{"title":"Duration and determinants of biologic initiation in the treatment of severe asthma","authors":"Tatsuya Imabayashi , Toshiyuki Tanaka , Kohei Yamamoto , Kazuki Jinno , Shunya Tanaka , Sayaka Uda , Tatsuya Yuba , Chieko Takumi","doi":"10.1016/j.resinv.2025.06.003","DOIUrl":"10.1016/j.resinv.2025.06.003","url":null,"abstract":"<div><h3>Background</h3><div>Factors influencing biologic initiation in severe asthma remain unclear.</div></div><div><h3>Methods</h3><div>We retrospectively evaluated the duration and determinants of biologic initiation in 54 patients with severe asthma who were started on biologics at our hospital between 2018 and 2024.</div></div><div><h3>Results</h3><div>The median age was 74 years, and 72.2 % of the patients were biologic-naïve. Patients required a median of three explanations for biologic initiation, with 25.9 % requiring four or more. These patients had a higher prevalence of pre-prescribed oral corticosteroids (OCS) for anticipated exacerbations (58.3 % vs. 7.1 %, P < 0.001) and more frequent exacerbations (median, 4 vs. 1; P = 0.004). Multivariate analysis identified pre-prescribed OCS as an independent factor requiring four or more explanations (adjusted odds ratio, 10.50; P = 0.008). Exacerbation was the primary determinant of initiation (64.8 %).</div></div><div><h3>Conclusions</h3><div>Pre-prescribed OCS and frequent exacerbations contributed to delays in biologic initiation. To facilitate timely initiation, habitual pre-prescribed OCS use without an action plan should be avoided.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 5","pages":"Pages 718-722"},"PeriodicalIF":2.4,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144231020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical and complete remission in patients with severe asthma with 24-month dupilumab treatment","authors":"Tomoko Tajiri , Motohiko Suzuki , Hirono Nishiyama , Tatsuro Suzuki , Yuki Amakusa , Keima Ito , Yuta Mori , Kensuke Fukumitsu , Satoshi Fukuda , Yoshihiro Kanemitsu , Takehiro Uemura , Hirotsugu Ohkubo , Masaya Takemura , Yutaka Ito , Tetsuya Oguri , Akio Niimi","doi":"10.1016/j.resinv.2025.06.002","DOIUrl":"10.1016/j.resinv.2025.06.002","url":null,"abstract":"<div><h3>Background</h3><div>A few studies have reported asthma clinical remission with 24-month dupilumab therapy; however, complete remission remains unknown. In this post hoc analysis of our previous study, the achievement rates of clinical and complete remissions, and the factors associated with clinical remission with 24-month dupilumab therapy were assessed in adult patients with severe asthma.</div></div><div><h3>Methods</h3><div>Twenty-eight patients who had participated in our previous study were included. The primary outcome was the achievement rates of three-component clinical remission, four-component clinical remission, and complete remission at 24 months. The secondary outcome was the factors associated with achievement of four-component clinical remission at 24 months. Three-component or four-component clinical remission was defined as: 1) no significant asthma symptoms; 2) oral corticosteroid-free; 3) exacerbation-free; with or without 4) normalized pulmonary function. Complete remission was defined as four-component clinical remission plus 5) the resolution of asthma-related inflammation and 6) negative airway hyperresponsiveness.</div></div><div><h3>Results</h3><div>At 24 months, 19 (68 %), 16 (57 %), and 2 patients (7 %) achieved three-component, four-component clinical remission, and complete remission, respectively. At 24 months, patients with a higher incidence of comorbid chronic rhinosinusitis with nasal polyps, lower incidence of comorbid depression/anxiety, higher type 2 biomarkers, lower inhaled corticosteroid dose, better asthma control at baseline, and fewer exacerbations, unscheduled physicians’ visit or hospitalization in the previous year more frequently achieved four-component clinical remission than those without (all P < 0.05).</div></div><div><h3>Conclusions</h3><div>The achievement rates of clinical or complete remission were maintained for up to 24 months in patients with severe asthma receiving dupilumab therapy.</div></div><div><h3>Trial registration</h3><div>This study was registered in the UMIN Clinical Trial Registry (UMIN000038669)</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 5","pages":"Pages 711-717"},"PeriodicalIF":2.4,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation and management of rheumatoid arthritis-associated interstitial lung disease","authors":"Yuhei Ito , Yoshiyuki Arinuma , Ayako Nakajima","doi":"10.1016/j.resinv.2025.05.011","DOIUrl":"10.1016/j.resinv.2025.05.011","url":null,"abstract":"<div><div>Interstitial lung disease (ILD) is a significant extra-articular manifestation of rheumatoid arthritis (RA) that is associated with increased mortality risk and has a profound influence on treatment strategies. Early detection using advanced diagnostic tools, such as