Ping On Ointment

The first study to treat moderate-to-severe eczema in infants and children 6 months to 5 years old with a biologic drug rather than immune-suppressing medications shows the drug was highly effective in reducing the signs and symptoms of eczema. More than half of children had at least a 75% reduction in signs of eczema and itch. Kids slept through night for first time instead of scratching. Parents saw children's personalities change as they were able to lead a normal life. The first study to treat moderate-to-severe eczema in infants and children 6 months to 5 years old with a biologic drug (monoclonal antibody) rather than immune-suppressing medications shows the drug was highly effective in reducing the signs and symptoms of moderate-to-severe eczema, report researchers involved in a new multi-site international phase III study led by Northwestern Medicine. A 16-week course of dupilumab, a medication that targets a key immune pathway in allergies, resulted in more than half the children having at least a 75% reduction in signs of eczema and highly significant reductions in itch with improved sleep. This is the first large-scale, randomized, placebo-controlled trial of a monoclonal antibody in any skin disease, including eczema, in children as young as 6 months. The study, which included 31 sites in Europe and North America, will be published Sept. 15 in The Lancet. "Preschoolers who are constantly scratching, awake multiple times a night with their parents, irritable and markedly curtailed in their ability to do what other children their ages can do improved to the extent that they sleep through the night, change their personalities and have a normal life -- as babies and children should," said lead study author Dr. Amy Paller, chair of dermatology at Northwestern University Feinberg School of Medicine and an attending physician at Ann & Robert H. Lurie Children's Hospital of Chicago. Eczema, also known as atopic dermatitis, is a chronic inflammatory skin disorder characterized by red, dry, often oozing skin and itch that can profoundly affect the lives of affected patients and their families. An estimated 19% or more of all children under 6 years of age have eczema and 85 to 90% of individuals affected overall with eczema have the onset of disease during the first five years of life. The children's debilitating itch leads to sleep disturbance, poor neurocognitive development and, on average, a full night of sleep lost per week. "The ability to take this drug will significantly improve the quality of life for infants and young children who suffer tremendously with this disease," Paller said. "Atopic dermatitis or eczema is so much more than just itchy skin. It is a devastating disease. The quality of life of severe eczema -- not only for the child but also parents -- is equivalent to many life-threatening diseases." As a result of this study, this medication is now available to infants and preschoolers as young as 6 months of age. It has "an outstanding safety profile" and does not even require any laboratory tests before starting the medication, Paller said. Although one-half to two-thirds of young children with eczema have mild symptoms, which can be handled with steroid ointment and moisturizers, the other one-third or more have moderate-to-severe disease and require more aggressive management. "Up to now, all we have had to treat more severe eczema is immune-suppressing medications, such as oral steroids, which we try to avoid in children, because they are associated with so many side effects and thus are not a preferred treatment for a chronic skin disease," Paller said. "The potential long-term impact on the development of the immune system in young children is also of concern with these immunosuppressants." During the past few years, a new medication has become available called dupilumab, which is the first "biologic" drug to treat eczema in a targeted manner, meaning a narrow attack on just what scientists have found is causing the manifestations of the disease in skin. This medication was found to be effective and safe in studies with adults, then adolescents, then other school-aged children. "But the group in whom we worry the most about safety -- those under 5 -- had not been tested and were unable to get this medication," Paller said. The parent or a health care provider gives the child a monthly shot to administer the medication. "The effect for most of these younger children is dramatic and at least as good as we've seen with the risky immunosuppressant medications," Paller said. Potential added benefit by treating associated allergies This medication has also been shown to be effective for treating asthma, gastrointestinal manifestations of allergy and other allergy-mediated problems but is not yet approved for these indications in infants and young children. In fact, 66% of children in this trial had developed their eczema during the first six months of life and, by the time of initiating the dupilumab, more than 80% had already developed at least one allergic disorder, such as asthma or food allergy. "By treating more aggressively to calm the immune system activation in these young children with early, severe eczema, we may also reduce the risk of their developing a range of allergic problems, changing their life beyond improving eczema," Paller said. "These associated allergic issues most often begin after the eczema starts." Children were randomized to receive either a placebo injection or the dupilumab (weight-based dosing) every four weeks for 16 weeks. Only children who were not responding adequately to topical medications were allowed to enroll, and they had to be of a high severity, even with the topical medications. As a result of the study, Paller said, scientists and physicians can start to better understand the relationships between eczema and a variety of allergic disorders and can consider the possibility of using this medication for other disorders that affect these very young children. The trial was sponsored by Regeneron Pharmaceuticals, Inc. and Sanofi, who jointly developed dupilumab.

