Advances in Therapy最新文献

{"title":"Long-Term Efficacy and Safety of Growth Hormone in Children Suffering from Short Stature in China (CGLS): An Open-Label, Multicenter, Prospective and Retrospective, Observational Study.","authors":"Wei Wu, Xiaoping Luo","doi":"10.1007/s12325-025-03146-2","DOIUrl":"https://doi.org/10.1007/s12325-025-03146-2","url":null,"abstract":"<p><strong>Introduction: </strong>Several primary and secondary disorders disrupting normal growth pattern are responsible for childhood short stature (SS; height less than 2 standard deviation score [SDS] or the third percentile). Pegylated recombinant human growth hormone (PEG-rhGH) is a long-acting growth hormone which has demonstrated efficacy and safety in pediatric growth hormone deficiency. However, limited data is present on its treatment pattern, extensive population use, and long-term follow-up. Therefore, a real-world study is required to evaluate the efficacy and safety of PEG-rhGH and recombinant human growth hormone (rhGH) in treating childhood SS.</p><p><strong>Methods: </strong>The proposed study will be an open-label, multicenter, prospective and retrospective, observational study that will recruit Chinese children aged ≥ 2 years with SS. The entire study will be categorized into three cohorts: retrospective, retrospective-prospective, and prospective. The study will recruit 10,000 patients including 3000 patients in the retrospective cohort and 7000 in the retrospective-prospective and prospective cohort, respectively. The total duration of this study will be 16 years. The primary objective will be to evaluate the long-term safety (incidence of all adverse events (AEs) and serious adverse events) of PEG-rhGH and rhGH for the treatment of patients with SS having growth hormone disorder (GHD), idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS), Prader-Willi syndrome (PWS), Noonan syndrome (NS), deficiency of the short stature homeobox gene on the X-chromosome (SHOX deficiency), and other causes of SS. The secondary objective will be to evaluate the efficacy of PEG-rhGH and rhGH for the treatment of patients with SS with different etiologies.</p><p><strong>Planned outcomes: </strong>The results may provide the evidence of long-term efficacy and safety of PEG-rhGH and rhGH by analyzing the existing patient data and will also provide a vast array of information, which can be used as reference evidence for the Chinese academic community to design national guidelines or consensus for patients with SS.</p><p><strong>Trial registration: </strong>The study has been registered at ClinicalTrials.gov (NCT06110910). Date of registration October 31, 2023.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809999","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":"The Real-World Impact of Glucagon-Like Peptide 1 Receptor Agonists on Asthma Control in People with High-Risk Asthma and Obesity.","authors":"Alan Kaplan, Heath Heatley, John Townend, Derek Skinner, Victoria Carter, Richard Hubbard, Tan Tze Lee, Mariko Siyue Koh, David Price","doi":"10.1007/s12325-025-03175-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03175-x","url":null,"abstract":"<p><p>To quantify the impact of Glucagon-like peptide1 receptor-agonists (GLP1-RAs) on asthma control, we analysed people with asthma and obesity, using the Optimum Patient Care Research Database (OPCRD). We identified 10,111 GLP1-RA exposed people and 50,555 unexposed controls. The exposed cohort had higher BMI and more uncontrolled asthma [risk domain asthma control (RDAC) and overall asthma control (OAC)]. The exposed cohort lost more weight and had improved asthma control for both RDAC (odds ratio 2.11 95% CI 1.90-2.36) and OAC (OR 2.10, 95%CI 1.81-2.45) scores. GLP1-RA drugs appear to improve asthma control for people with obesity.