Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

Article

作者: Karabudak, R ; Horakova, D ; Girard, M ; Hodgkinson, S ; Castillo-Triviño ; Gerlach, O ; Gray, O ; Cartechini, E ; de Gans, K ; McCombe, P ; Spitaleri, D ; Solaro, C ; Garber, J ; Sas, A ; Alroughani, R ; Duquette, P ; Ramo-Tello, C ; Prevost, J ; van Pesch, V ; Skibina, O ; Van Wijmeersch, B ; Patti, F ; Aguera Morales, E ; Oreja-Guevara ; Laureys, G ; van der Walt, A ; Shaygannejad, V ; John, N ; Spelman, T ; Gouider, R ; Rajda, C ; Csepany, T ; Izquierdo, G ; Grand'Maison, F ; Trojano, M ; Onofrj, M ; Ozakbas, S ; Jose Sa, M ; Hughes, S ; Soysal, A ; Buzzard, K ; Havrdova, E K ; De Luca, G ; Eichau, S ; Butzkueven, H ; Slee, M ; Herring, W L ; Iuliano, G ; Jokubaitis, V G ; Acosta, C ; Petersen, T ; Lugaresi, A ; Hyde, R ; Pucci, E ; Ferraro, D ; Sanchez-Menoyo, J L ; Moore, F ; Kalincik, T ; Rozsa, C ; Terzi, M ; Granella, F ; Simo, M ; Ampapa, R ; Fragoso, Y ; Bergamaschi, R

AIM:

To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).

METHODS:

Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.

RESULTS:

In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.

CONCLUSIONS:

This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

Article

2024-11-01·Australian critical care : official journal of the Confederation of Australian Critical Care Nurses

Prevalence, recovery, and factors associated with dysphagia in an older critically ill trauma cohort: A cross-sectional study

Article

作者: Tipping, Claire J ; Holland, Anne E ; Harrold, Meg ; Crisp, Janae ; Chan, Terry ; Freeman-Sanderson, Amy ; Hodgson, Carol L

BACKGROUND:

Patients admitted to the intensive care unit (ICU) following trauma often have multiple injuries, which can lead to disordered swallowing, dysphagia. The prevalence of dysphagia in trauma populations ranges between 4.2% and 86%; however, clinical and associated longitudinal health outcomes and patient-reported quality of life are unknown.

OBJECTIVES:

The objective of this study was to compare hospital and clinical outcomes for older critically ill trauma patients diagnosed with and without dysphagia up to 12 months after hospital admission. Secondary outcomes include characteristics of dysphagia assessment and recovery during indexed hospital admission.

METHODS:

Post hoc analysis of an observational study. All patients were recruited from a tertiary ICU trauma unit, all were aged above 50 years, with an expected ICU length of stay of >24 h. Criteria of dysphagia diagnosis were determined via presence of International Classification of Diseases (ICD-10) code (R13). Hospital, clinical, and health-reported quality-of-life data were collected.

RESULTS:

Ninety-eight patients were included with 79 (81%) being male, overall median injury severity scale: 21.5 (interquartile range: 14-29); 38 (38.8%) with spinal injury, 37 (37.8%) with multitrauma excluding head injury, and 23 (23.5%) with multitrauma including head injury. Prevalence of dysphagia was 29%, with patients diagnosed with dysphagia more likely to have required invasive mechanical ventilation (odds ratio [OR]: 4.0, 95% confidence interval [CI]: 1.25-12.78), for an increased duration (OR: 2.6, 95% CI: 0.27-4.92) and required longer ICU admission (OR: 2.98, 95% CI: 0.28-5.69). Recovery of swallow function was protracted beyond the indexed hospital admission, with only 18% of those diagnosed with dysphagia returning to a normal, unrestricted, oral diet by hospital discharge. At 6 and 12 months, functional disabilities were reported across the cohort with no significant differences between groups.

CONCLUSIONS:

In older critically ill trauma patients, dysphagia is common. Use and duration of invasive mechanical ventilation and increased ICU length of stay for survivors were significantly increased for those with dysphagia. Management of swallowing is required across the continuum of care commencing in and beyond ICU to optimise recovery and outcomes.

项与 Alfred Health 相关的新闻（医药）

2024-10-28

·GlobeNewswire-Health Care

Aravax Completes Recruitment into Phase 2 Study of PVX108, a novel immunotherapy for the Treatment of Peanut Allergy