- The AAD's update to the guideline on the management of actinic keratosis includes a 'strong recommendation' designation in the topical field therapy category MALVERN, Pa., Aug. 18, 2022 /PRNewswire/ -- Almirall, LLC, a global biopharmaceutical company focused on skin health, announced its microtubule inhibitor ointment, KLISYRI® (tirbanibulin), a topical field treatment for actinic keratosis (AK) of the face and scalp, received a strong recommendation designation in the AAD's American Academy of Dermatology's Focused Update to the Guidelines of Care for the Management of Actinic Keratosis.[1] According to the newly-updated AAD AK treatment guidelines, the strong recommendation for KLISYRI® comes with a high certainty of evidence in the topical treatment of AK. KLISYRI® is the only topical AK treatment agent with this distiction.[1] The AAD guidelines play a critical role in advancing care in dermatology and providing clinicians with unbiased and objective guidance in the selection of appropriate agents, based on best available clinical evidence. "The recent changes to the AK treatment guidelines are particularly significant for both healthcare providers and patients," says Pablo Alvarez, President and GM at Almirall US. "For clinicians, the revised guidelines further validate the strong clinical benefits of KLISYRI® and reinforce the strong clinical outcomes seen with KLISYRI® in clinical trials." The AAD's strong recommendation was supported by clinical outcomes that suggest the benefits of treating with KLISYRI® clearly outweigh the clinical risks based on the following critical and important outcome criteria[1]: Critical: Mean reduction in AK lesion counts from baseline to assessment Participant complete clearance (100%) Participant partial clearance (≥ 75%) Investigator global improvement index Participant global improvement index Withdrawals due to adverse events "The new guidelines are based on a systematic review that identified two phase III randomized, double-blinded parallel-group placebo-controlled trials, including 702 adult participants," says Brian Berman, MD, PhD, Professor Emeritus of Dermatology at the University of Miami Miller School of Medicine. "KLISYRI® met key clinical criteria required for its inclusion with 49% of KLISYRI patients achieving complete clearance (100%) of lesions (9% for vehicle) and no patients withdrew from clinical trials due to adverse events."[2] Please click here for the executive summary of the updated guidelines. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Ophthalmic Adverse Reactions KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible. Local Skin Reactions Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain. Please see Full Prescribing Information at . About KLISYRI®: KLISYRI® tirbanibulin ointment is a novel microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) on the face or scalp. KLISYRI® has a demonstrated efficacy and safety profile, and a convenient 5-day application period which is the shortest of any topical treatment for AK.[3] Click here to view full Prescribing Information. About Actinic Keratosis : Actinic keratosis or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet (UV) radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma, so all lesions should be treated by a dermatologist. Actinic keratosis is the most common pre-cancerous dermatological condition. AK is the second most common diagnosis made by dermatologists in the United States.[4] The reported prevalence of AK is between 11% and 25%.[5] About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patients' needs through science to improve their lives. Our Noble Purpose is at the core of our work: "Transform the patients' world by helping them realize their hopes and dreams for a healthy life." We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros. For more information, please visit . Legal warning This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law. References: 1. Eisen DB, Dellavalle RP, Frazer-Green L, Schlesinger TE, Shive M, Wu PA, et al. Focused update to the guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2022. doi: j.jaad.2022.04.013 2. Blauvelt A, Kempers S, Lain E, et al. Phase 3 trials of tirbanibulin ointment for actinic keratosis. New England Journal of Medicine. 2021;384(6):512-520 3. KLISYRI [package insert]. Malvern, PA: Almirall, LLC, 2021 4. Wilmer EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. Most common dermatologic conditions encountered by dermatologists and nondermatologists. CUTIS. 2014;94(6):285-92 5. Lim HW, MD, Collins SAB, et al. The burden of skin disease in the United States. J Am Acad Dermatol. 2017;76:958-72 US-TIRBA-2200087 Logo - SOURCE Almirall, LLC