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Yahoo
20 hours ago
- Yahoo
Enable Injections Announces enFuse® System Regulatory Approval in Brazil and MRHA Medical Device Registration in the UK
CINCINNATI, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Enable Injections, Inc. ('Enable'), a healthcare innovation company developing and manufacturing the enFuse® on-body drug delivery system, announced today that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) approved the enFuse system for administration of medication subcutaneously. Approval of enFuse technology by ANVISA demonstrates that the enFuse on-body injector and enFuse syringe and vial transfer systems adhere to applicable Brazilian safety and quality standards and requirements, allowing distribution throughout the country. The approval in Brazil marks a milestone in Enable's partnership with Sobi, announced in September 2024, with plans to develop and distribute the enFuse system for the administration of Empaveli®/Aspaveli® in Sobi territories. 'Obtaining approval for the enFuse system in Brazil is an important regulatory milestone that underscores our commitment to bring our innovative technology to as many patients as possible, globally, who could benefit from a more comfortable administration experience,' said Michael D. Hooven, Chairman and CEO of Enable Injections. 'By continuing to collaborate closely with our pharmaceutical partners, we remain steadfast in our mission to improve the lives of patients and caregivers through our wearable enFuse technology, minimizing disruption to their daily lives.' In addition, the enFuse technology is registered in the UK with the United Kingdom's Medicines and Healthcare products Regulatory Agency (UK MHRA) as of June 6, 2025 and received European Union Medical Device Regulation (EU MDR) CE Mark in March 2025. The enFuse on-body injector features hands-free, hidden needle drug delivery through a simple injection under the skin instead of intravenously, which is time-consuming and resource intensive. The enFuse system is designed to enhance the patient treatment experience by streamlining and improving at-home self-administration or in-clinic subcutaneous delivery of large volumes of pharmaceutical and biologic therapeutics. About Enable InjectionsCincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse on-body drug delivery system. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. Enable's enFuse technology received its first combination product U.S. FDA approval in 2023. For more information, visit Media Contact:Molly DevlinReal Chemistrymdevlin@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
a day ago
- Medscape
Ultrasound-Based Diagnosis of Early PsA Remains Elusive
BOGOTÁ, Colombia — Early detection and treatment of psoriatic arthritis (PsA) can prevent joint damage and improve long-term disease outcomes. But, to date, no biomarker has emerged that can reliably diagnose early PsA. At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 Annual Meeting and Trainee Symposium, researchers presented the latest results from a multiyear international effort to create an ultrasound-based scoring system for enthesitis that can be used to help diagnose early disease. Enthesitis, or inflammation, in the areas where tendons and ligaments attach to bones is a common feature in PsA and often among the first manifestations of the disease. The Diagnostic Ultrasound Enthesitis Tool (DUET) study, led by Lihi Eder, MD, of the University of Toronto, Toronto, Ontario, Canada, Sibel Aydin, MD, of the University of Ottawa, Ottawa, Ontario, and Gurjit Kaeley, MD, of the University of Florida College of Medicine in Jacksonville, Florida, sought to develop a new sonographic enthesitis scoring system to assist with the diagnosis of PsA. Eder, who presented the most recent findings from DUET at the conference, described the goal of the study as an ultrasound-based scoring system that can reliably distinguish PsA, scans as few sites as possible, and is reproducible, consistent, and simple to calculate. Patella, Triceps, and Achilles Tendon Sites Best in Discriminating Conditions Eder and her colleagues recruited 213 patients with rheumatologist-confirmed PsA (mean, 1.6 years since diagnosis), 100 patients with dermatologist-confirmed psoriasis and no history of PsA, and 106 control patients who had been seen by rheumatologists for noninflammatory musculoskeletal issues. None of the subjects were taking biologic therapies. The researchers scanned 16 entheseal sites in the upper and lower extremities for each patient. After a preliminary analysis, they chose six sites as the basis for their score and evaluated nearly 50 different combinations of sites. The final DUET score integrated both inflammatory and structural findings from the scanned sites. DUET scores were significantly higher in people with PsA than in control individuals, regardless of age, sex, and BMI, Eder reported. The patella, triceps, and Achilles tendon were the sites that discriminated best between patients with PsA and control individuals. While the DUET score had a specificity of over 70%, sensitivity was only about 50% across age groups, meaning that half the patients with early PsA had a negative score. When people presented with one or more tender entheses among the scanned sites, sensitivity rose to 60%. The sensitivity findings 'may be explained by the fact that enthesitis in joints is not seen in all patients with psoriatic arthritis,' Eder said. 