Olga Guillén-Martínez, Enrique Barrajón-Catalán, Daniel Martínez-Caballero Martínez, Leticia Soriano-Irigaray, Fernando Borrás-Rocher, Leonidas Cruzado-Vega, Alejandra Sabater-Belmar, Ana Cristina Murcia-López
{"title":"Design of a New Predictive Equation for the Induction Dose of Tacrolimus in Immediate Renal Transplantation.","authors":"Olga Guillén-Martínez, Enrique Barrajón-Catalán, Daniel Martínez-Caballero Martínez, Leticia Soriano-Irigaray, Fernando Borrás-Rocher, Leonidas Cruzado-Vega, Alejandra Sabater-Belmar, Ana Cristina Murcia-López","doi":"10.1007/s12325-026-03739-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03739-5","url":null,"abstract":"<p><strong>Introduction: </strong>Kidney transplantation is the treatment of choice for end-stage chronic kidney failure. It requires pharmacological immunosuppressive therapy to prevent graft rejection while minimizing adverse effects. Tacrolimus (TAC) is one of the most widely used agents in this setting. The aim of this study was to determine the proportion of patients achieving optimal TAC concentrations with a 0.10 mg/kg/12 h regimen, identify factors influencing this outcome, and develop a predictive model to optimize dosing.</p><p><strong>Methods: </strong>This retrospective observational study included kidney transplant recipients treated at Hospital General Universitario de Elche between January 2019 and January 2024.</p><p><strong>Results: </strong>Ninety-three patients were analyzed, including 56 men and 37 women. Demographic, clinical, and pharmacotherapeutic data were collected. Regression analysis showed TAC levels were associated with weight, body mass index, hematocrit, total proteins, and glutamate-pyruvate transaminase (GPT). Only 30% (26 patients) achieved optimal TAC concentrations with the current dosing formula during the initial pharmacokinetic monitoring. However, this study developed a new predictive formula that could theoretically enable better initial dosing adjustments in up to 76% (71) patients.</p><p><strong>Conclusion: </strong>The current TAC dosing framework can be improved and adapted to the specific patient population being treated. In this regard, although the number of patients is low and additional internal and external validations are needed, the new formula developed in this study not only improves the accuracy of prediction results but is also flexible and adaptable enough for use in other clinical settings. Graphical Abstract available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M Farris Sawaya, Molly E McNulty, Collin J St Germain, Ibraheem A Hachem, Meissy S Calix, Rhys M Lormand, Nicholas J E McComb, Abdallah A Abu Shehab, James Wrightson, Ahmed I Anwar, Cy J Fontenot, Alan D Kaye, Kevin S Murnane
{"title":"Brixadi for Stimulant Use Disorder: Evolving Pharmacologic Considerations and Clinical Implications.","authors":"M Farris Sawaya, Molly E McNulty, Collin J St Germain, Ibraheem A Hachem, Meissy S Calix, Rhys M Lormand, Nicholas J E McComb, Abdallah A Abu Shehab, James Wrightson, Ahmed I Anwar, Cy J Fontenot, Alan D Kaye, Kevin S Murnane","doi":"10.1007/s12325-026-03772-4","DOIUrl":"https://doi.org/10.1007/s12325-026-03772-4","url":null,"abstract":"<p><p>Substance use disorders are an increasing concern globally, causing a tremendous uptick in public health burden in recent years. Despite the growing attention these disorders receive, there remain no approved pharmacotherapies for stimulant use disorder, thereby contributing a major portion of this burden. This review examines the potential use of Brixadi, an extended-release injectable formulation of the widely used pharmacotherapy buprenorphine, indicated for opioid use disorder, in the treatment of stimulant use disorder. Psychostimulants, including cocaine, methamphetamine, and designer stimulants, all exert their effects by inhibiting or reversing the directionality of the monoamine transporters in the synaptic cleft. Inhibition or reversal of these transporters in the synaptic cleft allows dopamine, serotonin, and norepinephrine to remain in the synapse, which ultimately enhances their activity and contributes to the reinforcement of substance use. The reinforcement loop driven by excess neurotransmitters, particularly dopamine, provides a pharmacotherapeutic target via receptor interactions. Brixadi is an injectable extended-release buprenorphine primarily used to treat opioid use disorder. The