Advances in Therapy最新文献

{"title":"Real-World Treatment Patterns in Patients with Spinal Muscular Atrophy Receiving Multiple Disease-Modifying Therapies.","authors":"Walter Toro Jimenez, Min Yang, Wei Song, Dongni Ye, Esteban Lemus Wirtz, John Meehan, Sandra Reyna","doi":"10.1007/s12325-026-03710-4","DOIUrl":"https://doi.org/10.1007/s12325-026-03710-4","url":null,"abstract":"<p><strong>Introduction: </strong>Nusinersen (approved in 2016), onasemnogene abeparvovec (intravenous infusion [OAV], 2019; intrathecal injection, 2025), and risdiplam (2020) are disease-modifying therapies (DMTs) available in the US for spinal muscular atrophy (SMA). Real-world evidence on treatment patterns among patients receiving multiple DMT types remains limited.</p><p><strong>Methods: </strong>This retrospective study used the Komodo Health Research Database (2016-2024) to identify patients with SMA treated with DMTs. First DMT distribution and the proportion of patients receiving a second DMT were described for patients who initiated any DMT at age ≤ 2 years in 2022-2024 (following widespread newborn screening [NBS]). Patient characteristics, treatment sequences, and time between DMT initiations were described for patients with multiple DMTs whose first was initiated on/after May 2019, including subgroups receiving first DMT at age ≤ 2 years in 2022-2024.</p><p><strong>Results: </strong>Among patients who initiated any DMT at age ≤ 2 years in 2022-2024 (N = 257), 64.6% started with OAV, 24.9% with risdiplam, and 10.5% with nusinersen. Of these, 12.0%, 20.3%, 55.6% of patients treated with OAV, risdiplam, and nusinersen, respectively, received a second DMT. Among patients receiving multiple DMTs during 2019-2024 (N = 341), 75.4% first initiated nusinersen, 15.2% risdiplam, and 9.4% OAV; mean age at first DMT was 15.4 years overall (17.3, 15.2, and 0.8 years, respectively). Median time from first to second DMT was 18.9 months overall. Within this cohort, 44 patients initiated their first DMT at age ≤ 2 years in 2022-2024; OAV was the most common first DMT. All patients treated with risdiplam and most patients treated with nusinersen received OAV as their second DMT; median time from first to second DMT was 13.4 months.</p><p><strong>Conclusions: </strong>Following widespread NBS, OAV had the highest utilization among patients age ≤ 2 years as first or second DMT after nusinersen or risdiplam. Use of a second DMT type was lowest among patients who initiated OAV.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149056794","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":"Acute Tolerability and Long-Term Surveillance of Fecal Microbiota Transplantation in Children with Autism: A Real-World Study of 604 Procedures.","authors":"Youran Li, Wenwen Yu, Rulan Liu, Pei Xiao, Xiaolu Li, Ting Zhang","doi":"10.1007/s12325-026-03797-9","DOIUrl":"https://doi.org/10.1007/s12325-026-03797-9","url":null,"abstract":"<p><strong>Introduction: </strong>Fecal microbiota transplantation (FMT) is a promising adjunctive therapy for autism spectrum disorder (ASD), yet comprehensive, real-world safety data in pediatric populations remain limited. This study aimed to systematically evaluate the safety profile, temporal kinetics, and risk factors for adverse events (AEs) following FMT in children with ASD.</p><p><strong>Methods: </strong>We conducted a longitudinal observational study of 224 children with ASD (aged 2-17 years) who underwent a total of 604 FMT procedures. Interventions were administered via oral capsules (Caps), nasojejunal tube (NJT), or transendoscopic enteral tube (TET). AEs were systematically graded using common terminology criteria for AEs (CTCAE) criteria, and a multivariate generalized estimating equations (GEE) model was used to identify independent risk factors.</p><p><strong>Results: </strong>In our study, the overall incidence of AEs across 604 procedures was low at 2.5% (15/604 procedures). All documented AEs had an acute onset (< 48 h post-procedure), were strictly Grade 1 (mild) in severity, and spontaneously resolved (median duration 28.0 h). The most frequent symptoms were vomiting and irritability, with no severe or long-term AEs observed. Delivery route significantly impacted safety, and TET exhibited the highest AE rate (26.3%), whereas Caps (1.7%) and NJT (1.8%) demonstrated favorable tolerability. Multivariate analysis identified TET as the independent risk factor for AEs (adjusted odds ratio 21.90, P < 0.001).