Anju T Peters, Catherine Rolland, Louis Lavoie, Selwyn Fung, Daniel Basoff, Abhishek Chitnis
{"title":"The Burden of Chronic Rhinosinusitis Without Nasal Polyps: A Systematic Review of Epidemiological, Clinical, Humanistic, and Economic Evidence.","authors":"Anju T Peters, Catherine Rolland, Louis Lavoie, Selwyn Fung, Daniel Basoff, Abhishek Chitnis","doi":"10.1007/s12325-026-03575-7","DOIUrl":"https://doi.org/10.1007/s12325-026-03575-7","url":null,"abstract":"<p><p>Chronic rhinosinusitis (CRS) is a heterogeneous and often debilitating disease characterized by persistent sinonasal symptoms and inflammation and is phenotypically classified as CRS with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP). Although CRSsNP is the more prevalent phenotype (approximately 80%), it remains disproportionately understudied, leading to critical gaps in understanding and management. This systematic literature review synthesized current global evidence on the epidemiological, clinical, humanistic, and economic burden of CRSsNP, highlighting areas of unmet need and raising awareness of the impact of this disease. PRISMA-compliant searches were conducted for CRSsNP records published 2004-2024 (epidemiological studies 2014-2024) across six electronic databases. Targeted hand searches were performed for abstracts (2022-2024), health technology assessments, guidelines, and clinical trial registries. Of 2215 records identified, 157 met inclusion criteria. CRSsNP prevalence was 4.3-10.4% in the USA, South Korea, and Spain. Patients experienced a range of symptoms including nasal/sinus (obstruction, discharge, crusting), pain, sensory (anosmia, cacosmia), respiratory (cough, asthma), oral (dry throat, halitosis), and sleep impairment. There was considerable variability in the availability and use of tools to assess severity; this impeded cross-study comparisons, consistent disease staging, and treatment escalation criteria. Associated comorbidities included asthma, chronic obstructive pulmonary disease, gastroesophageal reflux disease, and primary antibody deficiencies. Humanistic burden was assessed using a variety of outcome measures and was higher for patients with CRSsNP than for controls. Limited data were available on economic burden. Currently available therapies were associated with high rates of treatment failure, inadequately controlled symptoms, and the need for multiple lines of therapy. CRSsNP is associated with considerable burden across clinical, humanistic, and economic domains, exacerbated by diagnostic variability, treatment limitations, and a lack of standardized research methodologies. This highlights the need for coordinated efforts among stakeholders to better address this chronic condition and support future improvements in patient outcomes.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759743","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}
Anju T Peters, Andréanne Côté, Xavier Muñoz, Changming Xia, Scott Nash, Megan Hardin, Lucía de Prado Gómez, Harry J Sacks, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz
{"title":"Coexisting Type 2 Inflammatory Conditions in Patients with Asthma Treated with Dupilumab: the RAPID Registry.","authors":"Anju T Peters, Andréanne Côté, Xavier Muñoz, Changming Xia, Scott Nash, Megan Hardin, Lucía de Prado Gómez, Harry J Sacks, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz","doi":"10.1007/s12325-026-03568-6","DOIUrl":"https://doi.org/10.1007/s12325-026-03568-6","url":null,"abstract":"<p><strong>Introduction: </strong>Coexisting type 2 inflammatory diseases such as allergic rhinitis (AR), atopic dermatitis (AD), chronic rhinosinusitis (CRS) and/or nasal polyposis (NP), eosinophilic esophagitis (EoE), and urticaria are common in asthma. RAPID (NCT04287621), a global prospective registry, aimed to characterize patients with asthma initiating dupilumab in a real-world clinical setting. This analysis investigated the prevalence of coexisting type 2 inflammatory diseases in these patients.</p><p><strong>Methods: </strong>Patients aged ≥ 12 years initiating dupilumab for asthma (primary indication) according to country-specific prescribing information were enrolled in RAPID. Patients had regular assessments at 1 month and thereafter every 3 months for up to 3 years, per standard of care across study sites.