Category Archives: Psoriasis

KIRKLAND, QC, Feb. 18, 2021 /CNW/ - Merck Canada Inc., an affiliate of Merck & Co., Inc., known as MSD outside the United States and Canada,announces today that HADLIMA is available and approved for the following indications:

HADLIMA is a fully human monoclonal antibody that binds to a specific protein called tumor necrosis factor (TNF-alpha), which is made by the body's immune system. People with RA, PsA, AS, CD, UC, HS or psoriasis have too much of TNF-alpha in their bodies.8 The presence of extra TNF-alpha in the body can attack normal healthy body tissues and cause inflammation, particularly in the bone, cartilage, joints, digestive tract and skin tissues. By binding to TNF-alpha, HADLIMA decreases the inflammation process of these diseases.9

Approximately six million (one in five) Canadians are living with arthritis, making it Canada's most prevalent chronic health condition.10 While there are many different subtypes of arthritis, inflammatory arthritis includes a group of conditions that impact the body's immune system. The most common forms of inflammatory arthritis are RA, AS and PsA.11

An estimated 270,000 Canadians live with inflammatory bowel disease (IBD), a group of disorders caused by inflammation in the intestines.12 The main forms of IBD are CD and UC.13 By 2030, the number of Canadians with IBD is expected to rise to 400,000 or approximately 1% of the population.14

It is estimated that over one million Canadians are currently living with HS, a chronic skin condition that causes lumps to appear in the folds of the skin.15 Psoriasis, also a chronic skin condition, affects approximately one million Canadians, and Ps affects approximately 90% of this patient population.16

Uveitis, an inflammatory disease that causes damage to the eye, causes about 20% of legal blindness. Every year, approximately 2% of the Canadian population is newly diagnosed with uveitis.17

"HADLIMA further expands Merck's portfolio of biosimilar treatments to address inflammatory and dermatological immune diseases," says AnnA Van Acker, President, Merck Canada. "We are very proud to bring more solutions and therapeutic choices to help improve the lives of Canadians with these chronic conditions."

About HADLIMA

HADLIMA is a biosimilar biologic drug (biosimilar) and authorized based on its similarity to HUMIRA. A biosimilar is a biologic drug that is highly similar to a biologic drug already authorized for sale.18 Biosimilars are assessed and approved by Health Canada against the same rigorous standards used to ensure the quality, efficacy and safety as in any other biologic drug.19 Biosimilars provide patients more treatment options to help manage their disease and symptoms.

Clinical efficacy and safety studies have been conducted in patients with RA to demonstrate clinical comparability between HADLIMA and HUMIRA. The extrapolation of these data to support uses of HADLIMA in IBD is based on the demonstrated comparability, in terms of product quality, non-clinical, human pharmacokinetic and clinical characteristics. Randomized clinical trials have not been conducted to compare HADLIMA to HUMIRA in patients with JIA, PsA, AS, adult CD, UC, HS, Ps, and adult uveitis.22

The types, frequency and severity of adverse events were comparable between HADLIMA and HUMIRA in the RA clinical trial. The most common expected adverse reactions with HADLIMA are injection site reactions and cough and cold symptoms. It should not be administered to patients with severe infections such as sepsis and tuberculosis. HADLIMA contains a Boxed Warning to alert health care professionals and patients about an increased risk of hepatosplenic T-cell lymphoma (HSTCL), a rare, serious lymphoma that is often fatal, which has been identified in patients treated with adalimumab injection. The Boxed Warning also notes allergic reactions, other cancers, lupus-like symptoms, nervous system diseases, serious infections and blood problems.

The Merck Harmony Patient Program provides free confidential patient-assistance services to patients who have been prescribed HADLIMA (adalimumab injection). To learn more visit MerckHarmony.ca.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world.

In Canada, Merck markets a broad range of vaccines, pharmaceutical and animal health products and is one of the top R&D investors in Canada, with investments totaling $89 million in 2019 and more than $1.3 billion since 2000. Basedin Kirkland, Qubec, Merck employs approximately 650 people across the country. For more information about our operations in Canada, visit http://www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties.If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2017 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

Please see the product monograph for HADLIMA (adalimumab injection) at: https://www.merck.ca/static/pdf/HADLIMA-PM_E.pdf

References

______________________________

1HADLIMA Product Monograph. Merck & Co. Inc. November 2020.