MELBOURNE, Australia, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Aravax, a clinical-stage biotechnology company developing next-generation immunotherapies designed to be safe, convenient, and precisely targeted, today announces it has completed patient recruitment into its Phase 2 study (AVX-201) of its novel, precision therapy PVX108 for the treatment of peanut allergy. Aravax’s PVX108 is an advanced immunotherapy designed to ‘re-train’ the immune system by administering engineered peptides to precisely target T cells and reverse the course of allergic disease. Unlike most treatments available, or under development for peanut allergy, PVX108 does not contain peanut proteins which put patients at significant risk of serious side effects, which leads to complex and burdensome dosing regimens. The study, which is being conducted under an U.S. FDA Investigational New Drug Application, has enrolled 95 patients across eight trial sites in the U.S. and six in Australia. Trial participants were children and adolescents aged four to 17 years with peanut allergy. The trial is a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of two dose levels of PVX108 versus placebo, administered monthly for one year. In Phase 1 trials, researchers observed that PVX108 produced relevant changes in the immune response to peanut protein, which continued to develop once dosing had completed. The primary endpoint of this Phase 2 study is ratio of maximum tolerated dose of peanut protein in a controlled food challenge at the end of the study period relative to baseline. Headline results are expected in H1 2026. Dr Pascal Hickey, CEO of Aravax, said: “The timely completion of recruitment across multiple sites in the U.S. and Australia, is a significant step for Aravax. There remains a critical need for better treatments for serious food allergies. PVX108 has been designed to provide a safe and convenient treatment which has the potential to reverse the course of allergic disease. We look forward to continuing evaluation of PVX108 efficacy in this potentially Phase 3-enabling study.” About Aravax Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation specific immunotherapies which are safe, effective and convenient. Aravax applies proprietary technology and know-how to design highly targeted immunotherapies, which reset the immune system to tolerate a specific allergen without evoking allergic reactions during treatment. The lead product, PVX108, is being developed for the treatment of peanut allergy. Founded in 2015 based on technology from Alfred Health and Monash University, Aravax is a private company headquartered in Melbourne. Its investors include Brandon Capital, Tenmile, Novartis Venture Fund, Breakthrough Victoria, Uniseed, UniSuper and Agati Capital. For more information visit: www.aravax.com.au About PVX108 PVX108 is an innovative precision immunotherapy containing a mixture of synthetic peptides which are designed to precisely target the T cells which drive peanut allergy. Each peptide represents a dominant T cell epitope from major peanut allergens. PVX108 does not contain natural extracts or whole allergens and has been engineered to be incapable of triggering acute allergic reactions. It has been designed to provide a safe, convenient and long-lasting treatment with monthly dosing through essentially needle-free intradermal administration. Media – Australia Kirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228 Media – International Sue Charles, Charles Consultants E: sue.charles@charles-consultants.com M: +44 (0)7968 726585

免疫疗法临床2期

2024-10-07

·PRNewswire

Medinol Announces Successful First-in-Human Implantation of ChampioNIR Drug-Eluting Peripheral Stent System in Australia

TEL AVIV, Israel, Oct. 7, 2024 /PRNewswire/ -- Medinol Ltd. is pleased to announce the successful First-in-Human (FIH) implantation of the ChampioNIR Drug-Eluting Peripheral Stent by Drs Gerard S.Goh and Thodur Vasudevan of the Alfred Hospital in Melbourne Australia, introducing a revolutionary advancement in the mechanics, durability and drug delivery of peripheral drug eluting stents. The ChampioNIR Drug-Eluting Peripheral Stent System poses a transformational technology designed to improve patient outcomes and procedural success. In a first of its kind hybrid mechanical design, radial support is provided by the metallic component of the stent, whereas longitudinal structure is provided by a bioresorbable polymeric mesh providing unsurpassed flexibility and long-term durability in even the most challenging anatomies. Furthermore, a unique drug-elution paradigm releases drug from the entire cylindrical area of the stent, drastically reducing diffusion distances and allowing, for the first time, therapeutic dosing of a large peripheral vessel with a 'limus' drug for an extended period of time. "We were impressed with ChampioNIR's deliverability and its straightforward deployment", said Prof. Gerard S Goh, Head of Interventional Radiology at The Alfred Hospital. "The Frictionless Deployment Mechanism made the precise positioning of the stent very straightforward". Dr. Yoram Richter, CEO of Medinol, added: "Medinol is excited to bring to clinical practice the culmination of years of research and development into novel stent designs, tailor-made for unmet clinical challenges in vascular interventions". The CHAMPIONSHIP First In Human study will enroll a total of 30 patients across 7 sites in Australia and the United States. Prof. Sahil Parikh, PI of the CHAMPIONSHIP study commented "The ChampioNIR stent represents a breakthrough in treatment for SFA lesions. I am excited to see this device come to life after years of development." About Medinol Founded in 1992, Medinol is a privately held company with offices in the U.S. and Israel, employing over 300 people. Extending more than 30 years of experience in the stent market, Medinol is aggressively changing paradigms in how disease states are diagnosed and treated. By designing cutting edge scaffolds for stenting multiple areas of the human body, dramatically reducing complications in Structural Heart procedures and providing real time insights into physiological metrics through Implantable Microsensors, Medinol looks years into the future to create pioneering medical devices. For more information, see . Contact: Jeff Roach [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-08-19

·Healthcare IT News

Alfred Health onboards cancer records to Oracle EHR

Hospital network Alfred Health in Victoria has onboarded and digitised the health records of their cancer patients to Oracle's EHR solution for oncology. WHY IT MATTERS Alfred Health finds significant value in Oracle Oncology in helping streamline pharmacy processes, with order information pushed directly from the EHR into the pharmacy management system. It also generates barcodes for each treatment, allowing nurses to readily check that a prescribed medication goes to the right patient and at the right dosage. "Completely digitising and making cancer treatment information easily available in our EHR makes guiding the overall treatment plan for patients more efficient," shared Alfred Health chief pharmacy information officer Erica Tong. Additionally, Oracle Oncology facilitates access to clinical trial opportunities and enables tracking of the progress of those enrolled in trials. THE LARGER TREND The hospital network has been improving the efficiency of its pharmacy processes. It has introduced electronic prescriptions within its EHR system, which come as a barcode and are presented to a community pharmacy for dispensing. Alfred Health has also integrated with Oracle EHR access to the national real-time prescription monitoring system, Safescript . This allows clinicians to view the prescription history of patients who are developing signs of drug dependence. Moreover, it was one of the first hospitals in the country to connect digital immunisation records from its EHR with the national registry, Australian Immunisation Register. In other related news, Northern Health , also based in Victoria, is the latest in the region to transition to digital medical records, powered by Oracle EMR. The Royal Flying Doctor Service has also moved to Oracle's cloud-based EMR system to enable the near real-time sharing of critical patient medical information.

100 项与 Alfred Health 相关的药物交易

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