</p><p><strong>Results: </strong>At the time of analysis, 205 patients were enrolled. Mean age of patients (stratified by type 2 coexisting disease) ranged from 42.3 to 57.3 years and mean body mass index from 29.9 to 31.8 kg/m<sup>2</sup>. Most patients were female (67.3% to 77.4%), and mean time since asthma diagnosis was 17.3 to 24.0 years, with mean duration of coexisting diseases ranging from 9.8 to 17.0 years. A total of 189 (92%) patients had ≥ 1 ongoing type 2 coexisting disease (AR, 80%; CRS and/or NP, 45% [CRS with NP, 47%; CRS without NP, 41%; NP, 12%]; AD, 27%; urticaria, 15%; and EoE, 3%).</p><p><strong>Conclusion: </strong>This analysis from the RAPID registry shows that type 2 coexisting diseases are highly prevalent in patients with asthma initiating dupilumab in a clinical practice setting and highlights the importance of properly assessing patients to improve patient care.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04287621.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759677","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}
Jami Peters, Sook-In Jung, Lauren Liu, Kimberly Suekawa-Pirrone, Keith Aizen, Jeong-A Lee, Yeon-Jae Kim
{"title":"The Safety and Effectiveness of B/F/TAF for HIV-1 in a Prospective Multicenter Observational Study in the Republic of Korea.","authors":"Jami Peters, Sook-In Jung, Lauren Liu, Kimberly Suekawa-Pirrone, Keith Aizen, Jeong-A Lee, Yeon-Jae Kim","doi":"10.1007/s12325-026-03595-3","DOIUrl":"https://doi.org/10.1007/s12325-026-03595-3","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the safety and the effectiveness of B/F/TAF in patients living with HIV-1 treated in real-world settings in the Republic of Korea (ROK).</p><p><strong>Methods: </strong>This prospective, multicenter, observational study aimed to enroll all patients initiating B/F/TAF at 45 sites between July 2019 and November 2023. Safety was assessed up to 48 weeks post-treatment initiation. HIV-1 RNA and CD4 + T-cell were recorded at baseline, and then at approximately 48 weeks (i.e., between 36 and 64 weeks) post-treatment initiation.</p><p><strong>Results: </strong>Of the 2844 patients enrolled, 2761 were analyzed (mean age 44 ± 14 years; 93.48% male; 81.53% treatment-experienced). Adverse events were reported in 37.16% of patients, adverse drug reactions (ADRs) in 5.40%, serious adverse events in 3.48%, and serious adverse drug reactions in 0.04%. No fatal ADRs were reported. Viral suppression rates (HIV-1 RNA < 50 copies/mL) were 97.83% for treatment-experienced patients, 93.84% for treatment-naïve, and 97.19% overall. CD4⁺ T-cell counts increased in both groups.</p><p><strong>Conclusion: </strong>In this large real-world cohort, B/F/TAF demonstrated a favorable safety profile and high effectiveness, consistent with prior studies. No new safety concerns were identified.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759749","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}
Amina H K Gouda, Nicholas E C Aitcheson, Kathryn J Steadman
{"title":"Low-Dose Naltrexone: What is the Evidence? A Narrative Review.","authors":"Amina H K Gouda, Nicholas E C Aitcheson, Kathryn J Steadman","doi":"10.1007/s12325-026-03612-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03612-5","url":null,"abstract":"<p><p>Naltrexone is prescribed off-label at low doses, typically 0.5-6.0 mg, for a variety of therapeutic indications. This review evaluates the clinical evidence for low-dose naltrexone (LDN). A literature search was conducted in February 2026 across PubMed, Embase and CINAHL for studies published from 1989 to 2026. Title and abstract searches for \"low dose naltrexone\" identified peer-reviewed English-language studies using doses of ≤ 12.5 mg in humans. A total of 105 studies were reviewed, including 15 randomised controlled trials (RCTs) in chronic pain, autoimmune and neuroimmune disorders, gastrointestinal disease, dermatological conditions, post-infectious syndromes, mental health and oncology. Across these fields, early positive findings from uncontrolled studies were rarely replicated in placebo-controlled trials. Most available evidence consists of case reports and small feasibility studies that are prone to publication bias and rely heavily on subjective outcomes. LDN is generally safe, inexpensive and well tolerated, with most studies using a daily dose of 4.5 mg. Although these features contribute to its appeal, current evidence does not support routine clinical use. LDN may have a pragmatic role in treatment-resistant cases where standard therapies have failed, provided its experimental status and uncertain efficacy are clearly explained. Larger, well-designed RCTs with objective endpoints, along with N-of-1 approaches to identify potential responders, are needed to clarify its true clinical value.