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810011","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":"A Cost-Effectiveness Analysis of Abemaciclib in Combination with Adjuvant Endocrine Therapy for HR+, HER2-, Node-Positive, High-Risk Early Breast Cancer.","authors":"Alison Davie, Sory Traoré, Waleed Badreldin, Astrid Torstensson, Esra Cakar, Anuja C McCullough, Susan Tempelaar, Elisabeth Fenwick, Peter S Hall","doi":"10.1007/s12325-025-03164-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03164-0","url":null,"abstract":"<p><strong>Introduction: </strong>The monarchE trial demonstrated that the addition of 2 years of abemaciclib to adjuvant endocrine therapy (ET) significantly reduced the risk of disease recurrence in patients with hormone receptor positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-), node-positive early breast cancer (EBC) at high risk of disease recurrence. Abemaciclib meets a critical unmet need for more effective adjuvant therapy for this patient population. This study evaluates the cost-effectiveness (CE) of abemaciclib plus ET compared to ET alone.</p><p><strong>Methods: </strong>A five-state cohort transition model, which presents a United Kingdom (UK) perspective, is parameterized using data from the monarchE trial and literature. Cost-effectiveness results are presented in terms of cost/quality-adjusted life year (QALY) over a lifetime time horizon. Various assumptions were tested through sensitivity and scenario analyses and uncertainty was assessed through probabilistic analysis.</p><p><strong>Results: </strong>Patients receiving abemaciclib plus ET were predicted to experience higher QALYs (11.16 compared to 10.42) at an increased cost (£87,541 compared to £48,625), leading to an incremental cost-effectiveness ratio (ICER) of £52,317 per QALY gain compared to ET alone. The increased costs associated with the addition of abemaciclib were partially offset by a reduction in distant disease recurrence and associated costs. The scenario and sensitivity analyses supported robust base case results.</p><p><strong>Conclusion: </strong>Despite the ICER exceeding usual willingness-to-pay (WTP) levels in the UK, a consequence of using list prices, the CE model utilizing the latest data cut from the monarchE trial, demonstrated that the upfront cost of abemaciclib reduces the risk of a terminal breast cancer prognosis and its associated cost and quality of life impact. The addition of 2 years of abemaciclib provides an option for the treatment of HR+, HER2-, node-positive, high-risk EBC.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809993","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":"Assessment of Access Barriers to Rifaximin Among Patients with Hepatic Encephalopathy Using Adjudicated Claims Data.","authors":"Arun Jesudian, Patrick Gagnon-Sanschagrin, Jessica Maitland, Kana Yokoji, Annie Guérin, Zeev Heimanson, Aaron Samson, Olamide Olujohungbe, Brock Bumpass","doi":"10.1007/s12325-025-03145-3","DOIUrl":"https://doi.org/10.1007/s12325-025-03145-3","url":null,"abstract":"<p><strong>Introduction: </strong>Continuous treatment with rifaximin 550 mg (hereafter rifaximin) is associated with lower hospitalization rates in patients with hepatic encephalopathy (HE); however, access barriers may exist. This study assessed gaps in rifaximin access and the impact of treatment gaps, particularly those resulting from claim rejections, on hospitalizations and healthcare costs among patients with HE in the United States.</p><p><strong>Methods: </strong>The IQVIA PharMetrics^® Plus database linked with Longitudinal Access and Adjudicated Data (2015-2022) were used to identify adults with HE who had ≥ 1 paid rifaximin prescription fill. Rifaximin treatment gaps were assessed during the 12-month period from the first observed attempt at receiving rifaximin (index date). Adjusted number of overt HE (OHE) hospitalizations and healthcare costs were compared over the 6 months following the index date between Cohort 1, who had no gap due to claim rejection and had < 7 days of treatment gap due to other reasons, and Cohort 2, who had ≥ 1 rejection gap or had ≥ 7 days of non-rejection gap.</p><p><strong>Results: </strong>During the year following the index date, 94.7% of the 1711 patients experienced a treatment gap, including 34.8% with initiation gaps from first attempt at receiving rifaximin to first paid claim (77.7% of initiation gaps due to rejected claims) and 72.0% with gaps in access during active treatment (14.8% of active treatment gaps due to rejected claims). Compared with Cohort 1 (n = 432; mean age 56.3 years), Cohort 2 (n = 679; mean age 54.8 years) had 1.55 times the incidence rate of OHE hospitalizations [adjusted incidence rate ratio: 1.55 (95% confidence interval: 1.10-2.20)] and incurred US$1579 more in healthcare-associated costs per-patient-per-month (all p < 0.05).