</p><p><strong>Conclusion: </strong>FMT demonstrates favorable acute tolerability in children with ASD, with long-term longitudinal surveillance showing no delayed adverse outcomes. Oral capsules are associated with a low AE rate and represent a preferred delivery route.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry, ChiCTR2200055943. Registered 28 January 2022, http://www.chictr.org.cn .</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149035840","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":"Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HZBio1 in Chinese Healthy Subjects: A Randomized Phase 1a Study.","authors":"Hongzhong Liu, Xin Zheng, Chuanqing Yang, Wei Tian, Ruijie Wan, Yu Wang, Yang Yu, Qian Wang, Hongyun Wang","doi":"10.1007/s12325-026-03792-0","DOIUrl":"https://doi.org/10.1007/s12325-026-03792-0","url":null,"abstract":"<p><strong>Introduction: </strong>Polyethylene glycol-modified (PEGylated) recombinant uricase is a promising guideline-recommended treatment for hyperuricemia and gout. This first-in-human, single ascending dose, phase 1a trial evaluated the tolerability, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of HZBio1 in Chinese healthy subjects.</p><p><strong>Methods: </strong>The present study enrolled healthy subjects (aged 18-45 years) between March 8, 2021 and January 14, 2022. Thirty subjects were randomly assigned into 5 HZBio1 cohorts (6 per dose cohort) following the dose escalation scheme, and 10 received placebo. Each subject received a single dose of HZBio1 (in the range 0.96-12 mg) or placebo, by intramuscular injection.</p><p><strong>Results: </strong>All treatment-emergent adverse events (TEAEs) were grade 1 or 2 in severity during a 35-day follow-up period. The TEAEs and drug-related TEAEs incidences were 76.7% versus 60.0% and 73.3% versus 60.0% in the HZBio1 and placebo cohorts, respectively. HZBio1 exposure increased in a greater than dose-proportional manner following single-dose administration across the 3- to 12-mg range. Plasma uric acid levels decreased following a single dose of HZBio1 and reached the nadir at 144-192 h. The reduction in uric acid concentration was most pronounced in the 9- to 12 mg HZBio1 cohorts. HZBio1 administration elicited low-titer anti-PEG (IgG, IgM) antibodies, whereas antidrug antibodies were rarely detected, and no subjects developed neutralizing antibodies.</p><p><strong>Conclusion: </strong>HZBio1 at doses of 3-12 mg was well tolerated in healthy subjects, had an acceptable pharmacokinetics profile, and promising urate-lowering effect.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04765995.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149035849","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":"Efficacy and Safety of EG12014 (Biosimilar Trastuzumab) Compared to Reference Trastuzumab in HER2-Positive Early Breast Cancer: A Phase III Randomized Study.","authors":"Chiun-Sheng Huang, Giorgi Dzagnidze, Barbara Grohmann-Izay, Lee-Cheng Liu, Néstor Llinás-Quintero, Ae-Ning Lin, Anand K Mishra, Denys Pominchuk, Aliaksandr Prokharau, Bernardo L Rapoport, Vladimir Semiglazov, Ling-Ming Tseng, Eduardo Y Ruiz, Sibylle Loibl","doi":"10.1007/s12325-026-03781-3","DOIUrl":"https://doi.org/10.1007/s12325-026-03781-3","url":null,"abstract":"<p><strong>Introduction: </strong>Trastuzumab biosimilar EG12014 (Herwenda^®; EirGenix/Sandoz) was approved by the European Medicines Agency (EMA) in 2023. We aim to demonstrate equivalent efficacy, and to compare safety, immunogenicity, and pharmacokinetic (PK) profiles, of EG12014 and reference trastuzumab (ref-TRA) in early breast cancer (EBC).</p><p><strong>Methods: </strong>This Phase III, randomized, multicenter, double-blind study included adult patients with EBC. In the neoadjuvant phase, patients received epirubicin and cyclophosphamide for four cycles, then were randomized (1:1) to four cycles of EG12014 or ref-TRA (loading/maintenance dose: 8/6 mg/kg) with paclitaxel. Following surgery, patients continued adjuvant EG12014, or were rerandomized (1:1) from ref-TRA to ref-TRA or EG12014. Patients completed 12 months of treatment. The primary endpoint was centrally-assessed pathological complete response (pCR; defined as ypT0/is ypN0) at the time of surgery. Additional efficacy, safety, immunogenicity, and PK endpoints were evaluated.