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759710","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":"Effectiveness of Galcanezumab and Traditional Oral Migraine Preventive Medications: Interim 3-Month Japan Subgroup Findings from the TRIUMPH Study.","authors":"Takao Takeshima, Yasuhiko Matsumori, Daisuke Danno, Tsubasa Takizawa, Kaname Ueda, Zhihong Cai, Chie Hashimoto, Hideaki Katagiri","doi":"10.1007/s12325-026-03588-2","DOIUrl":"https://doi.org/10.1007/s12325-026-03588-2","url":null,"abstract":"<p><strong>Introduction: </strong>Galcanezumab, a humanized calcitonin gene-related peptide monoclonal antibody, is approved in Japan for migraine prevention, but real-world effectiveness data are limited. This analysis describes the 3-month treatment outcomes of galcanezumab and traditional oral migraine preventive medications (TOMPs) in the TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems (TRIUMPH) study's Japan subgroup.</p><p><strong>Methods: </strong>TRIUMPH, an international, prospective, observational, 24-month cohort study, included adults with migraine who initiated or switched to galcanezumab or TOMP. Japan subgroup data were collected from September 2021 to November 2024. Physicians decided on the treatment course in routine clinical practice. The primary outcome was achieving a clinically meaningful response at 3 months, defined as a ≥ 50% reduction in monthly migraine headache days for episodic migraine and ≥ 30% for chronic migraine. Secondary outcomes included changes in migraine headache days and patient-reported outcomes (PROs): Migraine Disability Assessment (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Interictal Burden Scale-4 (MIBS-4), Migraine-Specific Quality of Life Questionnaire (MSQv2.1), and Work Productivity and Activity Impairment (WPAI). Inverse probability of treatment weighting was used to adjust for baseline differences in the primary analysis. No alpha was allocated for comparative formal testing between treatment groups.</p><p><strong>Results: </strong>Of 846 patients, 469 received galcanezumab and 377 received TOMPs. In the galcanezumab and TOMP groups, the 3-month weighted response rates were 59.4% and 38.3%, and the reduction in mean migraine headache days from baseline was - 6.2 [95% confidence interval (CI): - 6.9, - 5.5] and - 4.2 (95% CI: - 5.0, - 3.4), respectively. Mean change at 3 months from baseline was numerically higher in the galcanezumab group than in the TOMP group for all the PROs.</p><p><strong>Conclusions: </strong>Patients receiving galcanezumab had numerically greater 3-month response rates and experienced improved PROs after initiating galcanezumab. These real-world findings may help physicians make treatment decisions in clinical settings.</p><p><strong>Trial registration: </strong>EU PAS Register number-EUPAS33068.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759720","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}
David Jacobi, Esther Artime, Marine Bertrand, Aya Kayali, Atif Adam, Anastasia Lampropoulou