</p><p><strong>Conclusion: </strong>Prescription claim rejections frequently led to delays in rifaximin initiation and gaps in access during active treatment. Access barriers to rifaximin were associated with increased hospitalizations and healthcare costs in patients with HE.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794425","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":"Baseline Characteristics and Treatment Patterns of Patients with Atopic Dermatitis Treated with Oral Systemic Therapies: An Interim Analysis of the AD-REAL Study.","authors":"Matthias Augustin, Esther Serra-Baldrich, Julien Seneschal, Susanne Grond, Anastasia Lampropoulou, Mohamed Elrayes, Samuel Ogwu, Inmaculada de la Torre, Anthony Bewley, Andreas Pinter","doi":"10.1007/s12325-025-03137-3","DOIUrl":"https://doi.org/10.1007/s12325-025-03137-3","url":null,"abstract":"<p><strong>Introduction: </strong>AD-REAL is an ongoing 1-year multinational observational cohort study evaluating oral systemic therapies in the management of adults with atopic dermatitis (AD) in a real-world practice across four European countries. Herein, we provide insights on baseline disease characteristics and treatment patterns of patients treated with oral systemic therapies, including baricitinib.</p><p><strong>Methods: </strong>AD-REAL included adults with moderate-to-severe AD for ≥ 6 months, who were initiated on an oral systemic treatment in clinical practice and enrolled either in the baricitinib or the other oral systemic (OOS) cohort. Here, we report baseline characteristics, including clinician-assessed outcomes (Eczema Area and Severity Index [EASI]) and patient-reported outcomes (PROs), and explore AD subgroups based on body surface area (BSA) ≤ 40% and Itch numerical rating scale (NRS) ≥ 7. Continuous outcomes were reported using mean and standard deviation (SD) and categorical variables using frequencies. Baseline continuous variables with missing data were imputed using the multiple imputation method.</p><p><strong>Results: </strong>Baseline demographics were consistent across both baricitinib and OOS cohorts. Patients showed long disease duration (26.2 years), refractory to several systemic options, and a moderate EASI mean (SD) score of 17.5 (10.7). The majority (53.7%) presented with severe Validated Investigator Global Assessment (vIGA) and highly impacted Dermatology Life Quality Index (DLQI) score (14.0 [7.1]). At baseline, patients were predominantly female, with AD mainly affecting face/neck (89.4%) and upper extremities (90.3%). About 68.4% presented with BSA ≤ 40 and 33.8% with BSA ≤ 40 and Itch NRS ≥ 7. From those with BSA ≤ 40% and Itch NRS ≥ 7, 63.9% were treated with Janus kinase inhibitors (JAKi).</p><p><strong>Conclusion: </strong>This analysis provides key information on baseline disease characteristics of patients treated with oral systemics, including baricitinib. Most patients treated with oral systemics in AD-REAL had long-lasting disease, refractory to systemic therapies, with moderate skin affectation but severe itch and impact on quality of life. AD-REAL is the first study to show many patients in real-world practice who are treated with oral systemics present with BSA ≤ 40 and Itch NRS ≥ 7, and most of these patients were treated with JAKi.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794430","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":"Validation of an Administrative Claims-based Line of Therapy Algorithm for Women with Ovarian Cancer Using Medical Chart Review.","authors":"Daniel Simmons, John White, Valery Walker, Stephanie V Blank, Jiefen Munley, Kimmie McLaurin","doi":"10.1007/s12325-025-03174-y","DOIUrl":"https://doi.org/10.1007/s12325-025-03174-y","url":null,"abstract":"<p><strong>Introduction: </strong>New maintenance therapies to treat advanced ovarian cancer have added complexity to identifying lines of therapy (LOTs) for real-world evidence (RWE) studies. This study evaluated the performance of a claims-based algorithm that identifies LOTs among patients with ovarian cancer using medical chart review validation.