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BRUSSELS and ATLANTA, Sept. 29, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new interim results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of bimekizumab through to two years in adult patients with moderate to severe plaque psoriasis who completed one of the three Phase 3 pivotal studies. These data, together with additional findings from the Phase 3/3b clinical program for bimekizumab in psoriasis, were presented today across nine UCB-supported abstracts at the 30th European Academy of Dermatology and Venereology (EADV) Congress.

"Following the recent approval of bimekizumab in Europe, we are pleased to share new two-year data at EADV supporting the clinical value of bimekizumab in the treatment of moderate to severe psoriasis. The range of longer-term efficacy and safety data presented offer important new insights for the dermatology community and reflect our commitment to improving the standard of care for people with psoriasis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

Interim data from the BE BRIGHT study presented at EADV showed that patients treated with bimekizumab achieved sustained levels of skin clearance (PASI 90 and PASI 100) through to two years with continuous maintenance dosing, and that bimekizumab was generally well tolerated, with no new safety signals identified.1,2,3 Switching to bimekizumab following 24 weeks of adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 and PASI 100 responder rates up to two years.1,4 In addition, switching to bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulted in a sustained increase in PASI 100 responder rates up to week 100.2,5 Patients switching to bimekizumab after an inadequate response to ustekinumab at week 52 also showed sustained improvements in levels of skin clearance (PASI 90 and PASI 100).2

"In clinical practice, patients with moderate to severe plaque psoriasis may need to transition between biologics to optimally control their disease. Longer-term results from the BE SURE study and the BE BRIGHT open-label extension study shared at EADV 2021 demonstrated that switching from adalimumab to bimekizumab helped more patients with moderate to severe psoriasis to achieve and maintain completely clear skin, as measured by PASI 100, through two years of treatment," said Professor Diamant Thai, Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lbeck, Lbeck, Germany.

Longer-term results from BE SURE and BE BRIGHT open-label extension trial After completing the Phase 3 BE SURE trial, patients could enroll in the OLE study.1,4 In bimekizumab-randomized patients (320 mg every four weeks [Q4W] through two years), PASI 90 response rates were 91.2 percent at both weeks 16 and 104.1,4,5 PASI 100 response rates in this group were 61.6 percent at week 16 and 72.3 percent at week 104.1,4 In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through two years), the percentage of patients reaching PASI 90 was 89.4 percent at week 16 and 89.7 percent at week 104.1,4 Levels of PASI 100 response in this group were 62.8 percent at week 16 and 68.1 percent at week 104.1,4

Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained response rates (PASI 90 and PASI 100) through to two years (week 104), which were comparable to the response rates seen in patients receiving continuous bimekizumab treatment.1 Bimekizumab was well tolerated over two years, with no new safety signals.1

Bimekizumab data up to two years in patients switching from ustekinumab This analysis included adult patients from BE VIVID who were initially randomized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then every 12 weeks, or bimekizumab 320 mg Q4W through week 52.2,5 Based on the PASI 90 response at week 52, patients entering the OLE were re-randomized to bimekizumab 320 mg Q4W or Q8W.2

At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and 73.6 percent of bimekizumab-treated patients had achieved PASI 100.2, For all patients who switched from ustekinumab to bimekizumab the PASI 100 response increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9 percent at week 100, which was comparable to the response rate seen in patients receiving continuous bimekizumab treatment at week 68 (75.4 percent) through week 100 (68.8 percent).2 For patients who switched to bimekizumab following an inadequate response to ustekinumab at week 52, high levels of response were achieved. At week 56, after one dose of bimekizumab, 77.3 percent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100. These responses were sustained and further improved at week 100, with 84.1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, respectively. There were no unexpected safety findings in patients who switched from ustekinumab to bimekizumab during the OLE. 2

Pooled safety data from up to two years of treatment in Phase 2 and 3 clinical trialsAcross Phase 2 and 3 trials, the total bimekizumab exposure was 3,109.7 patient-years (N=1789).3Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 patient-years, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-years and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-years.3The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candidiasis (12.6 new cases per 100 patient-years) and upper respiratory tract infection (8.9 new cases per 100 patient-years).3 The EAIR for oral candidiasis showed a decrease compared with one year of bimekizumab treatment (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patient-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-years) compared with Q4W (16.4 per 100 patient-years).3 The majority of cases (98.5 percent of patients experiencing oral candidiasis) were mild or moderate and rarely led to study discontinuation.3

Modified non-responder imputation analyses

Non-responder imputation analyses

About BimekizumabBimekizumab is an investigational humanized IgG1 monoclonal antibody that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.4,5,7 Selective inhibition of IL-17F in addition to IL-17A has been shown to suppress inflammation to a greater extent than IL-17A inhibition alone.4,5,7

The efficacy and safety of bimekizumab have not been established. Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults.

About BE BRIGHT6BE BRIGHT (NCT03598790) is an ongoing, multicenter, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe plaque psoriasis. Patients who completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and BE SURE, were eligible to enroll in the BE BRIGHT study. More details can be found at ClinicalTrials.gov.