2The Arthritis Society. The Truth About Arthritis. Available at: https://arthritis.ca/about-arthritis/what-is-arthritis/the-truth-about-arthritis#:~:text=Today%206%20million%20Canadians%20have,to%20have%20arthritis%20than%20men. Accessed on February 16, 2021.

3Crohn's and Colitis Canada. Resources and Publications. Available at: https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report. Accessed on February 16, 2021.

4The Canadian Skin Patient Alliance. Hidradenitis Suppurativa. Available at: https://www.canadianskin.ca/hidradenitis-suppurativa#:~:text=Overview%20%2D%20What%20is%20HS,-Hidradenitis%20Suppurativa%20(HS&text=Lumps%20that%20are%20close%20together,out%20a%20dermatologist%20for%20help. Accessed on February 16, 2021.

5Canadian Dermatology Association. Psoriasis. Available at: https://dermatology.ca/public-patients/skin/psoriasis/. Accessed on February 16, 2021.

6Fighting Blindness Canada. Uveitis. Available at: https://www.fightingblindness.ca/eye-diseases-pathways/uveitis/. Accessed on February 16, 2021.

7HADLIMA Product Monograph. Merck & Co. Inc. November 2020.

8HADLIMA Product Monograph. Merck & Co. Inc. November 2020.

9HADLIMA Product Monograph. Merck & Co. Inc. November 2020.

10The Arthritis Society. The Truth About Arthritis. Available at: https://arthritis.ca/about-arthritis/what-is-arthritis/the-truth-about-arthritis#:~:text=Today%206%20million%20Canadians%20have,to%20have%20arthritis%20than%20men. Accessed on February 16, 2021.

11The Arthritis Society. Inflammatory arthritis. Available at: https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/inflammatory-arthritis#:~:text=The%20most%20common%20forms%20of,ankylosing%20spondylitis%20and%20psoriatic%20arthritis. Accessed on February 16, 2021.

12Crohn's and Colitis Canada. Resources and Publications. Available at: https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report. Accessed on February 16, 2021.

13Crohn's and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease In Canada. Available at: https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf. Accessed on February 16, 2021.

14Crohn's and Colitis Canada. Resources and Publications. Available at: https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report. Accessed on February 16, 2021.

15The Canadian Skin Patient Alliance. Hidradenitis Suppurativa. Available at: https://www.canadianskin.ca/hidradenitis-suppurativa#:~:text=Overview%20%2D%20What%20is%20HS,-Hidradenitis%20Suppurativa%20(HS&text=Lumps%20that%20are%20close%20together,out%20a%20dermatologist%20for%20help. Accessed on February 16, 2021.

16Canadian Dermatology Association. Psoriasis. Available at: https://dermatology.ca/public-patients/skin/psoriasis/. Accessed on February 16, 2021.

17Fighting Blindness Canada. Uveitis. Available at: https://www.fightingblindness.ca/eye-diseases-pathways/uveitis/. Accessed on February 16, 2021.

18Government of Canada. Biosimilar Biologic Drugs in Canada: Fact Sheet. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html. Accessed on February 16, 2021.

19Government of Canada. Biosimilar Biologic Drugs in Canada: Fact Sheet. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html. Accessed on February 16, 2021.

SOURCE Merck Canada

For further information: Media Contacts: Merck Canada Media Relations, 1-833-906-3725; Alannah Nugent, 647-458-3867

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HADLIMA (adalimumab injection) Now Available for the Treatment of Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic...

NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021

Positive Phase 3 data on topical roflumilast cream in plaque psoriasis reported in February

Advancing topical roflumilast into Phase 3 programs for atopic dermatitis, seborrheic dermatitis, and scalp psoriasis during 2021

Robust pipeline addressing unmet medical needs of over 20 million patients

Strong financial position with over $470 million in cash, cash equivalents and marketable securities, including the proceeds from recent equity offering, providing cash runway into 2023

WESTLAKE VILLAGE, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2020, and provided a business update.

2020 was a year of incredibly strong execution for Arcutis, said Frank Watanabe, Arcutis President and Chief Executive Officer. From our initial public offering in February through implementation of 18 clinical trials with three different product candidates involving more than 3,200 patients, we made tremendous progress advancing our mission of addressing significant unmet needs in medical dermatology. I am unbelievably grateful to the patients and physicians participating in our clinical trials, and to our amazing Arcutis team. This effort culminated in multiple notable milestones, including our recently reported positive pivotal Phase 3 results in plaque psoriasis, positive Phase 2 results in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis, and the landmark publication of plaque psoriasis Phase 2b data in the New England Journal of Medicine.

