Advances in Therapy最新文献

{"title":"Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.","authors":"Naotaka Usui, Dong Zhou, Bing Qin, Somsak Tiamkao, Leonor Cabral-Lim, Kheng Seang Lim, Shih-Hui Lim, Jing-Jane Tsai, Jun Watanabe, Weiwei Sun, Najla Dickson, Brian Moseley, Dimitrios Bourikas, Yushi Inoue","doi":"10.1007/s12325-025-03357-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03357-7","url":null,"abstract":"<p><strong>Introduction: </strong>We assessed the time course of treatment-emergent adverse events (TEAEs) in adult Asian patients (in Thailand, Japan, China, Philippines, Malaysia, Singapore, and Taiwan) with focal-onset seizures (FOS) during adjunctive brivaracetam (BRV) treatment.</p><p><strong>Methods: </strong>Post hoc analysis of EP0083/NCT03083665, a Phase 3, randomized, double-blind, placebo (PBO)-controlled trial that evaluated BRV 50 and 200 mg/day in adult Asian patients (≥ 16-80 years) with FOS. Following an 8-week prospective baseline, patients were randomized 1:1:1 to PBO, BRV 50 mg, or BRV 200 mg and entered a 12-week treatment period.</p><p><strong>Results: </strong>Overall, 448 patients (mean age 34.5 years; 53.8% female) received ≥ 1 dose of trial medication (PBO/BRV 50 mg/BRV 200 mg: n = 149/151/148 [Safety Set]). The overall incidence of TEAEs was similar across treatment arms (53.6-58.1%), and most TEAEs were mild in intensity (45.0-48.3%). Patients discontinuing BRV because of TEAEs (1.3% BRV 50 mg; 2.7% BRV 200 mg) discontinued during the first 5 weeks of treatment (for PBO, discontinuations due to TEAEs [3.4%] took place between weeks 1-8). The incidence of drug-related TEAEs was 18.1% in patients receiving PBO, 24.5% in those on BRV 50 mg/day, and 39.2% for BRV 200 mg/day; however, most were of mild intensity and did not lead to BRV discontinuation. The incidence of TEAEs and drug-related TEAEs was highest during the first week of adjunctive BRV treatment and decreased thereafter. The onset of drug-related somnolence and dizziness occurred mainly during the first week of treatment.</p><p><strong>Conclusion: </strong>In Asian adults with FOS, most drug-related TEAEs were mild in intensity, indicating that adjunctive BRV had a favorable tolerability profile when initiated at a potentially therapeutic dose without titration. The incidence of drug-related TEAEs including somnolence and dizziness was highest during the first week of adjunctive BRV treatment, abating thereafter. These tolerability data could help inform patient monitoring and treatment decisions when prescribing BRV.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03083665.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145051389","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":"Assessing the Benefits of Rapid Start Antiretroviral Therapy for Newly Diagnosed People with HIV in the United States.","authors":"Patrick S Sullivan, Cillian Copeland, James Jarrett, Uche Mordi, Nikos Kotsopoulos, Rui Martins, Hansel E Tookes","doi":"10.1007/s12325-025-03356-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03356-8","url":null,"abstract":"<p><strong>Introduction: </strong>International guidelines emphasize the need for earlier commencement of antiretroviral therapy (ART) among people with HIV (PWH). Reducing the time between HIV diagnosis and ART initiation can improve health outcomes, reduce healthcare utilization, and reduce HIV transmissions. This study evaluated the clinical and economic benefits associated with increasing uptake of rapid start ART among newly diagnosed PWH.</p><p><strong>Methods: </strong>A state transition disease model was developed in the United States setting to evaluate the benefits from earlier initiation of ART. The base case analysis compared two cohorts of 1000 newly diagnosed PWH: one following current patterns of ART initiation, and a counterfactual cohort where those receiving rapid start ART was doubled. Individuals were classified by different CD4 states at diagnosis and over time with viral suppression rates also being tracked. ART and CD4 state-specific healthcare costs were estimated over a 3-year time horizon. Averted HIV transmissions were calculated and used to estimate lifetime healthcare cost savings while CD4-specific mortality was also calculated. Several scenario analyses explored alternate assumptions related to the time at which PWH started ART after diagnosis.