extended-release mechanism enables sustained drug-receptor interaction, resulting in stable plasma drug concentrations. Buprenorphine is as a dual-acting agent, a partial μ-opioid receptor (MOR) agonist and a κ-opioid receptor (KOR) antagonist. KOR antagonism modulates symptoms of withdrawal in OUD, including dysphoria, stress, and drug cravings. Therefore, Brixadi's KOR antagonism may offer a promising pharmacologic target for stimulant use disorder recovery by mitigating these negative affective states. Additionally, the bimodal mechanism suggests that Brixadi may be a beneficial pharmacologic candidate for people who suffer from polysubstance use involving opioids and psychostimulants. While there is promise behind these developments, current studies are limited to preclinical trials and have not yet advanced toward clinical trials. However, Brixadi's extended-release profile and potential capability to minimize withdrawal-related dysphoria and stress-induced drug seeking present promise for further clinical investigation.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lytske J Bakker, Katharina Nickel, Zoe Cheah, Elizabeth A Sigworth, Bodille P M Blomaard, Reginald Villacorta, Lixian Jin, Kiran Davé, Claire L Simons, Craig Bennison
{"title":"Assessment of the Value of Nivolumab Plus Ipilimumab for Treating Microsatellite Instability-High/Mismatch Repair Deficiency Metastatic Colorectal Cancer: Indirect Treatment Comparison and Cost-Effectiveness Analysis.","authors":"Lytske J Bakker, Katharina Nickel, Zoe Cheah, Elizabeth A Sigworth, Bodille P M Blomaard, Reginald Villacorta, Lixian Jin, Kiran Davé, Claire L Simons, Craig Bennison","doi":"10.1007/s12325-026-03787-x","DOIUrl":"https://doi.org/10.1007/s12325-026-03787-x","url":null,"abstract":"<p><strong>Introduction: </strong>Colorectal cancer (CRC) is the third most common cancer and has the second highest global economic burden of all cancers. Among metastatic CRC (mCRC) cases, 4-5% are microsatellite instability-high/mismatch repair deficiency (MSI-H/dMMR) for which, up until recently, pembrolizumab was the recommended first-line treatment. This study has evaluated the cost-effectiveness of nivolumab plus ipilimumab versus pembrolizumab and chemotherapy in previously untreated, MSI-H/dMMR mCRC patients.</p><p><strong>Methods: </strong>A three-state semi-Markov model with a lifetime horizon was developed adopting a United States (US) healthcare payer perspective. Effectiveness data for nivolumab plus ipilimumab and chemotherapy were sourced from Checkmate-8HW (NCT04008030). Indirect treatment comparisons (ITCs) using Checkmate-8HW and KEYNOTE-177 informed comparisons with pembrolizumab. Methods included time-varying parametric analysis, fractional polynomials and matching adjusted indirect comparison. Utilities, resource use and costs were derived from trial data, US databases and literature.</p><p><strong>Results: </strong>Nivolumab plus ipilimumab dominated pembrolizumab in the base case analysis, as a first-line MSI-H/dMMR mCRC treatment yielding lower costs and greater quality-adjusted life years (QALYs) (Δ-US$58,819; Δ2.32). Compared with chemotherapy, costs and QALYs increased (Δ$58,783; Δ3.49) resulting in an incremental cost-effectiveness ratio (ICER) of $16,849. Across ITC methods, QALY gains versus pembrolizumab ranged from 1.65 to 2.35. Dominance over pembrolizumab was not maintained across all cost variations in scenario analyses, although resulting ICERs remained below commonly accepted US willingness-to-pay thresholds. The parameters most impactful of the ICER include the frequency of inpatient admissions with progressed disease and variations in drug dosing.</p><p><strong>Conclusions: </strong>This is the first study demonstrating that first-line treatment with nivolumab plus ipilimumab may offer significant health economic benefits over pembrolizumab when used to treat first-line MSI-H/dMMR mCRC patients. With QALY gains ranging from 1.65 to 2.35 across various ITC methodologies, nivolumab plus ipilimumab seems a compelling treatment option for first-line MSI-H/dMMR mCRC.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148910440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kazumasa Kamei, Miwa Enami, Hiroyuki Matsuda, Katsuya Yamagami, Yawen Dai, Masato Hoshi, Ernest H Law, Akira Yuasa