{"title":"The Overweight and Obesity Landscape in France: Data from the French Cohort of the Multi-country IMPACT-O Study.","authors":"David Jacobi, Esther Artime, Marine Bertrand, Aya Kayali, Atif Adam, Anastasia Lampropoulou","doi":"10.1007/s12325-026-03589-1","DOIUrl":"https://doi.org/10.1007/s12325-026-03589-1","url":null,"abstract":"<p><strong>Introduction: </strong>The epIdeMiology landscape PAtient Care paThways of Obesity (IMPACT-O) study was a multi-country, retrospective cohort study that utilised healthcare databases to determine the landscape/impact of overweight and obesity. Here we describe the sociodemographic, clinical and treatment characteristics of adults with a first record of overweight/obesity or obesity in France.</p><p><strong>Methods: </strong>This study utilised electronic medical records from the France longitudinal patient database (LPD) capturing data from general practitioners and specialist clinicians for 2018-2022. Included adults (≥ 18 years) had a diagnosis code and/or ≥ 1 body mass index of ≥ 25 kg/m<sup>2</sup> (overweight/obesity cohort) or ≥ 30 kg/m<sup>2</sup> (obesity cohort) and a ≥ 12-month observation period before and after their first record indicating overweight/obesity or obesity. Demographic and clinical parameters, including obesity-related complications (ORCs), as recorded by physicians contributing to the database, were described.</p><p><strong>Results: </strong>Of 10,206,481 subjects in the France LPD, 93,714 were included in the overweight/obesity and 46,252 in the obesity cohort; of these, 58.9% and 63.1%, respectively, had ORCs. Hypertension was the most frequently recorded ORC for both cohorts (28.8% and 32.9%, respectively). The proportion of people receiving pharmacological therapies with an effect on weight was ≤ 3%; no lifestyle interventions or bariatric surgery were recorded.</p><p><strong>Conclusion: </strong>These results highlight the high burden of ORCs in adults with overweight or obesity at first available record and the limited use of pharmacological treatment with an effect on weight. Improving weight-related data capture in centralised electronic medical records could facilitate the integration of multidisciplinary approaches and better support the management of obesity. Graphical Abstract available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147759705","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}
Adriana Boateng-Kuffour, Caitlin S Kelly, Huyen T Nguyen, Keval Chandarana, Katherine S Chapman, Liang Chen, Emilee M Cornelius, Wendy A Wolf, William H Polonsky
{"title":"The Lived Experiences of Adult Continuous Glucose Monitor Users with Type 1 Diabetes with Recurrent Severe Hypoglycemic Events and Impaired Awareness of Hypoglycemia: A Qualitative Study.","authors":"Adriana Boateng-Kuffour, Caitlin S Kelly, Huyen T Nguyen, Keval Chandarana, Katherine S Chapman, Liang Chen, Emilee M Cornelius, Wendy A Wolf, William H Polonsky","doi":"10.1007/s12325-026-03585-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03585-5","url":null,"abstract":"<p><strong>Introduction: </strong>Although type 1 diabetes (T1D) technology has improved health outcomes for many, some people continue to experience severe hypoglycemic events (SHEs). This study reviews the history of SHEs and impaired awareness of hypoglycemia (IAH) compound risk for future SHEs, and describes the lived experiences of SHEs among adult people with T1D (pwT1D) with recurrent SHEs (≥ 2/year) and IAH who use continuous glucose monitors (CGMs).</p><p><strong>Methods: </strong>In this online survey study with eligible CGM-users from the T1D Exchange Registry, participants were asked open-ended questions on the impact of SHEs on their lives, then responses were analyzed thematically. Participants reporting ≥ 2 SHEs in the last year and IAH were included in the analytic sample.</p><p><strong>Results: </strong>Participant (n = 158) responses were coded into 12 thematic categories. A total of 82% of participants reported one or more of the following themes: Emotional and Psychological Impact of SHEs, Social/Relationships Impacts, and Attempts to Prevent and Cope. Specifically, nearly half of participants described the Emotional and Psychological Impact of SHEs (49.4%), with fear around hypoglycemia being especially prominent (e.g., \"I worry I might pass out and not wake up…\"). Over one-third of participants described impacts of SHEs on their Social Relationships (33.5%), including increased distress from their loved ones. Remaining themes described impacts on numerous other domains of life.</p><p><strong>Conclusion: </strong>Adult pwT1D using CGMs who had recurrent SHEs and IAH experience substantial burden in their daily lives. New therapeutic options to help this population eliminate SHEs and meet T1D treatment goals would be especially beneficial.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147715782","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}