</p><p><strong>Results: </strong>Doubling the proportion of newly diagnosed PWH receiving rapid start ART averted 7 HIV transmissions and 0.3 deaths per 1000 people, corresponding to numbers needed to treat of 141 and 3502, respectively. This leads to cost savings resulting from reduced healthcare resource use and lifetime cost savings from preventing new HIV transmissions.</p><p><strong>Conclusion: </strong>Reducing the time between HIV diagnosis and ART initiation can provide clinical and economic benefits by eliminating transmissions that might occur while individuals are viremic but not on treatment. The additional costs of providing ART required for this increase achieve high levels of return when considering the lifetime healthcare cost burden of onward HIV transmissions potentially averted by early ART start.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038971","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":"Healthcare Costs Associated with Adverse Events in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder (ADHD): A Claims-Based Study.","authors":"Jeff Schein, Maryaline Catillon, Anaïs Lemyre, Alice Qu, Frederic Kinkead, Marjolaine Gauthier-Loiselle, Martin Cloutier, Ann Childress","doi":"10.1007/s12325-025-03345-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03345-x","url":null,"abstract":"<p><strong>Introduction: </strong>Adverse events (AEs) are common in pediatric patients receiving attention-deficit/hyperactivity disorder (ADHD) treatment; however, real-world studies on their costs from a payer's perspective are lacking. Therefore, this study investigated the healthcare costs associated with selected AEs among pediatric patients receiving ADHD treatment in the United States.</p><p><strong>Methods: </strong>Using a retrospective cohort design, patients aged 6-17 years who received pharmacologic treatment for ADHD were identified from US claims data (October 1, 2015-September 30, 2023) and were categorized into AE and AE-free cohorts, separately for each studied AE. The eight selected AEs had statistically significant risk differences in a matching-adjusted indirect comparison of ADHD treatments and were identifiable from claims with ICD-10-CM codes. Entropy balancing was used to create cohorts with similar characteristics. Total excess healthcare costs and costs associated with AE-specific claims per patient per month (PPPM) were compared across balanced cohorts with vs. without a given AE.</p><p><strong>Results: </strong>Overall, 393,919 patients (mean age: 12.5 years; male: 65.4%; stimulant monotherapy: 71.8%) were included, among whom 13.6% had ≥ 1 studied AE that resulted in a medical encounter during their treatment episode. The most prevalent AEs were upper abdominal pain (5.2%), vomiting (3.4%), and insomnia (3.2%). All AEs were associated with substantial AE-specific costs PPPM (asthenia: $196; somnolence: $171; insomnia: $169; vomiting: $106; dizziness: $92; upper abdominal pain: $91; irritability: $75; decreased weight: $46) and total excess healthcare costs PPPM (asthenia: $1178; somnolence: $821; vomiting: $427; insomnia: $404; dizziness: $380; upper abdominal pain: $336; irritability: $231; decreased weight: $219; all p < 0.01).</p><p><strong>Conclusions: </strong>AEs were common during ADHD treatment episodes in pediatric patients and were associated with significant healthcare costs. ADHD treatments with a favorable safety profile could help alleviate the economic burden of AEs.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145032425","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 Indirect Treatment Comparison of Avalglucosidase Alfa versus Cipaglucosidase Alfa Plus Miglustat in Patients with Late-Onset Pompe Disease.","authors":"Mark E Roberts, Irina Proskorovsky, Patricia Guyot, Pragya Shukla, Nathan Thibault, Alaa Hamed, Ruth Pulikottil-Jacob, Lasair O'Callaghan, Laurence Pollissard","doi":"10.1007/s12325-025-03301-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03301-9","url":null,"abstract":"<p><strong>Introduction: </strong>No head-to-head studies comparing the efficacy of avalglucosidase alfa (AVA) with cipaglucosidase alfa + miglustat (Cipa+mig) have been conducted in patients with late-onset Pompe disease (LOPD). Two indirect treatment comparisons (ITCs) were conducted to estimate the effects of AVA versus Cipa+mig.