</p><p><strong>Results: </strong>In the neoadjuvant phase, 405 and 402 patients were randomized to EG12014 and ref-TRA, respectively. In the adjuvant phase, 386 patients continued EG12014, 188 continued ref-TRA, and 188 switched from ref-TRA to EG12014. The primary objective, to demonstrate equivalent efficacy between EG12014 and ref-TRA, was achieved: the risk difference between treatment arms in pCR rate was - 0.004 (95% CI - 0.072 to 0.065), with the 95% CI entirely within the predefined equivalence margin of - 0.13 to 0.13 (EMA requirement). Equivalence was also demonstrated regarding the risk ratio, with a relative risk of 0.992 (90% CI 0.880-1.118) and the 90% CI completely within the predefined equivalence margin of 0.741-1.349 (US Food and Drug Administration requirement). Secondary efficacy endpoints, including overall response prior to surgery and overall survival, were also comparable between treatments. Safety, immunogenicity and PK profiles were comparable between treatments and were not impacted by switching.</p><p><strong>Conclusion: </strong>Trastuzumab biosimilar EG12014 and ref-TRA have equivalent efficacy, and comparable safety, immunogenicity, and PK profiles, in patients with EBC. Clinical trial registration NCT03433313; EudraCT Number 2017-003973-33.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149035914","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":"Comparative Effectiveness of Once-Weekly Semaglutide Versus Sulfonylureas, DPP4 Inhibitors, and Thiazolidinediones in Patients with Type 2 Diabetes and Chronic Kidney Disease.","authors":"James Amamoo, Yan Wang, Hongjiao Liu, Manasvi Sundar, Yan Song, Lin Xie, Sherif Mehanna, Josh Noone, Caroline Swift, Matthew R Weir","doi":"10.1007/s12325-026-03744-8","DOIUrl":"https://doi.org/10.1007/s12325-026-03744-8","url":null,"abstract":"<p><strong>Introduction: </strong>Once-weekly (OW) semaglutide has shown renal benefits in clinical trials for patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). This study compared clinical outcomes between OW semaglutide and selected oral glucose-lowering medications in real-world settings.</p><p><strong>Methods: </strong>Adults with T2D and CKD were identified from the Optum's de-identified Clinformatics^® Data Mart Database (01/01/2016-06/30/2023). Two samples were included: patients ineligible for or with suboptimal response to sodium-glucose cotransporter type 2 inhibitor (SGLT2i) (sample 1) and patients meeting the eligibility criteria for renal outcome analysis [sample 2; no estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m² during the 6 months before the index date and no evidence of dialysis, kidney transplantation, or kidney failure at baseline]. In sample 1, glycated hemoglobin (HbA1c), eGFR, body weight, and systolic blood pressure (SBP) were described and compared using linear mixed-effects models. In sample 2, composite renal outcome consisting of dialysis, kidney transplantation, sustained eGFR < 15 mL/min/1.73 m², or all-cause death, was evaluated and compared using Cox proportional hazard model.</p><p><strong>Results: </strong>Using model-based estimates at 12 months, OW semaglutide was associated with greater reductions in HbA1c (- 0.54%), body weight (- 6.69 kg), SBP (- 3.63 mmHg), and greater improvement in eGFR (2.06 mL/min/1.73 m²) compared to controls (all P < 0.05), with effects largely sustained during follow-up. Moreover, OW semaglutide was associated with a significantly lower risk of the composite renal outcome (adjusted hazard ratio = 0.78, 95% confidence interval: 0.62, 0.99).</p><p><strong>Conclusions: </strong>In real-world practice, OW semaglutide has been associated with sustained benefits in glycemic control, eGFR improvement, weight loss, and SBP reduction over selected oral glucose-lowering medications among patients with T2D and CKD who were ineligible for or with suboptimal response to SGLT2i. It has also been associated with a reduced risk of the composite renal outcome in patients meeting the eligibility criteria for the renal outcome analysis.