Coinfection

More than 50 organizations urged Congressional leaders to extend the CMS waiver to enable hospitals and health systems to continue building out the logistics, supply chain, and workforce for hospital-at-home programs. LAS VEGAS — Francisco Dizon, 77 years old, sat comfortably in his living room as a team of clinicians took his vital signs and administered IV medications to treat his urinary tract infection. While he received medical treatment, his wife, Esperanza, stood close by, speaking with the medical team and graciously offering them something to eat. The couple, who were college sweethearts and have been married 56 years, are now familiar with the realities of managing serious health challenges as Francisco, who has diabetes, makes frequent trips to the hospital. Instead of another hospital stay, they opted for DispatchHealth’s hospital alternative care-at-home program, called advanced care, to address Francisco’s UTI. Opting for hospital-level services in their home meant Esperanza could stay by Francisco’s side in a place that’s familiar and where they can continue their daily routines. It eliminates the stress of driving back and forth from the hospital and fears that her husband will get a hospital-acquired infection. “It’s more comfortable here [at home],” Esperanza said, and then she added with a laugh, “I can cook for him.” She says her husband sleeps better at home and enjoys her home-cooked meals. As a caregiver, seeing Francsico resting comfortably at home also gives her peace of mind. Having care teams come to the home feels more personal, she noted. “They are really good,” she added, referring to the DispatchHealth clinicians who were making daily visits to their home, including nurse practitioner Ronnie Bordador, Richard Harris, lead registered nurse and registered nurse Paul Manabat. The advanced care program includes twice daily in-person hospital-style rounding support. Patients also have 24/7 access to medical providers through DispatchHealth’s registered nurse command center. At the same time, remote monitoring devices and biosensors provide care teams with real-time health data and will alert clinicians to any adverse change in Francisco’s health. UTIs are responsible for one million emergency room visits in the U.S. and 100,000 hospitalizations each year, according to 2017 data. Francisco is one of thousands of patients who have received hospital-level services in their homes as health systems and payers move more care out of the four walls of hospitals and into patients’ homes. “They’re pros, they know what they are doing,” Francisco said while the clinicians ran his bloodwork using a handheld blood analyzer device and chatted with him about his medical regime and medications. “They call and check on you, especially when I had a fever, that's nice,” Francisco said. “They can also see it from there," he said, motioning to a tablet on a nearby table displaying his vital sign readings. “They can see my blood pressure, my oxygen, so if there’s a problem, they come right away.” Bordador, a nurse practitioner, previously worked in hospital intensive care units and sees the value of at-home care models. “It's a different approach to the hospital. Here, I can see how patients evolve and how the care evolves. For Francisco, he doesn't need to stay in the hospital for 10 days just for the IV antibiotics,” he said. Mark Prather, M.D., and his partner Kevin Riddleberger launched DispatchHealth in 2013 to combine mobile technology with an old-school service: the house call. DispatchHealth started by offering urgent medical care at home as an option for patients to receive same-day treatment for serious health concerns. In 2019, the company expanded to offer a home-based alternative to hospitalization called its advanced care program. The company also offers post-acute care in the home and “last-mile care” to support population health initiatives. Dispatch sends medical teams to patients' homes armed with mobile blood work labs, portable ultrasounds, in-home imaging and IV medication, most of the standard equipment found in hospitals, to diagnose and treat patients. DispatchHealth claims that in the past decade, its medical teams have treated more than one million people in their homes across more than 30 states in the country. The company has expanded the capabilities of its advanced care model to treat patients across 100-plus diagnostic-related groups (DRGs). Proponents of hospital-at-home services tout quality and safety benefits leading to positive patient outcomes as well as significant cost savings. DispatchHealth evaluated more than 1,000 patients treated over 18 months and found that its at-home services resulted in 58% emergency room avoidance, nearly half the average 30-day hospital readmissions (national average of 20% compared to 9.3% among DispatchHealth patients) and sky-high patient satisfaction rates (98%), according to DispatchHealth data