About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements UCB This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

For further information, contact UCB:

Corporate Communications

Laurent Schots,

Media Relations, UCB

T +32.2.559.92.64

[emailprotected]

Investor Relations

Antje Witte,

Investor Relations, UCB

T +32.2.559.94.14 [emailprotected]

Brand Communications

Eimear O'Brien,

Brand Communications, UCB

T +32.2.559.92.71

[emailprotected]

U.S. Immunology Communications

Nicole Herga

U.S. Communications, UCBT 404.226.7591, [emailprotected]

References

1 Thai D, Vender R, de Rie M, et al. Safety and efficacy of bimekizumab through 2 years in patients with moderate to severe plaque psoriasis: Longer-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension trial. Presented at EADV 2021.2 Leonardi C, Sator PG, Morita A, et al. Bimekizumab efficacy and safety up to two years in patients with moderate to severe plaque psoriasis switching from ustekinumab: Interim results from the BE BRIGHT open-label extension trial. Presented at EADV 2021.3 Reich K, Sthle M, Okubo Y, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to two years of treatment in phase 2 and 3 clinical trials. Presented at EADV 2021. 4 Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.5 Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.6 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?term=NCT03598790&draw=2&rank=1. Last accessed September 20217 Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

SOURCE UCB, Inc.

http://www.ucb.com

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New Bimekizumab Two-Year Data in Moderate to Severe Plaque Psoriasis Presented at the 30th European Academy of Dermatology and Venereology Congress -...

LONG BEACH, Calif., & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced final results from the Phase 3 PSOARING 3 long-term extension study of its investigational product tapinarof, a 1% once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults. The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. In addition, in the study tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options, said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.

Eligible patients completing PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a 4-week follow-up. Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks. PSOARING 3, which enrolled 763 patients, was designed to assess the safety and real-world use of tapinarof, and included prespecified analyses of duration of remittive effect off-therapy (defined as off-therapy maintenance of a PGA score of 0 or 1) and durability of response on-therapy. Outcomes were based on Physician Global Assessment (PGA) scores. Results from a planned interim analysis of data from PSOARING 3 were previously announced in February 2021.

Efficacy Data

With a high rate of complete disease clearance, a 4-month median remittive effect for patients entering with a PGA score of 0, and durable response with long-term use demonstrated in the PSOARING 3 study, the data for tapinarof continues to impress me over time, said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, and PSOARING 3 study investigator. As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.

Safety Data

Results from the interim analysis of PSOARING 3, along with results from the previously reported Phase 3 PSOARING 1 and PSOARING 2 trials, served as the basis for the New Drug Application that Dermavant submitted to the U.S. Food and Drug Administration (FDA) in May 2021. The FDA accepted the application and assigned a Prescription Drug User Fee Act target action date in Q2 2022.

We are excited to offer a more detailed picture at EADV of the long-term efficacy and safety profile of tapinarof in PSOARING 3, said Philip M. Brown, MD, J.D., Chief Medical Officer of Dermavant. We look forward to engaging with the FDA on our NDA in due course, as we work to bring tapinarof to plaque psoriasis patients as expeditiously as possible.

About Dermavants Phase 3 Program for Tapinarof in Psoriasis

Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavants focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The companys robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older. For more information, please visit http://www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress...

Psoriatic arthritis and mental health are deeply connected. Because the condition is so unpredictable, you may never know exactly how youre going to feel when you wake up in the morning, which can trigger really complicated feelings of anxiety, depression, and even guilt.

Psoriatic arthritis, a chronic inflammatory condition that affects about 30%1 of people with psoriasis, causes joint pain, stiffness, and swelling, as well as immense fatigue that can make the simplest tasks feel impossible, from brushing your teeth to chopping up vegetables for dinner. Especially in the midst of a flare, you might have to quickly change your plans to accommodate your condition or prioritize rest when your symptoms are hard to deal with.

Understandably, managing all of this can affect how you feel about your body and your life, and the weight of these emotions can be a lot to navigate on your own on top of already painful symptoms. In fact, about 33% of people with psoriatic arthritis reported being at least mildly anxious and 20% experienced mild depression, according to a 2020 review of studies involving more than 31,000 people with psoriatic arthritis published in the journal Clinical Rheumatology.2

So we asked people who have psoriatic arthritis (PsA) about how they take care of their mental well-being when day-to-day life starts to feel isolating, frustrating, or overwhelming. Here are some psoriatic arthritis strategies that make a true difference for them.

Jocelyn Hall, 35, who was diagnosed with psoriatic arthritis when she was 28, says her symptoms are well-managed and she is able to remain active thanks to medication. But she still feels anxious knowing there is a risk for unpredictable flare-ups. Plus, she sometimes feels judged by coworkers who dont understand why she has difficulty moving some days, like when she has trouble carrying heavy plates at her job in a restaurant.

To process her emotions, she finds it helpful to talk with a therapist, who encourages her to think about being kinder to herself during stressful times. She helps me maintain good expectations for myself, not ones that push me too far, Hall tells SELF.

For Meaghan Ingram, 28, who was diagnosed with psoriatic arthritis at 26, the symptoms go beyond physical pain. When Im in a flare and I cant move, the depression hits pretty hard and fast, Ingram tells SELF. She has worked with a therapist who incorporated cognitive behavioral therapy (CBT)which involves reframing unhelpful thoughts and changing thinking patterns3in their sessions.

Now Ingram practices acceptance and commitment therapy (ACT) strategies on her own, using The Happiness Trap book (Amazon, $8). This form of psychotherapy teaches her to observe and sit with her thoughts without trying to fix them. It's about accepting where Im at in that moment, and not trying to be anything else, she says.

Even though it can be helpful, finding a therapist is a tricky process for many people, and it may not be accessible for everyone. If you have insurance, you can contact your provider for mental health professionals in your area. Websites like Open Path, Inclusive Therapists, and Thero.org include directories of therapists who accept reduced-fee payments if you dont have insurance or dont want to use your insurance benefits. And finally, you can check the Association for Behavioral and Cognitive Therapies for a therapist that specifically practices CBT.

Psoriatic arthritis support groups can be invaluable, according to the people we talked to. The thing that's gotten me through this change in my life has been the community that I've found online, Ingram says. Theres just something so special about being able to really connect with people that understand my day-to-day, what I feel, and what Im going through.

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Psoriatic Arthritis and Mental Health Self-Care Tips - Self

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:

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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

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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.

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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

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