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149029695","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":"Using Pre-Study Patient Interviews to Refine Electronic Patient-Reported Outcomes in Clinical Research of Ustekinumab Induction for Ulcerative Colitis (SIRIUS Study).","authors":"Katsumasa Nagano, Shun Emoto, Yukiko Nishimura, Mizue Sugi, Mizuki Amano, Shinichi Yoshigoe, Kunihiro Nishimura, Katsuyoshi Matsuoka","doi":"10.1007/s12325-026-03770-6","DOIUrl":"https://doi.org/10.1007/s12325-026-03770-6","url":null,"abstract":"<p><strong>Introduction: </strong>Daily electronic patient-reported outcome (ePRO) collection enables assessment of symptom fluctuations in ulcerative colitis (UC); however, high-frequency data entry can impose operational and psychological burdens that may affect data quality and feasibility. Incorporating patient perspectives during study preparation may help mitigate these challenges. Structured pre-study patient interviews were conducted to inform potential refinements to ePRO questionnaire design and operational procedures in the SIRIUS study, a prospective observational study in Japanese patients with UC, and to explore their potential impact on study feasibility, including retention and ePRO completion.</p><p><strong>Methods: </strong>Before initiating the SIRIUS study, pre-study patient interviews were conducted by an operationally independent external organization. The pre-study interviews assessed the usability and acceptability of the planned ePRO application and materials. Patient feedback was thematically analyzed to inform potential refinements to questionnaire wording, manuals, onboarding support, troubleshooting procedures, and compensation. These refinements were considered for inclusion in the SIRIUS study.</p><p><strong>Results: </strong>Twenty-six adults with UC participated in interviews. Patient input identified key usability and burden-related issues and led to several modifications: questionnaire items were revised to reduce the burden associated with recalling pre-onset bowel habits for stool frequency, and the overall condition scale was adjusted to allow for both improvement and worsening. Manuals were simplified and tailored to varying levels of technological literacy, onboarding included in-person support, and a dedicated troubleshooting hotline was established. Compensation was set at an appropriate level. A total of 135/136 enrolled patients (99.3%) completed the ustekinumab induction period in the SIRIUS study, and the daily ePRO completion rate was 94.2%.</p><p><strong>Conclusions: </strong>Structured patient input prior to study initiation identified modifiable barriers to high-frequency ePRO collection and informed concrete refinements to study design and operations. While causality cannot be inferred from this uncontrolled case study, high retention and ePRO completion rates were observed, suggesting that patient-informed refinements may have supported participant understanding and adherence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04963725 (registered July 8, 2021). https://clinicaltrials.gov/study/NCT04963725?cond=Ulcerative%20Colitis&term=daily&intr=Ustekinumab&rank=2.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015270","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":"Correction: Sepiapterin: A Distinct, Dual Mechanism of Action that Leads to Potential Treatment Benefits Across the Spectrum of Phenylketonuria Disease Severities.","authors":"Melissa Lah, Jessica Kopesky, Erika Vucko","doi":"10.1007/s12325-026-03774-2","DOIUrl":"https://doi.org/10.1007/s12325-026-03774-2","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015268","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":"Association Between Health-Related Quality of Life In Patients with Colorectal Cancer and Their Informal Caregivers.","authors":"Peng Zhang, Feifei Chen, Yuheng Jia, Lixin Hong, Zhigang Wang, Jianli Zhao, Yi Yang, Shan Jiang","doi":"10.1007/s12325-026-03789-9","DOIUrl":"https://doi.org/10.1007/s12325-026-03789-9","url":null,"abstract":"<p><strong>Introduction: </strong>Cancer care increasingly relies on informal caregivers, and patients and caregivers are often managed and studied as patient-caregiver dyads. However, evidence on the association between health-related quality of life (HRQoL) in colorectal cancer patients and their caregivers remains limited. This study aimed to examine the association between patients' and caregivers' HRQoL and identify factors associated with caregivers' HRQoL.</p><p><strong>Methods: </strong>A multicenter cross-sectional study was conducted involving 119 colorectal cancer patient-caregiver dyads. HRQoL for both patients and caregivers was assessed using the EQ-5D-5L questionnaire. Descriptive analyses were performed, followed by Tobit regression to evaluate the association between patient and caregiver EQ-5D-5L utility scores and by logistic regression to examine the associations between patients' EQ-5D-5L utility scores and caregivers' HRQoL dimensions.