Advances in Therapy最新文献

{"title":"Mobility and Quality of Life in Adults with Paediatric-Onset Hypophosphatasia Treated with Asfotase Alfa: Results from UK Managed Access Agreement","authors":"Katie E. Moss,&nbsp;Richard Keen,&nbsp;Shona Fang,&nbsp;Alexandros Zygouras,&nbsp;Muhammad K. Javaid,&nbsp;Tarekegn Geberhiwot,&nbsp;Kenneth E. S. Poole,&nbsp;Peter Selby,&nbsp;Jennifer S. Walsh,&nbsp;Judith S. Bubbear","doi":"10.1007/s12325-025-03168-w","DOIUrl":"10.1007/s12325-025-03168-w","url":null,"abstract":"<div><h3>Introduction</h3><p>Hypophosphatasia (HPP) is a rare disease caused by deficient tissue–non-specific alkaline phosphatase (ALP) activity. Asfotase alfa is a tissue–non-specific ALP enzyme-replacement therapy which was reimbursed in the UK under a Managed Access Agreement (MAA). This analysis assessed safety and effectiveness of asfotase alfa in adults with HPP.</p><h3>Methods</h3><p>This prospective, observational data collection included adults with paediatric-onset HPP enroled in the MAA and treated with asfotase alfa for ≥ 6 months to 5 years. Assessments included mobility, pain, and health-related quality of life (HRQoL), each reported at regular intervals through year 3. Analgesic use, fractures, and events of interest (EOIs) were each reported continuously throughout follow-up.</p><h3>Results</h3><p>Of 28 enroled treated adults, 24 were assessed for effectiveness. Distance walked in the 6-Minute Walk Test was median (min, max) 172.5 m (0.0, 380.0; <i>n</i> = 24) at baseline and improved by 157.3 m (− 171.0, 479.5; <i>n</i> = 16) at month 6; results were sustained throughout follow-up. Median (min, max) Bleck score was 6.0 (2.0, 9.0; <i>n</i> = 24) at baseline and increased to 6.5 (5.0, 9.0; <i>n</i> = 10) at month 36. Median (min, max) aggregate Brief Pain Inventory Short Form severity score was 8.0 (4.3, 10.0; <i>n</i> = 24) at baseline and improved to 4.4 (1.0, 7.8; <i>n</i> = 10) at month 36. During follow-up, 8 participants (33.3%) decreased or discontinued opioid use throughout follow-up and 4 (16.7%) reported fractures. Median (min, max) EQ-5D-3L utility scores improved from 0.21 (− 0.26, 0.60; <i>n</i> = 24) at baseline by 0.15 (− 0.36, 0.91; <i>n</i> = 24) at month 6 and were similar throughout follow-up. Injection site reactions were the most common treatment-related EOI, reported in 17 participants (60.7%). Three participants reported treatment-related serious adverse events.</p><h3>Conclusion</h3><p>Asfotase alfa treatment improved mobility, physical function, pain, and HRQoL and was well tolerated. These data show the benefit of asfotase alfa in adults with paediatric-onset HPP.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2429 - 2444"},"PeriodicalIF":3.4,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03168-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143727379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pembrolizumab in Patients of Chinese Descent with Microsatellite Instability-high/Mismatch Repair Deficient Advanced Solid Tumors: KEYNOTE-158 Final Analysis","authors":"Xiaohua Wu,&nbsp;Yimin Mao,&nbsp;Nong Xu,&nbsp;Yuxian Bai,&nbsp;Dong Wang,&nbsp;Xiaojun Chen,&nbsp;Xianli Yin,&nbsp;Yanhong Deng,&nbsp;Jianwei Yang,&nbsp;Jieqing Zhang,&nbsp;Jie Tang,&nbsp;Yi Huang,&nbsp;Jiayi Li,&nbsp;Suxia Luo,&nbsp;Hong Zheng,&nbsp;Weidong Zhao,&nbsp;Miaomiao Xu,&nbsp;Nan Li,&nbsp;Yixiang Mao,&nbsp;Alexander Gozman,&nbsp;Jianming Xu","doi":"10.1007/s12325-025-03142-6","DOIUrl":"10.1007/s12325-025-03142-6","url":null,"abstract":"<div><h3>Introduction</h3><p>KEYNOTE-158 (NCT02628067) supported the US Food and Drug Administration approval of pembrolizumab for microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) advanced solid tumors. Incidence of MSI-H/dMMR tumors in patients of Chinese descent is similar to that of Western populations. Cohort L of KEYNOTE-158 evaluated pembrolizumab in patients of Chinese descent with previously treated MSI-H/dMMR tumors. We previously reported an objective response rate (ORR) of 70% in 20 patients from cohort L which supported the approval in China of pembrolizumab in patients with MSI-H/dMMR solid tumors. Here we present results of the final analysis for 30 patients with median follow-up of 18 months.