Clinical therapeutics最新文献

{"title":"Cost-Effectiveness of Perioperative Nivolumab for Stage III Non–Small-Cell Lung Cancer: A Perspective From The United States","authors":"Jingyi Sun MD ,&nbsp;Na Zhang PhD ,&nbsp;Qiong Chen MD ,&nbsp;Ziyu Dai MD","doi":"10.1016/j.clinthera.2025.07.002","DOIUrl":"10.1016/j.clinthera.2025.07.002","url":null,"abstract":"<div><h3>Purpose</h3><div>The NADIM II trial demonstrated that combining perioperative nivolumab, an immune checkpoint inhibitor, with intensified chemotherapy significantly enhanced pathological complete response rates and overall survival in patients with surgically resectable stage III non–small-cell lung cancer (NSCLC) compared to those receiving chemotherapy alone. However, concerns persist regarding the substantial cost of immunotherapy. Our study aims to evaluate the cost-effectiveness of neoadjuvant treatment combining nivolumab with chemotherapy versus standard neoadjuvant chemotherapy alone in resectable stage III NSCLC patients within the U.S. healthcare system.</div></div><div><h3>Methods</h3><div>Using data from the NADIM II trial, we developed a Markov model with 3 distinct health states to accurately simulate the overall health outcomes of NSCLC patients following different treatment strategies. This model not only computed essential economic metrics such as life years (LY), quality-adjusted life years (QALY), incremental cost-effectiveness ratio (ICER), and total costs but also ensured robustness through sensitivity and subgroup analyses.</div></div><div><h3>Findings</h3><div>The group receiving nivolumab plus chemotherapy achieved 7.89 QALYs (9.75 LYs) at a total cost of $428,701.08, whereas the chemotherapy-alone group attained 6.80 QALYs (8.53 LYs) with total costs amounting to $318,550.20. This resulted in an incremental cost of $110,150.88. Considering a willingness-to-pay (WTP) threshold of $150,000/QALY in the United States, the ICER was determined to be $100,879.21/QALY ($90,193.76/LY).</div></div><div><h3>Implications</h3><div>Based on these findings, in the United States, the perioperative use of nivolumab combined with chemotherapy appears to be cost-effective compared to chemotherapy alone for patients with stage III NSCLC, given a WTP threshold of $150,000/QALY.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 754-760"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of Three Prominent Corticosteroid Side Effects in a Large Asthma Population by Age, Sex and ICD-10 Asthma Severity with Recommendations for Screening","authors":"Bowen Yao ,&nbsp;Thomas Wilson PhD ,&nbsp;Ruitao Zou ,&nbsp;Nicholas Orfan MD","doi":"10.1016/j.clinthera.2025.06.020","DOIUrl":"10.1016/j.clinthera.2025.06.020","url":null,"abstract":"<div><h3>Purpose</h3><div>The adverse effects of corticosteroid therapy in the treatment of asthma have been extensively documented and explored over the past several decades. Prominent among these adverse effects are osteoporosis, cataracts, and osteonecrosis. We assessed the prevalence of these 3 well-known side effects of corticosteroid therapy for asthma in asthmatics versus nonasthmatics from a general adult population of 3.5 million individuals. The objective of the study was to make data-driven recommendations regarding screening for the 3 aforementioned comorbidities in specific asthmatic populations.</div></div><div><h3>Methods</h3><div>Using the Colorado all payers claims database with dates of service January 1, 2017 through June 30, 2020, we determined the prevalence of osteoporosis, cataracts, and osteonecrosis by asthma severity, age, and sex compared with an age and sex matched nonasthmatic comparator group.</div></div><div><h3>Findings</h3><div>Asthmatics generally showed an earlier onset and higher prevalence of these 3 side effects which correlated with asthma severity, often reaching statistically significant divergence from the nonasthmatic comparator group. Patterns of prevalence with regard to both age and sex were distinctive for each side effect.