Mr. Watanabe continued, 2021 will be a transformational year for Arcutis as we continue to rapidly advance our innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies. Based on positive Phase 3 data, we anticipate submitting a New Drug Application to the FDA for topical roflumilast cream as a potential once daily topical treatment for plaque psoriasis this year. We are excited to advance three additional programs into pivotal Phase 3 trials in 2021. Our focus on addressing the gap in dermatology drug development currently includes four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients, representing a potential revenue opportunity of between $3 billion and $8 billion.

Story continues

Pipeline Updates

ARQ-151 (topical roflumilast cream) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a cream formulation, being developed as a potential treatment for plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis.

Reported positive results from the two pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2) in patients with plaque psoriasis; New Drug Application (NDA) submission to U.S. FDA anticipated in the second half of 2021.

Pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) initiated in January 2021 with topline data anticipated in the second half of 2022.

Reported positive results from the Phase 2 long-term safety study as a potential once-daily chronic topical treatment for plaque psoriasis.

ARQ-154 (topical roflumilast foam) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a foam formulation, designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, being developed as a potential treatment for seborrheic dermatitis and scalp psoriasis.

Reported positive topline data from Phase 2b study in patients with scalp and body psoriasis which affects more than 2.5 million of the 6 million psoriasis patients in U.S with active disease.

Announced advancement of seborrheic dermatitis into Phase 3 development, anticipating initiation of a single pivotal Phase 3 study (STRATUM) in the second or third quarter of 2021, with topline data anticipated in the second or third quarter of 2022.

Pending discussions with regulators, the Company expects to initiate its Phase 3 program in scalp psoriasis in the second half of 2021, with topline data anticipated in the second half of 2022.

ARQ-252 - a potent and highly selective topical small molecule inhibitor of Janus kinase type 1 (JAK1), being developed as a potential treatment for chronic hand eczema and other inflammatory dermatoses.

Completed enrollment of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated by mid-2021.

The Company anticipates initiating a Phase 2a study in vitiligo in the first quarter of 2021.

ARQ-255 - an alternative topical formulation of ARQ-252 designed to reach deeper into the skin in order to potentially treat alopecia areata.

Recent Corporate Highlights

Terrie Curran appointed to Arcutis Board of Directors

Arcutis common stock (ARQT) added to the Nasdaq Biotechnology Index

Matthew Moore joined the Company as Chief Business Officer

Completed underwritten public offering of common stock in February 2021 with gross proceeds of $221.4 million and net proceeds of $207.4 million

Fourth Quarter and Full Year 2020 Summary Financial Results

Cash, cash equivalents, restricted cash and marketable securities were $286.0 million as of December 31, 2020, compared to $101.3 million as of December 31, 2019. Arcutis believes that its current cash, cash equivalents and marketable securities of over $470 million, including the $207.4 million net proceeds from its recent financing, will be sufficient to fund its operations into 2023.

Research and development (R&D) expenses for the quarter ended December 31, 2020 were $27.4 million compared to $10.8 million for the corresponding period in 2019. R&D expenses for the year ended December 31, 2020 were $115.3 million compared to $36.5 million for the corresponding period in 2019. These year-over-year increases were primarily due to the initiation of multiple clinical trials during the last year.

General and administrative (G&A) expenses for the quarter ended December 31, 2020 were $6.7 million compared to $2.2 million for the corresponding period in 2019. G&A expenses for the year ended December 31, 2020 were $21.3 million compared to $6.6 million for the corresponding period in 2019. These year-over-year increases were primarily due to higher headcount and professional services costs, including the costs associated with being a public company.

Net loss was $34.0 million, or $0.79 per basic and diluted share, for the quarter ended December 31, 2020 compared to $12.6 million, or $6.13 per basic and diluted share, for the corresponding period in 2019. Net loss was $135.7 million, or $3.80 per basic and diluted share, for the year ended December 31, 2020 compared to $42.0 million, or $22.78 per basic and diluted share, for the corresponding period in 2019.

About Arcutis - Bioscience, applied to the skin.Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The companys lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; expectations with regard to the timing of data events anticipated during 2021/2022; and the Companys belief that its current cash, cash equivalents and marketable securities, including the net proceeds from its recent financing, will be sufficient to fund its operations into 2023. 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.