</p><h3>Methods</h3><p>Eligible patients who had confirmed unresectable or metastatic MSI-H/dMMR tumors, and one or more prior lines of therapy, received 200 mg pembrolizumab Q3W (up to 35 cycles) until progression, toxicity, or withdrawal. Primary endpoint was ORR per RECIST 1.1 by central review. Secondary endpoints were duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.</p><h3>Results</h3><p>Thirty patients were enrolled; 7 (23%) were aged ≥ 65 years, and 20 (67%) were female. With median follow-up of 18 months, ORR was 66.7%. Median DOR was not reached (NR), with 12-month DOR rate of 85.9%. Median PFS was NR, with 18-month PFS rate of 63.0%. Median OS was NR, with 18-month OS rate of 78.8%. Treatment-related adverse events (AE) were reported in 22 (73%) patients. Grade 3–4 treatment-related AEs occurred in 7 (23%) patients. Immune-mediated AEs occurred in 11 (37%) patients of which 2 (7%) had grade 3 AEs. No grade ≥ 4 immune-mediated AEs occurred.</p><h3>Conclusion</h3><p>Pembrolizumab continues to provide clinically meaningful antitumor activity and durable responses with a manageable safety profile in patients of Chinese descent with MSI-H/dMMR advanced solid tumors. These results are consistent with those reported for patients in the global population and further support the use of pembrolizumab in patients of Chinese descent with MSI-H/dMMR tumors.</p><h3>Trial Registration Number</h3><p>NCT02628067.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2480 - 2489"},"PeriodicalIF":3.4,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690721","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":"Point of Care Nucleic Acid Testing for Influenza-Like Illness: A Cost–Consequence Analysis for High-Risk Patients in Primary Care in Germany","authors":"Johannes Pöhlmann,&nbsp;Anika Joecker,&nbsp;Tanja Wittki,&nbsp;Tray Brown,&nbsp;Richard F. Pollock,&nbsp;Jordan Chase","doi":"10.1007/s12325-025-03156-0","DOIUrl":"10.1007/s12325-025-03156-0","url":null,"abstract":"<div><h3>Introduction</h3><p>Influenza A/B virus, severe acute respiratory coronavirus 2 (SARS-CoV-2), and respiratory syncytial virus (RSV) cause similar symptoms, often referred to as influenza-like illness, but require different treatments which must be administered within a short timeframe after symptom onset. This necessitates rapid detection and accurate differentiation by primary care providers, ideally at point of care (POC). POC nucleic acid tests such as the multiplex, real-time polymerase chain reaction (PCR) Xpert^® Xpress CoV-2/Flu/RSV <i>plus</i> (Xpert Xpress) offer a faster, more accurate alternative compared to antigen testing, clinical judgement alone, or send-out PCR. This cost–consequence analysis evaluated Xpert Xpress versus conventional testing methods, from a German statutory health insurance (SHI) perspective.</p><h3>Methods</h3><p>A 1-year decision tree was developed to compare Xpert Xpress with antigen testing, send-out PCR, and empiric diagnosis, for influenza A/B virus, SARS-CoV-2, and RSV. The model accounted for diagnostic accuracy and projected the share of patients receiving results within guideline-recommended treatment windows. Data on test accuracy, treatment effects, and costs were sourced from literature and German databases. The main outcome was total cost to the SHI for the 2023/24 respiratory illness season.</p><h3>Results</h3><p>Xpert Xpress was associated with the highest number of net correct treatment courses (<i>n</i> = 443,600) versus empiric diagnosis (<i>n</i> = 239,250), antigen testing (<i>n</i> = 347,218), and send-out PCR (<i>n</i> = 280,527). Acquisition costs were highest for Xpert Xpress (EUR 38.4 million versus EUR 27.4 million for antigen testing and EUR 33.5 million for send-out PCR) but were offset by reduced hospitalization and intensive care costs. Overall, Xpert Xpress was associated with cost savings of EUR 1.97 million versus empiric diagnosis, EUR 10.1 million versus antigen testing, and EUR 20.8 million versus send-out PCR.</p><h3>Conclusions</h3><p>Using Xpert Xpress at POC combined fast turnaround with high diagnostic accuracy, thereby increasing correct treatment courses while reducing total costs for influenza, COVID-19, and RSV, offering substantial savings to the German SHI.