</div></div><div><h3>Implications</h3><div>Based on our findings, we suggest customized screening guidelines for osteoporosis, cataracts, and osteonecrosis for specific subpopulations of asthmatics as defined by age, sex, and asthma severity.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 667-672"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Effects of Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas in Combination with Metformin: A Hospital-Based Cohort Study of Patients With Type 2 Diabetes","authors":"Jui Wang PhD ,&nbsp;Kuo-Liong Chien MD, PhD ,&nbsp;Hon-Yen Wu MD, PhD","doi":"10.1016/j.clinthera.2025.06.001","DOIUrl":"10.1016/j.clinthera.2025.06.001","url":null,"abstract":"<div><h3>Purpose</h3><div>The influence of dipeptidyl peptidase-4 inhibitors (DPP4i) on clinical parameters in patients with type 2 diabetes (T2DM) remain controversial. This study compared the effects of DPP4i versus sulfonylureas (SU) on glucose, lipid, and renal profiles among patients with T2DM.</div></div><div><h3>Methods</h3><div>In this retrospective cohort study, we used the Integrated Medical Database of National Taiwan University Hospital (NTUH-iMD) to identify patients aged ≥40 years with T2DM diagnosed between 2008 and 2016. Using propensity score matching at a ratio of 1:1, we matched patients who received DPP4i with those who received SU as add-on therapy to metformin. The primary outcomes were changes in blood levels of clinical profiles, including hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), total cholesterol (TC), triglyceride (TG), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol, creatinine, and estimated glomerular filtration rate.</div></div><div><h3>Findings</h3><div>A total of 475 matched pairs of DPP4i and SU users were followed for a mean duration of 2.0 years. Both DPP4i and SU significantly reduced HbA1c, FPG, TC, TG, and LDL-C. Compared with SU, DPP4i showed a borderline greater reduction in HbA1c (effect estimate for the change of levels = –0.12%; 95% confidence interval (CI), –0.24% to 0%) and a nonsignificant difference in FPG (effect estimate for the change of levels = –4.09 mg/dL; 95% CI, –8.54 to 0.36 mg/dL).</div></div><div><h3>Implications</h3><div>Both DPP4i and SU improve glucose and lipid control in T2DM patients on metformin. DPP4i showed a modest advantage in improving glycemic control, suggesting it may be a preferred second-line therapy over SU.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 713-719"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Intravenous Oxyhydrogen Nanobubble on Chronic Kidney Disease: Case Series","authors":"Olly Indrajani MD, PhD ,&nbsp;Aditya T. Hernowo MD, PhD ,&nbsp;Christyanita P. Ekasari MSc ,&nbsp;Ricki Yudhanata MD ,&nbsp;Sutiman B. Sumitro DSc","doi":"10.1016/j.clinthera.2025.06.018","DOIUrl":"10.1016/j.clinthera.2025.06.018","url":null,"abstract":"<div><h3>Background</h3><div>Chronic kidney disease (CKD) is a progressive condition with limited treatment options that often lead to significant morbidity. Oxyhydrogen nanobubbles (HHOnb), a form of ultrafine gas-in-liquid dispersion containing hydrogen and oxygen, have shown potential therapeutic benefits due to their antioxidative and anti-inflammatory properties. This exploratory case series investigates the effects of intravenous HHOnb therapy in three patients with varying stages of CKD.</div></div><div><h3>Methods</h3><div>Three patients with CKD underwent a series of ten HHOnb infusions over a period of two to three months. The patients, aged 43–70, presented with additional comorbidities including hypertension, diabetes mellitus, and polycystic kidney disease. Clinical parameters, including glomerular filtration rate (GFR), serum creatinine, blood pressure, and uric acid levels, were monitored alongside subjective health improvements.