Luis Puig, Philipp Sewerin, Christopher Schuster, Khai Jing Ng, Manny Papadimitropoulos, Sneha Gadagamma, Mercedes Nuñez, Anastasia Lampropoulou
{"title":"Real-World Evidence for Ixekizumab in the Treatment of Psoriasis, Psoriatic Arthritis, and Axial Spondyloarthritis: Systematic Literature Review 2022–2023","authors":"Luis Puig, Philipp Sewerin, Christopher Schuster, Khai Jing Ng, Manny Papadimitropoulos, Sneha Gadagamma, Mercedes Nuñez, Anastasia Lampropoulou","doi":"10.1007/s12325-025-03258-9","DOIUrl":"10.1007/s12325-025-03258-9","url":null,"abstract":"<div><h3>Objective</h3><p>To describe the results of a systematic literature review of real-world outcomes with ixekizumab in psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA).</p><h3>Methods</h3><p>Databases, conference proceedings, and additional sources were searched for real-world studies in ≥ 25 patients treated with ixekizumab for PsO, PsA, or axSpA. Data on clinical effectiveness, patient-reported outcomes, treatment patterns, safety, and economic burden were extracted.</p><h3>Results</h3><p>A total of 118 publications were included, 96 in PsO, 16 in PsA, 5 in both PsO and PsA, and 1 in axSpA. Most focused on clinical effectiveness and treatment patterns. Ixekizumab was effective in real-world settings, and the anti-interleukin (IL)-17A biologics were more effective for skin clearance than comparator biologics. Anti-IL-17A biologics were effective for challenging body areas (nails, scalp, genitals, palmoplantar regions), and ixekizumab was associated with a higher chance of obtaining Dermatology Life Quality Index scores of 0/1 than secukinumab or other biologics. Ixekizumab was associated with generally high persistence/drug survival. No unexpected safety signals were identified.</p><h3>Conclusion</h3><p>Real-world ixekizumab use for PsO and PsA is effective and safe, with a positive impact on patient quality of life. More data are needed to draw conclusions for real-world ixekizumab use in axSpA.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4224 - 4254"},"PeriodicalIF":4.0,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03258-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658135","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":"Interferon in Liver Diseases: Recent Advances","authors":"Yuting Gao, Yuhang Yin, Pengpeng Xie, Deyu Zhang, Hongyu Li, Xingshun Qi","doi":"10.1007/s12325-025-03291-8","DOIUrl":"10.1007/s12325-025-03291-8","url":null,"abstract":"<div><p>Interferons (IFNs) are a pivotal class of cytokines with multifaceted roles in antiviral defense, immune regulation, and antitumor activity. Structural and functional distinctions among IFN types (I, II, and III) underlie their diverse biological effects. IFN production is initiated by pattern recognition receptor signaling, containing Toll-like receptors, RIG-I-like receptors, and the cGAS-STING axis, which activates downstream pathways, such as JAK-STAT, PI3K-AKT, NF-κB, and MAPK signaling pathways. These pathways critically influence the pathogenesis, progression, therapeutic management, and prognosis of liver diseases. This review delineates the mechanistic roles of IFN-associated signaling in viral hepatitis, non-alcoholic fatty liver disease, alcohol-associated liver disease, liver fibrosis, and hepatocellular carcinoma. We further elucidate IFN-mediated regulatory networks in viral defense, metabolic dysregulation, immune responses, and inflammatory activation. By integrating these insights, the review provides a novel therapeutic direction to unravel context-specific IFN dynamics and address unmet needs in the management of liver diseases, thereby fostering personalized approaches to improve clinical outcomes.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4210 - 4223"},"PeriodicalIF":4.0,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03291-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658134","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}
Kelli R. Franzenburg, Rolf Hansen, Mark Suett, Stephen F. Thompson, Martin Sergerie, David Garcia, Howard C. Margolese