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2385 - 2402"},"PeriodicalIF":3.4,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03156-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Evidence for Baricitinib in the Treatment of Rheumatoid Arthritis in Spain: A Systematic Literature Review","authors":"José Rosas,&nbsp;Joaquín Belzunegui,&nbsp;Blanca Hernández-Cruz,&nbsp;Itxaso Aguirregabiria,&nbsp;Sebastián Moyano,&nbsp;Amelia Cobo,&nbsp;Silvia Díaz-Cerezo","doi":"10.1007/s12325-025-03161-3","DOIUrl":"10.1007/s12325-025-03161-3","url":null,"abstract":"<div><h3>Introduction</h3><p>Baricitinib is a Janus kinase inhibitor approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) in adults who have responded inadequately, or are intolerant, to disease-modifying antirheumatic drugs (DMARDs). This systematic literature review was conducted to understand the use of baricitinib in RA in the real-world setting in Spain.</p><h3>Methods</h3><p>Embase and MEDLINE databases were systematically searched for publications (in English or Spanish) published between March 2017 and June 2023; Spanish data presented at national rheumatology congresses were also obtained, with a date limitation of 2021–2023.</p><h3>Results</h3><p>Nineteen eligible publications were identified (5 full papers, 14 conference abstracts), including more than 1000 patients who received baricitinib for RA in Spain. Most patients were older and female with long disease duration, and moderate-to-severe active disease. Studies included both biologic DMARD-experienced and DMARD-naïve patients, and most patients received baricitinib 4 mg/day. Baricitinib persistence ranged from 6 to 48 months, with ineffectiveness (primary or secondary) being the most frequently reported reason for discontinuation. Baricitinib was consistently shown to decrease disease activity, across all outcome measures (Disease Activity Score-28 for RA, the Simplified and Clinical Disease Activity Indexes, swollen and tender joint counts and patient-reported outcomes). Thirteen studies reported safety outcomes, with discontinuation rates due to adverse events ranging from 9.5 to 20%. Across these studies, adverse events of interest included eleven cases of herpes zoster, six serious infections, two major adverse cardiovascular events, and three malignant neoplasms.</p><h3>Conclusion</h3><p>These results suggest baricitinib is effective in the real-world setting in Spain, with a consistent safety profile, similar to findings reported in clinical studies and in real-world studies conducted in other countries.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2403 - 2428"},"PeriodicalIF":3.4,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03161-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials","authors":"Yuki Otani,&nbsp;Brian G. Feagan,&nbsp;Geert R. D’Haens,&nbsp;Rodrigo Escobar,&nbsp;Nathan J. Morris,&nbsp;Christopher D. Payne,&nbsp;Michelle Ugolini Lopes,&nbsp;Xin Zhang","doi":"10.1007/s12325-025-03158-y","DOIUrl":"10.1007/s12325-025-03158-y","url":null,"abstract":"<div><h3>Introduction</h3><p>Mirikizumab, a p19-directed antibody against interleukin-23 (IL-23), is administered by subcutaneous (SC) injection. Injection site pain (ISP) associated with citrate buffers may negatively affect patient adherence to SC-administered treatments. We assessed the bioequivalence and safety of the citrate-free (CF) and original formulations of mirikizumab.</p><h3>Methods</h3><p>The formulations were assessed in three phase 1, two-arm, randomized, single-dose, parallel design studies in healthy participants: study A (NCT04548219), study B (NCT05515601), and study C (NCT05644353). Participants were randomized 1:1 to either formulation, then further randomized to injection site locations of abdomen, arm, or thigh. The relative bioavailability (RBA) study A had a primary objective of assessing the RBA of a single 200 mg dose. Bioequivalence (BE) studies B and C had the primary objective of assessing the BE of a 200 and 300 mg dose, respectively. In all studies, the primary endpoints were <i>C</i>_max, AUC(0–∞), and AUC(0–<i>t</i>_last). The secondary objective was to assess safety and tolerability by treatment-emergent adverse events and serious adverse events. In study A, ISP was quantified prospectively using the 100-mm validated visual analogue scale (VAS) assessment form.