</p><p><strong>Methods: </strong>ITCs were conducted using simulated treatment comparisons (STCs), adjusting for differences in prognostic factors and treatment effect modifiers. An analysis of patients who were naïve to enzyme replacement therapy (ERT-naive) used anchored STC with individual patient data (IPD) from the Phase 3 COMET (NCT02782741) study of AVA versus alglucosidase alfa (ALG) and aggregate data from patients who were ERT-naïve in the Phase 3 PROPEL (NCT03729362) study of Cipa+mig versus ALG + placebo. For patients who were ERT-experienced, an analysis used unanchored STC with IPD for AVA from the COMET open-label extension, and from NEO-1 (NCT01898364)/NEO-EXT (NCT02032524) studies, and aggregate Cipa+mig data from PROPEL and ATB200-02 (NCT02675465).</p><p><strong>Results: </strong>In patients who were ERT-naïve, the difference (95% confidence interval, CI) in mean change from baseline (CFB) at Weeks 49-52 in forced vital capacity percent predicted (FVCpp) showed a numerical improvement for AVA versus Cipa+mig with values of 5.49% (- 0.87, 11.86) with mixed model repeated measures analysis (MMRM/MMRM) and 4.69% (- 3.22, 12.61) with MMRM/analysis of covariance (ANCOVA). For the 6-min walk test (6MWT), differences were 57.08 m (11.04, 103.12) with MMRM/MMRM and 41.88 m (- 5.46, 89.22) with MMRM/ANCOVA, the former being statistically significant (p < 0.02) and the latter numerically in favour of AVA. In patients who were ERT-experienced, at Weeks 48-52 differences for AVA versus Cipa+mig with MMRM/MMRM (CIs/p values unavailable) were 1.40% for FVCpp and 18.85 m for 6MWT; with MMRM/Mean CFB, differences of 1.16% (- 1.88, 4.19) for FVCpp and 7.67 m (- 21.67, 37.02) for 6MWT, indicating a numerical improvement in favour of AVA.</p><p><strong>Conclusions: </strong>ITCs suggest more favourable respiratory and mobility outcomes with AVA versus Cipa+mig in patients with LOPD, regardless of prior ERT-experience.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013645","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":"Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus.","authors":"Cristina Arriens, Eric F Morand, Anca D Askanase, Richard Furie, Ronald F van Vollenhoven, Yoshiya Tanaka, Kevin Connors, Monica Davey, Kimberly Young, Giovanni Franchin, Richard Meier, Vaishali Shah, Carolina Leite de Oliveria, Coburn Hobar","doi":"10.1007/s12325-025-03299-0","DOIUrl":"https://doi.org/10.1007/s12325-025-03299-0","url":null,"abstract":"<p><strong>Background and objectives: </strong>Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, demonstrated efficacy across the primary endpoint and all key secondary endpoints in the phase 2 PAISLEY SLE trial in patients with active systemic lupus erythematosus (SLE). Here, we describe 2 phase 3 trials [POETYK SLE-1 (NCT05617677), POETYK SLE-2 (NCT05620407)] which will assess the efficacy and safety of deucravacitinib in patients with active SLE. These phase 3 trials have been designed to replicate the successful elements of the phase 2 trial, including its glucocorticoid-tapering strategy and disease activity adjudication.</p><p><strong>Methods: </strong>In these global, phase 3, randomized, double-blind, placebo-controlled trials, patients aged 18-75 years with active SLE receiving background standard-of-care treatment will be randomized 3:2 to receive deucravacitinib or placebo for 52 weeks of double-blind treatment. Patients receiving glucocorticoids will be instructed to taper, unless significant disease activity is present, to a threshold dose level during the double-blind treatment period. At week 52, eligible patients may continue to an optional 104-week open-label extension phase, in which all patients will receive deucravacitinib.</p><p><strong>Planned outcomes: </strong>The primary endpoint of SLE Responder Index-4 response and all secondary endpoints will be assessed at week 52. Safety and tolerability will be assessed throughout the trials. In each trial, planned randomization includes patients in multiple countries across North and South America, Europe, and the Asia-Pacific region.</p><p><strong>Conclusions: </strong>The POETYK SLE-1 and SLE-2 trials in progress are important to the continued evaluation of deucravacitinib as a potential well-tolerated and effective therapy option for patients with SLE.