Advances in Therapy最新文献

{"title":"Body Mass Index Progression, Development of Complications and Healthcare Costs Over 8 Years in UK Individuals Living With Overweight/Obesity.","authors":"Luca Busetto, Silvia Capucci, João D da Rocha Fernandes, Sara Holloway, Abd A Tahrani, Andrew Thompson, Jonathan Pearson-Stuttard","doi":"10.1007/s12325-025-03285-6","DOIUrl":"https://doi.org/10.1007/s12325-025-03285-6","url":null,"abstract":"<p><strong>Introduction: </strong>A detailed understanding of the risk factors for and impacts of body mass index (BMI) progression in people living with obesity is vitally needed. In this retrospective observational study, we examined the relationships between BMI progression, obesity-related complications (ORCs) and healthcare costs in individuals living with overweight or obesity in the UK.</p><p><strong>Methods: </strong>Data were from the Discover database of linked primary and secondary care records from 2.7 million individuals in North West London, UK. Included individuals were ≥ 18 years old, had a BMI of ≥ 25.0 kg/m² at index (date of first eligible BMI measurement during the study period: 1 January 2007 to 31 December 2019) and had no evidence of intentional weight loss. We examined BMI progression (increase) of ≥ 5% and ≥ 10% over 8 years in demographic and ORC subgroups, and compared ORCs and costs between groups with and without BMI progression.</p><p><strong>Results: </strong>In total, 290,051 individuals were included, of whom 31.4% experienced BMI progression of ≥ 5% during follow-up, with most progression occurring from year 1 to year 3. Proportions of individuals with ≥ 5% BMI progression were highest in the following subgroups: 18-29 years (45.8%), 30-39 years (39.2%), polycystic ovary syndrome (41.4%), asthma (34.5%), depression (33.9%) and women (33.9%). Total annual healthcare costs per person per year were £1000 for those with no BMI progression, £1143 for those with 5 to < 10% progression and £1251 for those with ≥ 10% progression. Groups with progression were more likely to develop ≥ 3 ORCs than those without.</p><p><strong>Conclusion: </strong>Younger adults, women and people with specific ORCs were most likely to experience BMI progression, which was associated with increased health and economic burden. Targeting high-risk subgroups with interventions to prevent weight gain could limit the clinical and economic impacts of obesity.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726458","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 Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT).","authors":"Hubert Marotte, Alain Cantagrel, Fabienne Coury, Thierry Schaeverbeke, Maryse Assing, Meriem Kessouri, Yves Brault, Bruno Fautrel","doi":"10.1007/s12325-025-03304-6","DOIUrl":"https://doi.org/10.1007/s12325-025-03304-6","url":null,"abstract":"<p><strong>Introduction: </strong>ReFLECT was a French multicenter, observational cohort study evaluating the effectiveness and safety of CT-P13, an infliximab (IFX) biosimilar, in a real-world setting. Here, we describe the results for patients with rheumatic disease.</p><p><strong>Methods: </strong>Eligible patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) were recruited and received intravenous CT-P13 induction and/or maintenance therapy. Patients were either naive to IFX (IFX-naive) or had been previously treated with IFX originator or another IFX biosimilar (IFX-switched). CT-P13 persistence (primary objective) was measured as a time-dependent variable during a 2-year follow-up period. Safety was also assessed.</p><p><strong>Results: </strong>The patient population comprised 142 patients with RA (IFX-naive: n = 70; IFX-switched: n = 69; other [i.e., previously received IFX, but received another treatment before switching to CT-P13]: n = 3); 411 patients with AS (IFX-naive: n = 189; IFX-switched; n = 201; other: n = 21); and 96 patients with PsA (IFX-naive: n = 44; IFX-switched: n = 47; other: n = 5). After 2 years of follow-up, CT-P13 persistence rates were 49.6% (95% confidence interval [CI] 40.4-60.8%), 62.7% (95% CI 56.6-69.5%), and 73.0% (95% CI 62.7-85.1%) in patients with RA, AS, and PsA, respectively. CT-P13 persistence was greater for IFX-switched than IFX-naive groups in patients with RA (65.4% [95% CI 52.8-81.0%] vs. 33.3% [22.7-49.1%]) and AS (66.5% [95% CI 58.3-76.0%] vs. 56.6% [47.6-67.4%]) and was similar between IFX-switched and IFX-naive groups in patients with PsA (75.9% [95% CI 62.2-92.8%] vs. 72.0% [57.5-90.1%]). The main reason for CT-P13 discontinuation was loss of response (RA/AS/PsA) in both IFX-naive (38.6%/23.3%/22.7%) and IFX-switched 18.8%/18.4%/12.8%) groups. Among patients (RA, AS, and PsA), 52.1%, 57.9%, and 56.3%, respectively, reported ≥ 1 adverse event (AE), and 14.1%, 11.4%, and 10.4%, respectively, reported serious AEs.