{"title":"Comparative Cost-Effectiveness of Advanced Treatment Sequences for Moderately to Severely Active Ulcerative Colitis in Japan.","authors":"Kazumasa Kamei, Miwa Enami, Hiroyuki Matsuda, Katsuya Yamagami, Yawen Dai, Masato Hoshi, Ernest H Law, Akira Yuasa","doi":"10.1007/s12325-026-03757-3","DOIUrl":"https://doi.org/10.1007/s12325-026-03757-3","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcerative colitis (UC) is a chronic immune-mediated inflammatory disease characterized by a relapsing course, substantial symptom burden, and long-term healthcare utilization. Although multiple advanced therapies (ATs) are available for patients with moderately to severely active UC, evidence to guide optimal treatment sequencing remains limited, particularly in Japan. This study evaluated the cost-effectiveness of clinically relevant AT sequences for moderately to severely active UC in Japan.</p><p><strong>Methods: </strong>A hybrid decision-tree and Markov model was developed to compare AT sequences over a lifetime horizon from the payer perspective. The model captured both induction and maintenance phases for each therapy. Efficacy and safety inputs were derived from a previously published Bayesian network meta-analysis and supplemented with Japan-specific clinical and economic data. Costs and quality-adjusted life years (QALYs) were discounted at an annual rate of 2.0%. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness was assessed against a Japanese cost-effectiveness threshold of JPY 7,500,000 per QALY (USD 49,547 per QALY).</p><p><strong>Results: </strong>A total of 79 treatment sequences were evaluated. First-line etrasimod followed by second-line upadacitinib yielded the greatest health benefit (17.801 QALYs). Four treatment sequences-infliximab followed by ustekinumab, infliximab followed by etrasimod, infliximab followed by upadacitinib, and etrasimod followed by upadacitinib-were located on the efficiency frontier. Compared with infliximab-ustekinumab, infliximab-etrasimod resulted in an ICER of JPY 1,095,181 (USD 7235) per QALY. In turn, infliximab-upadacitinib had an ICER of JPY 1,218,896 (USD 8052) per QALY compared with infliximab-etrasimod. Etrasimod-upadacitinib had an ICER of JPY 6,684,442 (USD 44,160) per QALY compared with infliximab-upadacitinib. All ICERs were below the Japanese cost-effectiveness threshold.</p><p><strong>Conclusion: </strong>Under the assumptions of this model, a treatment sequence with first-line etrasimod followed by second-line upadacitinib was identified as the most cost-effective strategy for advanced therapy-naïve patients with moderately to severely active UC in Japan.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148910523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chahan Suolinge, Cai Dema, Xinyue Wu, Bijian Jiang, Chen Lu, Jing Li
{"title":"Effectiveness and Safety of Nefecon in Primary IgA Nephropathy Across Different Baseline Proteinuria Levels: A Real-World Study.","authors":"Chahan Suolinge, Cai Dema, Xinyue Wu, Bijian Jiang, Chen Lu, Jing Li","doi":"10.1007/s12325-026-03784-0","DOIUrl":"https://doi.org/10.1007/s12325-026-03784-0","url":null,"abstract":"<p><strong>Introduction: </strong>IgA nephropathy (IgAN) is a chronic autoimmune kidney disease characterized by the deposition of immune complexes containing galactose-deficient IgA1 (Gd-IgA1) in the glomerulus. Nefecon is a targeted-release formulation of the budesonide that reduces excess production of Gd-IgA1. This study aimed to evaluate the real-world effectiveness and safety of nefecon across different baseline proteinuria levels in this disease population.</p><p><strong>Methods: </strong>In this retrospective real-world study, 28 patients with IgAN who received nefecon for more than 9 months were consecutively included between September 2024 and March 2025. Data on demographics and clinical characteristics, outcomes, and safety were collected and analyzed.</p><p><strong>Results: </strong>After 9 months of nefecon treatment, proteinuria reduced from 1.7 ± 1.2 to 0.6 ± 0.5 g/day (55.8% reduction), while estimated glomerular filtration rate improved from 80.3 ± 24.6 to 86.2 ± 25.4 mL/min/1.73 m<sup>2</sup> (5.0% increase). Nefecon appeared to preserve renal function across patients with varying baseline proteinuria levels, with signals of greater benefit when initiated earlier in the disease course. Seventeen patients (60.7%) experienced adverse events (AEs), with the most common events being acne (21.4%). No severe AEs or treatment-related deaths were observed.