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT05617677 and NCT05620407.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013720","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":"Patient Preferences and Understanding of Glaucoma Treatment: A Nationwide Survey by the French Glaucoma Society.","authors":"Paul Bastelica, Antoine Labbe, Marwan Sahyoun, Christophe Baudouin, Cédric Lamirel, Muriel Poli, Jean-Paul Renard, Antoine Rousseau, Cédric Schweitzer, Florent Aptel","doi":"10.1007/s12325-025-03353-x","DOIUrl":"https://doi.org/10.1007/s12325-025-03353-x","url":null,"abstract":"<p><strong>Introduction: </strong>Glaucoma treatment predominantly involves the use of topical anti-glaucoma eye drops, with patient adherence influenced by individual preferences. This study aimed to assess these preferences and highlight the importance of personalized treatment approaches among ophthalmologists.</p><p><strong>Methods: </strong>This French multicenter, cross-sectional study involved 21 ophthalmologists-members of the Board of Directors of the French Society of Glaucoma-from both public and private practices, who distributed a standardized questionnaire to their patients with glaucoma. The questionnaire collected data on demographics, treatment-related experiences, patient preferences, and the prioritization of six treatment criteria: cost, efficacy, dosing frequency, side effects, environmental impact, and ease of use.</p><p><strong>Results: </strong>A total of 798 patients with glaucoma participated. There was no strong preference between multi-dose bottles and single-dose units (32.0% vs. 37.4%, respectively, with 29.2% of patients showing no preference). Side effects were reported by 31.8% of patients, and the use of artificial tears was significantly higher among those with longer treatment durations (31.3% for ≤ 2 years vs. 65.6% for > 20 years, p = 0.001). Notably, 63% of patients were unaware that their eye drops could contain preservatives. Regarding generics, 29.9% of patients had previously used one, while only 25.6% were willing to switch from their prescribed brand to a generic equivalent. Adherence was suboptimal, with only 66.2% of patients reporting being compliant. Younger age (p < 0.001) and lack of awareness about preservatives (p < 0.001) were significantly associated with non-adherence. When ranking treatment criteria, patients prioritized efficacy, followed by side effects, ease of use, cost, and environmental impact.</p><p><strong>Conclusion: </strong>This nationwide survey conducted by the French Glaucoma Society underscores the diversity of patient preferences and the critical need for personalized glaucoma care. A substantial proportion of patients feels insufficiently informed about preservatives and generics, which may negatively impact adherence. Enhanced patient education and individualized treatment strategies are essential for improving outcomes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013712","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":"Obesity as a Chronic Disease: A Narrative Review of Evolving Definitions, Management Strategies, and Cardiometabolic Prioritization.","authors":"Vidhi Singh, Jia Sun, Susan Cheng, Alan C Kwan, Amanda Velazquez","doi":"10.1007/s12325-025-03352-y","DOIUrl":"https://doi.org/10.1007/s12325-025-03352-y","url":null,"abstract":"<p><p>Obesity is a multifactorial, complex disease that is driven by genetic, biological, environmental, and behavioral factors. In this review, we explain the key contributors to obesity, limitations in current definitions, its relationship with cardiometabolic health, and recent advancements in treatment. Obesity is characterized by the presence of excess and dysfunctional adipose tissue, driven by chronic inflammation and maladaptive energy homeostasis. Although body mass index (BMI) has historically been used to diagnose obesity, BMI provides a limited evaluation of individual patients because it fails to specifically quantify adiposity, which is the primary determinant of metabolic impact in these patients. There is an ongoing and necessary shift in treating obesity with a weight-inclusive approach that aims to address obesity upstream and prevent downstream cardiometabolic health complications. This approach is being supported by various treatment