</p><p><strong>Conclusion: </strong>After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in > 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT02925338.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726462","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 Maintained up to 3 Years in Adults with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan.","authors":"Carlos de Castro, Richard J Kelly, Morag Griffin, Christopher J Patriquin, Brian Mulherin, Britta Höchsmann, Veena Selvaratnam, Raymond Siu Ming Wong, Peter Hillmen, Regina Horneff, Uchendu O Uchendu, Yiwei Zhang, Elena Surova, Johan Szamosi, Regis Peffault de Latour","doi":"10.1007/s12325-025-03310-8","DOIUrl":"https://doi.org/10.1007/s12325-025-03310-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pegcetacoplan, the first C3 and C3b inhibitor for paroxysmal nocturnal hemoglobinuria (PNH), demonstrated efficacy and safety in C5 inhibitor-experienced and -naive patients in the phase 3 studies PEGASUS (NCT03500549) and PRINCE (NCT04085601), respectively. This integrated analysis of PEGASUS, PRINCE, and their subsequent open-label extension study (NCT03531255) evaluated pegcetacoplan long-term efficacy and safety.</p><p><strong>Methods: </strong>Efficacy was assessed from pegcetacoplan initiation through 2.5 years (PRINCE) and 3 years (PEGASUS) by measuring hemoglobin, lactate dehydrogenase (LDH), absolute reticulocyte count (ARC), indirect bilirubin, and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores. Transfusion avoidance and safety were assessed during pegcetacoplan monotherapy. Of 133 patients in PRINCE and PEGASUS, 114 enrolled in the extension. Most patients (PRINCE, 81.1%; PEGASUS, 75.0%) were transfusion dependent at trial entry and baseline hemoglobin was below normal.</p><p><strong>Results: </strong>Pegcetacoplan markedly and rapidly (within 4 weeks) improved all efficacy measures, which stabilized close to (hemoglobin, FACIT-Fatigue) or within (LDH, ARC, indirect bilirubin) normal range for up to 3 years; annual transfusion avoidance rates were 79.5-86.4% in PRINCE and 71.2-79.2% in PEGASUS. No new safety concerns were identified over 3 years. Serious adverse events were reported in 73 (55.3%) patients, deemed pegcetacoplan related in 6 (4.5%) patients. Most injection site reactions were mild, and their incidence decreased over time. Five (3.8%) deaths occurred (none deemed pegcetacoplan related); 37 (28.0%) patients experienced clinically significant and laboratory-confirmed breakthrough hemolysis; 4 thrombotic events occurred in 3 (2.3%) patients; no meningitis cases were reported.</p><p><strong>Conclusion: </strong>Pegcetacoplan efficacy and safety was sustained for up to 3 years in patients with PNH, with or without prior C5 inhibitor treatment, verifying the long-term favorable clinical profile of this proximal complement inhibitor.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03500549 (PEGASUS), NCT04085601 (PRINCE), and NCT03531255 (307 OLE).</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726459","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 Bioequivalence, Safety, and Immunogenicity of DMB-3115, an Ustekinumab Biosimilar, and EU- and US-Stelara in Healthy Adult Participants: A Randomized, Double-Blind, Single-Dose Study.","authors":"Jun Morita, Rainard Fuhr, Thomas Koernicke, Naoki Cho, Thin Thin Mencarini, Hideki Fushimi","doi":"10.1007/s12325-025-03290-9","DOIUrl":"https://doi.org/10.1007/s12325-025-03290-9","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the pharmacokinetic bioequivalence between DMB-3115 and ustekinumab (EU-Stelara or US-Stelara) as well as the safety and immunogenicity of these drugs in healthy adult participants.</p><p><strong>Methods: </strong>This was a randomized, double-blind, three-arm parallel-group study. Healthy participants aged 18-55 years were randomly assigned in a 1:1:1 ratio to receive a single subcutaneous injection (45 mg) of either DMB-3115, EU-Stelara, or US-Stelara. Participants were stratified into two body weight groups (< 80 vs. ≥ 80 kg). Participants were followed for 16 weeks. The primary pharmacokinetic (PK) endpoints were area under the concentration-time curve from time zero to infinity (AUC_inf), AUC from time zero to the time of the last quantifiable concentration (AUC_last), and maximum serum concentration (C_max). Immunogenicity was tested using antidrug antibody (ADA) assays.