novel sphingosine 1-phosphate receptor (S1PR) 1, 4 and 5 modulator (S1PR1,4,5) found to be highly efficacious in a mouse model of atopic dermatitis; and health economics and outcomes research on a predictive model from real-world data for identifying patients with psoriasis who are at risk for developing psoriatic arthritis.

"This robust body of research presented at EADVs 30th Anniversary Congress shows Bristol Myers Squibbs commitment to transforming medicine through science in diseases like moderate to severe plaque psoriasis and demonstrates the progress we are making as we build a differentiated portfolio of new treatments for serious dermatologic immune-mediated conditions," said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. "By focusing on addressing the pressing treatment gaps that continue to exist for those impacted by dermatologic diseases, our goal is to elevate standards of care and deliver novel, well-tolerated therapies that help patients achieve better disease control."

Bristol Myers Squibb-sponsored abstracts presented at EADVs 30th Anniversary Congress can be found below and accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on dermatologic immune-mediated diseases.

Late Breaking Presentation

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Richard WarrenPresentation Number: 2857Thursday, September 30, 3:45 4:45 p.m. CESTLate Breaking News Session

Clinical Presentations

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Prior Treatment in the Phase 3 POETYK PSO-1 and PSO-2 TrialsAuthor: Richard WarrenPresentation Number: FC03.06Thursday, September 30, 2:30 3:30 p.m. CESTOral presentation

Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active Psoriatic Arthritis in a Phase 2, Randomized, Double-Blind, Placebo-Controlled TrialAuthor: Philip MeasePoster Number: P0371Presentation Topic: Biologics, Immunotherapy, Targeted Therapy

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Scalp Psoriasis: Analysis of the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Andrew BlauveltPoster Number: P1391Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy by Prespecified Baseline Demographics in the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Melinda GooderhamPoster Number: P1393Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Integrated Laboratory Parameter Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Diamant ThaiPoster Number: P1407Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Baseline Disease Characteristics from the Phase 3 POETYK PSO-1 and PSO-2 TrialsAuthor: Joseph F. MerolaPoster Number: P1410Presentation Topic: Psoriasis

Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Onset of Action in the Phase 3 POETYK PSO-1 and POETYK PSO-2 TrialsAuthor: Neil KormanPoster Number: P1411Presentation Topic: Psoriasis

Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary Using Patient-Derived Outcomes from the Phase 3 POETYK PSO-1 and PSO-2 Trials of Deucravacitinib Versus Placebo and Apremilast in Moderate to Severe Plaque PsoriasisAuthor: Kim A. PappPoster Number: P1453Presentation Topic: Psoriasis

Preclinical Presentations

BMS-986166, a Novel S1PR1,4,5 Modulator, is Highly Efficacious in a Mouse Model of Atopic DermatitisAuthor: Jenny XiePoster Number: P0176Presentation Topic: Atopic Dermatitis/Eczema

Translational & Clinical Pharmacology Presentations

Selective Inhibition of Tyrosine Kinase 2 (TYK2) Protects Hair Follicles from Immune Privilege Collapse Induced by Interleukin (IL)-12 StimulationAuthor: Janin EdelkampPresentation Number: FC02.04Thursday September 30, 2021, 11:15 a.m. 12:15 p.m. CESTOral Presentation

Deucravacitinib, a Selective Tyrosine Kinase 2 (TYK2) Inhibitor: Overview of Clinical Pharmacology Including ADME, Food and pH Effects, Pharmacokinetics in Special Populations, and Drug-Drug InteractionsAuthor: Anjaneya ChimalakondaPoster Number: P1336Presentation Topic: Psoriasis

Health Economics and Outcomes Research (HEOR) Presentations

Development and Validation of a Claims-Based Algorithm to Identify Psoriasis SeverityAuthor: Joe ZhuoPoster Number: P0692Presentation Topic: Dermatology and Internal medicine, Including Skin Manifestations of Systemic Diseases

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action and is the first and only selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for use in any country.

About the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies

PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating deucravacitinib versus placebo and Otezla. Bristol Myers Squibb thanks the patients and investigators who participated in these clinical trials.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate to severe psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients Lives

Bristol Myers Squibb is inspired by a single vision transforming patients lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and multiple sclerosis. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission and perhaps even cures in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most the promise of living a better life.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Otezla (apremilast) is a registered trademark of Amgen Inc.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibbs business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibbs Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005581/en/

Contacts

Bristol Myers SquibbMedia Inquiries: media@bms.com

Investors: Tim Power609-252-7509Timothy.Power@bms.com

Nina Goworek908-673-9711Nina.Goworek@bms.com

See more here:
Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements...