</p><p><strong>Conclusion: </strong>In the real-world practice, nefecon was associated with favorable antiproteinuric and renal benefits with acceptable safety in patients with IgAN, including those with relatively low baseline proteinuria. This study suggests a potential benefit of early intervention following diagnosis.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148910505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Real-World Longitudinal Treatment Outcomes for Patients with Metastatic Castration-Sensitive Prostate Cancer in Japan.","authors":"Taketo Kawai, Fumiko Kiyonaga, Satoshi Uno, Hirotaka Shibata, Atsushi Saito","doi":"10.1007/s12325-026-03759-1","DOIUrl":"https://doi.org/10.1007/s12325-026-03759-1","url":null,"abstract":"<p><strong>Introduction: </strong>With recent approvals in Japan, identifying optimal first-line therapy for metastatic castration-sensitive prostate cancer (mCSPC) is critical. We evaluated real-world outcomes of androgen-deprivation therapy (ADT) plus androgen receptor signaling inhibitors (ARSIs) as first-line therapies using prostate-specific antigen (PSA) responses and treatment duration.</p><p><strong>Methods: </strong>This retrospective study used the Medical Data Vision database (May 2020-April 2024). The study population included males with mCSPC, with two cohorts: cohort 1 (with PSA data); cohort 2 (all eligible patients).</p><p><strong>Primary endpoint: </strong>cumulative incidence of ≥ 90% PSA reduction (PSA90) during the first-line period. Secondary endpoints: PSA50; PSA ≤ 0.2 ng/mL; time to PSA progression (TTPP); time-to-treatment discontinuation (TTD). Endpoints were estimated using the Kaplan-Meier method evaluated using the Cox proportional hazards model, adjusted for baseline characteristics.</p><p><strong>Results: </strong>In cohort 1 (n = 1306), cumulative PSA90 response rates were higher with ADT + ARSI ± docetaxel (ARSI-based treatments) than with ADT alone or ADT + nonsteroidal antiandrogens (NSAAs) (at 3 months: ADT alone, 63.2%; ADT + NSAAs, 69.3%; ADT + enzalutamide, 91.8%; ADT + apalutamide, 90.9%; ADT + abiraterone, 90.7%; ADT + darolutamide + docetaxel, 81.2%). Cumulative PSA50 and PSA ≤ 0.2 ng/mL response rates were consistent with PSA90 findings. Median TTPP was longer for ARSI-based treatments versus ADT alone and ADT + NSAA. No significant differences were observed among ARSI-based treatments across these PSA-related endpoints. In cohort 2 (n = 11,737), the median TTD was longer for ARSI-based treatments versus ADT alone and ADT + NSAAs. Notably, ADT + apalutamide showed a shorter median TTD than other ARSI-based treatments.</p><p><strong>Conclusion: </strong>Compared with ADT alone or ADT + NSAA, ARSI-based treatments showed faster PSA declines and longer treatment durations. While ARSI-based treatments demonstrated similar PSA-lowering effects, differences in treatment continuation likely reflect real-world clinical management influenced by not only PSA response but also adverse events and patient characteristics.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148900009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tracee Short, John Lawlor, Patrick Martyka, Joshua H Wolf, Jessica M Felton, Alison A Smith, Yosef Y Nasseri, Moshe Barnajian, W Matthew Vassy, Michael Cormican, Pranat Kumar, John J Choi, Lung Lau, John H Loftus, Nicole P Bernal, Christopher A Butts, Claire S Dillingham, Kyle J Leneweaver, Jessica Simon, Brandon A Bosque, D Adam Young, Barnaby C H May
{"title":"Safety of Ovine Forestomach Matrix Across 474 Soft Tissue Defects: Interim Results from the Prospective Multicenter MASTRR Registry.","authors":"Tracee Short, John Lawlor, Patrick Martyka, Joshua H Wolf, Jessica M Felton, Alison A Smith, Yosef Y Nasseri, Moshe Barnajian, W Matthew Vassy, Michael Cormican, Pranat Kumar, John J Choi, Lung Lau, John H Loftus, Nicole P Bernal, Christopher A Butts, Claire S Dillingham, Kyle J Leneweaver, Jessica Simon, Brandon A Bosque, D Adam Young, Barnaby C H May","doi":"10.1007/s12325-026-03768-0","DOIUrl":"https://doi.org/10.1007/s12325-026-03768-0","url":null,"abstract":"<p><strong>Introduction: </strong>Well-powered, prospective, registry-based clinical studies present the opportunity for broad safety surveillance of bioscaffolds used in soft tissue reconstruction but remain limited in the field. The Myriad™ Augmented Soft Tissue Reconstruction Registry (\"MASTRR Registry\") was established as an ongoing multicenter prospective registry to evaluate the real-world safety and performance of ovine forestomach matrix (OFM)-based devices in complex soft tissue reconstruction.