</div></div><div><h3>Results</h3><div>Patient A. A 70-year-old woman with CKD grade 3a experienced a reduction in serum creatinine from 0.98 mg/dL to 0.82 mg/dL and an improvement in GFR from 59 mL/min/1.73 m² to 73.2 mL/min/1.73 m². She reported reduced leg swelling and increased vitality. Patient B. A 52-year-old man with CKD grade 4 and class III obesity showed a decrease in serum creatinine from 3.0 mg/dL to 2.86 mg/dL, an increase in GFR from 23 mL/min/1.73 m² to 24.4 mL/min/1.73 m², and improved sleep quality. Blood pressure reduced from 167/82 mmHg to 145/85 mmHg. Patient C. A 43-year-old man with CKD grade 4 and massive polycystic kidney disease reported reduced fatigue and normalized urination. His serum creatinine decreased from 3.26 mg/dL to 3.09 mg/dL, and his GFR improved from 22 mL/min/1.73 m² to 23.6 mL/min/1.73 m².</div></div><div><h3>Conclusion</h3><div>Although based on a small number of cases, this preliminary case series suggests that intravenous HHOnb therapy may provide renal and systemic benefits in CKD patients. Further controlled and larger-scale studies are necessary to validate these findings and assess long-term safety and efficacy.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages e13-e17"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Intravenous Immunoglobulin or Plasmapheresis in Myasthenic Crisis and Worsening Myasthenia Gravis Compared to Without Rescue Treatment","authors":"Jayantee Kalita DM ,&nbsp;Nagendra B. Gutti DM ,&nbsp;Faim Ahamed MD ,&nbsp;Roopali Mahajan DM ,&nbsp;Varun Kumar Singh DM","doi":"10.1016/j.clinthera.2025.06.012","DOIUrl":"10.1016/j.clinthera.2025.06.012","url":null,"abstract":"<div><h3>Purpose</h3><div>There is a paucity of studies on intravenous immunoglobulin (IVIg)/plasmapheresis (PLEX) compared with no rescue treatment (NRT) in myasthenic crisis (MC) and worsening myasthenia gravis (WMG). We report the efficacy of RTs (IVIg and PLEX) compared with NRT in MC/WMG.</div></div><div><h3>Methods</h3><div>Patients with MC and those having worsening in the MG Foundation of America classification by ≥2 grades were included. Their clinical findings, precipitating causes, and MG Activity of Daily Living (MGADL) and MG Quality of Life (MGQoL)-15 scores were noted. Patients were either treated with IVIg (400 mg/kg/d for 5 days) or PLEX (20–25 mL/kg × 5 sessions), and nonaffording patients received only standard care. The primary outcome was improvement in MG Foundation of America classification by ≥2 grades, and the secondary outcomes included MG Activity of Daily Living score, MG Quality of Life-15 score, Myasthenia Muscle Score, and days of mechanical ventilation (MV), hospital stay, and reaching pre-worsening status at 1 month.</div></div><div><h3>Findings</h3><div>Forty-four patients were included; 19 had MC and 25 had WMG. They were treated for MG for 2 to 19 years. Forty-one (93.2%) patients achieved the primary end point; 22 (95.7%) in RT and 19 (90.5%) in NRT (<em>P</em> = 0.60). The overall odds ratio of RT for the primary outcome was 1.20 (95% CI, 0.70–23.50; <em>P</em> = 0.13). The RT group had an overall hazard ratio of 0.93 (95% CI, 0.37–2.40; <em>P</em> = 0.96) for duration of MV, had hospital stay of 0.78 days (95% CI, 0.34–1.94; <em>P</em> = 0.80), and achieved pre-worsening MG status in 0.99 days (95% CI, 0.40–2.40; <em>P</em><span> = 0.72) compared with NRT after adjusting for age, triggers, dose of acetylcholine esterase inhibitors (AChEIs), and azathioprine at baseline. PLEX had an edge over IVIg in reducing the duration of MV and hospital stay, but overall hazard ratio was not significant. The RT group, however, required a lower dose of AChEIs (</span><em>P</em> = 0.04). Ten patients had mild adverse effects.