Shannon L Piche, Michelle D Becker, Shubha Bhat, Linda L Huang, Sunanda V Kane
{"title":"Integration of Ustekinumab Biosimilars into Inflammatory Bowel Disease Care: Evidence, Implementation, and Patient-Centered Considerations.","authors":"Shannon L Piche, Michelle D Becker, Shubha Bhat, Linda L Huang, Sunanda V Kane","doi":"10.1007/s12325-026-03584-6","DOIUrl":"https://doi.org/10.1007/s12325-026-03584-6","url":null,"abstract":"<p><p>The recent introduction of ustekinumab biosimilars represents a pivotal advancement in the management of inflammatory bowel disease (IBD), offering opportunities to enhance access to advanced therapy and reduce healthcare costs without compromising treatment efficacy. IBD, encompassing Crohn's disease and ulcerative colitis, imposes a substantial economic burden on patients and the health care system, with biologics driving most direct costs. Biosimilars have successfully reduced expenditures across various therapeutic classes, notably anti-tumor necrosis factor agents, and now extend these benefits to interleukin-12/23 inhibitors. This review summarizes the regulatory, clinical, and practical considerations for integrating ustekinumab biosimilars into IBD care in the United States. Food and Drug Administration approval is based on rigorous totality-of-evidence evaluations, leveraging pharmacokinetic, immunogenicity, and efficacy studies in sensitive populations such as moderate-to-severe plaque psoriasis, with regulatory extrapolation to IBD indications. Clinical trials of eight ustekinumab biosimilars have consistently demonstrated therapeutic equivalence, including maintenance of efficacy and safety following single or multiple switches from the reference product. Implementation in IBD practice requires careful navigation of operational and patient-centered challenges. Key considerations include coordination of intravenous induction and subcutaneous maintenance therapy across medical and pharmacy benefits, product-specific storage and device differences, and proactive mitigation of the nocebo effect through shared decision making and structured patient education. Ustekinumab biosimilars are poised to expand therapeutic accessibility and support healthcare cost containment. Successful adoption will depend on clinician familiarity, streamlined operational workflows, and patient-centered strategies to maintain confidence, minimize treatment disruption, and optimize long-term outcomes in IBD management.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147715731","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}
Lisa A Beck, Eric L Simpson, Diamant Thaçi, Marjolein de Bruin-Weller, Mette Deleuran, Yoko Kataoka, Andrew Blauvelt, Andreas Wollenberg, Lawrence F Eichenfield, Faisal A Khokhar, Anna Coleman, Michael Van Spall, Yonghao Ma, Elena Avetisova, Annie Zhang, Tien V Nguyen
{"title":"Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study.","authors":"Lisa A Beck, Eric L Simpson, Diamant Thaçi, Marjolein de Bruin-Weller, Mette Deleuran, Yoko Kataoka, Andrew Blauvelt, Andreas Wollenberg, Lawrence F Eichenfield, Faisal A Khokhar, Anna Coleman, Michael Van Spall, Yonghao Ma, Elena Avetisova, Annie Zhang, Tien V Nguyen","doi":"10.1007/s12325-026-03582-8","DOIUrl":"https://doi.org/10.1007/s12325-026-03582-8","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with atopic dermatitis (AD) are at an increased risk for infections. Here, we report a confirmatory follow-up study analyzing the incidence of infections in adults with moderate-to-severe AD treated with dupilumab for up to 5 years.</p><p><strong>Methods: </strong>Infections in adults with moderate-to-severe AD treated with dupilumab 300 mg weekly (qw) or every 2 weeks (q2w; approved regimen) were assessed for up to 5 years in the open-label extension study, LIBERTY AD OLE. Topical corticosteroids (TCS) and calcineurin inhibitors (TCI) were permitted. Exposure-adjusted incidence rates [number of patients with at least one event per 100 patient-years (nP/100 PY)] are reported. Since the OLE had no control arm, safety results from the placebo + TCS arm of the 1-year LIBERTY AD CHRONOS study are included for comparisons.