</p><h3>Results</h3><p>The primary objective was met in all studies. The RBA study found no significant difference in exposure between the formulations. BE was demonstrated between CF and original mirikizumab in both BE studies, with the 90% confidence intervals of the ratios of geometric least squares means within the pre-specified equivalence limits of 0.80 and 1.25. The frequency of ISP and injection site reactions (ISRs) was lower for CF than original mirikizumab in all studies. Furthermore, a significant difference in mean VAS score was observed in study A.</p><h3>Conclusion</h3><p>Mirikizumab CF and original formulations were bioequivalent. The CF formulation was associated with less pain and fewer ISRs, with no other notable differences in safety profiles.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier NCT04548219, NCT05515601, NCT05644353.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2369 - 2384"},"PeriodicalIF":3.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03158-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143672893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Up-to-Date Description of the Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs) in Italy: Evidence from Real Clinical Practice","authors":"Valentina Perrone,&nbsp;Chiara Veronesi,&nbsp;Maria Ciappetta,&nbsp;Domenico Lucatelli,&nbsp;Andrea Cinti Luciani,&nbsp;Luca Degli Esposti","doi":"10.1007/s12325-025-03153-3","DOIUrl":"10.1007/s12325-025-03153-3","url":null,"abstract":"<div><h3>Introduction</h3><p>The prescription of non-steroidal anti-inflammatory drugs (NSAIDs) covered by the Italian National Health Service is limited to certain pathologies defined in the 2018 update of Note 66 of the Italian Medicines Agency (AIFA), meant to ensure appropriate use of NSAIDs. This analysis was conducted in real clinical practice to describe NSAID utilization from 2019 to 2022 with respect to Note 66 update.</p><h3>Methods</h3><p>For this real-world analysis, data were extracted from the administrative databases of healthcare institutions covering ~ 9.1 million citizens. From 2019 to 2022, all subjects with ≥ 1 NSAID prescription were identified. Demographic and clinical characteristics, the proportion of NSAID-treated patients over time, the most prescribed molecules, and drug consumption defined as daily dose (DDD) per 1000 inhabitants/day were recorded.</p><h3>Results</h3><p>The percentage NSAID-treated patients showed a slight increase over time (1.9–3.0%). The most prescribed active ingredients were diclofenac, ketoprofen, nimesulide, etoricoxib, and ibuprofen. NSAID consumption increased from 15.5 to 16.8 DDD/1000 inhabitants/day over 2020–2022, especially in older patients (65–74 years group: 36.2–39.3 DDD/1000 inhabitants/day). From 2019 to 2022, 2,811,910 patients with NSAID prescription(s) in Note 66 were identified, whose average age was 59.7 years. Among them, 0.1–1.0% received NSAIDs for rheumatic diseases and 11.9% in the oncological setting. While diclofenac, etoricoxib, and ketoprofen were commonly prescribed at medium–low dosage as recommended, ibuprofen was used at high dosage (600 mg) in 80% of cases.</p><h3>Conclusion</h3><p>The analysis showed that patients prescribed with NSAIDs were relatively young (~ 60 years), in contrast with the pathologies covered by Note 66, which typically affect elderly people. Moreover, rheumatic and oncological diseases were poorly represented, thus it is possible that NSAIDs might have been prescribed for indications outside the note. These findings suggest that the use of NSAIDs for pain management in Italy should be optimized, properly weighting their risks and benefits.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2354 - 2368"},"PeriodicalIF":3.