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Medscape
29-05-2025
- Business
- Medscape
Spesolimab Provides Sustained Improvement of GPP and QOL
In a secondary analysis of phase 2b spesolimab data in generalized pustular psoriasis (GPP), nearly two-thirds of patients who received 300 mg monthly doses maintained clear or nearly clear skin through 48 weeks' follow-up, and nearly one quarter of treated patients maintained minimal GPP impact on quality of life (QOL). Nevertheless, investigators said, the presence of moderate QOL impairment despite clear or nearly clear skin at baseline highlighted the chronic nature of GPP and patients' need for effective long-term treatment. Similar observations emerged from a separate study that characterized GPP flares and treatment patterns. Skin Symptoms and QOL In the post hoc analysis of Effisayil 2 data, investigators led by Kenneth B. Gordon, MD, professor of dermatology, Medical College of Wisconsin, Milwaukee, found that overall, 20.0% of patients who received monthly subcutaneous spesolimab 300 mg (after a 600 mg subcutaneous loading dose) had sustained improvement in both GPP Physician Global Assessment (GPPGA) and Dermatology Life Quality Index (DLQI) scores through week 48 compared with 3.2% of the placebo cohort. Regarding skin manifestations, 63.3% of patients treated with spesolimab experienced sustained improvement, which investigators defined as having a GPPGA score of 0/1 at all Effisayil 2 study visits through week 48 without other investigator-prescribed medications. The corresponding figure among patients on placebo was 29.0%. The study recently appeared in the Journal of the American Academy of Dermatology ( JAAD ). As for QOL, 24.1% of spesolimab-treated patients maintained DLQI scores of 0/1 through week 48 vs 3.2% for placebo. Patients reported at baseline that GPP's biggest impact on QOL stemmed from itch, soreness, and pain; embarrassment; and the disease's effects on social activities and clothing choices. Although patients in Effisayil 2 had GPPGA 0/1 at baseline, Gordon and colleagues noted that the mean baseline DLQI scores of 11.1 and 7.2 in the 300 mg monthly and placebo groups, respectively, indicated that despite patients' having clear or nearly clear skin, moderate QOL burden persisted. Spesolimab, a monoclonal antibody that blocks interleukin (IL)-36 signaling known to be involved in GPP, was first approved by the US Food and Drug Administration in 2022 for treating flares in adults with GPP. Approval was expanded in 2024 for the treatment of GPP in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg. Real-World Data In a separate study also recently published in JAAD , investigators found that among 638 eligible patients with GPP from the OMNY Health real-world data platform, 63% experienced at least one GPP flare between January 2017 and January 2023. The mean annualized flare rate was 0.91 per patient per year, with a mean inter-flare interval of 5.9 months. Patients who experienced flares were more likely to be women, younger than 65 years, non-White, Hispanic, or Latino, and had moderate or severe GPP and a history of infectious or parasitic disease. Treatment strategies were diverse, nonstandardized, and off-label, with patients frequently switching or discontinuing biologics and/or nonsteroidal systemic treatments. 'GPP patients continue to experience frequent flares with traditional off-label therapies in the real-world setting,' wrote authors led by Jamie W. Rhoads, MD, MS, of the University of Utah School of Medicine, Salt Lake City. Among patients who experienced multiple flares, they added, 66% had a second flare within 6 months of their first. Together, said James G. Krueger, MD, PhD, the D. Martin Carter professor in clinical investigation and co-director of the Center for Clinical and Translational Science at The Rockefeller University, New York City, the two papers examine how patients view their health status between flares and what the frequency of reflaring might be. He was not involved with the studies but provided comments in an interview with Medscape Medical News . Fear of Flaring Patients worry about GPP flares, said Krueger, because such flares constitute a medical emergency with potentially severe, life-threatening symptoms that could require hospitalization for weeks while receiving traditional immunosuppressants. And GPP is so rare that a practicing dermatologist may see only a few cases in their career. 