Contact:Heather Rowe Armstrong Vice President, Investor Relations & Corporate Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740

ARCUTIS BIOTHERAPEUTICS, INC.Balance Sheets(In thousands)

December 31,

2020

2019

ASSETS

Current assets:

Cash and cash equivalents

$

65,082

$

63,336

Restricted cash

1,542

Marketable securities

219,359

37,929

Prepaid expenses and other current assets

6,843

5,209

Total current assets

292,826

106,474

Property and equipment, net

2,016

227

Operating lease right-of-use asset

3,349

264

Other assets

78

47

Total assets

$

298,269

$

107,012

LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY (DEFICIT)

Current liabilities:

Accounts payable

$

7,140

$

1,405

Accrued liabilities

15,462

3,654

Operating lease liability

178

Total current liabilities

22,602

5,237

Operating lease liability, noncurrent

4,964

129

Other long-term liabilities

82

184

Total liabilities

27,648

5,550

Convertible preferred stock

166,491

More here:
Arcutis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update - Yahoo Finance

Olivia Bowen has shared before and after snaps of her psoriasis in a candid Instagram post.

The Love Island star, 27, was diagnosed with the skin condition when she was 17.

In her post she proudly revealed the patches across her stomach and chest have improved thanks to prescription cream.

In her post, the excited reality TV star, wrote: "Progress!!! Last week they were sooo raised, angry, red & itchy [sic].

"A week on and they're becoming lighter & less angry! I went to the doctors & was prescribed cream So fingers crossed!"

Alex Bowen's wife also shared a snap of the current state of her abs.

Updating fans who are unaware of her condition, she explained: "A few of you catching up, this is called guttate psoriasis.

"I have had it a couple times before, I've had it like this (all over my body head to toe] once before when I was 17. It usually stays with me around 3/4 months. Some days it's horrible & painful & makes me feel terribly insecure.

"Other days I pick myself up & remind myself there are many many things worse than a wee skin condition, and that's what I hold onto! It's just skin, who I am is important [sic]."

She also shared that she wouldn't be revealing the name of her prescription cream.

Olivia added: "It is prescribed & very strong so it would be irresponsible for me to suggest out to everyone & anyone.

"All I can say is definitely definitely contact your doctors and go throughout them. It really is worth it, it's not embarrassing, it'll help [sic]."

Last month Olivia reached out on social media to ask her followers to help her find a sun bed which she says will stop her psoriasis from spreading all over her body.

The Love Island star asked her fans for recommendations for UVB light sun beds as she revealed using them was the only thing that helped her psoriasis when she was a teenager.

See the original post:
Olivia Bowen shares snaps of psoriasis as she tells how condition has improved - OK! magazine

Chalk another one up for Bristol Myers Squibbs psoriasis drugthe TYK2 inhibitor outshone placebo and Amgens Otezla in a second phase 3 study, teeing up discussions with regulators.

The study, known as POETYK PSO-2, tested the drug, deucravacitinib, against placebo and Otezla in 1,020 patients with moderate to severe plaque psoriasis, the company said in a statement. After 16 weeks of treatment, significantly more patients taking Bristol Myers drug than placebo had a 75% reduction of psoriasis area and severity and clear or almost clear skin as measured by the static Physicians Global Assessment, a visual assessment of psoriasis.

In addition to meeting these co-primary endpoints, deucravacitinib also beat Otezla on these measures, hitting key secondary endpoints.

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

RELATED: Bristol Myers' psoriasis drug beats Amgen rival in phase 3

The company reported the results in broad strokes with plans to present detailed data at a future medical meeting. The news comes three months after Bristol Myers reported a similar performance in the 666-patient POETYK PSO-1 study, in which deucravacitinib also outperformed placebo and Otezla.

The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule, said Samit Hirawat, M.D., chief medical officer of Bristol Myers Squibb.

Deucravacitinib works by blocking TYK2, an enzyme involved in the IL-12, IL-12 and type 1 IFN pathways, which play a role in psoriasis and other immune-mediated diseases. Bristol Myers is developing the drug for psoriatic arthritis, lupus and inflammatory bowel disease.

