Advances in Therapy最新文献

{"title":"Regional Citrate Anticoagulation Versus Systemic Heparin in Continuous Kidney Replacement Therapy: Examining the Role of Evidence in Health Technology Assessment","authors":"Carla Rognoni,&nbsp;Robert Pohlmeier,&nbsp;Rosanna Tarricone","doi":"10.1007/s12325-025-03186-8","DOIUrl":"10.1007/s12325-025-03186-8","url":null,"abstract":"<div><h3>Introduction</h3><p>Continuous kidney replacement therapy (CKRT) is an established treatment supporting kidney function in patients with severe acute kidney disease. Systemic heparin and regional citrate anticoagulation (RCA) are the main anticoagulation strategies to prevent dialysis filter loss due to clotting, a complication of all KRT, including CKRT. The present study aims to comprehensively compare two anticoagulation strategies by collecting available clinical and economic evidence for an adult population under CKRT through a systematic literature review and meta-analysis.</p><h3>Methods</h3><p>Randomized controlled trials, prospective/retrospective observational studies and economic analyses, involving systemic heparin or RCA, were searched through PubMed and Web of Science databases. Extracted data focused on clinical parameters, adverse events and cost items. Meta-analyses were conducted on data points with numeric outcomes to compare the two anticoagulation techniques. An evaluation of the quality of the evidence was also conducted using the GRADE system.</p><h3>Results</h3><p>Seventy-two studies were eligible for this meta-analysis. Statistically significant differences between heparin and RCA were observed in ionized calcium levels (mmol/l; heparin 1.19, RCA 1.13), bleeding events (heparin 12.6%, RCA 2.4%), filter lifespan (hours; heparin 16.43, RCA 36.69), clotting issues (heparin 50.7%, RCA 21.3%), filter failure rate (heparin 67.7%, RCA 13.5%), hypocalcemia (heparin 0.1%, RCA 4.4%) and alkalosis (heparin 0.4%, RCA 6.6%) rates. Limitations include heterogeneity across studies, particularly for RCA, and potential biases, although the overall methodological quality ranged from moderate to low.</p><h3>Conclusions</h3><p>Based on the evidence presented, despite higher rates of hypocalcemia and alkalosis, RCA demonstrates advantages over heparin, including a reduction in bleeding events, prevention of filter clotting and improvement in filter lifespan. Additionally, the cost outcome demonstrated comparable statistics depending on the RCA protocol considered, which supports the potential cost-effectiveness of RCA. RCA provides clear clinical and potential organizational benefits and comparable cost statistics with a reasonable level of confidence in the evidence for the economic data.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2606 - 2638"},"PeriodicalIF":3.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03186-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963789","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":"Incidence and Prevalence of Chronic Spontaneous Urticaria Among Adult and Pediatric Populations in the United States","authors":"Yvonne Geissbühler,&nbsp;Maria M. Balp,&nbsp;Aine McConnon,&nbsp;Justin Gomme,&nbsp;Sarah J. McKenna,&nbsp;Ravneet K. Kohli,&nbsp;Weily Soong","doi":"10.1007/s12325-025-03172-0","DOIUrl":"10.1007/s12325-025-03172-0","url":null,"abstract":"<div><h3>Introduction</h3><p>Published evidence on the epidemiology of chronic spontaneous urticaria (CSU) in the USA is limited. This study aimed to estimate the age- and/or sex-standardized incidence and prevalence of diagnosed CSU in the US population.</p><h3>Methods</h3><p>The target population was identified using three anonymized databases: Optum Electronic Health Record (EHR), Optum Clinformatics Data Mart (CDM), and Truven Health MarketScan. The study population consisted of adult (aged ≥ 18 years) and pediatric (aged &lt; 18 years) patients with diagnosed CSU based on ≥ 2 relevant International Classification of Diseases version 9 and/or 10 (ICD-9 and/or ICD-10) codes recorded ≥ 6 weeks apart. The data identification period for Optum EHR and Optum CDM was from January 1, 2012 to December 31, 2018, and for MarketScan it was January 1, 2012 to December 31, 2017. In Optum EHR the incidence rate and prevalence were standardized by age and sex as compound strata and by age (adult and pediatric populations separately), and in both Optum CDM and MarketScan, data was standardized by sex as a single stratum of adult and pediatric populations. The age- and sex-standardized incidence rate and prevalence were calculated and reported per 100 person-years and per 100 persons (%), respectively.</p><h3>Results</h3><p>A total of 108,384 patients (adults, 72.1%; pediatric patients, 27.9%) from Optum EHR, 107,682 (adults, 78.5%; pediatric patients, 21.5%) from Optum CDM, and 278,311 (adults, 63.5%; pediatric patients, 36.5%) from MarketScan were identified with CSU diagnosis during the identification period. The age- and sex-standardized incidence rate of diagnosed CSU among adult and pediatric populations in Optum EHR during the identification period (2012–2018) was 0.039 and 0.066 per 100 person-years, respectively, while the prevalence was 0.120% and 0.193%, respectively. The age-standardized incidence rate of diagnosed CSU among adult and pediatric populations in Optum CDM (2012–2018) was 0.094 and 0.109 per 100 person-years, respectively, while the prevalence was 0.277% and 0.304%, respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence were 0.096 per 100 person-years and 0.283%, respectively. The age-standardized incidence rate of diagnosed CSU among adult and pediatric populations in MarketScan (2012–2017) was 0.102 and 0.097 per 100 person-years, respectively, while the prevalence was 0.256% and 0.264%, respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence were 0.088 per 100 person-years and 0.244%, respectively.