options, notably glucagon-like peptide-1 receptor agonists like semaglutide and tirzepatide, that also have promising effects on cardiovascular, renal, and liver health. Advances in precision medicine, gut microbiome research, and Multi-target therapies support personalized therapeutic approach. Despite these developments, less than 25% of individuals living with obesity are receiving evidence-based treatment. There is an urgent need to improve health care delivery to patients with obesity through timely, affordable, and multimodal treatments that promote sustainable and sustained weight loss. Increasing board certification of practicing physicians through the American Board of Obesity Medicine will be critical to improving access and quality of care.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999416","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":"Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants.","authors":"Xin Zhang, Yuki Otani, Christopher D Payne, Nathan J Morris, Laiyi Chua, Rodrigo Escobar, Sihe Wang, Galen Shi","doi":"10.1007/s12325-025-03335-z","DOIUrl":"10.1007/s12325-025-03335-z","url":null,"abstract":"<p><strong>Introduction: </strong>Mirikizumab, a humanized anti-interleukin-23p19 monoclonal antibody, is approved for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). Two phase 1, open-label, two-arm, randomized studies compared pharmacokinetics and safety of mirikizumab (200 mg, Study AMBW; 300 mg, Study AMBX) to establish bioequivalence. Mirikizumab was administered subcutaneously using an autoinjector or a prefilled syringe (PFS) as a single dose in healthy participants.</p><p><strong>Methods: </strong>Participants (male and female) were randomized 1:1 to mirikizumab by a PFS (reference) and an autoinjector (test). Participants were sub-randomized (1:1:1) to one of three injection sites (abdomen, arm, thigh) and stratified into one of three weight groups. Primary endpoints were maximum observed drug concentration (C_max), and area under concentration versus time curves (time zero to infinity [AUC_0-∞]; time to last time point with measurable concentration [AUC_0-tlast]). Secondary objectives were safety and immunogenicity.</p><p><strong>Results: </strong>In Study AMBW, 90% confidence intervals (CIs) for the ratios (autoinjector to PFS) of geometric least squares mean values for C_max, AUC_0-∞, and AUC_0-tlast were within prespecified bioequivalence limits (0.80-1.25). Similar results were observed in Study AMBX, after administration of mirikizumab 300 mg, with bioequivalence achieved for AUC_0-tlast and AUC_0-∞, while the upper bound of the 90% CI of the geometric least squares mean ratio for C_max was slightly above the bioequivalence upper threshold. Overall safety of mirikizumab was similar between devices in both studies. Immunogenicity was similar overall in Study AMBW, but slightly higher (autoinjector versus PFS) in Study AMBX.</p><p><strong>Conclusion: </strong>Mirikizumab administered by autoinjector or PFS was considered bioequivalent at the 200-mg UC maintenance dose and the 300-mg CD maintenance dose. Safety and immunogenicity profiles were comparable between autoinjector and PFS. Availability of an autoinjector option may be preferred by some patients and may help improve patient adherence to treatment.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov NCT04607733; NCT05069896.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938793","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":"Patient and Physician Preferences for Maintenance Treatment in Advanced Non-Small Cell Lung Cancer: Insights into Treatment Selection.","authors":"Manasee V Shah, Caitlyn T Solem, Anne Liao, Kelly F Bell, Yao Wang, Hongbo Yang, Yan Meng, Mingchen Ye, Umit Tapan","doi":"10.1007/s12325-025-03347-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03347-9","url":null,"abstract":"<p><strong>Introduction: </strong>Advanced/metastatic non-small cell lung cancer (a/mNSCLC) is associated with a poor prognosis. Although maintenance therapy after first-line (1L) induction treatment can extend survival, it may also present with drawbacks like risk of certain adverse events (AEs), underscoring the need for shared decision-making between patients and their treating physicians. This study aimed to quantify the extent to which maintenance treatment attributes impact the preferences of patients and physicians after 1L induction therapy for a/mNSCLC.