</p><p><strong>Results: </strong>A total of 296 participants (n = 99 in the DMB-3115 group, n = 99 in the EU-Stelara group, and n = 98 in the US-Stelara group) received the study drug and were included in the safety analysis. Of these, one participant in the DMB-3115 group had no valid PK data and was excluded from the PK analysis. The 95% confidence intervals (CI) for the ratios of geometric least squares means (DMB-3115/EU-Stelara and DMB-3115/US-Stelara) of the primary PK endpoints (AUC_inf, AUC_last, and C_max) were within the prespecified bioequivalence range of 80-125%. Originally this study was designed for the comparison of EU and US Stelara with two formulations of DMB-3115. To avoid multiplicity, a 95% CI was chosen. After that, only one formulation was selected. However, overall design was not changed. Using a 95% CI provided a more stringent level for the bioequivalence evaluation and was acceptable for European Medical Agency and US Food and Drug Administration. The proportions of participants reporting any treatment-emergent adverse event (TEAE) were similar among the three groups. The most common TEAEs were headache, nasopharyngitis, back pain, diarrhea, and oropharyngeal pain. Most TEAEs were mild or moderate in severity, and no TEAEs led to study discontinuation. The incidences of participants with post-dose ADAs and neutralizing antibodies in DMB-3115 tended to be lower among the groups.</p><p><strong>Conclusion: </strong>DMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and immunogenicity profile after a single subcutaneous injection in parallel groups of healthy adult participants.</p><p><strong>Clinical trial registration: </strong>European Union Clinical Trials Register: number 2018-004033-33; date of registration 17 October 2018.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726461","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, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1β Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study.","authors":"Hongzhong Liu, Yuping Yuan, Wei Tian, Tianhong Luo, Qian Xu, Xiaoyan Zhu, Rui Chen","doi":"10.1007/s12325-025-03279-4","DOIUrl":"https://doi.org/10.1007/s12325-025-03279-4","url":null,"abstract":"<p><strong>Introduction: </strong>The pro-inflammatory cytokine interleukin-1β (IL-1β) is an important therapeutic target for treating autoinflammatory diseases. Firsekibart is a high affinity, fully human monoclonal antibody targeting IL-1β, which selectively binds to and neutralizes IL-1β. Here, we investigated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of firsekibart administered as a single-dose, subcutaneous injection in healthy Chinese participants.</p><p><strong>Methods: </strong>This first-in-human, double-blind, phase 1 trial of firsekibart included healthy Chinese participants (≥ 18 to ≤ 50 years old) divided into five dose-escalated groups: 0.3, 1.0, 2.0, 4.0, and 6.0 mg/kg. In each group, participants were randomized in a 3:1 ratio to receive firsekibart or placebo. The primary endpoint was the safety and tolerability, primarily assessed by monitoring adverse events (AEs). Secondary endpoints included the evaluation of immunogenicity, PK, and PD.</p><p><strong>Results: </strong>A total of 40 participants were enrolled in the study, receiving either firsekibart (n = 30) or placebo (n = 10); all participants completed the study. Treatment-emergent AEs (TEAEs) occurred in 86.7% of participants receiving firsekibart and 90.0% receiving placebo. There were no reports of grade ≥ 3 TEAEs, serious AEs, or TEAEs leading to study withdrawal or death. The incidence of TEAEs in the firsekibart group was not dose dependent. No PK/PD changes or safety events related to immunogenicity were observed. Serum concentration of firsekibart at each sampling timepoint increased proportionally with dose (0.3-6.0 mg/kg). The area under the concentration-time curve from zero to infinity (AUC_0-∞) showed a linear relationship with the dose of firsekibart. Overall, there were no treatment or dose-related trends observed in PD parameters, and no significant correlation was found between PK parameters and total serum IL-1β levels.</p><p><strong>Conclusion: </strong>Firsekibart had an acceptable safety profile and was well tolerated in healthy Chinese participants across all investigated doses, supporting future investigation of firsekibart as a potential treatment option for inflammatory diseases.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04337437 (retrospectively registered on April 7, 2020).