</p><p><strong>Results: </strong>Of the 2677 patients included, 2207 (82.4%) completed up to week 52, 557 (20.8%) up to week 148, and 334 (12.5%) up to week 260; 226 patients (8.4%) switched from qw to q2w during the trial due to a protocol amendment. Overall infections (70.69 nP/100 PY), serious infections (0.87 nP/100 PY), severe infections (0.92 nP/100 PY), and infections leading to treatment discontinuation (0.34 nP/100 PY) were consistent with previous 4-year open-label extension (OLE) analyses and were low compared with 1-year results from the CHRONOS placebo + TCS arm. The cumulative number of patients with treatment-emergent serious or severe infections, non-herpetic or herpetic infections, and total skin infections decreased throughout the OLE study period. Limitations of this study include the absence of a placebo arm in the OLE, decreasing sample size at later time points, inclusion of qw dosing analyses (different from approved q2w dosing), and possible confounding effects of TCS/TCI use that may impact infection rates.</p><p><strong>Conclusions: </strong>Long-term dupilumab treatment for up to 5 years in adults with moderate-to-severe AD is not associated with an increased overall risk of infections. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT01949311, NCT02260986.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147715755","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}
Akio Tanaka, Yumi Kang, Junichi Danjo, Takashi Matsuo, Hitoe Torisu-Itakura, Simran Marwaha, Peter Anderson, James Piercy, Atushi Otsuka
{"title":"Treatment Patterns and Perceptions of Treatment Options in Japanese Pediatric and Adolescent Patients with Atopic Dermatitis.","authors":"Akio Tanaka, Yumi Kang, Junichi Danjo, Takashi Matsuo, Hitoe Torisu-Itakura, Simran Marwaha, Peter Anderson, James Piercy, Atushi Otsuka","doi":"10.1007/s12325-026-03536-0","DOIUrl":"https://doi.org/10.1007/s12325-026-03536-0","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a relapsing, chronic inflammatory skin condition characterized by intense itching and eczematous lesions. AD is common in pediatric patients, but treatment options are limited for these patients and data on treatment patterns are scarce. This study aimed to descriptively evaluate treatments used in pediatric AD and physician- and patient-reported perspectives of available options in real-world practice in Japan.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi Real World Pediatric and Adolescent AD Disease Specific Programme™, a cross-sectional survey, with retrospective data collection, of physicians and patients in Japan from July to December 2022. Physicians completed patient record forms for their next 3-10 consecutively consulting patients, collecting data on demographics and clinical characteristics, treatment regimens, and perceptions around treatment choice and satisfaction. Patients/caregivers also provided their perceptions on treatment choice and satisfaction. Analyses were descriptive.</p><p><strong>Results: </strong>Overall, 55 physicians provided data for 537 pediatric patients, with 111 patients/caregivers also reporting data. The patient population was 63.3% (n = 340) male, and mean ± standard deviation age was 12.6 ± 4.2 years, with 54.0% (n = 290) of patients classified as pediatric (aged ≤ 14 years) and 46.0% (n = 247) adolescent (aged 15-17 years). Patient treatments included topical corticosteroids (TCS; 89.1%, n = 457/513), biologics (12.3%, n = 63/513), oral JAK-is (7.6%, n = 39/513), and immunosuppressants (1.8%, n = 9/513). Physicians reported that they believe better control could be achieved in 64.8% (n = 332) of patients compared with 93.1% (n = 81) of patients self-reporting this.</p><p><strong>Conclusions: </strong>TCS was the most common treatment in pediatric AD management, in agreement with the current guideline recommendation. Overall, most physicians and patients believed that better control could be achieved. However, in mild patients, most patients believed better control could be achieved, while physicians did not. This suggests that views of disease control, and desire for improved disease control, may differ between physicians and patients.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728028","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}