'Given that almost no center takes in this type of patient,' he added, 'there's a lack of knowledge about the natural course of GPP and how best to manage patients with this disease.' James G. Krueger, MD, PhD Before spesolimab's approval for GPP, he said, broadly acting immunosuppressants targeted GPP indirectly. The fact that doctors could quell flares using such medications did not mean that patients' inflammation had resolved, Krueger added. 'It means their inflammatory state may have been suppressed to the point that they didn't need hospitalization. But many of these patients report significant symptoms or quality-of-life issues between flares.' Mechanistically, Krueger said, only around one quarter of patients with GPP possess a genetic mutation in a control protein called the IL-36 receptor antagonist, which normally would prevent the overblown IL-36 response that characterizes GPP. Nevertheless, he said, the mutation spotlights the IL-36 cytokine family as the most important, consistent aberration in causing GPP. 'This is one of the instances where a rare disease has a known genetic association, and that genetic problem can be fixed to a large extent by a therapeutic antibody. This antibody essentially replaces the function of the missing protein by binding to a receptor for IL-36 in a way that prevents it from being activated.' Accordingly, said Krueger, spesolimab approximates a molecular replacement therapy for GPP. 'And I believe that's why spesolimab works remarkably fast.' Ultimately, Krueger said, both articles mainly address medical dermatologists at referral centers who treat patients with more complicated GPP flares. 'The general practitioner should be aware that there are care pathways for acute and chronic GPP that may keep people under enough control that they can avoid recurrent emergency visits to either a dermatologist or an emergency room.' The new information about the likelihood that a patient will have lifelong disease 'helps with getting into the mindset that you're going to need to manage most of these patients over a long time period, not episodically,' he added. The spesolimab study was supported by Boehringer Ingelheim, maker of spesolimab; authors reported financial relationships with many companies that manufacture psoriasis drugs, including AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, and others. The second study was also supported by Boehringer Ingelheim. Rhoads had received consulting fees from Boehringer Ingelheim, Eli Lilly, and Genentech. Another author of the second study is an employee of OMNY Health, a contractor to Boehringer Ingelheim for the real-world study, and had received consulting fees from Boehringer Ingelheim, Eli Lilly, and Genentech. Two authors are Boehringer Ingelheim employees, and another author had received research grants and is a consultant to and had received honoraria from Boehringer Ingelheim. Krueger has been a consultant and lecturer for Boehringer Ingelheim and has analyzed biopsy samples from Effisayil 1 and 2 for future publications, but he is not an Effisayil author.


Medscape
12-05-2025
- Health
- Medscape
Inside Topical Minoxidil's Toxic Threat to Household Pets
SAN DIEGO — New hair, new problems: A pair of reports are shedding light on the growing danger posed to household pets by topical minoxidil (Rogaine), the popular over-the-counter treatment for androgenetic alopecia. One study, presented here at the annual meeting of the Society for Investigative Dermatology (SID), reported a 965% increase in minoxidil poisoning reports to the American Society for the Prevention of Cruelty to Animals (ASPCA) Animal Poison Control Center from 2013 to 2024, perhaps reflecting a 13-fold increase in Google searches for the drug. And a scoping review of studies describing cases of minoxidil toxicosis in cats and dogs, published on April 4 in the Journal of the American Academy of Dermatology ( JAAD ), found that dogs were often exposed to minoxidil while rummaging through trash or chewing packaging, whereas cats were more likely to be exposed by lying on contaminated bedding or licking human skin. Shari Lipner, MD, PhD 'Minoxidil's increasing popularity poses a preventable but growing threat to pets,' said Shari Lipner, MD, PhD, dermatologist at Weill Cornell Medicine, New York City, and a co-author of the study presented at SID, in an interview. 