published in a white paper. The company says it’s one the first providers in the country to also onboard patients directly into its alternative hospitalization program without the patient ever setting foot into a brick-and-mortar facility. The company’s analysis aimed to build the case that home-based care could be safe, high quality and produce excellent outcomes, Patrick Kneeland, M.D., vice president of medical affairs at DispatchHealth, said in an interview. “As policies are coming into play and as payers are thinking about where to invest their time and resources, the analysis shows that this is a model that's viable and safe for patients,” Kneeland said. Lobbying CMS and Congress to support hospital-at-home Hospital-at-home programs got a big boost in 2020 when the Centers for Medicare and Medicaid Services (CMS) launched the Acute Hospital Care at Home Waiver during the COVID-19 pandemic. CMS allowed certain Medicare-certified hospitals to treat patients with inpatient-level care at home using Section 1135 waivers of the Social Security Act. CMS waived specific hospital Conditions of Participation that require 24-hour onsite nursing for patients. Home-based services for lower-acuity patients help hospitals address critical capacity issues by freeing up hospital beds for the sickest patients without increasing health system costs, proponents of the programs say. “For us, this a pressure release valve and it's desirable by consumers and patients and so it's a win-win all around in relieving some of the burden that our brick-and-mortar facilities face day in and day out," Heather O’Sullivan, president of Healthcare at Home at Mass General Brigham, one of the largest programs in the country, told Fierce Healthcare last fall. And demographic trends will drive demand for these services, experts say. As the population ages — the percentage of the global population aged 65 and above is expected to rise from 10% in 2022 to 16% in 2050 — at-home care will be crucial to meet healthcare demand and help older seniors age in place. As of March 1, 315 hospitals across 131 systems in 37 states have been approved to participate in the Acute Hospital Care at Home program. Before the waiver, 20 of these programs existed across the U.S. However, that CMS waiver is set to expire at the end of this year and legislative action is needed to extend the waiver or make the program permanent. Healthcare heavyweights, the American Medical Association and the American Telemedicine Association joined major health systems like Geisinger and Mass General Brigham along with tech-enabled companies to pen a letter to Congressional leaders calling for at least a five-year extension to the CMS waiver. “Without an extension, Medicare beneficiaries will lose access to Hospital-at-Home programs that have been demonstrated to provide excellent clinical outcomes and lower the costs of care,” the groups wrote in the letter released today. The American Academy of Home Care Medicine, Moving Health Home, Best Buy Health, DispatchHealth and Biofourmis were among the organizations who signed the letter. Hospital-at-home programs grew rapidly in the past three years despite the uncertainty of future Medicare reimbursement for the services, the groups noted in the letter. “The waiver must be extended to enable hospitals and health systems nationwide to continue building out the logistics, supply chain, and workforce for Hospital-at-Home (HaH) and to encourage multiple payers outside the Medicare program, including Medicaid programs, to enter the HaH market,” the groups wrote. Many proponents would like to see CMS and Congress make the waiver permanent, but a five-year extension would provide more certainty as regulators and lawmakers continue to evaluate the outcomes. “For the program to continue to grow, health systems need to get a policy signal that this is something that lawmakers care about and want to see move,” said Krista Drobac, founder of Moving Health Home, an organization that advocates for policy reform to support care at home. Hospital-at-home has moved from experimental to a strategic priority for many health systems, Drobac noted. “The evidence and the fact that patients are happier is driving the momentum and excitement behind this movement,” she said. Building the case for high-quality care in the home While hospital-at-home programs have grown, there have been concerns about the quality of care provided in patients’ homes and whether it’s on par with hospital-based care along with issues around cost savings and patient safety. There are also concerns that care at home may shift undue burden onto family caregivers. According to a DispatchHealth case study, the hospital-at-home model can help alleviate rather than exacerbate caregiver stress. More caregivers (95%) preferred in-home care over the traditional hospital setting, the majority (96%) found in-home care to be less stressful by the majority of caregivers