This article was originally published here

Dermatol Ther (Heidelb). 2021 Sep 29. doi: 10.1007/s13555-021-00610-z. Online ahead of print.

ABSTRACT

More than 12 months have passed since the World Health Organization (WHO) declared Coronavirus Disease 19 (COVID-19), caused by the SARS-CoV2 virus, to be a pandemic on 11 March 2020. The entire world scientific community agrees that at this time vaccine is the most promising weapon to combat the infection and the severity of the disease. According to the document Draft landscape of COVID-19 candidate vaccines by WHO, 272 vaccines against SARS-CoV-2 virus are in development, although only four of these, produced by Pfizer-BioNTech (Pfizer, Inc. and BioNTech), Moderna, AstraZeneca, and Janssen companies, respectively, have been approved by European Medicines Agency and Italian Medicines Agency and subsequently distributed nationwide for use. These vaccines are the result of highly innovative procedures and are quite different from each other in terms of composition. Even clinicians in various medical fields may be unfamiliar with the effects of these vaccines. There is the strong emerging need for dermatologists to understand the crucial role of vaccines, with a focus on the need to vaccinate patients suffering from immune-mediated skin diseases, such as psoriasis, while taking the ongoing treatment into consideration regarding the timing of vaccination. Similarly, psoriasis patients aware of having an immune-mediated and inflammatory disease are increasingly asking the dermatologist information about the efficacy and safety of vaccines against SARS-CoV-2 virus. In this narrative review of the literature and critical analysis of the recommendations of the Italian Ministry of Health, we analyze the implications of the vaccination campaign on dermatological patients with psoriasis undergoing immunosuppressive treatment.

PMID:34586598 | DOI:10.1007/s13555-021-00610-z

See the original post:
Vaccines Against SARS-CoV-2 in Psoriasis Patients on Immunosuppressive Therapy: Implications of Vaccination Nationwide Campaign on Clinical Practice...

NORTH CHICAGO, Ill., Sept. 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI, 150 mg) in adults with active psoriatic arthritis for one year (52 weeks).1 These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

KEEPsAKE-1 included adult patients with active psoriatic arthritis who responded inadequately to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). KEEPsAKE-2 included adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).2-5 In the first phase of the studies (Period 1), patients were randomized to risankizumab or placebo until week 24.1 At week 24, the open label extension (Period 2) began, and all patients were treated with risankizumab.1,4,5

The new long-term data from the open-label extension period showed that 70 and 58 percent of patients initially treated with risankizumab achieved American College of Rheumatology 20 (ACR20) response in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where patients with missing data were categorized as non-responders.1 Among patients initially treated with risankizumab, 43 percent in KEEPsAKE-1 and 32 percent in KEEPsAKE-2 achieved ACR50 response, and 26 percent in KEEPsAKE-1 and 17 percent in KEEPsAKE-2 achieved ACR70 response at one year.1

Additionally, at one year, 68 and 64 percent of patients initially treated with risankizumab and with a body surface area 3 percent at baseline achieved a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2, respectively.1

"Millions of people still suffer daily with symptoms of psoriatic arthritis, driving us to advance treatment options for these patients," said Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "These new analyses at one year support the potential of risankizumab to maintain improvements across multiple manifestations of psoriatic arthritis."

In terms of improvement in physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), patients initially randomized to risankizumab reported mean reduction (i.e., improvement) of 0.41 and 0.26 from baseline in HAQ-DI score for KEEPsAKE-1 and KEEPsAKE-2, respectively, at week 52.1

In addition, pooled results from KEEPsAKE-1 and KEEPsAKE-2 showed that 76 and 55 percent of patients achieved the resolution of dactylitis and resolution of enthesitis, respectively, at week 52.1

"Dactylitis is a common symptom in psoriatic arthritis that can cause severe swelling in the fingers and toes that result in everyday tasks becoming difficult," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "These results provide important insights on how both biologic-nave and experienced patients may benefit from treatment with risankizumab."

Both KEEPsAKE-1 and KEEPsAKE-2 demonstrated consistent long-term safety profiles with those shared at week 24, with no new safety findings observed from week 24 through week 52.1 Serious treatment-emergent adverse events (TEAE) occurred at 7.4 events/100 patient-years (E/100 PYs) and 9.4 E/100 PYs in KEEPsAKE-1 and KEEPsAKE-2, respectively.1 Rates of serious infections in KEEPsAKE-1 and KEEPsAKE-2 were 2.8 and 2.0 E/100 PYs, respectively.1 The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE-1 was 2.3 E/100 PYs and 1.6 E/100 PYs in KEEPsAKE-2.1 In KEEPsAKE-1, there were two deaths and both were not related to the study drug per investigator.1 There were no deaths reported in KEEPsAKE-2.1 In KEEPsAKE-2, three major adverse cardiac events (MACE) were reported, which were not related to the study drug per the investigator.1 No MACE were reported in KEEPsAKE-1.1

In January 2021, AbbVie announced positive top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, showing that risankizumab (150 mg) achieved the primary endpoint of ACR20 response versus placebo during the 24-week double-blinded, placebo-controlled, parallel-group period (period 1).2,3

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

Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.6,7 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.6,7

About KEEPsAKE-1 and KEEPsAKE-22-5

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24.