Read the original post:
Bristol Myers' psoriasis drug strikes again, beating Amgen's Otezla in a 2nd pivotal trial - FierceBiotech

TUESDAY, Feb. 2, 2021 (HealthDay News) -- Skin infections in the first two years of life are associated with pediatric psoriasis, according to a study recently published in the Journal of the American Academy of Dermatology.

Yi-Ju Chen, M.D., Ph.D., from Taichung Veterans General Hospital in Taipei, Taiwan, and colleagues conducted a nationwide nested case-control study to examine the impact of infantile infection and antibiotic exposure on pediatric psoriasis development. A total of 1,527 patients with pediatric psoriasis were identified and matched with 15,270 control individuals without psoriasis.

The researchers found that in both groups, the mean age was 9.9 3.7 years. In a multivariate analysis, independent associations with pediatric psoriasis were seen for atopic dermatitis (adjusted odds ratio, 2.07) and a family history of psoriasis, especially for the mother (adjusted odds ratio, 9.86) or other first-degree relatives (adjusted odds ratio, 5.49). Significant associations with pediatric psoriasis were seen for skin viral and bacterial infections (adjusted odds ratio, 1.35) and fungal infections (adjusted odds ratio, 1.71) in the first two years of life. No correlation was seen for systemic antibiotic exposure.

"Our results suggest that skin and fungal infections in early life are associated with pediatric psoriasis development," the authors write. "The role of early-life microbiota dysbiosis in the pathogenesis of pediatric psoriasis might be worth further investigation."

Abstract/Full Text (subscription or payment may be required)

Continue reading here:
Skin Infections in Early Childhood Linked to Pediatric Psoriasis - HealthDay News

WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical treatment for plaque psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

On the studies primary endpoint of Investigator Global Assessment (IGA) Success at week 8, roflumilast cream 0.3% had an IGA Success rate in DERMIS-1 of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and in DERMIS-2 an IGA Success rate of 37.5% compared to a vehicle rate of 6.9% (P<0.0001). IGA Success was defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

In DERMIS-1 and DERMIS-2, roflumilast cream was generally safe and well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate in severity. Overall, 90% of patients who were randomized to roflumilast cream in the studies completed the full 8 weeks. Among subjects receiving roflumilast cream, there were only 5 discontinuations in DERMIS-1 due to a TEAE (1.7% of subjects) and 1 discontinution in DERMIS-2 due to TEAE (0.3% of subjects), and there were no treatment-related Serious Adverse Events (SAEs).

We are delighted with the strength of these Phase 3 data, which surpassed the already positive results we saw in our Phase 2 studies, said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis Chief Medical Officer. These data reinforce our conviction that topical roflumilast is exceptionally well suited to address the unmet needs in the topical treatment of psoriasis, offering an ideal combination of efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, the ability to use the drug chronically in any anatomical area, and a very favorable safety and tolerability profile. Based on the strength of these Phase 3 data, we anticipate submission of our NDA to the U.S. FDA in the second half of 2021. Importantly, we want to express our appreciation to the trial participants and the clinical investigators for their commitment to this important research effort.

The impact of plaque psoriasis extends beyond the serious physical burdens of the disease, with many patients experiencing adverse psychological and social effects as well, said Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. The existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability. These data demonstrate once-daily topical roflumilast cream was well-tolerated and achieved early and significant improvements in psoriasis signs and symptoms, including having a profound impact on itch.

The Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates submission of its NDA to the FDA in the second half of 2021.

Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8079585. A live webcast of the call will be available on the "Investors" section of the company's website, http://www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

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

About Topical Roflumilast Cream

Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). 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 Arcutis - Bioscience, applied to the skin.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The Company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The Companys lead product candidate, topical roflumilast, has the potential to become the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit http://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding roflumilast creams potential as a treatment for plaque psoriasis; and expectations with regard to the timing of potential NDA submission in 2021. 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, 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.

Investors and Media:Heather Rowe ArmstrongVice President, Investor Relations & Corporate Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740

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Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis -...

Psoriasis is a chronic skin condition that causes red, itchy patches or bumps on the skin. It can develop anywhere on the body, including the genitals. About 63% of adults with psoriasis may experience genital psoriasis at least once in their lifetime.

"Genital psoriasis can occur anywhere on the genitals, but the tip of the penis and in folds of skin are the most common locations," says Jeffrey M. Cohen, MD, assistant professor of dermatology at Yale School of Medicine. It can also affect the crease between the buttocks, skin above the genitals, and inner and upper thigh areas.