</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706001","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":"Evaluation of XSB-001 (Ranibizumab Biosimilar) Physicochemical and Biological Stability in Prepared Syringes for Intravitreal Injection.","authors":"Robert Björnestedt, Sean Waters, Aušrinė Paišytė, Fabricio Furlan, Christian Wanner","doi":"10.1007/s12325-025-03319-z","DOIUrl":"https://doi.org/10.1007/s12325-025-03319-z","url":null,"abstract":"<p><strong>Introduction: </strong>Vascular endothelial growth factor A (VEGF-A) is a key driver of neovascularization and vascular permeability in retinal diseases such as neovascular age-related macular degeneration and diabetic macular edema. XSB-001 (Ximluci^®), a ranibizumab biosimilar has demonstrated equivalent safety, efficacy, and biological activity to reference ranibizumab, supporting its use in these indications.</p><p><strong>Methods: </strong>This study evaluates the extended physicochemical and biological stability of XSB-001 under real-world handling conditions for 30 days. XSB-001 was stored at 5 ± 3 °C in vials and prepared into two syringe types. Samples were maintained under monitored conditions for 30 days, with a subset exposed to room temperature, humidity and indoor lighting or protected from light for 48 h.</p><p><strong>Results: </strong>Across all test conditions, XSB-001 maintained expected liquid physical state, clarity, and color within specification limits, besides charge variants. High monomer purity (99.6%), high molecular weight species (0.4%) and low molecular weight species (< 0.35%) were observed, satisfying all required criteria. Size exclusion-high-performance liquid chromatography (SE-HPLC) analysis confirmed monomer content at 99.6%, surpassing the ≥ 99.0% requirement. Reverse-phase high-performance liquid chromatography (RP-HPLC) showed consistent main peak purity of 97.3%, exceeding the ≥ 97.0% criterion. Strong cation exchange high-performance liquid chromatography (SCX-HPLC) recorded main peak values between 96.5 and 96.6%, meeting the ≥ 96.5% threshold. Acidic (1.7%) and basic species (1.6-1.7%) were consistently within specification limits (≤ 2.5%). Sub-visible particulate analysis indicated particle counts within acceptable limits. Protein concentration was stable across storage conditions, ranging from 9.9 to 10.4 mg/ml.</p><p><strong>Conclusion: </strong>These findings support the extended stability of XBS-001 stored in unopened vials and subsequently prepared syringes (and independent of syringe type), optimizing patient care and treatment management efficiency.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706000","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":"Key Learnings from Clinical Research and Real-World Evidence on Asfotase Alfa Effectiveness in Hypophosphatasia: 10 Years Post-Approval.","authors":"Aliya A Khan, Eric T Rush, Craig Wakeford, Daniel Staub, Maria Luisa Brandi","doi":"10.1007/s12325-025-03309-1","DOIUrl":"https://doi.org/10.1007/s12325-025-03309-1","url":null,"abstract":"<p><p>First reported in 1948, hypophosphatasia (HPP) is a rare systemic disease caused by deficient activity of tissue-nonspecific alkaline phosphatase (ALP) enzyme. Patients with HPP experience skeletal and dental manifestations such as rickets/osteomalacia, fractures, pseudofractures, and premature tooth loss, as well as nonskeletal symptoms such as pain and muscle weakness, which result in impaired mobility and poor quality of life. For decades, no specific treatment was available for HPP and the disease was often fatal in infants. Asfotase alfa is a tissue-nonspecific ALP enzyme replacement therapy (ERT) that received first regulatory approval in 2015 in Japan, the European Union, and the United States for the treatment of HPP. This review draws from clinical trial findings, real-world evidence, and relevant case study data demonstrating the safety and effectiveness of asfotase alfa in improving a broad range of skeletal and nonskeletal manifestations in both pediatric and adult patients. Asfotase alfa has been shown to be well tolerated, with manageable side effects. Further, asfotase alfa treatment has improved survival and respiratory outcomes, skeletal outcomes, physical and motor function, pain, disability, and quality of life in patients with HPP. This evidence-based review aims to generate a foundation for improving the understanding of disease pathophysiology, hence enhancing the effectiveness of ERT in patients with HPP.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726460","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 Prophylaxis Outcomes with rIX-FP and rFIXFc for Males with Hemophilia B: Pooled Analysis of Medical Chart Data from Germany and Italy.","authors":"Johannes Oldenburg, Martin Olivieri, Songkai Yan, Ying Yang, Radovan Tomic, Xiang Zhang, Douglass Drelich, Natalie Jakobs, Mariasanta Napolitano","doi":"10.1007/s12325-025-03303-7","DOIUrl":"https://doi.org/10.1007/s12325-025-03303-7","url":null,"abstract":"<p><strong>Introduction: </strong>The current standard of care for people with severe hemophilia B is prophylaxis with factor IX (FIX) products. This analysis assessed the effectiveness of prophylaxis for people with hemophilia B (PwHB) receiving rIX-FP or rFIXFc prophylaxis in Germany and Italy.