</p><p><strong>Methods: </strong>The algorithm was developed previously utilizing the Optum Research Database (ORD), a US database that contains administrative claims data. To validate the algorithm, LOT results generated using claims data vs chart data were compared at the patient level by calculating the percent agreement between total number of active and maintenance LOTs, type of therapy (neoadjuvant vs adjuvant classification), and type of regimen (individual drugs). Patients with a diagnosis of ovarian cancer who initiated chemotherapy between December 1, 2014, and September 15, 2017, were included in the study. We report descriptive statistics, the percentage correspondence between medical records and claims data, and kappa statistics to measure the magnitude of agreement.</p><p><strong>Results: </strong>A total of 294 patients were included in the analysis; 164 received only chemotherapy and no maintenance, 77 received bevacizumab, and 53 patients received poly (ADP-ribose) polymerase inhibitors (PARPi). Mean age was 64.9 years, and 47.3% had stage III cancer. The algorithm demonstrated substantial agreement between claims and medical records for total number of lines of active and maintenance therapy (weighted kappa 0.65 and 0.62 p < 0.0001). There was moderate-to-substantial agreement for neoadjuvant and adjuvant therapy (kappa 0.56 and 0.62 p < 0.0001). The algorithm performed best at identifying early treatment with a regimen match of 82% and 88% agreement for first-line active and first-line maintenance, respectively.</p><p><strong>Conclusion: </strong>We validated an administrative claims-based algorithm that demonstrates strong concordance with medical records for identifying LOT among patients with ovarian cancer. The algorithm can be applied in future studies to analyze treatment patterns and outcomes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794490","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":"Evinacumab for Homozygous Familial Hypercholesterolemia: The Italian Cohort of the ELIPSE HoFH Study","authors":"Gabriella Iannuzzo,&nbsp;Ilenia Calcaterra,&nbsp;Marco Gentile,&nbsp;Claudia Stanzione,&nbsp;Francesca De Ruberto,&nbsp;Maria Donata Di Taranto,&nbsp;Giuliana Fortunato,&nbsp;Matteo Di Minno","doi":"10.1007/s12325-025-03160-4","DOIUrl":"10.1007/s12325-025-03160-4","url":null,"abstract":"<div><h3>Introduction</h3><p>Homozygous familial hypercholesterolemia (HoFH) is a severe rare genetic disorder characterized by elevated plasma low-density lipoprotein (LDL) cholesterol levels. Here, we report data from the Italian cohort of the Evinacumab Lipid Studies in Patients with Homozygous Familial Hypercholesterolemia (ELIPSE HoFH) trial.</p><h3>Methods</h3><p>ELIPSE HoFH was conducted at 30 sites in 11 countries, with 2–10 patients enrolled per country. The study included patients aged ≥ 12 years with LDL cholesterol ≥ 70 mg/dl (1.8 mmol per liter) at screening despite stable maximally tolerated lipid-lowering therapy. Patients were randomly assigned evinacumab (15 mg/kg every 4 weeks) or matching placebo for 24 weeks, with an option for a 24-week open-label extension or follow-up period thereafter. The Italian cohort included seven patients assigned to evinacumab.</p><h3>Results</h3><p>Five patients (3 males and 2 females) received evinacumab and were included in this report. Substantial and consistent reductions in LDL cholesterol from baseline levels were observed in all patients at all follow-up time points. Overall, an 84.5% decrease in median (range) LDL cholesterol was observed, from 323 (203–587) mg/dl in 2016 to 50.0 (13–103) mg/dl (<i>P</i> = 0.043) in 2019, with LDL cholesterol levels stable through 2023. Total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, and triglycerides decreased markedly over time. Evinacumab was well tolerated, with no treatment-related adverse events reported.</p><h3>Conclusion</h3><p>Evinacumab substantially lowered LDL cholesterol levels in patients with HoFH regardless of the degree of LDL receptor function, with low levels sustained over 5 years of follow-up.