'Dermatologists must educate patients about risks, advocate for clearer product warnings, and emphasize immediate veterinary care if exposure occurs. Even small doses can be lethal, particularly for cats.' Minoxidil, a vasodilator, was initially developed as an antihypertensive, and the topical formulation became a treatment for androgenetic alopecia in the 1980s. The first reported poisoning of a pet — a dog — came in 2018, Lipner said, and more than 200 cases were documented by 2021. However, 'we suspected that most dermatologists and their patients were unaware of the risk,' Lipner said. 'Our study is the first to examine whether the increasing popularity of topical minoxidil has led to more pet poisonings.' Lipner and colleagues examined reports of minoxidil poisoning from the ASPCA Animal Poison Control Center and found that the number grew from 20 in 2013 to 213 in 2024. The study authors also examined Google Trends data and found that searches for minoxidil consistently rose from 2013 to 2024, reaching their highest level in 2024. Why are pets so vulnerable to minoxidil? Cats don't have crucial liver enzymes needed for their bodies to process toxins in a process known as glucuronidation, 'making them unable to safely metabolize chemicals like minoxidil,' said Eric McMullen, MD, a dermatology resident at the University of Toronto, Toronto, Ontario, Canada, and a co-author of the journal study. 'In cats and dogs, the potent cardiovascular effects of topical minoxidil pose serious risks to a pet's heart and lungs,' he told Medscape Medical News . Sharon Gwaltney-Brant, DVM, PhD, a veterinary toxicologist and adjunct professor at the University of Illinois Urbana-Champaign's College of Veterinary Medicine, told Medscape Medical News that their smaller body sizes also make cats more susceptible, 'which means it takes less total amount of drug to have an effect compared with larger species such as dogs and humans.' Gwaltney-Brant, co-author of a landmark 2021 study on minoxidil toxicity in dogs and cats, added that 'the grooming behavior of cats may increase exposure to minoxidil that gets on their coats via spills, pillowcase residue, etc. Several cases of cats licking their owner's scalps following minoxidil application have been reported.' For her part, Lipner noted that pets may also be exposed by licking contaminated sinks or chewing discarded bottles. 'While rare, we discovered cases where pet owners intentionally applied minoxidil to animals, likely trying to help with pet hair growth.' Specifically, the scoping review published in JAAD found that dogs were more likely to have been exposed through 'exploratory' behavior like rummaging through trash or eating packaging (88% of the cases), while cats were mostly exposed indirectly through methods like licking human skin or lying on contaminated bedding (96% of cases). For that review, McMullen and co-authors examined four single-incident reports and two case series of minoxidil poisoning in pets (68 cats; 26 dogs; average age, 3.6 years; mean weight, 5.5 kg). In more than half of the reported cases, the pets had no symptoms, but 97.8% of the pets had to be hospitalized. The pets were exposed orally (70.2%), dermally (9.6%), or both (20.2%). The most common symptoms were hypotension (43.6%), lethargy (33.3%), tachycardia (27.7%), and tachypnea (21.3%). All dogs survived, but 10 (14.7%) cats died. The study presented at SID examined 267 cases in dogs and 434 in cats from 2013 to 2024: 77% of pets were exposed orally, 4.9% dermally, and 15.8% both orally and dermally. Six pets were exposed by inhalation, one aurally, and one ocularly. The exposure method was unknown in eight pets. In 54% of cases, the pets had no symptoms, and three cats died. With regard to prevention, Lipner said, 'dermatologists should warn pet owners to store minoxidil securely (eg, locked cabinets), wash hands immediately after applying it, keep pets away from treated areas (eg, do not let cats lick your skin or sleep on your pillow after use), and dispose of bottles in sealed trash bins that pets will not be able to open,' Lipner said. For his part, McMullen emphasized the importance of discarding any used tissues, cotton pads, or gloves in a sealed bin, and he said pets should be limited from sleeping on beds. 'Switching to oral minoxidil is also a reasonable option when the above measures are not possible,' he said. Moving forward, 'ideally, these risks to pets would be explicitly listed in product labelling and monographs, which is currently not the case,' said journal study co-author Jeffrey Donovan, MD, PhD, assistant professor in the Dermatology and Skin Science at the University of British Columbia, Vancouver, British Columbia, Canada, in an interview. 'As awareness grows, we hope that fewer and fewer pets will be harmed by toxic drug interactions.'