There are many ways to treat genital psoriasis, but mild topical corticosteroids are the first line of treatment. Here's how you can recognize, treat, and avoid irritating genital psoriasis.

Genital psoriasis is a form of inverse psoriasis, which commonly occurs in skin folds such as the underarms, under the breasts, and around the genital area.

"[It] generally presents as pink somewhat raised areas. Sometimes, these can be scaly, and other times, they may not be. The spots tend to be itchy, but they can also feel irritated," says Cohen.

Thick, scaly patches called plaques can also appear on the affected area, which are either red with silvery or white buildup (for lighter skin tones) or purple, gray, or dark brown (for darker skin tones). You may experience discomfort, pain, itching, and cracking of the skin.

Treatments for psoriasis vary from one person to another, and some individuals might need a combination of treatments to reduce their symptoms.

Important: Almost 50% of genital psoriasis patients don't discuss symptoms with their physicians due to shyness and fear of judgment, which may result in undertreatment. Genital psoriasis is common in psoriasis patients and is nothing to be ashamed of.

"Studies have shown that for many patients, genital psoriasis interferes with their sex lives, for reasons such as embarrassment or discomfort, but there is no health risk (for either partner) if someone with genital psoriasis has sex," says Cohen.

Genital psoriasis might also be mistaken for eczema or fungal infection. "It is important to note that several skin conditions can look quite similar in the genital region, and a diagnosis of genital psoriasis should be made by a board-certified dermatologist," says Cohen.

Psoriasis develops due to an overreaction of the body's immune response, which causes inflammation. As a result, new skin cells grow too fast and move to the surface, manifesting in reddish and itchy bumps.

Here are some tips to avoid irritation and further discomfort from genital psoriasis:

"Scratching or touching psoriasis cannot cause it to spread from one part of the body to another. It is also important to note that psoriasis is not at all contagious to others," says Cohen.

There are plenty of treatment plans for genital psoriasis, and what works for one person might not work for another. Although it is a chronic condition that reduces the quality of life, proper treatment can improve it.

About 70% to 80% of cases of psoriasis are mild, requiring only topical treatments. They can come in the form of corticosteroids, which are creams and ointments that reduce inflammation when applied to the skin, or nonsteroidal agents, medications that don't contain or are not steroids, like calcineurin inhibitors that suppress the immune system and reduce symptoms.

Biologics, or medications that target specific parts of the immune system, can be very effective for many types of psoriasis and generally come in the form of a pill, injection, or intravenous infusion. "Good moisturizers, such as Vaseline, are also helpful for patients with genital psoriasis," says Cohen.

Psoriasis doesn't go away and is present for someone's entire life. "However, some people experience long periods of time when psoriasis is not active," says Cohen. Following a treatment plan closely can reduce symptoms and avoiding certain irritants can help improve your genital psoriasis.

Genital psoriasis is a chronic skin condition that can develop anywhere on the genitals, buttocks, and thigh areas. Symptoms include red and itchy patches of skin that may or may not be scaly.

To avoid discomfort and irritation, moisturize the affected area and wear breathable underwear. Genital psoriasis is treated with topical medications and biologics (aka medications that target the cause of psoriasis), so talk to your healthcare provider to discuss the best treatment plan for you.

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Genital psoriasis: Signs, symptoms, and treatment options - Insider - INSIDER

Beata Kowalewska,1 Barbara Jankowiak,1 Mateusz Cybulski,1 Elbieta Krajewska-Kuak,1 Dzmitry Fiodaravich Khvorik2

1Department of Integrated Medical Care, Medical University of Bialystok, Bialystok, Poland; 2Department of Dermatovenerology, Medical University in Grodno, Grodno, Belarus

Correspondence: Beata KowalewskaDepartment of Integrated Medical Care, Medical University of Bialystok, 7A Curie-Skodowskiej Str., Bialystok, 15-096, PolandTel +48 85 748 55 28Email beata.kowalewska@umb.edu.pl