</div></div><div><h3>Implications</h3><div>All the patients with MC and WMG improved irrespective of RT or NRT, and the RT group required a lower dose of AChEIs at 1 month. A multicenter randomized controlled trial may confirm these observations.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages e1-e6"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Raised Intracranial Pressure in Children Treated With Elexacaftor/Tezacaftor/Ivacaftor: Need for Surveillance","authors":"Cristina Fevola PhD ,&nbsp;Andrea Di Rita MD ,&nbsp;Martino Vannucchi MD ,&nbsp;Alice Noris MD ,&nbsp;Flavio Giordano MD ,&nbsp;Vito Terlizzi MD","doi":"10.1016/j.clinthera.2025.07.007","DOIUrl":"10.1016/j.clinthera.2025.07.007","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 821-822"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peripheral Neuropathy in Patients With Ovarian Cancer Administrating Poly ADP-Ribose Polymerase Inhibitors: A Real-World Study Based on Bayesian Disproportionality Analysis of the US Food and Drug Administration Adverse Event Reporting System","authors":"Chenguang Yang MSc ,&nbsp;Xuan Song MSc ,&nbsp;Hongmei Sun MSc ,&nbsp;Xi Chen MD ,&nbsp;Chengjiang Liu MD ,&nbsp;Yi Yang MD ,&nbsp;Zhongjian Wang MD ,&nbsp;Jing Zhu MD ,&nbsp;Min Chen MSc","doi":"10.1016/j.clinthera.2025.04.016","DOIUrl":"10.1016/j.clinthera.2025.04.016","url":null,"abstract":"<div><h3>Purpose</h3><div>The aim of this study was to analyze adverse events in terms of safety signals and conduct pairwise comparisons on the constituent ratios of the reporting rates, severity, and outcomes of peripheral neuropathy among poly ADP-ribose polymerase inhibitors in the treatment of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (collectively referred to as EOC) leveraging the US Food and Drug Administration Adverse Event Reporting System.</div></div><div><h3>Methods</h3><div>Data on peripheral neuropathy reports related to EOC treatment submitted to the US Food and Drug Administration Adverse Event Reporting System from the first quarter of 2015 to the third quarter of 2024 were collected. Three poly ADP-ribose polymerase inhibitors are identified: olaparib, niraparib, and rucaparib<span>. The primary composite end point of this study was the safety signals for peripheral neuropathy in patients with EOC receiving poly ADP-ribose polymerase inhibitors treatment, whereas the secondary end points included the safety signals for sensory neuropathy<span><span>, autonomic neuropathy, and </span>motor neuropathy. All analyses were conducted using Stata 18.0 MP software.</span></span></div></div><div><h3>Findings</h3><div>A total of 300,810 eligible records were included, among which there were 70,332 reports of peripheral neuropathy. For the primary composite end point, a safety signal related to peripheral neuropathy was detected with niraparib (reporting odds ratio [ROR] = 1.47; information component [IC]₀₂₅ = 0.21), whereas no safety signal was found with olaparib or rucaparib. For the secondary end points, safety signals related to autonomic, sensory, and motor neuropathies were detected with niraparib (ROR = 1.42, IC₀₂₅ = 0.21; ROR = 1.39, IC₀₂₅ = 0.20; ROR = 1.31, IC₀₂₅ = 0.17), whereas no signals were identified with olaparib and rucaparib.</div></div><div><h3>Implications</h3><div>For patients with EOC, prudent surveillance of peripheral neuropathy is warranted when administrating niraparib. Certainly, more large-scale and long-term follow-up period studies were entailed.