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03153-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143661962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevention and Treatment of Intraoperative Complications During Gynecological Laparoscopic Surgery: Practical Tips and Tricks—A Narrative Review","authors":"Matteo Giorgi,&nbsp;Giorgia Schettini,&nbsp;Luca La banca,&nbsp;Alberto Cannoni,&nbsp;Alessandro Ginetti,&nbsp;Irene Colombi,&nbsp;Nassir Habib,&nbsp;Ramon Rovira,&nbsp;Francesco Martire,&nbsp;Lucia Lazzeri,&nbsp;Errico Zupi,&nbsp;Gabriele Centini","doi":"10.1007/s12325-025-03165-z","DOIUrl":"10.1007/s12325-025-03165-z","url":null,"abstract":"<div><p>Several complications can occur during laparoscopic gynecological surgery. The insertion of trocars and the induction of pneumoperitoneum are essential steps, but they can still pose potential risks during laparoscopic surgery. Bowel injuries are the most common during gynecological procedures as a result of thermal damage and trocar placement, while vessel injuries may carry a high mortality rate. Gynecologic surgeons should be aware of the risks associated with laparoscopic procedures and be able to prevent and treat potential complications. We conducted a literature search using three electronic databases (Pubmed/MEDLINE, Google Scholar, Embase) from inception to May 2024 to identify the most common intraoperative gynecological laparoscopic complications, including those related to trocar insertion, bowel, urinary, and vessel injury. The aim of this narrative review is to describe the most common complications during gynecological laparoscopic surgery and to outline the safety rules and techniques necessary for their prevention and treatment.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2089 - 2117"},"PeriodicalIF":3.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03165-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143661964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Real-World Study on the Use, Effectiveness, and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression: INTEGRATE Study","authors":"Patricio Molero,&nbsp;Angela Ibañez,&nbsp;Javier de Diego-Adeliño,&nbsp;J. Antoni Ramos-Quiroga,&nbsp;Marta García Dorado,&nbsp;Paola M. López Rengel,&nbsp;Pilar A. Saiz","doi":"10.1007/s12325-025-03149-z","DOIUrl":"10.1007/s12325-025-03149-z","url":null,"abstract":"<div><h3>Introduction</h3><p>The INTEGRATE study aimed to provide information on the use, effectiveness, and safety of esketamine nasal spray (ESK-NS) for the treatment of treatment-resistant depression (TRD) in real-world practice in Spain.</p><h3>Methods</h3><p>This was an observational, cross-sectional, retrospective study conducted in adults aged 18–74 years who met the criteria for TRD. The weekly impact of ESK-NS on depressive symptoms was evaluated by clinical judgment using four categories (nonresponse, response, remission, not available). The onset of action 24 h after administration was also evaluated. Information on adverse events was collected from the medical records.</p><h3>Results</h3><p>We included 196 patients, of whom 189 were considered evaluable; the mean (SD) number of previous episodes was 3.7 (3.0). According to the investigator’s judgment, 152 (80.4%) of 189 patients were in response or remission in the induction phase, and 54 (90%) of 60 during the maintenance phase. The proportions of patients in remission were 9.5%, 18.7%, and 38.3% during the induction, optimization, and maintenance phases, respectively. Fifty-three (28.0%) patients experienced an improvement in depressive symptoms within the first 24 h after the first administration of ESK-NS. Most adverse events reported with ESK-NS were mild and did not require any action with the study drug; the number of adverse events decreased over time, especially during the first 4 weeks.</p><h3>Conclusion</h3><p>Consistent with the available evidence, the results of this study indicate that ESK-NS is an effective and safe option to consider within the therapeutic algorithm for TRD.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2335 - 2353"},"PeriodicalIF":3.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143661950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Noninterventional, Cross-Sectional Study to Assess Patient Prostate Cancer Treatment Preferences and Experiences in Europe","authors":"Emmanuelle Kaltenbach,&nbsp;Ana Maria Rodriguez-Leboeuf,&nbsp;Patrick Cabri,&nbsp;Mickael Henry-Szatkowski,&nbsp;Mehmet Inceer,&nbsp;Emma Karim,&nbsp;Valérie Perrot,&nbsp;Giuseppe Fallara,&nbsp;Matteo Ferro","doi":"10.1007/s12325-025-03152-4","DOIUrl":"10.1007/s12325-025-03152-4","url":null,"abstract":"<div><h3>Introduction</h3><p>Gonadotropin-releasing hormone (GnRH) agonist injection frequency does not affect prostate cancer treatment efficacy; however, it may influence treatment satisfaction, adherence, and overall healthcare utilization. This study addressed the limited information available on real-world patient experience with GnRH treatments by surveying a diverse population of patients with prostate cancer in Europe.