</p><p><strong>Methods: </strong>A retrospective, de-identified chart review included PwHB ≥ 12 years with severe/moderate hemophilia B from Germany or Italy, receiving prophylaxis with rIX-FP or rFIXFc for ≥ 12 months. The primary outcome was FIX consumption; the secondary outcomes were dosing interval, annualized bleeding rate (ABR), annualized spontaneous bleeding rate (AsBR), and annualized joint bleeding rate (AjBR). These outcomes were also explored in PwHB with pre- and post-rIX-FP switch data.</p><p><strong>Results: </strong>Of 194 PwHB, 107 and 87 received rIX-FP and rFIXFc prophylaxis, respectively. The mean FIX consumption of rIX-FP was significantly lower compared to rFIXFc (42.4 vs. 65.2 IU/kg/week, p = 0.0001), with mean dosing intervals of 9.5 days (rIX-FP) and 7.9 days (rFIXFc). The mean bleeding rates for rIX-FP versus rFIXFc, respectively, were: ABR 0.7 versus 1.1 (p = 0.6704), AsBR 0.1 versus 0.3 (p = 0.3427), and AjBR 0.3 versus 0.4 (p = 0.5296). Subgroup analyses for PwHB with severe and moderate hemophilia B separately showed similar numerical patterns when comparing these outcomes. In the 18 patients with switch data, a significant reduction in FIX consumption was observed (median 51.7 to 33.3 IU/kg/week, p = 0.0069), and the mean dosing interval was extended (7.2-9.5 days). The ABR (median 1.6-0.0, p = 0.0172; n = 18) and AjBR (median 0.6-0.0, p = 0.0200; n = 14) decreased significantly, while the AsBR decreased but not significantly (median 0.2-0.0, p = 0.1460; n = 14).</p><p><strong>Conclusion: </strong>rIX-FP prophylaxis was associated with reduced FIX consumption versus rFIXFc and offered equally effective or potentially improved bleed protection. Additionally, PwHB who switched to rIX-FP achieved significant decreases in FIX consumption, ABR, and AjBR compared with their prior FIX product.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144688595","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":"Evaluating the Compositional Quality of Probiotics Containing Bacillus clausii in India.","authors":"Dhanasekhar Kesavelu, Sridhar Ganpathy, Pramod Jog, Bhaswati Acharya, Vivek Saxena, Nivedita Telang, Nilesh Gaikwad","doi":"10.1007/s12325-025-03289-2","DOIUrl":"https://doi.org/10.1007/s12325-025-03289-2","url":null,"abstract":"<p><strong>Introduction: </strong>The quality of probiotics is crucial for their effectiveness and safety. Many studies have found discrepancies between the claimed and the actual content of microorganisms in probiotics. However, only few studies have assessed the quality of these products in India. This study aimed to evaluate the quality of various probiotics containing Bacillus clausii in India.</p><p><strong>Methods: </strong>Eleven commercially available probiotics containing Bacillus clausii were selected: Enterogermina® (reference product), Bifilac clausii™, Entromax®, Progermina™, Entroflora™, Novogermina™, Tufpro™, Gutgermina®, Eco-All™, Entero clausi™, and Medogermina®. Suspensions were cultured and subcultured in selective media to identify Bacillus clausii colonies. Purity, viable spore load, and antibiotic resistance were assessed.</p><p><strong>Results: </strong>The assessed parameters varied significantly among the probiotics. Enterogermina® was contamination-free, with a spore count of 2 billion/5 mL and showed resistance to all tested antibiotics. Progermina™ and Eco-all™ had higher spore counts than claimed but were contaminated with Bacillus cereus. Contaminants were found in all products except Enterogermina® and Medogermina®. Most of the products showed no antibiotic resistance.</p><p><strong>Conclusion: </strong>The study revealed significant differences in the quality of probiotics on the Indian market, highlighting concerns about their potency and safety. Stringent quality control is necessary to ensure consumer safety and help healthcare professionals make informed decisions.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144688592","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: Effectiveness and Safety of Tezepelumab in a Diverse Population of US Patients with Severe Asthma: Initial Results of the PASSAGE Study.","authors":"Njira L Lugogo, Praveen Akuthota, Kaharu Sumino, Sameer K Mathur, Autumn F Burnette, Andrew W Lindsley, Jean-Pierre Llanos, Claudio Marchese, Christopher S Ambrose, Benjamin Emmanuel","doi":"10.1007/s12325-025-03316-2","DOIUrl":"https://doi.org/10.1007/s12325-025-03316-2","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144688591","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}