</p><p><strong>Methods: </strong>Eligible patients (aged ≥ 18 years in the UK and US) were diagnosed with a/mNSCLC and had stable disease with or responded to 1L induction therapy. Eligible physicians were licensed oncologists with ≥ 5 years' experience in a/mNSCLC treatment who had treated ≥ 20 such patients in the past year. Surveys assessed the patients' and physicians' perspectives regarding the current treatment landscape of a/mNSCLC, and a discrete choice experiment assessed their preferences regarding treatment characteristics. Data were collected using choice cards, designed to capture treatment attribute preferences including efficacy (progression-free survival [PFS] and overall survival [OS]), chance (risk) of new brain metastasis (BM), and selected AEs.</p><p><strong>Results: </strong>Among 34 UK and 48 US patients, the three most important treatment attributes (in order) were chance of new BM, OS, and risk of severe neutropenia. Among 51 UK and 50 US treating physicians, the 3 most important treatment attributes (in order) were OS, chance of new BM, and PFS.</p><p><strong>Conclusion: </strong>In this real-world survey, OS and chance of new BM were the two most important maintenance treatment attributes for patients with a/mNSCLC and treating physicians. However, the risk of severe neutropenia carried greater relative importance, while PFS carried lesser relative importance, for patients than physicians. These results highlight the differing emphasis placed on attributes by patients and physicians when selecting maintenance treatment.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938846","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 Weight Loss Observed With Semaglutide and Tirzepatide in Patients with Overweight or Obesity and Without Type 2 Diabetes (SHAPE).","authors":"Carmen D Ng, Victoria Divino, Julia Wang, Joshua C Toliver, Marcio Buss","doi":"10.1007/s12325-025-03340-2","DOIUrl":"https://doi.org/10.1007/s12325-025-03340-2","url":null,"abstract":"<p><strong>Introduction: </strong>Semaglutide 2.4 mg injection (Wegovy^®), a glucagon-like peptide-1 (GLP-1) receptor agonist, was approved by the US Food and Drug Administration for weight management in June 2021. Tirzepatide, a glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist, was approved for type 2 diabetes mellitus (T2DM; Mounjaro^®) in May 2022 and weight management (Zepbound^®) in November 2023. Due to limited data on the long-term effectiveness of these medications, this study assessed real-world weight loss with semaglutide 2.4 mg or tirzepatide after 1 year in patients with overweight or obesity and without T2DM.</p><p><strong>Methods: </strong>This retrospective cohort study included adults with overweight or obesity and ≥ 1 pharmacy claim for semaglutide 2.4 mg or tirzepatide in the US Komodo Health database between June 4, 2021, and December 15, 2023. Patients had continuous enrollment for 1 year before (baseline period) and 1 year after (follow-up period) the index date (date of treatment initiation) and persistence on therapy (no gap of > 30 days' supply) during follow-up. Patients with T2DM at baseline were excluded. Weight change from index to 1 year was descriptively assessed.</p><p><strong>Results: </strong>Overall, 9916 patients were included (semaglutide 2.4 mg, n = 6794; tirzepatide, n = 3122). Baseline characteristics were descriptively similar for semaglutide 2.4 mg and tirzepatide: mean age was 47.8 and 49.5 years, 79.8% and 77.9% were female, and mean index weight was 104.5 and 104.9 kg, respectively. After 1 year of follow-up, the mean weight loss from baseline with semaglutide 2.4 mg and tirzepatide was - 14.6 and - 17.2 kg, respectively, with percent weight loss of - 14.1% and - 16.5%. Most (83.5%) patients treated with semaglutide 2.4 mg reached the maximum dose (2.4 mg), while 25.9% of patients treated with tirzepatide reached the maximum dose (15 mg).</p><p><strong>Conclusion: </strong>Findings suggest semaglutide 2.4 mg and tirzepatide are used in descriptively similar populations and both resulted in clinically meaningful weight loss after 1 year of treatment.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938848","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}