The primary endpoint for both studies was the achievement of ACR20 response at week 24 from the treatment with the study medication. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and MDA at week 24. Other secondary endpoints included ACR50 and ACR70 (not controlled for multiplicity) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period.

More information on these trials can be found at http://www.clinicaltrials.gov(KEEPsAKE-1: NCT03675308;KEEPsAKE-2: NCT03671148).

About risankizumab (SKYRIZI)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8,9 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.8 In April 2019 SKYRIZI was approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The approved dose for SKYRIZI is 150 mg, administered by subcutaneous injection prefilled pen or prefilled syringe at week 0 and 4, and every 12 weeks thereafter.Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.10-12

Important EU Safety Information aboutSKYRIZI(risankizumab)9

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) atwww.ema.europa.eu.

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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvieon Twitter,Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking Statements

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

###

References:

SOURCE AbbVie

https://abbvie.com/

See the rest here:
AbbVie Presents Late-Breaking Data on Risankizumab (SKYRIZI) in Psoriatic Arthritis at the 30th European Academy of Dermatology and Venereology (EADV)...

Clinically and statistically significant improvement in PASI-50 score achievedEDP1815 safety and tolerability data comparable to placebo in studyEDP1815 advancing towards registration studies in psoriasisManagement to host conference call at 8:00 a.m. ET

CAMBRIDGE, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX medicines as a new modality of orally delivered treatments for inflammatory disease, today announced positive data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the Psoriasis Area and Severity Index (PASI) score, as measured by the proportion of patients achieving at least 50% improvement in PASI from baseline at the week 16 timepoint, was observed in the study. EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19.

These clinical results represent a significant advancement for those who live with inflammatory disease. This is the first Phase 2 study to demonstrate that we can harness the small intestinal axis to make a clinical impact on patients with an oral product candidate with safety and tolerability data comparable to placebo, said Simba Gill, Chief Executive Officer of Evelo. Based on these data, we intend to advance EDP1815 towards registration studies in psoriasis. We look forward to discussing our proposed next steps with health and regulatory authorities. This milestone brings us one step closer to realizing our vision of transforming healthcare by developing broadly acting oral, safe, effective, and affordable medicines to address the unmet needs of hundreds of millions of patients who live with inflammatory diseases.

In the Phase 2 study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint was the mean percentage change in PASI between treatment and placebo and was prespecified as a Bayesian analysis. The Bayesian approach provides an estimate of the probability that EDP1815 is superior to placebo. The 16-week primary endpoint gave probabilities that EDP1815 is superior to placebo ranging from 80% to 90% across the prespecified analyses and cohorts.

Story continues

The responder endpoint reports the proportion of patients who had a meaningful clinical response, which is defined as PASI-50 or greater. 25% to 32% of patients across the three cohorts who were treated with EDP1815 achieved a PASI-50 at week 16 compared to 12% on placebo. In cohorts 1 and 2 this difference in response rate was statistically significant (p <0.05). Cohort 3 was directionally similar (25% vs. 12%). The pooled PASI-50 response across all three EDP1815 cohorts, an exploratory analysis, was 29% vs. 12% for placebo and was also statistically significant with a p-value of 0.027. An increase in the number of capsules of EDP1815 did not lead to a dose response.

Additionally, several patients on EDP1815 achieved a PASI-75 or better, which was sustained or improved post treatment. For individuals who had a PASI-50 response or better, consistent effects in secondary and exploratory endpoints, including improvements in patient reported outcomes such as Dermatology Life Quality Index (DLQI) and Psoriasis Symptom Inventory (PSI), were observed.

EDP1815 was observed to be well tolerated in the Phase 2 study. The safety data were comparable to placebo and consistent with what was previously reported in a Phase 1b study. Adverse events (AEs) classified as gastrointestinal were comparable between active and placebo groups, with no meaningful differences in rates of diarrhea, abdominal pain, nausea, or vomiting. There were no related serious adverse events.