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 673-680"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetic Drug Interactions of TPN171 When Coadministration With Rifampicin or Itraconazole","authors":"Liyu Liang MSc ,&nbsp;Haiping Qin M.Med ,&nbsp;Gangyi Liu BSc ,&nbsp;Hongjie Qian PhD ,&nbsp;Liang Xin MSc ,&nbsp;Qingqing Wu M.Med ,&nbsp;Chen Yu BSc ,&nbsp;Zhen Wang PhD ,&nbsp;Yu Wang PhD ,&nbsp;Huaqing Duan MSc ,&nbsp;Jingying Jia MSc","doi":"10.1016/j.clinthera.2025.06.005","DOIUrl":"10.1016/j.clinthera.2025.06.005","url":null,"abstract":"<div><h3>Purpose</h3><div>TPN171, a novel, highly selective, and potent phosphodiesterase type 5 (PDE5) inhibitor, is currently under clinical development for the treatment of pulmonary arterial hypertension (PAH) and erectile dysfunction (ED). The drug is mainly metabolized by the cytochrome P450 (CYP) enzyme 3A4. We evaluated the pharmacokinetic (PK) profile and safety of TPN171, both alone and in combination with itraconazole (a CYP3A4 potent inhibitor) or rifampin (a CYP3A4 potent inducer), in healthy Chinese volunteers.</div></div><div><h3>Methods</h3><div>In this open-label, fixed-sequence study, TPN171 (10 mg) was administered orally once daily on Days 1 and 6 in Cohort 1, followed by oral itraconazole (200 mg) once daily from Days 3 to 6. Cohort 2 received oral TPN171 (20 mg) once daily on Days 1 and 10, with concurrent oral rifampin (600 mg) once daily administered from Days 3 to 10. Twenty-four healthy subjects were enrolled (12 per cohort). The PK parameters of TPN171 were estimated through noncompartmental analysis with its plasma concentration detection. Comparisons of the maximum plasma concentration (C_max) and the area under the concentration–time curve extrapolated to infinity (AUC_0-∞) for TPN171 were conducted between conditions with and without coadministration of itraconazole or rifampin.</div></div><div><h3>Findings</h3><div>The C_max and AUC_0-∞ for TPN171 were increased by 76.00% (least squares geometric mean ratios (LSGMR), 176.00% [90% CI, 160.37%–193.15%]) and 185.67% (LSGMR, 285.67% [90% CI, 261.87%–311.64%]) when combined with itraconazole versus TPN171 alone. The C_max and AUC_0-∞ of TPN171 were reduced by 74.53% (LSGMR, 25.47% [90% CI, 21.98%–29.50%]) and 90.14% when combined with rifampin versus TPN171 alone (LSGMR, 9.86% [90% CI, 9.08%–10.71%]). Spontaneous penile erection was the most frequently reported adverse event, occurring in 17 (70.83%) of the 24 subjects.</div></div><div><h3>Implications</h3><div>CYP3A4 potent inhibitors and inducers can significantly affect the exposure level of TPN171, especially the inducers. Therefore, when taking TPN171, it is recommended to avoid concomitant administration with CYP3A4 potent inhibitors or potent/moderate inducers, or adjust the dosage of TPN171.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 706-712"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Vunakizumab Treatment on Detailed Dimensions of Patient-Reported Outcomes in Moderate-to-Severe Plaque Psoriasis Patients: A Post-Hoc Analysis of a Randomized Controlled Trial (NCT04839016)","authors":"Lijing Lv MM,&nbsp;Yan Zhang MDPhD","doi":"10.1016/j.clinthera.2025.06.017","DOIUrl":"10.1016/j.clinthera.2025.06.017","url":null,"abstract":"<div><h3>Purpose</h3><div>This post-hoc analysis aimed to explore the effect of vunakizumab treatment on detailed dimensions of patient-reported outcomes (PROs) in moderate-to-severe plaque psoriasis patients.</div></div><div><h3>Methods</h3><div>This post-hoc analysis derived data from a randomized controlled trial (NCT04839016), which compared the efficacy and safety of vunakizumab with placebo in patients with moderate-to-severe plaque psoriasis. Patients were randomized 2:1 to receive vunakizumab 240 mg or placebo subcutaneously. At week (W)12, patients on placebo were switched to vunakizumab 240 mg. A total of 461 moderate-to-severe plaque psoriasis patients receiving vunakizumab and 229 patients receiving placebo were included in this post-hoc analysis. PROs included the Dermatology Life Quality Index (DLQI), itch numeric rating scale, EuroQol five-dimensional five-level (EQ-5D-5L), and Short Form-36 (SF-36). Items related to anxiety, depression, pruritus, pain, physical function, vitality, and health transitions were extracted from the DLQI, EQ-5D-5L, and SF-36.