</p><p><strong>Methods: </strong>The interim safety analysis included prospective subject data from the first 411 subjects and 474 defects undergoing reconstruction with OFM-based devices from 10 participating sites. The analysis included subjects from trauma, colorectal, burn, and limb salvage specialties. All adverse events (AEs) were categorized based on severity, causality in relation to the investigational device, and correlated to the surgical procedure and relationship to the index defect.</p><p><strong>Results: </strong>Subjects represented a medically complex population with substantial comorbidity burden and challenging defect characteristics. Most defects were chronic (59.8%) and classified as Centers for Disease Control class II (38.2%) or III (50.4%), indicating that nearly 90% of defects were clean-contaminated or contaminated. Exposed structures (11.4%) and osteomyelitis (15.0%) were also common. A broad range of defect etiologies were included, such as diabetic foot ulcers (22.6%), traumatic injuries (16.5%), ostomy takedowns (11.2%), and pilonidal sinuses (10.8%). Across 411 subjects 12.2% experienced one or more AE. No AEs were determined to be definitively related to OFM-based devices and only a single AE (0.2%) was considered probably device-related. AEs occurring at the index defect were infrequent and included superficial infection (2.9%), dehiscence (3.2%), and deep tissue infection (0.7%).</p><p><strong>Conclusion: </strong>The registry framework provides a valuable mechanism for evaluating device safety and performance under real-world conditions. OFM-based devices demonstrated a favorable safety profile across a broad range of reconstructive applications, surgical specialties, and defect types, with only a single application required in most patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05243966.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148886007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Glastras, Meaghan Read, Aslı Zeynep Ozdemir Saltik, Marianne Huynh, Gabrielle Challis, Michelle Hill, Martin Field, Richard Pollock, Simona de Portu
{"title":"Long-Term Cost-Effectiveness of an Advanced Hybrid Closed-Loop Automated Insulin Delivery System Versus Multiple Daily Insulin Injections Plus Continuous Glucose Monitoring in Adults with Type 1 Diabetes in Australia.","authors":"Sarah Glastras, Meaghan Read, Aslı Zeynep Ozdemir Saltik, Marianne Huynh, Gabrielle Challis, Michelle Hill, Martin Field, Richard Pollock, Simona de Portu","doi":"10.1007/s12325-026-03752-8","DOIUrl":"https://doi.org/10.1007/s12325-026-03752-8","url":null,"abstract":"<p><strong>Introduction: </strong>The MiniMed™ 780G (MM780G) advanced hybrid closed-loop system has been shown to help improve glycemic control compared with continuous glucose monitoring plus multiple daily injections of insulin (MDI) in people with type 1 diabetes (T1D). The long-term health economic outcomes with MM780G versus MDI + CGM in people with T1D in Australia and HbA1c levels above target were investigated.</p><p><strong>Methods: </strong>The analysis was performed using the IQVIA Core Diabetes Model. Clinical input data were sourced from a randomized controlled trial with HbA1c reductions of 1.54% for MM780G and 0.2% for MDI + CGM, from a baseline of 9.04%, were used in the analysis. The analysis was performed from a payer perspective over a time horizon of 50 years and an annual discount rate of 5% was applied to future costs and outcomes.</p><p><strong>Results: </strong>In the base case, use of the MM780G was projected to lead to higher quality-adjusted life expectancy versus MDI + CGM (mean [SD] 13.32 [0.11] versus 11.81 [0.11] quality-adjusted life years [QALYs]; difference 1.51 QALYs). Mean [SD] total costs were also higher (AUD 367,341 [6700] versus AUD 317,819 [6943]), resulting in an incremental cost-effectiveness ratio (ICER) of AUD 32,840 per QALY gained. The results were most sensitive to changes in time horizon; over shorter time horizons (< 20 years) the ICER exceeded AUD 50,000 per QALY gained. Results were also sensitive to the inclusion of hypoglycemic event rates and the quality-of-life benefits associated with reduced fear of hypoglycemia.