</p><h3>Conclusion</h3><p>The findings of this study highlight a general increasing trend in the incidence and prevalence of diagnosed CSU over time among the US population. Comparatively, the incidence and prevalence were higher among pediatric patients than adults.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2808 - 2820"},"PeriodicalIF":3.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03172-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953191","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":"Real-World Maintenance Treatment Patterns Among Patients with Advanced Non-Small Cell Lung Cancer","authors":"Manasee V. Shah,&nbsp;Caitlyn T. Solem,&nbsp;Kelly F. Bell,&nbsp;Amine Aziez,&nbsp;Xuezheng Sun,&nbsp;Mandy Du,&nbsp;Ella X. Du,&nbsp;Hongbo Yang,&nbsp;Hongjue Wang,&nbsp;Qi Hua,&nbsp;Umit Tapan","doi":"10.1007/s12325-025-03178-8","DOIUrl":"10.1007/s12325-025-03178-8","url":null,"abstract":"<div><h3>Introduction</h3><p>Immuno-oncology (IO) agents and pemetrexed are approved for the first-line (1L) maintenance treatment (1LMT) of advanced/metastatic non-small cell lung cancer (a/mNSCLC). This international retrospective chart review assessed real-world treatment patterns and outcomes in patients with a/mNSCLC lacking targetable mutations.</p><h3>Methods</h3><p>Oncologists from seven countries (Canada, France, Germany, Italy, Spain, UK, USA) provided deidentified, medical chart-derived data on randomly selected adults with a/mNSCLC who remained stable or responded to 1L chemotherapy + IO. Treatment patterns, overall survival (OS), progression-free survival (PFS), and healthcare resource utilization (HCRU) were compared by maintenance treatment use following propensity score weighting. The effects of adding pemetrexed to IO-containing 1LMT was investigated in patients with non-squamous/mixed histology.</p><h3>Results</h3><p>Of 942 patients analyzed, 680 initiated 1LMT. After weighting, 1LMT was associated with longer median PFS (17.7 vs 7.1 months; HR [95% CI] 0.63 [0.41–0.85]), similar OS (31.7 vs 31.0 months; 0.82 [0.47–1.17]), and fewer mean monthly hospitalizations (0.03 vs 0.1; <i>p</i> &lt; 0.01) versus no 1LMT. Among 469 patients with non-squamous/mixed histology who initiated an IO-containing 1LMT, 283 received IO only while 186 received IO + pemetrexed. Median time to treatment discontinuation (20.0 vs 11.0 months; <i>p</i> &lt; 0.001), PFS (21.1 vs 11.1 months; HR [95% CI] 0.56 [0.37–0.76]), and OS (35.3 vs 27.3 months; 0.70 [0.41–0.98]) were longer for patients receiving IO only versus IO + pemetrexed. Fewer patients administered IO only experienced fatigue (28.3% vs 39.8% [IO + pemetrexed];<i> p</i> &lt; 0.05) and anemia (16.6% vs 31.2%; <i>p</i> &lt; 0.001).</p><h3>Conclusion</h3><p>1LMT was associated with significantly longer PFS and similar OS, without substantially increasing HCRU, among the current study population with a/mNSCLC. Adding pemetrexed to 1LM IO did not confer significant clinical benefit in patients with non-squamous/mixed histology and these patients incurred more adverse events. Additional 1LMT options are needed to further improve clinical outcomes.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2782 - 2796"},"PeriodicalIF":3.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964080","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 Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux®) in Healthy Chinese Male Subjects","authors":"Jia Xu,&nbsp;Junyou Ge,&nbsp;Yaling Li,&nbsp;Shulin Liu,&nbsp;Sicong Li,&nbsp;Jing Si,&nbsp;Juncheng Liu,&nbsp;Xiaoxue Zhu,&nbsp;Yanhua Ding","doi":"10.1007/s12325-025-03193-9","DOIUrl":"10.1007/s12325-025-03193-9","url":null,"abstract":"<div><h3>Introduction</h3><p>This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux^®) in healthy Chinese male subjects.</p><h3>Methods</h3><p>We conducted a randomized, single-dose, double-blind, parallel-controlled phase I study in which 82 healthy subjects were randomized equally into the A140 group and the cetuximab group. Both the test and comparator drug were administered as a single intravenous (IV) dose of 250 mg/m². Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of the A140 to cetuximab for area under the concentration–time curve from time zero to the last measurable concentration (AUC_0–<i>t</i>) were within the predefined bioequivalence range of 80–125%.</p><h3>Results</h3><p>The results showed that the 90% CI of the GMR for PK parameters (AUC_0–<i>t</i>, AUC_0–∞, <i>C</i>_max) between the A140 and cetuximab groups were all within the predefined equivalent interval of 80–125%. Furthermore, the types of treatment-related adverse events were similar between the two groups, with an incidence of 100%. However, approximately 80% of these events belonged to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or 2. Anti-drug antibody (ADA) profiles were comparable between the A140 and the cetuximab group.