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier NCT03399786 registered 16 January 2018.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2465 - 2479"},"PeriodicalIF":3.4,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03160-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Composite Number Needed to Treat for Semaglutide in Populations with Overweight or Obesity and Established Cardiovascular Disease Without Diabetes","authors":"Christopher Lübker,&nbsp;Jigish Bhavsar,&nbsp;Ruben Duque do Vale,&nbsp;Scott S. Emerson,&nbsp;Emil Nørtoft,&nbsp;Jorge Plutzky,&nbsp;Geraint Roberts,&nbsp;Jens Magelund Tarp,&nbsp;A. Michael Lincoff","doi":"10.1007/s12325-025-03176-w","DOIUrl":"10.1007/s12325-025-03176-w","url":null,"abstract":"<div><h3>Introduction</h3><p>Number needed to treat (NNT), an outcome measure derived from the estimated risk results of clinical trials, is widely used to demonstrate value to stakeholders by identifying how many patients require treatment to avoid one event of interest. However, NNTs calculated for primary trial endpoints may underestimate a treatment’s value by not considering other outcomes. In this secondary analysis of data from the SELECT cardiovascular (CV) outcomes trial, we aimed to determine the NNT for semaglutide for major adverse cardiovascular events (MACE), in addition to NNTs when other clinically and payer-relevant outcomes are included.</p><h3>Methods</h3><p>This study is a secondary analysis of data from the randomized, double-blind SELECT trial (ClinicalTrials.gov NCT03574597) of once-weekly subcutaneous administration of semaglutide compared with placebo in 17,604 patients with overweight or obesity and with established cardiovascular disease (CVD) (39.8 months mean follow-up). The outcomes were NNT_3P-MACE (based upon the trial’s composite primary endpoint of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke), NNT_EXTENDED (inclusive of NNT_3P-MACE, hospitalization for any cause, coronary revascularization, and non-CV death), and NNT_CKM (inclusive of NNT_EXTENDED, glycated hemoglobin level [HbA_1c] ≥ 6.5%, and a 5-point nephropathy composite).</p><h3>Results</h3><p>The relative risk reductions observed for the events comprising the NNTs were 20% (NNT_3P-MACE), 20% (NNT_EXTENDED), and 41% (NNT_CKM). At 1 and 4 years post initiation of semaglutide, NNT_3P-MACE was 125 and 58, NNT_EXTENDED was 49 and 25, and NNT_CKM was 20 and 11, respectively.</p><h3>Conclusion</h3><p>When clinically and payer-relevant outcomes from the SELECT trial are included in calculations of NNT, semaglutide was associated with greater risk reductions and lower estimates of NNT than for the primary endpoint alone. Our findings suggest that including the broader effects of semaglutide beyond the primary trial endpoint recognizes additional value to stakeholders.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2513 - 2525"},"PeriodicalIF":3.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03176-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare Utilization and Costs of Care in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation After Initiating Oral Therapies: Real-World Analysis in the US Medicare Population","authors":"Eric Shah,&nbsp;Tsung-Ying Lee,&nbsp;Zachary Baldwin,&nbsp;Jens Kort,&nbsp;Masakazu Ando,&nbsp;Steven W. Champaloux,&nbsp;Mena Boules,&nbsp;Yuri Sanchez Gonzalez","doi":"10.1007/s12325-025-03163-1","DOIUrl":"10.1007/s12325-025-03163-1","url":null,"abstract":"<div><h3>Introduction</h3><p>Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common functional intestinal disorders which impact all age groups, yet there is limited comparative evidence on the economic benefits of treatment of these conditions on the elderly. We assessed differences in healthcare resource utilization (HCRU) and total costs of care among Medicare-insured patients initiating linaclotide, lubiprostone, or plecanatide after 1 year.