</p><h3>Methods</h3><p>This noninterventional, cross-sectional study included adults with locally advanced or metastatic prostate cancer in Belgium, France, Italy, Spain, and the UK. Data were collected via a one-time self-administered electronic survey (October–December 2023) that assessed patient preferences for injection frequency, satisfaction, healthcare resource utilization, and involvement in treatment decision-making.</p><h3>Results</h3><p>Of 414 participants, 53.9% preferred a 6-month injection frequency, while 27.3% preferred a 3-month frequency. Among those receiving injections every 6 months, 77.0% were satisfied; 62.7% of those receiving injections every 3 months were satisfied. Two-thirds of participants (65.7%) were aware of different frequencies of injections. Among those who preferred a 3-month injection frequency, routine and perceived control over their disease were important factors, with 38.1% receiving injections at the same frequency as doctor visits. Among those preferring a 6-month frequency, convenience and routine were important; however, 7.2% indicated that their preference was based on a dislike or fear of injections. Of those with no preference, 60.3% indicated that this was because they deferred to their doctor’s advice. Most patients required transport to their injection appointment, and of those who were employed, 79.2% required time off from work. Accompaniment to an injection appointment was also important, with 66.2% of patients never attending alone.</p><h3>Conclusion</h3><p>The high satisfaction rates, particularly among those receiving injections every 6 months, suggest that less-frequent injections may be more convenient and preferable for many patients. These insights can help to guide patient-centric care and treatment decisions in prostate cancer management.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2314 - 2334"},"PeriodicalIF":3.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03152-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143661854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeting PACAP: Beyond Migraine to Cluster, Menstrual, and Post-traumatic Headaches","authors":"Lanfranco Pellesi,&nbsp;Mona Ameri Chalmer,&nbsp;Song Guo,&nbsp;Thien Phu Do,&nbsp;Zheman Xiao,&nbsp;Paolo Martelletti","doi":"10.1007/s12325-025-03166-y","DOIUrl":"10.1007/s12325-025-03166-y","url":null,"abstract":"<div><p>The pituitary adenylate cyclase-activating peptide (PACAP) pathway is a critical focus in the pathophysiology of several headache disorders. PACAP influences headache pathophysiology through interactions with distinct receptors (PAC₁, VPAC₁, and VPAC₂) and pathways linked to neurovascular and hormonal regulation. Evidence supports its role in the modulation of trigeminal and parasympathetic systems, implicated in cluster headaches and menstrual migraine, and its involvement in sensitizing pain pathways post trauma in post-traumatic headaches. Early clinical trials targeting PACAP signaling show promise, with one study demonstrating efficacy in migraine prophylaxis. This narrative review synthesizes current evidence while addressing gaps in understanding PACAP’s precise mechanisms. Future research should prioritize expanding the scope of PACAP-focused investigations across diverse headache types, aiming to establish it as a therapeutic target for several headache disorders. Success in ongoing and future trials could redefine headache management for millions of underserved patients worldwide.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 5","pages":"2078 - 2088"},"PeriodicalIF":3.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03166-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143655867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}