</p><h3>Conclusion</h3><p>A140 demonstrated similar PK to cetuximab and comparable safety and immunogenicity in healthy Chinese male subjects.</p><h3>Trial Registration</h3><p>CTR20182229 (https://www.chinadrugtrials.org.cn/).</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2797 - 2807"},"PeriodicalIF":3.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960867","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":"Lidocaine—A Promising Candidate for the Treatment of Cancer-Induced Bone Pain: A Narrative Review","authors":"Lihan Luo,&nbsp;Yuqi Cheng,&nbsp;Hanxi Wang,&nbsp;Li Li,&nbsp;Hanyun Niu,&nbsp;Yuzhu Yang,&nbsp;Qianqian Zhou,&nbsp;Jiannan He,&nbsp;Jianhong Xu","doi":"10.1007/s12325-025-03192-w","DOIUrl":"10.1007/s12325-025-03192-w","url":null,"abstract":"<div><p>Pain is one of the most common symptoms in patients with cancer, with cancer-induced bone pain (CIBP) significantly affecting their quality of life. Opioids are commonly used as first-line treatments for cancer pain, but their use requires caution due to non-mechanistic analgesia and significant side effects. As a result, there is a need for new non-opioid drugs that target cancer pain through specific mechanisms. Recent studies on the anticancer effects of lidocaine have highlighted its potential benefits in both treating cancer and alleviating cancer-induced pain. This article discusses the mechanism of action and clinical applications of lidocaine in cancer pain management, and suggests new treatment approaches for patients with CIBP.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2587 - 2605"},"PeriodicalIF":3.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144058198","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":"An Expert Opinion on Current and Future Treatment Approaches in IgA Nephropathy","authors":"Richard J. Glassock","doi":"10.1007/s12325-025-03187-7","DOIUrl":"10.1007/s12325-025-03187-7","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2545 - 2558"},"PeriodicalIF":3.4,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03187-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957489","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":"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,&nbsp;Xiaoping Luo","doi":"10.1007/s12325-025-03146-2","DOIUrl":"10.1007/s12325-025-03146-2","url":null,"abstract":"<div><h3>Introduction</h3><p>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><h3>Methods</h3><p>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><h3>Planned Outcomes</h3><p>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><h3>Trial Registration</h3><p>The study has been registered at ClinicalTrials.gov (NCT06110910). Date of registration October 31, 2023.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2957 - 2969"},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03146-2.pdf","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":"OA","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,&nbsp;Heath Heatley,&nbsp;John Townend,&nbsp;Derek Skinner,&nbsp;Victoria Carter,&nbsp;Richard Hubbard,&nbsp;Tan Tze Lee,&nbsp;Mariko Siyue Koh,&nbsp;David Price","doi":"10.1007/s12325-025-03175-x","DOIUrl":"10.1007/s12325-025-03175-x","url":null,"abstract":"<div><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></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2950 - 2956"},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03175-x.pdf","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":"OA","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,&nbsp;Sory Traoré,&nbsp;Waleed Badreldin,&nbsp;Astrid Torstensson,&nbsp;Esra Cakar,&nbsp;Anuja C. McCullough,&nbsp;Susan Tempelaar,&nbsp;Elisabeth Fenwick,&nbsp;Peter S. Hall","doi":"10.1007/s12325-025-03164-0","DOIUrl":"10.1007/s12325-025-03164-0","url":null,"abstract":"<div><h3>Introduction</h3><p>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><h3>Methods</h3><p>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><h3>Results</h3><p>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><h3>Conclusion</h3><p>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></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2767 - 2781"},"PeriodicalIF":3.4,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03164-0.pdf","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":"OA","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,&nbsp;Patrick Gagnon-Sanschagrin,&nbsp;Jessica Maitland,&nbsp;Kana Yokoji,&nbsp;Annie Guérin,&nbsp;Zeev Heimanson,&nbsp;Aaron Samson,&nbsp;Olamide Olujohungbe,&nbsp;Brock Bumpass","doi":"10.1007/s12325-025-03145-3","DOIUrl":"10.1007/s12325-025-03145-3","url":null,"abstract":"<div><h3>Introduction</h3><p>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><h3>Methods</h3><p>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 &lt; 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><h3>Results</h3><p>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 (<i>n</i> = 432; mean age 56.3 years), Cohort 2 (<i>n</i> = 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 <i>p</i> &lt; 0.05).</p><h3>Conclusion</h3><p>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></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2739 - 2753"},"PeriodicalIF":3.4,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03145-3.pdf","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}