'It is a heterogeneous disease.' 'We should be aware of the limitation that this tool that does not recognize all patients with PsA,' Eder continued. 'But the sensitivity improves when tender entheses are present,' she noted, adding that her group is conducting additional studies to validate DUET in real-world settings. The DUET study, which has funding from industry, is a GRAPPA-led initiative. GRAPPA co-founder and current president Arthur Kavanaugh, MD, of the University of California, San Diego, said in an interview during the conference that the results were clinically meaningful, even if not as discriminatory as hoped. 'In the clinic, you don't necessarily use ultrasound on people if they're not tender,' Kavanaugh said. 'I think everyone had wanted a very simple answer, that this [scoring system] was going to be perfect,' he added. 'And you saw a very thorough attempt to try and make it so. But the data are the data.' Philip Mease, MD, of the Swedish Medical Center in Seattle, a GRAPPA co-founder and past president, concurred. The sensitivity numbers 'were less than I would have hoped for,' he said. 'But that's the nature of the beast. This is a really difficult thing to assess.' Mease added that it was helpful for him to learn which scanning sites are the most informative. 'This will be very useful for people who do ultrasound as part of their practice,' he said.
Medscape
2 days ago
- Medscape
Support Needed for Psoriasis Patients' Poor-Quality Sleep
TOPLINE: Patients with psoriasis have significantly more difficulty sleeping, particularly in new environments, than matched individuals without the condition. Problems sleeping also rose in conjunction with disease severity. METHODOLOGY: Researchers enrolled 12 patients diagnosed with psoriasis and 12 control subjects matched for age, sex, and BMI to undergo 3 nights of sleep-lab analysis. People with obstructive sleep apnea were excluded from the study. Patients completed disease questionnaires to assess severity and other disease characteristics and underwent blood draws to look for inflammatory markers. TAKEAWAY: Multivariate analyses showed that on the first, or adaptation, night of of the 3-night sleep lab study, patients with psoriasis spent significantly less time asleep while in bed (76% vs 89%), had significantly less total sleep time (363 vs 421 minutes), and experienced significantly more nighttime awakening (89 vs 40 minutes) than matched controls (P < .05 for all), indicating poorer adaptability and greater sensitivity to disruption. Patients with more severe psoriasis also saw less time asleep while in bed, lower total sleep time, longer time until REM sleep, and lower percentage of time spent in REM sleep during the study. Overall, across the 3 nights of the study, patients with psoriasis slept nearly an hour less each night than healthy controls, a finding that did not reach statistical significance (P = .13). The difference persisted after adjusting for itch, anxiety, and depression, all factors that can influence sleep quality. IN PRACTICE: 'We don't have the time to tackle all the different comorbidities in patients [with psoriasis] and talk about every symptom that they are having,' said study author Tina Bhutani, MD, dermatologist with the University of California, San Francisco, and in private practice. 'But what we can quickly ask is if they are having trouble sleeping, or if they wake up multiple times during the night or whether they feel rested in the morning. That way we can provide them with resources where they can get more support.' SOURCE: Bhutani and her colleagues conducted the research, which Bhutani presented by video conference at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 Annual Meeting and Training Symposium in Bogotá, Colombia. LIMITATIONS: The small sample size meant that some results of interest did not reach statistical significance. DISCLOSURES: GRAPPA provided funding for the study. Bhutani disclosed having served as an advisor or speaker for or receiving research funding from, AbbVie, Amgen, Arcutis, Aslan, Boehringer Ingelheim, Bristol Myers Squibb, Castle, CorEvitas, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB.