and also felt more informed about the patient’s daily care plan during in-home care. Critics of these programs, led by the largest union of registered nurses, say care-at-home technologies are unproven and cite a lack of research comparing the cost and quality of hospital and at-home care. National Nurses United calls these programs “home all alone” and published a report in September 2022 condemning the waiver program, calling it a “grave threat to patient care.” Recent research has shown positive patient outcomes from hospital-at-home programs. CMS released data in November based on 11,000 patients admitted into Acute Hospital Care at Home programs between November 2021 and March 2023. According to that research, published in the Journal of the American Medical Association Health Forum, patients who received hospital-level care at home through the waiver program had low mortality rates and minimal complications related to escalations back to brick-and-mortar hospitals. The overall proportion of patients transferred from home back to the hospital was 7.20%. One study conducted by researchers at Mass General Brigham looking at 6,000 patients across the country found low rates of mortality, less use of skilled nursing facilities, and less need for escalation in medical care for patients taken care of at home instead of in the hospital. “For hundreds of years, since the inception of hospitals, we’ve told patients to go to a hospital to get acute medical care. But in the last 40 years, there’s been a global movement to bring care back to the home,” said corresponding author David Michael Levine, M.D., clinical director for research and development for Mass General Brigham’s Healthcare at Home. “We wanted to conduct this national analysis so there would be more data for policymakers and clinicians to make an informed decision about extending or even permanently approving the waiver to extend opportunities for patients to receive care in the comfort of home.” Many advocates for hospital-at-home contend that it can be safer for patients by reducing the risk of hospital-acquired infections. On any given day, one in 31 facility-based patients will be diagnosed with a secondary infection, which, according to Centers for Disease Control and Prevention research, results in at least $28.4 billion in direct medical costs annually. According to DispatchHealth's analysis, there were no secondary infections among the more than 1,000 patients treated at home through its program.   Proponents of these programs also point out that sending providers into patients’ homes gives them a broader, 360-view of a patient’s life to identify things like fall risks, malnutrition or other social needs. DispatchHealth clinicians say they are literally in the kitchen with their patients, often learning more than what most primary care doctors know about their patients. Taking this a step further, the company now works with Instacart to enable its providers to prescribe food interventions, much like traditional medications, right to patients' homes. "Often, in the hospital, the family is not directly involved in the care, they don’t know what’s going on,” Harris, a lead R.N. at DispatchHealth, said. “We get the family involved, we get the patient involved and we have the same nurses working with patients day in and day out so everybody communicates well and we all are on the same page about the patient care. It just creates a much better experience.” Is the living room the future of hospital care? McKinsey & Company estimates that up to $265 billion worth of care services, representing up to 25% of the total cost of care, for Medicare fee-for-service and Medicare Advantage beneficiaries could shift from traditional facilities to the home by 2025 without a reduction in quality or access. “That number represents a three- to fourfold increase in the cost of care being delivered at home today for this population, although how the shift will affect reimbursement rates is not yet clear,” McKinsey & Company senior partners wrote in the 2022 report. Investors also are banking on a shift to more at-home care. Investment in health-at-home solutions reached $4.7 billion in 2021 from $2.2 billion in 2022, according to data from VC firm 7WireVentures. Medically Home, a clinical, logistical and technological model for hospital-at-home care, has raised $275 million backed by investors including medtech company Baxter International and medical transportation and mobile medic company Global Medical Response. The company works with health systems, physician groups, and payers to deliver care to patients in their homes for approximately 20 organizations in as many states. Health system partners include Mayo Clinic, Kaiser Permanente, Cleveland Clinic, ChristianaCare and OSF HealthCare, among others. DispatchHealth has raised $417 million backed by investors like Tiger Global, Humana, Alta Partners, Echo Health Ventures, Oak HC/FT and