</div></div><div><h3>Findings</h3><div>DLQI and itch numeric rating scale scores at W4, W8, and W12 were lower in the vunakizumab group than in the placebo group (all <em>P</em> &lt; 0.001). EQ-5D-5L and SF-36 mental/physical component scores at W4, W8, and W12 were higher in the vunakizumab group than in the placebo group (all <em>P</em> &lt; 0.001). The mean DLQI (W0: 11.3 ± 6.9, W12: 2.2 ± 3.0, W52: 1.5 ± 3.1) and itch numeric rating scale (W0: 5.6 ± 2.6, W12: 1.6 ± 1.7, W52: 1.0 ± 1.5) scores were decreased from W0 to W52 after vunakizumab treatment. EQ-5D-5L scores (W0: 80.3 ± 16.3, W12: 90.4 ± 8.0, W52: 92.4 ± 8.1) as well as SF-36 mental (W0: 47.8 ± 10.2, W12: 53.7 ± 7.1, W52: 54.5 ± 6.9) and physical (W0: 51.4 ± 6.3, W12: 55.6 ± 4.5, W52: 55.7 ± 5.0) component scores increased from W0 to W52 after vunakizumab treatment. Anxiety, depression, pruritus, and pain were attenuated after vunakizumab treatment. Physical function, vitality, and health transitions were enhanced after vunakizumab treatment.</div></div><div><h3>Implications</h3><div>Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 729-739"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trastuzumab Deruxtecan and Sacituzumab Govitecan for Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Low Metastatic Breast Cancer: A Cost-Effectiveness Analysis","authors":"Mengwei Zhang MD ,&nbsp;Gengwei Huo MD ,&nbsp;Zhenzhen Liu MD ,&nbsp;Min Yan MD","doi":"10.1016/j.clinthera.2025.05.017","DOIUrl":"10.1016/j.clinthera.2025.05.017","url":null,"abstract":"<div><h3>Objective</h3><div>We aim to analyze the pharmacoeconomic characteristics of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in the treatment of patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-low (HER2-low) metastatic breast cancer who have previously undergone chemotherapy.</div></div><div><h3>Methods</h3><div>A cost-effectiveness study was conducted to compare these two treatment options with chemotherapy, respectively, in terms of their economic impact and clinical outcomes from the perspective of the United States payer. A partitioned survival model with a lifetime horizon comprising three distinct states was utilized for the simulation process of patients receiving trastuzumab deruxtecan or sacituzumab govitecan (in the T-DXd or SG group, respectively). The relevant health preference information and cost data were gathered from published articles.</div></div><div><h3>Results</h3><div>The T-DXd group, when compared to chemotherapy, provided an additional 0.34816 quality-adjusted life years (QALYs). This benefit was associated with an incremental cost of $222,149, resulting in an incremental cost-effectiveness ratio (ICER) of $638.066 per QALY. For the SG group, in comparison to chemotherapy, an extra 0.17469 QALYs were yielded. This gain was accompanied by an incremental cost of $221,830, leading to an ICER of $1,269,849 per QALY. The ICERs for both T-DXd and SG surpass the predetermined willingness-to-pay (WTP) threshold of $150,000 per QALY. The univariate sensitivity analysis revealed that the costs of SG and T-DXd had a certain influence on the results, whereas other variables had minimal impact.</div></div><div><h3>Conclusion</h3><div>From the perspective of a U.S. payer, at a willingness-to-pay (WTP) threshold of $150,000 per QALY, both T-DXd and SG were unlikely to be cost-effective compared to chemotherapy for HR+ and HER2-low metastatic breast cancer patients who have previously undergone chemotherapy. However, relative to SG, T-DXd achieved greater QALYs without a significant increase in cost.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 9","pages":"Pages 740-745"},"PeriodicalIF":3.6,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}