{"title":"Efficacy and Safety of TV-46000 and Second-Generation Long-Acting Injectable Antipsychotics for Schizophrenia: A Systematic Literature Review and Network Meta-Analysis of Randomized Controlled Trials","authors":"Kelli R. Franzenburg, Rolf Hansen, Mark Suett, Stephen F. Thompson, Martin Sergerie, David Garcia, Howard C. Margolese","doi":"10.1007/s12325-025-03274-9","DOIUrl":"10.1007/s12325-025-03274-9","url":null,"abstract":"<div><h3>Introduction</h3><p>TV-46000 [once monthly (q1m) or once every 2 months (q2m)] is a subcutaneously administered long-acting injectable antipsychotic (LAI) formulation of risperidone for the treatment of schizophrenia in adults. As second-generation LAIs become available, understanding comparative efficacy and safety is needed.</p><h3>Methods</h3><p>We undertook a systematic literature review (SLR; January 1, 2020 to May 11, 2023) and network meta-analyses (NMAs) of randomized controlled clinical trials to compare the efficacy and safety of TV-46000 q1m and q2m with second-generation LAIs approved in Canada and used for treatment of schizophrenia [intramuscular aripiprazole monohydrate q1m, paliperidone palmitate q1m (PP1M), and paliperidone palmitate once every 3 months (PP3M)]. The primary efficacy outcome was relapse rate at 6 months, while safety outcomes were adverse event (AE)-related discontinuation, significant weight gain (≥ 7%), treatment-related AEs, and injection-site pain.</p><h3>Results</h3><p>Sixty-one records from 24 studies were included in the SLR, and 6 were included in the NMAs. For the relapse rate at 6 months, all treatments were significantly better than placebo, with relative risks (RRs) ranging from 0.23 for TV-46000 q1m to 0.46 for PP1M 50–150 mg eq and no significant differences among LAIs. There were no significant differences between TV-46000 and either placebo or PP1M 25–100 mg eq for AE-related discontinuation. TV-46000 q1m, PP1M 25–100 mg eq, and TV-46000 q2m were significantly less likely to cause weight gain ≥ 7% than PP3M (RR: 0.09, 0.09, and 0.06, respectively) or PP1M 50–150 mg eq (0.08, 0.08, and 0.06, respectively). Treatment-related AEs were significantly less likely with PP1M 25–100 mg eq, TV-46000 q1m, and placebo than PP3M (RR: 0.48, 0.62, and 0.66, respectively). There were no significant differences in injection-site pain between groups.</p><h3>Conclusion</h3><p>TV-46000 q1m and q2m demonstrated comparable efficacy and safety to second-generation LAIs approved in Canada and used for maintenance treatment of schizophrenia.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4188 - 4209"},"PeriodicalIF":4.0,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03274-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144641533","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}
Yan Zhao, Litao Zhang, Liming Wu, Bin Yang, Jinyan Wang, Yumei Li, Qingchun Diao, Jingyi Li, Qing Sun, Xiaohong Zhu, Xiaoyong Man, Lihua Wang, Yanyan Feng, Tao Cai, Huiming Zeng, Linfeng Li, Jianyun Lu, Hong Ren, Fuqiu Li, Qianjin Lu, Xiaohua Tao, Rong Xiao, Chao Ji, Chao Liang, Yanping Qiu, Bo Chen, Jianzhong Zhang
{"title":"Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial","authors":"Yan Zhao, Litao Zhang, Liming Wu, Bin Yang, Jinyan Wang, Yumei Li, Qingchun Diao, Jingyi Li, Qing Sun, Xiaohong Zhu, Xiaoyong Man, Lihua Wang, Yanyan Feng, Tao Cai, Huiming Zeng, Linfeng Li, Jianyun Lu, Hong Ren, Fuqiu Li, Qianjin Lu, Xiaohua Tao, Rong Xiao, Chao Ji, Chao Liang, Yanping Qiu, Bo Chen, Jianzhong Zhang","doi":"10.1007/s12325-025-03284-7","DOIUrl":"10.1007/s12325-025-03284-7","url":null,"abstract":"<div><h3>Introduction</h3><p>Atopic dermatitis (AD) significantly impairs quality of life and requires long-term management. This post hoc analysis aimed to evaluate the effect of stapokibart (an anti-IL-4Rα antibody) on patient-reported outcomes (PROs) in adults with moderate-to-severe AD from a phase 3 trial (NCT05265923).</p><h3>Methods</h3><p>Eligible patients were randomized 1:1 to receive stapokibart 300 mg (loading dose 600 mg) (<i>n</i> = 251) or placebo (<i>n</i> = 249) every 2 weeks (Q2W) for 16 weeks. Subsequently, both groups received stapokibart 300 mg Q2W for 36 weeks and were followed-up for 8 weeks. Main PROs analyzed included percentage change from baseline in the Dermatology Life Quality Index (DLQI) and the Patient-Oriented Eczema Measure (POEM) scores, response rates of weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) score ≤ 4 and ≤ 1, DLQI score ≤ 5, and POEM score ≤ 7 over 52-week treatment.</p><h3>Results</h3><p>A higher proportion of patients in the stapokibart group achieved weekly average of daily PP-NRS score ≤ 4 compared with the placebo-stapokibart group at week 16 (49.8% vs. 24.2%, <i>p</i> < 0.0001); the proportion at week 52 increased to 84.9% and 80.9%, respectively. Weekly average of daily PP-NRS score ≤ 1 was achieved in 35.2% and 32.1% of patients in stapokibart and placebo-stapokibart groups, respectively, at week 52. The stapokibart group had greater improvements in DLQI and POEM scores compared with the placebo-stapokibart group over weeks 4–16, and the improvements continued during maintenance period in both groups. The proportion of patients achieving DLQI score ≤ 5 was 46.2% versus 28.8% at week 16 (<i>p</i> < 0.0001) and 68.7% versus 73.6% at week 52 in the stapokibart versus placebo-stapokibart groups. POEM score ≤ 7 was achieved in 45.8% versus 22.5% of patients at week 16 (<i>p</i> < 0.0001) and 67.8% versus 62.7% at week 52.