Questa Capital. The company provides its urgent medical care service in 57 distinct markets and its hospital alternative advanced care program in 14 cities. The company has built up partnerships with major insurance companies for its mobile services including Humana, UnitedHealthcare, Aetna, Cigna and Anthem BlueCross BlueShield. “A lot of the work we've done over the past five years of developing this program has been creativity with payers and our experts in healthcare contracting to figure out the novel mechanisms that will allow payers to put this in one of their benefits, and do so in a way that is within the regulatory landscape,” Kneeland said. “We have some interesting intellectual property around how you actually implement the payer models and the payer partnerships around this because it's not ‘out of the box.’” Many health systems across the country have been hesitant to invest in hospital-at-home programs without a permanent reimbursement structure. But others have doubled down on their investments to build out their at-home care programs. Mass General Brigham was an early adopter, and its Home Hospital program is one of the largest acute home-based care models in the country. MGB has made Healthcare at Home one of its most strategic priorities, with plans to shift 10% of inpatient care to patients' homes over the next five years. Health systems and companies like DispatchHealth continue to face the challenge of building the case to payers and regulators that these programs can improve outcomes and lower costs. “There’s the question of scale. How do you continue to scale this so that the resources put into these models reach the biggest potential patient impact? We need to continue to prove out that we're able to scale these models well and reach a patient population that is nationally significant in terms of bending the cost curve,” Kneeland said. Expanding these programs geographically and reaching rural populations will be critical to the growth of hospital-at-home, experts say, and to do that, providers will need to lean heavily on tech, specifically advanced virtual care and remote monitoring technologies. Providers and payers will continue to work through the complex operational and financial issues required to stand up and build these services. But in living rooms and bedrooms across the country, patients like Francisco and his wife Esperanza see it as an easy choice, an alternative option that moves health closer to home.

MADISON, N.J.--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA Timber Pharmaceuticals, Inc., a LEO Pharma company, today presents preliminary results from the ASCEND trial in a late-breaking session at the 2024 American Academy of Dermatology (AAD) Annual Meeting. 1 The results offer a first look at the safety, efficacy and pharmacokinetic (PK) data from 17 adult and adolescent participants (aged 12-64 years) enrolled in the open-label maximum use arm of the phase 3 ASCEND trial. 1 These late-breaker results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology. ASCEND is a clinical trial of TMB-001, a polyethylene glycol (iPEG™) based investigational topical isotretinoin being developed for the treatment of moderate-to-severe X-linked and autosomal recessive congenital ichthyosis (CI). 3 CI is a group of rare genetic keratinization disorders that leads to dry, thickened, and scaling skin. 4-7 Currently, no specific treatments are approved by the U.S. Food and Drug Administration (FDA) to treat CI. 2 Patients enrolled in the open-label maximum use arm of the ASCEND trial with 75-90% body surface area involvement and moderate-to-severe disease on the Investigator Global Assessment (IGA) scale (IGA scores ≥3) were included in this analysis. 1 TMB-001 results showed that, from baseline to Week 12, the mean total Investigator Global Assessment (IGA) composite scaling and fissuring score decreased from 3.2 to 1.6 (p=0.0001). In the same timeframe, 59% of patients achieved a ≥2 point decrease in IGA scores from baseline, while 82% demonstrated a clinically significant (≥1 point) improvement in IGA scores from baseline. 1 No serious adverse events (SAEs) were reported. 1 65% of participants experienced at least 1 adverse event (AE), with a total of 35 events. 1 The top three treatment-emergent AEs were erythema (N=7), pruritus (N=4), and stinging/pain (N=2). 1 “ The preliminary findings from the ASCEND trial are encouraging and indicate the potential of TMB-001 to provide hope for those living with X-linked and autosomal recessive CI,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “ We know that the management of this disease can be incredibly challenging and, given the limited treatment options available, we remain focused on pushing the development of TMB-001 forward with the goal of helping to address this considerable unmet need.” The results were taken from participants in the open-label maximal use arm of the ASCEND trial. This arm aimed to analyze the PKs of TMB-001 by determining the level of systemic exposure of isotretinoin and metabolites. 