Introduction: Psoriasis is a chronic inflammatory disease of the skin having a profound effect on the quality of life and contributing to the sense of stigmatization in the affected patients. The aim of this study was to analyze the effect of psoriasis severity on the quality of life and sense of stigmatization in psoriatics and to investigate relationships between these measures and sociodemographic variables.Patients and Methods: The study included 111 patients with psoriasis. The inclusion criteria of the study were the diagnosis of psoriasis and written informed consent to participate. The study was based on a short survey prepared by the authors and four validated scales: Dermatology Life Quality Index (DLQI), 6-item Stigmatization Scale, 33-item Feelings of Stigmatization Questionnaire, and Psoriasis Area and Severity Index (PASI).Results: Mean PASI score for the study group was 14 pts. Most respondents presented with low DLQI scores, with the mean value of 10.8 pts suggesting that the disease-related ailments were not extremely burdensome for the majority of the patients. Mean stigmatization scores for the 6- and 33-item scale were 7 8 and 81 82 pts, respectively.Conclusion: The severity of psoriasis was the strongest determinant of the quality of life measured with the DLQI. Also, the levels of stigmatization determined with the 6- and 33-item scale correlated significantly with PASI scores.

Keywords: psoriasis, quality of life, stigmatization, psoriasis severity, psychodermatology, DLQI, PASI

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Effect of Disease Severity on the Quality of Life and Sense of Stigmat | CCID - Dove Medical Press

Almost one-third of people with moderate to severe psoriasis suffer from mental health issues like anxiety and depression. Almirall wants to change that througha new collaboration with Happify Health.

The Barcelona-based pharma will launch a digital wellness program called Claro with Happify, which develops digital therapeutics for people with chronic disease, leaning on its team of scientists, physicians and gaming experts to help people manage mental health.

RELATED: Almirall 'Shared Skin' dermatology disease awareness campaign gets employees involved

The new Almirall program will feature a user experience the company called "meaningful, dynamic and fun," and it willbe delivered through the pharma companys patient support program in the U.K., Spain, Italy and France.

Almirall chose Happify because of its demonstrated positive impact on the mental health of patients with chronic conditions, including psoriasis, in published research, Francesca Domenech Wuttke, Almiralls chief digital officer, said.

The medical dermatology-focused pharma nabbed a recent approval in France for Ilumetri, an anti-IL-23p19 to treat psoriasis, with a launch expected soon. Almirall has a development and sales license for Ilumetri with Sun Pharmaceutical in Europe with launches already underway in Germany, the U.K., Switzerland, Austria, Denmark, Italy, Belgium, the Netherlands and Spain.

RELATED: Allergan preludes major selloffs with $650M Almirall dermatology sale

Almirall sharpened its focus in dermatology in 2018 when it acquired Allergans medical dermatology portfolio. The $650 million deal included brands Aczone, Tazorac, Azelex, Cordran Tape and Seysara.

Digital therapeutics, meanwhile, have been hit or miss in the pharma space, with some pioneers in the field already having moved on. Novartis ended itsPear Therapeutics partnership in 2019 after helping bring to marketthefirst FDA-approved digital therapeuticsreSET and reSET-O for substance use disorder and opioid use disorderand the first directlydetailedby a drugmaker. At the time, Novartis' Sandoz said Pear was now able to support its own commercial operations.

Otsuka and Proteus' mental health "digital pill" partnership also dissolved last year. Otsuka now owns thedigital therapeutics, including theAbilify MyCite smart pill technology, after a bankruptcy court winin August.

More digital therapeutics fromOrexo launchedlastfall, too: Vorvidafor problematic drinking and Deprexis for depression. Orexoalso markets drug products including Subsolv for opioid use disorder.

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Almirall enlists Happify to boost psoriasis patients' mental health with digital therapeutics - FiercePharma

When you have psoriasis, the right workout clothes keep your skin happy so you can better enjoy exercising.

Image Credit: LumiNola/E+/GettyImages

If you have psoriasis, you may put a lot of thought into the clothes you wear. Maybe you strategically choose pieces that cover up affected areas of your skin or ones that make you feel your best. But perhaps the most important reason is the fact that what you wear can keep your skin happy or lead to a flare-up.

Psoriasis a skin disease marked by red, itchy patches of skin covered with silvery scales tends to come and go in cycles, going from remission to flaring again if something sets it off, according to the Mayo Clinic. Certain types of clothing can sometimes be the trigger.

The general recommendation is to avoid tight-fitting clothes, because they may irritate the skin, says Lisa Anthony, MD, a board-certified dermatologist at Westmed Medical Group. That might sound like a problem, because that eliminates most popular styles of workout clothing but don't let that keep you away from exercise.

"Regular exercise is not only a great way to de-stress and build confidence, but it will improve heart health," Dr. Anthony says, adding that people with psoriasis are at increased risk of cardiovascular health problems.