</p><h3>Conclusion</h3><p>Stapokibart significantly improved PROs in adults with moderate-to-severe AD through 52-week treatment.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifier, NCT05265923.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4527 - 4539"},"PeriodicalIF":4.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615771","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}
Mark G. Lebwohl, John Y. Koo, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Joanna Kolinek, Paweł Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, YunJu Bae, DaBee Jeon, EunJin Choi, JungBin Cha, HyunJin Lee, SuJin Choi, David M. Pariser
{"title":"Correction to: Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study","authors":"Mark G. Lebwohl, John Y. Koo, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Joanna Kolinek, Paweł Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, YunJu Bae, DaBee Jeon, EunJin Choi, JungBin Cha, HyunJin Lee, SuJin Choi, David M. Pariser","doi":"10.1007/s12325-025-03235-2","DOIUrl":"10.1007/s12325-025-03235-2","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4720 - 4723"},"PeriodicalIF":4.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03235-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615770","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}
David T. Rubin, Alison Potts Bleakman, Simon Travis, Marla Dubinsky, Stefan Schreiber, Remo Panaccione, Theresa Hunter Gibble, Cem Kayhan, Tommaso Panni, Eoin Flynn, Angelo D. Favia, Christian Atkinson, Sonal Saxena, Toshifumi Hibi
{"title":"Broad Impact of Bowel Urgency in Ulcerative Colitis and Crohn’s Disease: US, European, and Japanese Patient and Healthcare Professional Perspectives from the Communicating Needs and Features of IBD Experiences (CONFIDE) Survey","authors":"David T. Rubin, Alison Potts Bleakman, Simon Travis, Marla Dubinsky, Stefan Schreiber, Remo Panaccione, Theresa Hunter Gibble, Cem Kayhan, Tommaso Panni, Eoin Flynn, Angelo D. Favia, Christian Atkinson, Sonal Saxena, Toshifumi Hibi","doi":"10.1007/s12325-025-03296-3","DOIUrl":"10.1007/s12325-025-03296-3","url":null,"abstract":"<div><h3>Introduction</h3><p>Bowel urgency affects the quality of life of patients with Crohn’s disease (CD) and ulcerative colitis (UC). This study used data from the Communicating Needs and Features of IBD Experiences (CONFIDE) survey to explore patient and healthcare professional (HCP) perceptions on the broad impacts of bowel urgency on patients’ emotions and daily lives.</p><h3>Methods</h3><p>Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe UC or CD (defined based on previous treatment, steroid use, and/or hospitalization) and HCPs specialized in gastroenterology in Europe (France, Germany, Italy, Spain, UK), United States (US), and Japan. Data were summarized using descriptive statistics.</p><h3>Results</h3><p>The analysis included 200 US, 556 European, and 124 Japanese patients with UC and 215 US, 547 European, and 99 Japanese patients with CD; and 200 US, 503 European, and 100 Japanese HCPs. Patients experiencing bowel urgency in the past month and HCPs reported high emotional (up to: 97% patients, 97% HCPs) and daily life (up to: 85% patients, 97% HCPs) impacts due to bowel urgency in the US, Europe, and Japan. In all geographies, these impacts were similar among patients with UC and CD. Although patients and HCPs reported a broad impact of bowel urgency, HCPs perceived a higher impact than patients, but it was not among the top three most impactful symptoms on HCPs’ treatment decisions.</p><h3>Conclusions</h3><p>Bowel urgency affects the emotions and daily life of patients with UC or CD in the US, Europe, and Japan. A multidisciplinary approach is required to enhance care and develop suitable treatment strategies.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4510 - 4526"},"PeriodicalIF":4.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03296-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607128","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}
Peter C. Taylor, Thomas Bieber, Rieke Alten, Torsten Witte, James Galloway, Walter Deberdt, Maher Issa, Ewa Haladyj, Inmaculada De La Torre, Susanne Grond, Andreas Wollenberg