1 To do this, the change from baseline of isotretinoin (ISO), 4-oxo-isotretinoin (4-O-ISO), tretinoin (TR), and 4-oxo-tretinoin (4-O-TR) after 14 days of twice-daily application of TMB-001 was assessed. 1 The data demonstrated low systemic concentrations across all four molecules examined after 14 days of twice-daily application of TMB-001. 1 The steady-state mean peak plasma concentrations (ng/mL) in the 17 participants were 4.5 for ISO, 9.0 for 4-O-ISO, and low to not calculable for TR and 4-O-TR. 1 “ X-linked and autosomal recessive CI can be incredibly challenging to live with, and in my experience patients are often impacted both psychically and psychologically by a host of symptoms,” said Dr. Christopher Bunick, Lead Author and Associate Professor of Dermatology, Yale School of Medicine. “ With no specific treatment currently available, CI patients are currently having to deal with their condition with minimal support. I hope that the data and insights presented today can help provide new knowledge and support for this patient community.” In January 2024, LEO Pharma finalized the acquisition of Timber Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. Upon completion, the Timber Pharmaceuticals lead investigational product candidate, TMB-001, was added to LEO Pharma’s pipeline. TMB-001 is under investigation and has not been evaluated by any health authority. About the ASCEND Trial An ongoing, multicenter phase 3 study to evaluate the efficacy and safety of TMB-001 0.05% topical ointment in the treatment of congenital ichthyosis (CI) in subjects (aged ≥6 years) with either the autosomal recessive congenital ichthyosis (ARCI) or X-linked recessive ichthyosis (XLRI) subtypes. 3 The clinical trial is divided into two parts. The first is a randomized, double-blind, vehicle-controlled phase III study. Its objective is to ascertain the efficacy of TMB-001 0.05% topical ointment as a treatment for CI compared with vehicle during 12 weeks of treatment. 3 In the second part of the trial, a subset of preselected centers will recruit subjects in parallel with either the ARCI or XLRI subtypes for enrollment into an Optional Maximal Use arm. The primary objective of this part of the trial is to determine systemic exposure of isotretinoin and metabolites after single or multiple applications of TMB-001 0.005% ointment. Its primary endpoint is an assessment of individual concentrations of 4-oxo-isotretinoin (4-O-ISO), tretinoin (TR), 4-oxo-tretinoin (4-O-TR) and change from baseline. 3 About Congenital Ichthyosis Congenital ichthyosis (CI) is a group of rare genetic keratinization disorders that can lead to dry, thickened, and scaling skin. 4-7 Most cases of ichthyosis are inherited, but some types develop in association with genetic syndromes or diseases, such as Hodgkin's Lymphoma. 8,9 People living with CI may have limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing. 4-7 About TMB-001 TMB-001, topical isotretinoin in the company’s investigational patented polyethylene glycol (IPEG™) delivery system, is being developed for the treatment of moderate-to-severe subtypes of congenital ichthyosis (CI). During Q4 2021, the positive topline results for its Phase 2b CONTROL Study were announced. In Q1 2022, TMB-001 received both Breakthrough Therapy Designation and Fast Track Status from the U.S. Food and Drug Administration (FDA). The Phase 3 ASCEND clinical trial was initiated in Q2 2022. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,400 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion. References Bunick CG, et al. Efficacy, Safety and Pharmacokinetics of First 17 Adult and Adolescent Subjects in Maximal Use Portion of Vehicle Controlled ASCEND Trial of Polyethylene Glycol (iPEG™)-Based Topical Isotretinoin 0.05% (TMB-001) for Treatment of Congenital Ichthyosis. Presented at American Academy of Dermatology (AAD) 2024 Annual Meeting, San Diego, Ca., March 8-12, 2024. Hernández-Martin A, Aranegui B, Martin-Santiago A, Garcia-Doval I. A systematic review of clinical trials of treatments for the congenital ichthyoses, excluding ichthyosis vulgaris. J Am Acad Dermatol . 2013;69(4):544-549.e8. ClinicalTrials.gov. National Library of Medicine (U.S.). The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis (ASCEND). Identifier: NCT05295732. https://classic.clinicaltrials.gov/ct2/show/NCT05295732 Oji V, Traupe H. Ichthyosis: clinical manifestations and practical treatment options. Am J Clin Dermatol. 2009;10(6):351-364. Takeichi T, Akiyama M. Inherited ichthyosis: Non-syndromic forms. J Dermatol. 2016;43(3):242-251. Vahlquist A, Gånemo A, Virtanen M. Congenital ichthyosis: an overview of current and emerging therapies. Acta Derm Venereol. 2008;88(1):4-14. Lilly E, Bunick CG. Congenital Ichthyosis: A Practical Clinical Guide on Current Treatments and Future Perspectives. Clin Cosmet Investig Dermatol. 2023;16:2473-2479. Haber R, Feghali J, Nadir U, Yi MD, Cahn BA. Acquired ichthyosis: a clinical review. Arch Dermatol Res. 2023;315(9):2529-2543. Mishra K, Jandial A, Gupta K, Prakash G, Malhotra P. Ichthyosis: A Harbinger of Lymphoma. BMJ Case Rep. 2018;2018:bcr2018224229. MAT-71602 March 2024