</p><h3>Methods</h3><p>Retrospective analysis from the Merative™ MarketScan^® Medicare Database (January 2017–September 2023), including adult patients who initiated a qualifying IBS-C/CIC medication (linaclotide, lubiprostone, plecanatide) (index date defined as date of initiation) and had at least 6 months of pre-index and 12 months of post-index continuous benefit coverage under fee-for-service Medicare plans. For HCRU and all-cause total cost (medical + pharmacy) outcomes, 12-month comparisons were characterized via count (for HCRU) or cost ratios between linaclotide and lubiprostone, and linaclotide and plecanatide. Generalized linear regression models adjusting for key baseline patient characteristics and 6-month pre-index HCRU and cost were used to estimate differences in outcomes at 12 months between treatment groups.</p><h3>Results</h3><p>A total of 7916 Medicare patients were included in the analysis, of whom 5773 initiated linaclotide, 1856 initiated lubiprostone, and 287 initiated plecanatide. After adjusting for key patient characteristics and pre-index HCRU, count ratios &gt; 1 demonstrated that patients who received lubiprostone versus linaclotide had significantly greater HCRU (<i>P</i> &lt; 0.05) at 12 months. After 12 months follow-up, adjusted all-cause total costs of care were significantly lower among patients who received linaclotide versus lubiprostone or plecanatide, largely driven by lower all-cause medical costs observed in patients who received linaclotide (<i>P</i> &lt; 0.05).</p><h3>Conclusion</h3><p>These findings suggest that linaclotide treatment may be associated with lower total healthcare costs compared to lubiprostone and plecanatide for patients initiating IBS-C/CIC-related drugs in Medicare populations.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2500 - 2512"},"PeriodicalIF":3.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03163-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Loncastuximab Tesirine Versus Polatuzumab Vedotin Plus Bendamustine and Rituximab in Relapsed/Refractory DLBCL After ≥ 2 Lines of Therapy: Matching-Adjusted Indirect Comparison","authors":"Koo Wilson,&nbsp;Francesca Chiodi,&nbsp;Abby Paine,&nbsp;Zalmai Hakimi,&nbsp;Victoria Ward,&nbsp;Tom Macmillan,&nbsp;Daniel Eriksson,&nbsp;Silvia Mappa","doi":"10.1007/s12325-025-03169-9","DOIUrl":"10.1007/s12325-025-03169-9","url":null,"abstract":"<div><h3>Introduction</h3><p>Despite recent approvals of new treatments, relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) remains challenging to treat, with limited durable responses and a high proportion of patients relapsing after two or more lines of therapy. Loncastuximab tesirine (Lonca) is a highly potent CD19-targeted antibody drug conjugate with convenient dosing for patients with third-line R/R DLBCL.</p><h3>Methods</h3><p>In the absence of head-to-head trials, unanchored matching-adjusted indirect comparisons (MAICs) were conducted to compare the relative efficacy and safety of Lonca with polatuzumab vedotin + bendamustine and rituximab (Pola + BR).</p><h3>Results</h3><p>Four studies included in the MAICs were identified via systematic review and hand-searching. Lonca (LOTIS-2) was compared with three comparator studies for Pola + BR (GO29365 extension study, COTA database, Dal et al. 2023). Overall, there was no evidence of a difference in overall response and complete response (CR) rates. Despite Pola + BR demonstrating a higher CR rate in the GO29365 extension study, this did not translate into significant improvements in progression-free or overall survival. Survival analyses indicated similar efficacy between treatments across studies, with most comparisons/meta-analyses showing no statistically significant differences. Lonca had significantly lower odds of Grade 3–4 infections, any serious adverse event (SAE), and specific SAEs including febrile neutropenia, pneumonia and pyrexia. Of the safety endpoints analyzed, none indicated significant differences in favor of Pola + BR.</p><h3>Conclusion</h3><p>These results suggest no evidence of a difference in efficacy between the two treatments and potentially more favorable safety profile for Lonca compared with Pola + BR in patients with R/R DLBCL after two or more lines of treatment.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2445 - 2464"},"PeriodicalIF":3.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03169-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}