</p><p><strong>Results: </strong>The mean EQ-5D-5L utility score was 0.936 (SD 0.060) for caregivers and 0.747 (SD 0.263) for patients. Pain/discomfort (44.54%) and anxiety/depression (43.70%) were the most commonly reported problems among caregivers. Patients' HRQoL was positively associated with caregivers' HRQoL (p = 0.045). Patients' duration since diagnosis and clinical stage, as well as caregivers' educational level, were significantly associated with caregivers' HRQoL. Patients' EQ-5D-5L utility score was also significantly associated with caregivers' reporting of anxiety/depression (OR = 0.112, p = 0.026).</p><p><strong>Conclusions: </strong>HRQoL in colorectal cancer patients was significantly associated with that of their caregivers, underscoring the importance of considering both members of the patient-caregiver dyad in clinical care. These findings support routine caregiver assessment and suggest that psychologically informed supportive care may be considered in colorectal cancer nursing care and survivorship planning.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015242","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":"Review of the Impact of Weight Loss and Body Mass Index in Clinical Trials of Nintedanib in Interstitial Lung Disease.","authors":"Michael Kreuter, R Matthew Kottmann, Fengming Luo, Carl Coeck, Madhu Kanakapura, Christina Schlecker, Ivana Ritter, Tomohiro Handa","doi":"10.1007/s12325-026-03785-z","DOIUrl":"https://doi.org/10.1007/s12325-026-03785-z","url":null,"abstract":"<p><strong>Introduction: </strong>Weight loss and malnutrition are poor prognostic factors in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). In this review, the effect of weight loss and body mass index (BMI) on the decline in forced vital capacity (FVC) was assessed using published secondary analyses of the placebo arms of clinical trials of nintedanib in IPF and PPF, as well as previously unpublished analyses of the INPULSIS trials in IPF.</p><p><strong>Methods: </strong>Published secondary analyses of placebo arms from clinical trials of nintedanib in IPF and PPF were reviewed. In addition, previously unpublished analyses of pooled INPULSIS trial data in IPF were conducted to evaluate the relationship between baseline BMI, weight loss, and FVC decline.</p><p><strong>Results: </strong>In published analyses, both low BMI at baseline and weight loss during treatment were associated with greater decline in FVC. New analyses of INPULSIS data indicated that the effect of weight loss on FVC decline was most pronounced in patients with lower BMI (< 25 kg/m²) at baseline. In those with mid-range BMI (25 to < 30 kg/m²), patients with weight loss > 5% also had a greater decline in FVC than those who lost ≤ 5% body weight. An adverse effect of weight loss was not observed in patients with high baseline BMI (≥ 30 kg/m²). While gastrointestinal events and weight loss are recognised side effects for nintedanib, patients treated with nintedanib had lower FVC decline than those given placebo in all subgroups, regardless of weight loss or baseline BMI.</p><p><strong>Conclusion: </strong>Increased attention to nutrition and management of gastrointestinal side effects to help patients adhere to treatment can improve outcome of treatment for IPF and PPF.</p><p><strong>Clinical trial registrations: </strong>ClinicalTrials.gov identifier: NCT02999178 (INBUILD), registered December 19, 2016.</p><p><strong>Clinicaltrials: </strong>gov identifiers: NCT01335464 and NCT01335477 (INPULSIS-1 and INPULSIS-2), both registered April 13, 2011.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015281","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":"Correction to: Uncontrolled Hypertension Prevalence, Characteristic Profiles, and Risk of Cardiorenal and Metabolic Outcomes: Insights from the EnligHTN Study.","authors":"Terry McCormack, Naomi R Ben Dor, Tom Norris, Alexia Giannoula, Esteban Coto, Kirsty M Rhodes, Stefan Franzén, Carmen Suárez Fernández, Joachim Weil, Jesper N Bech, Vivek Bhalla","doi":"10.1007/s12325-026-03795-x","DOIUrl":"https://doi.org/10.1007/s12325-026-03795-x","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015320","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}