{"title":"Correction to: Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications","authors":"Peter C. Taylor, Thomas Bieber, Rieke Alten, Torsten Witte, James Galloway, Walter Deberdt, Maher Issa, Ewa Haladyj, Inmaculada De La Torre, Susanne Grond, Andreas Wollenberg","doi":"10.1007/s12325-025-03244-1","DOIUrl":"10.1007/s12325-025-03244-1","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4717 - 4719"},"PeriodicalIF":4.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03244-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607129","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 Safety and Effectiveness of Vadadustat in Patients with Chronic Kidney Disease-Related Anemia: Interim Analysis of Postmarketing Surveillance in Japan","authors":"Masaomi Nangaku, Kazuyo Sasaki, Jing Bi, Kiichiro Ueta, Kenichi Nishimura, Takafumi Hashimoto, Mihoko Hata","doi":"10.1007/s12325-025-03272-x","DOIUrl":"10.1007/s12325-025-03272-x","url":null,"abstract":"<div><h3>Introduction</h3><p>Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat chronic kidney disease (CKD)-related anemia. This interim analysis presents findings from postmarketing surveillance (PMS) conducted in Japan, assessing the safety and effectiveness of vadadustat in real-world clinical practice.</p><h3>Methods</h3><p>This ongoing 2-year observational, multicenter, prospective surveillance collected data from November 2020 to June 2024 to assess adverse drug reactions (ADRs) and hemoglobin (Hb) levels in patients with CKD-related anemia. ADRs of special interest included malignant tumors, thromboembolism, hepatic impairment, hypertension, cardiovascular events excluding thromboembolism, retinal hemorrhage-related ADRs, and the progression of autosomal dominant polycystic kidney disease.</p><h3>Results</h3><p>This interim analysis included 2263 patients enrolled from 420 sites across Japan, with 2191 and 2142 patients analyzed for safety and effectiveness, respectively. The safety analysis population comprised 1429 patients with non-dialysis-dependent (NDD)-CKD, 174 with peritoneal dialysis-dependent (PD)-CKD, and 588 with hemodialysis-dependent (HD)-CKD. The median treatment duration was 365.0 days overall (365.0 days for NDD-CKD and PD-CKD, and 189.0 days for HD-CKD). Treatment with vadadustat was discontinued in approximately half of the patients in each CKD group during the observation period. ADRs and serious ADRs were observed in 14.79% and 6.30% of the patients, respectively. The most common ADRs were nausea (1.19%) and diarrhea (1.14%). ADRs of special interest occurring in more than 1% of patients were malignant tumors (1.14%) and thromboembolism (1.05%).</p><p>The mean changes in Hb levels from baseline to 12 months in patients who switched from erythropoiesis-stimulating agents (ESAs) to vadadustat and in those without prior ESA use were as follows: 0.30 g/dL and 1.12 g/dL for patients with NDD-CKD; 0.30 g/dL and 0.34 g/dL for PD-CKD; and 0.18 g/dL and 0.90 g/dL for HD-CKD, respectively. Across all CKD subgroups, mean Hb levels increased after treatment with vadadustat in patients with baseline Hb levels < 10 g/dL.</p><h3>Conclusion</h3><p>In this interim analysis, we identified no new safety concerns beyond those outlined in the Japanese package insert for vadadustat, which is based on the results from pivotal clinical trials. The ongoing PMS will continue to offer valuable insights into the safety and effectiveness of vadadustat in real-world clinical practice.</p><h3>Trial Registration</h3><p>UMIN000042349.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4486 - 4509"},"PeriodicalIF":4.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03272-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607131","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}
Kristina S. Boye, Amy Clark, Chisom Kanu, Lisa M. Neff, Anne M. Skalicky
{"title":"Development of the Pediatric Weight Questionnaire (PWQ™) for Children and Adolescents with Obesity","authors":"Kristina S. Boye, Amy Clark, Chisom Kanu, Lisa M. Neff, Anne M. Skalicky","doi":"10.1007/s12325-025-03277-6","DOIUrl":"10.1007/s12325-025-03277-6","url":null,"abstract":"<div><h3>Introduction</h3><p>Development of obesity management medications (OMMs) for use in children and adolescents calls for patient-reported outcome (PRO) measures to evaluate treatment efficacy. Existing weight-specific symptom and impact PROs are limited to age ≥ 11 years and may not fully capture treatment benefit of new OMMs.