I am very encouraged to see this Phase 2 data of EDP1815 in psoriasis, said Benjamin Ehst, M.D., Ph.D., Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center, and Chief Investigator of EDP1815-201. It advances our scientific understanding of how to treat systemic inflammatory diseases and offers the prospect of a truly novel modality of treatment for patients with psoriasis. A drug with the combination of efficacy and safety results as observed here will likely be well received by dermatologists and their patients with mild and moderate disease, who are often faced with limited treatment options.

EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 study designed to evaluate three doses of an enteric capsule formulation of EDP1815 versus placebo in 249 patients with mild and moderate psoriasis over a 16-week treatment period. In the study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint is mean percentage reduction in PASI score at 16 weeks. Secondary endpoints include the proportion of study participants who achieve a PASI-50 response or greater and other clinical measures of disease such as Physicians Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, PSI, and DLQI. Todays results report out on the initial treatment phase of the study, which is now complete, and includes the 16-week treatment period with a 4-week follow-up. A six-month follow-up phase of the study is ongoing.

Conference CallEvelo will host a conference call and webcast at 8:00 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 5177247. A live webcast of the event will also be available under News and Events in the Investors section of Evelo's website at http://ir.evelobio.com. The archived webcast will be available on Evelo's website approximately two hours after the completion of the event and will be available for 30 days following the call.

About PsoriasisPsoriasis is a common chronic immune-mediated inflammatory skin disease, affecting up to 3% of the population worldwide. The disease is driven by Th17-inflammation, which results in the formation of thick red plaques with scaling. Psoriatic lesions can appear anywhere on the body but are most often seen on the knees, elbows, scalp, and lumbar area. In addition to the skin lesions, there are systemic manifestations including arthritis and fatigue, and a strong association with depression and metabolic syndrome.

Patients with mild and moderate psoriasis are underserved by current treatments. Topical therapies do not control systemic inflammation, have low rates of compliance, and in the case of topical steroids are not recommended for long-term use. The majority of novel therapies, including injectable high-cost biologics, are only approved for patients with moderate and severe disease. Even in the severe patient population, the majority of eligible patients do not receive biologics, instead opting for topical therapies or oral systemic therapies, which are associated with tolerability issues and/or with monitoring requirements tied to safety concerns.

About Evelo BiosciencesEvelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that are designed to act on the small intestinal axis, SINTAX, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. Evelos first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelos therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit http://www.evelobio.com and engage with Evelo on LinkedIn.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the development of EDP1815, the promise and potential impact of EDP1815, the timing of and plans for clinical studies, and the timing and results of clinical study readouts.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical studies, and the continuity of our business; that we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical studies, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; issues with the protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our managements and principal stockholders ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us.

These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the three months ended June 30, 2021, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

ContactInvestors:Kendra Sweeney, 239-877-7474ksweeney@evelobio.com

Media:Jessica Cotrone, 978-760-5622jcotrone@evelobio.com

Read the original post:
Evelo Biosciences Announces Positive Phase 2 Clinical Data with EDP1815 in Psoriasis; Confirms Ability to Harness the Small Intestinal Axis, SINTAX,...

AUGUSTA, Ga. (WJBF) Researchers at the Medical College of Georgia are finding promising results when using glycerin to treat psoriasis, an inflammatory condition in which cells build up and create dry, scaly patches on skin.

Dr. Wendy Bollag and her team have found glycerin stages a four-pronged attack against psoriasis.

It inhibits the growth and promotes maturation in skin cells, Bollag, a cell physiologist and skin researcher at the Medical College of Georgia and Charlie Norwood VA Medical Center, explains. It also shows when its converted to fat, it can inhibit inflammation. Even the glycerin itself tends to be good at decreasing oxidative stress, which is another byproduct of inflammation. It also seems to be good at helping to repair the barrier. It helps with the normalization of skin cells.

Glycerin is sold at pharmacies, and is an ingredient found in moisturizers and even sports drinks, according to Bollag. Her team found that when applied to skin topically, psoriasis symptoms were alleviated.

Its a moisturizer. It improves the barrier. It softens the skin. It helps get rid of skin cells that are piling up.

Because its a moisturizer, it tends to reduce the scaling that you tend to see with psoriasis, she adds.

Bollag suggests glycerin be mixed with water in a one-to-one ratio before it is applied onto effected areas of skin. If used daily, she says results can be seen within two weeks. However, Bollag admits this treatment may be best suited for mild cases of psoriasis. She suggests people with more severe cases use their prescribed medications and treatments to clear the psoriasis first, and then use glycerin to keep it from flaring up.

Go here to see the original:
MCG scientists see results treating psoriasis with glycerin - WJBF-TV