Yahoo
09-04-2025
- Health
- Yahoo
JAAD Publishes Study on AVAVA's Focal Point Technology™, A Breakthrough in Laser Treatments for All Skin Tones
Peer-Reviewed Research Validates AVAVA's Revolutionary Approach to Aesthetic Laser Treatments BOSTON and NEW YORK, April 09, 2025 (GLOBE NEWSWIRE) -- AVAVA, a leader in medical aesthetics innovation, recently published a groundbreaking peer-reviewed study in the Journal of the American Academy of Dermatology (JAAD). This study highlights the power of AVAVA's proprietary Focal Point Technology™, redefining energy-based skin treatments by offering unmatched precision and versatility for patients of all skin tones. JAAD's recognition affirms the groundbreaking nature of AVAVA's approach. The study demonstrates how Focal Point Technology™ delivers energy at precise depths up to 2mm, allowing healthcare practitioners to tailor treatments to a variety of skin concerns while minimizing damage to the skin's surface. This results in smoother, revitalized skin with shorter recovery times, making aesthetic treatments more accessible to a broader range of individuals. At the heart of this technology is a ring-shaped laser beam that penetrates deeply into the skin, through a super-cooled treatment window (ComfortCool™) creating controlled zones of coagulation. This process stimulates renewal of natural collagen and elastin, rebuilding the skin from the inside out while sparing critical surface layers. AVAVA's groundbreaking product maximizes clinical outcomes while minimizing visible injury and supporting faster recovery, making treatments more accessible and appealing to patients. 'AVAVA is delivering something truly unique—a way for doctors to treat patients across every skin tone with precision and ease,' said Dr. R. Rox Anderson, a globally renowned laser pioneer and AVAVA Board member. 'For years, patients with darker skin tones have faced limited options due to the risks associated with traditional lasers. AVAVA changes that equation, opening new doors for new treatments while allowing physicians to treat all skin fearlessly.' 'Skin health should be universal, and AVAVA is making that vision a reality,' said Irina Erenburg, Ph.D., CEO of AVAVA. 'Our Focal Point Technology™ allows doctors to personalize treatments, meet the needs of all patients, and deliver revitalized skin with precision and confidence. This study is a testament to the power of innovation and its ability to transform care for patients and providers alike.' AVAVA's innovation extends beyond laser technology with AVAVASync™, a first-of-its-kind digital platform that seamlessly connects treatments, devices, and practice management. By combining real-time system intelligence with advanced workflow tools, AVAVASync™ enhances treatment precision, operational efficiency, and provider control—setting a new standard for modern aesthetics. For physicians, AVAVA represents a new level of treatment flexibility, to customize depth, energy, and density to align with individual patient needs and a wide range of patient skin conditions. Patients benefit from a treatment experience that rejuvenates the skin from within – without disrupting daily life. About AVAVAAVAVA™ is a trailblazer in energy-based technology, redefining how energy is delivered. Powered by Focal Point Technology™, AVAVA has pioneered a new approach to energy delivery, offering unmatched precision and unlocking new possibilities in medical aesthetics. Dedicated to advancing science, AVAVA builds on a legacy of industry innovation to create technologies that benefit all skin tones and types. Bridging science and care, AVAVA delivers energy with purpose and impact. With fearless vision and boundless energy, AVAVA is shaping the next generation of aesthetic technologies. For more information, visit About Blossom InnovationsBlossom Innovations is at the forefront of dermatology and aesthetics, developing impactful technologies that empower doctors and improve patient outcomes. With a legacy of collaboration and innovation, Blossom is shaping the future of the industry. Media Contact:Stephanie MitchellVP, MarketingAVAVA949.751.9879smitchell@ in to access your portfolio