You'll just need to be strategic about how you dress for your workouts. Here's a guide to choosing the best workout clothes when you have psoriasis, including general tips on what to look for and a few specific pieces that fit within those guidelines.

No matter what you decide to exercise in, be sure to wash your workout clothes in detergents that are gentle on the skin. Laundry detergents that are fragrance-free and dye-free are recommended to reduce the risk of irritation, Dr. Anthony says.

The Best Workout Tops When You Have Psoriasis

When shopping for workout tops, you'll want to avoid tight, form-fitting styles if you can, because they can rub against the skin and lead to irritation, Dr. Anthony says. "Looser-fitting clothing will reduce friction and trauma to the skin," she says.

1. JoyLab Womens Tie-Back Active Tank Top

Image Credit: LIVESTRONG.com Creative

This loose-fitting tank from Target's activewear line features an open back, which amps up the breathability and minimizes contact between the fabric and your skin. We also love it for its affordable price and punchy style.

2. Outdoor Voices Ready Set Shortsleeve

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This Austin-based brand offers a full line of gear designed to get you moving. To start, go for this versatile tee. Its boxy fit and slightly cropped length keep the air flowing. Plus, it's made out of OV's Sweatee fabric, a performance cotton with sweat-wicking properties.

3. Zella Splits Ribbed Tank

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Because a loose fit is the way to go, this racerback tank from Zella is another good addition to your workout wardrobe.

Pro tip: Choose the white color instead of black Dr. Anthony says wearing light colors will minimize the appearance of flakes.

The Best Sports Bras When You Have Psoriasis

It's hard to get away from a tight fit when shopping for sports bras. So focus on fabric instead. Some materials, such as synthetic fabrics and wool, can cause skin irritation and thereby a psoriasis breakout, Dr. Anthony says.

"To minimize skin irritation, choose cotton fabric that is more breathable or a performance fabric that reduces irritation from sweat and moisture," she says.

1. Splits59 Bianca Techflex Bra

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Andrea Fornarola, CPT, ACE, an AFAA-certified fitness instructor and founder/CEO of Elements Fitness Studio, loves this line for her sensitive skin.

"The comfortable sports bras are supportive but don't have the uncomfortable, heavy elastic bands," she says.

This bra also features flatlock seams that minimize chafing a definite plus for psoriasis skin.

2. Athleta Ultimate Printed Bra

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Look for the SuperSonic fabric from this Gap-owned brand it's designed specifically to wick sweat away from the skin and dry quickly to keep your skin fresh.

You've got a few options if you're sticking to light colors, including orchid pink, white and oasis blue. Plus, you're bound to find a size that fits your body this sports bra is available in size XXS to 3X.

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The Elevation Bra from this California-based brand offers a supportive fit that'll keep up with even your most intense workouts. It's also made with a moisture-wicking material and scores style points for its high neck and strappy back.

4. lululemon Like a Cloud Bra Light Support

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If the day is calling for a lower-impact workout like yoga, consider this light-support sports bra from lululemon. This bra features four skinny straps, which is an on-trend design choice and also a good choice for those with psoriasis because it leaves lots of space for skin to breathe.

The Best Workout Bottoms When You Have Psoriasis

You'll want to follow all the same advice when shopping for workout bottoms: breathable fabrics and loose fits will minimize the risk of flare-ups.

1. lululemon Hotty Hot Short High-Rise Long

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These four-inch shorts (also available in a shorter style) feature the Canadian retailer's lightweight Swift fabric, which combines stretchiness, sweat-wicking properties and mesh side panels for extra ventilation.

2. Athleta Salutation Stash Pocket II 7/8 Tight

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Fornarola turns to Athleta for the brand's "really comfortable high-waisted leggings that stay in place and breath as your body heats up and cools down."

This style features the brand's super-soft Powervita fabric and side pockets beneath the hips for storage.

3. Nike Dri-FIT Attack Shorts

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The lightweight, sweat-wicking material on these Nike workout shorts gives you room to move and your skin room to breathe.

Buy it: Nike.com; Price: $25

4. GapFit Runaround Joggers

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The looser fit and breathable quick-dry fabric make these GapFit joggers a must-have for low-intensity workouts (and for lounging post-workout, too). Choose from a range of light colors, including white, tan khaki, pink English rose and vintage palm.

Buy it: Gap.com; Price: $47-$70

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