MADISON, N.J.--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82 nd American Academy of Dermatology (AAD) Annual Meeting. The event is being held from March 8 th to 12 th in San Diego, California. “ Our growing body of clinical evidence reinforces our passion and commitment to advancing the standard of care in medical dermatology ,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer. “ We are incredibly excited to have this opportunity at the 2024 AAD Annual Meeting to showcase our efforts to address patient needs across multiple skin conditions, including two late-breaker presentations regarding the potential treatment of CHE and CI, both of which are well known to disrupt the lives of countless people around the world.” With eight abstracts accepted in total for the meeting, 1-8 AAD is the latest major dermatology congress in which LEO Pharma will underscore a commitment to advancing scientific innovation and development in medical dermatology, with the aim of making a fundamental difference for people living with skin conditions. “ The AAD meeting is one of the most important milestones in the medical dermatology calendar in the United States, a country where skin conditions are estimated to affect as many as 1 in 3 people. I am proud that we can follow up on our 2023 AAD program with this level of critical data,” s aid Brian Hilberdink, EVP and President, Region North America, LEO Pharma. “ The opportunity to collaborate and deliberate with the research community and healthcare professionals at the scale that this meeting allows is key to bringing about meaningful change and improved outcomes for people living with skin conditions. We are honored to share our latest findings and look forward to engaging with the community while gathering more insights that will help benefit patients.” The first late-breaker presentation on March 9 th will outline the key results of the DELTA-3 trial, which assessed the long-term safety and efficacy of investigational delgocitinib cream in adults with moderate-to-severe CHE. This is the first time the key results have been shared at a medical congress. 1 Additional data for delgocitinib cream will also be presented as e-posters, including pooled analyses of the pivotal phase 3 DELTA-1 and DELTA-2 trials. 4,5,6 An additional late-breaker presentation on March 10 th will outline the preliminary results from the maximum use arm of the ASCEND trial, which examined the efficacy, safety and pharmacokinetics of investigational TMB-001 in adult and adolescent subjects with moderate-to-severe X-linked and Autosomal Recessive CI. 2 Additional data, presented as an e-poster, also based on the ASCEND trial, will examine the pharmacokinetics of TMB-001 compared to oral isotretinoin. 7 Adbry ® (tralokinumab-ldrm) data will be shared during the annual meeting as an e-poster summarizing results from the ECZTEND trial investigating the stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe AD. 3 Finally, one temtokibart (LEO 138559) e-poster will be delivered and will analyze individual patient responses to IL-22RA1 inhibition in a phase 2a monotherapy trial for moderate-to-severe AD, 8 following up on the late-breaking presentation of the phase 2a trial that was presented at AAD 2023. The company’s full roster of accepted presentations at the 2024 AAD Congress includes: Delgocitinib Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial Author: Melinda Gooderham Abstract #: 56059 LB presentation: Saturday March 09 at 11:10 – 11:20 AM PST Location: Room 20BCD Efficacy and safety of delgocitinib cream in adults with moderate-to-severe chronic hand eczema: pooled results of the Phase 3 DELTA-1 and -2 trials Author: Robert Bissonnette Abstract #: 52715 E-poster presentation​ Delgocitinib cream reduces itch and pain in adults with moderate-to-severe chronic hand eczema: pooled analyses of the Phase 3 DELTA-1 and -2 trials Author: Andrea Bauer Abstract #: 53696 E-poster Systemic exposure and safety profile of delgocitinib cream in adults with moderate-to-severe chronic hand eczema in the Phase 3 DELTA-2 trial Author: Melinda Gooderham Abstract #: 53695 E-poster Adbry ® (tralokinumab-ldrm) Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis Author: Andrew Blauvelt Abstract #: 53133 E-poster Temtokibart Individual patient responses to IL-22RA1 inhibition in a Phase 2a monotherapy trial for moderate-to-severe atopic dermatitis Author: Melinda Gooderham Abstract #: 53111 E-poster TMB-001 Efficacy, Safety and Pharmacokinetics of First 17 Adult and Adolescent Subjects in Maximal Use Portion of Vehicle Controlled ASCEND Trial of