</p><p><strong>Conclusions: </strong>In Australia, in people with T1D and HbA1c above target, the use of the MM780G was projected to lead to improved long-term clinical outcomes versus MDI + CGM. Over a long-term time horizon, MM780G is likely to be cost-effective compared with MDI + CGM in this specific group of people.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148886080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hematology at a Crossroads: Why Young Physicians in Italy Are Turning Away.","authors":"Maria Ciccone","doi":"10.1007/s12325-026-03782-2","DOIUrl":"https://doi.org/10.1007/s12325-026-03782-2","url":null,"abstract":"<p><p>According to recent data 21% of hematology fellowship applications in Italy remained unfilled [1]. Similarly, medical specialties such as surgery, pathology, radiotherapy, and emergency medicine have seen a significant reduction in the number of applicants. Coupled with the chronic shortage of nursing staff, the outlook for hematology as a specialty is concerning: within a few years, Italy risks lacking key healthcare professionals to treat patients with hematological malignancies.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148872612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tomás José González-López, Nuria Bermejo-Vega, Rocío Cardesa-Cabrera, Natalia Acedo, Josefa Luis-Navarro, Sunil Lakhwani, Silvia Bernat, Guillermo Enrique Haces-Tirado, Pilar Galán, María Luisa Lozano, Daniel Martínez-Carballeira, Roberto Hernández-Martin, Reyes Jimenez-Bárcenas, Begoña Navas-Elorza, Shally Marcellini, Ana Torres-Tienza, Alvaro Perona-Blázquez, Carmen Benet, Dolores Fernandez-Jimenez, Carolina López-Santamaría Castro, Isidro Jarque, Violeta Martínez, Isabel González-Gascón-Y-Marín, Gloria García-Donás Gabaldón
{"title":"Early Use of Fostamatinib in Immune Thrombocytopenia.","authors":"Tomás José González-López, Nuria Bermejo-Vega, Rocío Cardesa-Cabrera, Natalia Acedo, Josefa Luis-Navarro, Sunil Lakhwani, Silvia Bernat, Guillermo Enrique Haces-Tirado, Pilar Galán, María Luisa Lozano, Daniel Martínez-Carballeira, Roberto Hernández-Martin, Reyes Jimenez-Bárcenas, Begoña Navas-Elorza, Shally Marcellini, Ana Torres-Tienza, Alvaro Perona-Blázquez, Carmen Benet, Dolores Fernandez-Jimenez, Carolina López-Santamaría Castro, Isidro Jarque, Violeta Martínez, Isabel González-Gascón-Y-Marín, Gloria García-Donás Gabaldón","doi":"10.1007/s12325-026-03769-z","DOIUrl":"https://doi.org/10.1007/s12325-026-03769-z","url":null,"abstract":"<p><strong>Introduction: </strong>Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, prevents antibody-mediated platelet destruction and has proven efficacy and safety in immune thrombocytopenia (ITP). However, evidence from real-world use in earlier treatment lines is limited. Here the objective was to evaluate the effectiveness and safety of fostamatinib as second- or third-line therapy in adult patients with ITP in Spain.</p><p><strong>Methods: </strong>This multicenter study included 72 adult patients treated with fostamatinib across 22 Spanish centers, assessed retrospectively and prospectively. Demographic, clinical, and laboratory data, treatment responses, and adverse events (AEs) were analyzed.</p><p><strong>Results: </strong>Median age was 67 years, and 55.6% of patients were women. The median time from ITP diagnosis to fostamatinib initiation was 17 months, and the baseline platelet count was 28 × 10<sup>9</sup>/L. Bleeding manifestations were present in 26.4% of patients. Overall, 83.3% achieved a response and 65.3% a complete response. Response rates were 76.0% with second-line and 87.2% with third-line fostamatinib, with complete response rates of 56.0% and 70.2%, respectively. The median time to platelet response was 10.5 days, and the median time to peak platelet count was 62 days. Forty patients (55.5%) received fostamatinib as monotherapy. AEs occurred in 44.4% of patients, were predominantly grade 1-2, and most commonly consisted of diarrhea and hypertension. Treatment discontinuation due to insufficient effectiveness occurred in 27.8% of patients.</p><p><strong>Conclusion: </strong>Fostamatinib demonstrated high effectiveness and acceptable tolerability as second- or third-line therapy for adult ITP in real-world clinical practice.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148872559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}