</p><h3>Methods</h3><p>A targeted literature review was conducted to identify obesity symptom and impact outcomes and weight-specific PROs relevant to children and adolescents 6–17 years of age. Concept elicitation (CE) interviews were conducted by telephone with children and adolescents, including parents of children 6–11 years of age, to identify relevant weight-specific concepts. Key concepts relevant to three developmental age groups—6–7, 8–11, and 12–17 years—informed the creation of a pediatric weight-specific PRO to assess key symptoms and impacts of obesity: the Pediatric Weight Questionnaire (PWQ). Cognitive interviews (CI) were conducted by telephone to assess the comprehension, relevance, and comprehensiveness of the PWQ across the three age groups.</p><h3>Results</h3><p>Eight domains were identified from the literature as relevant to pediatric obesity: physical symptoms, physical function, psychological health, emotional behavior/function, family and social relationships, school functioning, and health-related quality of life. No existing weight-specific PRO encompassing these domains was identified. Twenty CE interview participants (mean age 11.4 years, 60% female, 50% Hispanic/Latino) confirmed that physical symptoms and physical, emotional, and social impacts were most relevant to their weight experience. The 23-item PWQ for adolescents 12–17 years of age and the 17-item PWQ for children 8–11 years of age are self-administered, while the 13-item PWQ for children 6–7 years of age is interviewer-administered. The three versions of the PWQ were evaluated with 34 CI participants (mean age 12 years, 64.7% female, 17.6% Hispanic/Latino), who found the PWQ easy to complete, relevant, and comprehensive.</p><h3>Conclusion</h3><p>The PWQ provides a means of assessing the impact of obesity and benefits of treatment in children and adolescents 6–17 years of age with obesity. Study findings support the content validity of this new measure for use in pediatric obesity clinical trials and observational research.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4464 - 4485"},"PeriodicalIF":4.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03277-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607130","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}
Matthew Zirwas, Nicole Princic, Megan K. Richards, Aamir Qureshi, Lorenzo Sabatelli, Peter Lio
{"title":"Burden of Atopic Dermatitis in Patients Initiating Systemic Therapies in the United States","authors":"Matthew Zirwas, Nicole Princic, Megan K. Richards, Aamir Qureshi, Lorenzo Sabatelli, Peter Lio","doi":"10.1007/s12325-025-03286-5","DOIUrl":"10.1007/s12325-025-03286-5","url":null,"abstract":"<div><h3>Introduction</h3><p>This study aimed to describe treatment patterns, frequency of comorbidities, and healthcare cost burden among patients with atopic dermatitis (AD) initiating systemic therapy (or re-initiating it after more than 12 months) versus matched controls without AD.</p><h3>Methods</h3><p>Patients with AD initiating oral corticosteroids (OCS), immunosuppressants (SIS), or biologics between 1/1/2017 and 6/30/2022 (index = first treatment) were identified for analysis in the MarketScan claims databases. Patients were continuously enrolled 12 months before (baseline) and after index (follow-up). Direct and propensity score matching were used to adjust for baseline differences between cases and controls. Comorbidities and all-cause healthcare costs within service categories were compared between AD cases and matched controls during follow-up and treatment patterns were described for all patients with AD.</p><h3>Results</h3><p>A total of 20,503 patients with AD were identified. On index,12% initiated biologics, 86% OCS, and 2% SIS, and discontinuation rates were high during follow-up (SIS: 80%; biologics: 35%) The incidence of several comorbidities, including cardiovascular disease, atopic conditions, and mental health disorders, was higher in the AD cohort compared with matched controls (<i>p</i> < 0.001). Patients with AD (vs. matched controls) also had significantly higher mean total all-cause healthcare costs (US$15,134 vs. $6832; <i>p</i> < 0.001).</p><h3>Conclusions</h3><p>Patients with AD who are initiating systemic treatment experience an increased risk of being newly diagnosed with several comorbidities and higher healthcare costs compared with matched controls, which places increased burden on patients and healthcare systems.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 9","pages":"4447 - 4463"},"PeriodicalIF":4.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590249","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}