Polyethylene Glycol (iPEG™)-Based Topical Isotretinoin 0.05% (TMB-001) for Treatment of Congenital Ichthyosis Author: Christopher G. Bunick Abstract #: 56255 LB presentation: Sunday March 10 at 03:00 – 03:10 PM PDT Location: Room 20BCD The Phase 3 Vehicle-Controlled ASCEND Trial of Polyethylene Glycol (iPEG™) Based Topical Isotretinoin (TMB-001 0.05% ointment) for Treatment of X-Linked and Autosomal Recessive Congenital Ichthyosis: Analysis of Pharmacokinetic Results Compared with 80 mg Oral Isotretinoin ​ Author: Christopher G. Bunick Abstract #: 51523 E-poster About chronic hand eczema Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 9,10 HE is the most common skin disorder of the hands 11 with a one-year prevalence rate of approximately 9%. 12 In a substantial number of patients, HE can develop into a chronic disease. 11 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 13 About atopic dermatitis Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 14 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 15 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 15,16 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 17 About congenital ichthyosis Congenital ichthyosis (CI) is a group of rare genetic keratinization disorders that can lead to dry, thickened, and scaling skin. 18-21 Most cases of ichthyosis are inherited, but some types develop in association with genetic syndromes or diseases, such as Hodgkin's Lymphoma. 22,23 People living with CI may have limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing. 18-21 About delgocitinib Delgocitinib cream is an investigational, potential first-in-class, topical pan-Janus kinase (JAK) inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 24 Delgocitinib has not been approved by any health authority. The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 25 LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults, which is currently not approved by any health authority. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About Adbry ® (tralokinumab-ldrm) Adbry ® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza ® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. 15,16 Adbry ® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). 26 Adbry is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan. U.S. INDICATION AND IMPORTANT SAFETY INFORMATION What is ADBRY? ADBRY ® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids. It is not known if ADBRY is safe and effective in children under 12 years of age. Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients. What should I discuss with my healthcare provider before starting ADBRY? Tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY. are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/ . are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ADBRY? See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes. Use ADBRY exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much ADBRY to inject and when to inject it. ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard. ADBRY is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time. If you inject -too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to. What are the possible side effects of ADBRY? ADBRY can cause serious side effects including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems itching skin rash swelling of the face, mouth, and tongue fainting, dizziness, feeling lightheaded (low blood pressure) hives Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision. The most common side effects of ADBRY include: Upper respiratory tract infections Eye and eyelid inflammation, including redness, swelling, and itching Injection site reactions High count of a certain white blood cell (eosinophilia) These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use. About temtokibart Temtokibart (LEO 138559) is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis. 27 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24. 27 Temtokibart does not bind to the IL-22 cytokine itself. 27 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About TMB-001 TMB-001, topical isotretinoin in the company’s investigational patented polyethylene glycol (IPEG™) delivery system, is being developed for the treatment of moderate-to-severe subtypes of congenital ichthyosis (CI). During Q4 2021, the positive topline results for its Phase 2b CONTROL Study were announced. In Q1 2022, TMB-001 received both Breakthrough Therapy Designation and Fast Track Status from the U.S. Food and Drug Administration (FDA). The Phase 3 ASCEND clinical trial was initiated in Q2 2022. A bout LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,300 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Gooderham M, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial. 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Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17–21 2023; New Orleans, LA. MAT-71520 March 2024