high-resolution computed tomography (HRCT), is crucial for evaluating RA-ILD and optimising patient outcomes. The traditional classification of RA-ILD into usual interstitial pneumonia and non-specific interstitial pneumonia patterns is challenging because RA-ILD exhibits features distinct from those of idiopathic interstitial pneumonia. Furthermore, the extent of ILD, as assessed using HRCT, has been increasingly recognised as a critical prognostic factor, emphasising its clinical relevance. As RA-ILD represents an organ-specific manifestation of a systemic inflammatory disease, its management should prioritise effective arthritis control. Growing evidence suggests that optimal arthritis control may mitigate the risk of RA-ILD development and progression. RA-ILD has often been diagnosed in advanced stages and managed using glucocorticoids (GCs) and immunosuppressive agents. However, increasing awareness of the toxicity associated with long-term use of GCs has prompted a shift toward the use of molecular-targeted therapies instead. Emerging data support the potential use of methotrexate in patients with RA and early-stage ILD, and the impact of molecular-targeting disease-modifying antirheumatic drugs on RA-ILD. Nintedanib, which has been shown to slow pulmonary function decline, should be considered in the appropriate stages of RA-ILD. As comprehensive follow-up strategies are essential for monitoring disease progression and guiding individualised treatment plans, effective management of RA-ILD requires multidisciplinary collaboration among rheumatologists, pulmonologists, and radiologists with continued research to improve RA-ILD outcomes.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 699-710"},"PeriodicalIF":2.4,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144212930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Innovative palliative approaches for terminal respiratory diseases: Exploring the effectiveness and pharmacokinetics of the blonanserin transdermal patch","authors":"Katsutoshi Ando , Ayumi Suzuki , Hiroki Yoshida","doi":"10.1016/j.resinv.2025.05.014","DOIUrl":"10.1016/j.resinv.2025.05.014","url":null,"abstract":"<div><h3>Background</h3><div>The blonanserin transdermal patch, the first antipsychotic patch approved in Japan for schizophrenia, was reported to reduce the prevalence of terminal delirium from 70.4 % to 16.3 % and manage refractory dyspnea in respiratory disease (Respir Invest 2023; 240–6). While parkinsonism and akathisia have been reported as adverse events in over 10 % of patients with schizophrenia, such side effects were rare in our terminally ill patient population. To further investigate its effectiveness in this patient population, we conducted a retrospective study with the additional aim of evaluating its pharmacokinetic profile.</div></div><div><h3>Methods</h3><div>We retrospectively reviewed the medical records of 150 terminally ill patients with respiratory diseases receiving home medical care and treated with the blonanserin transdermal patch. Plasma blonanserin levels were measured in 32 patients and compared with reconstructed clinical trial data using a normal distribution model.</div></div><div><h3>Results</h3><div>Twenty-eight patients (18.7 %) developed terminal delirium, which is consistent with our previous study findings. The treatment-emergent adverse events included extrapyramidal symptoms (5.3 %) and skin-related reactions (2.0 %). In previous clinical trials, plasma concentrations on days 7–8 following administration of the 40-mg blonanserin patch were reported as 0.70 ± 0.31 ng/mL, whereas in our study, the corresponding value was markedly lower at 0.29 ± 0.29 ng/mL. Additionally, statistical analysis confirmed that plasma concentrations in our population were significantly lower than those reported in clinical trial data (p = 0.022).</div></div><div><h3>Conclusion</h3><div>The blonanserin transdermal patch demonstrated therapeutic effectiveness and a favorable safety profile in terminally ill patients with respiratory diseases, despite reduced plasma concentrations.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 686-692"},"PeriodicalIF":2.4,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144189386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mechanisms of resistance to antibody–drug conjugates in cancers","authors":"Yuya Murase , Shigeki Nanjo , Tsukasa Ueda , Yifeng Liu , Shunichi Nomura , Sachiko Arai , Nanao Terada , Hayato Koba , Yuichi Tambo , Seiji Yano","doi":"10.1016/j.resinv.2025.05.012","DOIUrl":"10.1016/j.resinv.2025.05.012","url":null,"abstract":"<div><div>Cancer treatment has evolved dramatically in recent years with the advent of various modalities, including molecular-targeted drugs, monoclonal antibodies, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor T-cell therapy. Antibody–drug conjugates (ADCs) represent an important breakthrough in cancer treatment, and some ADCs have been approved for use in several types of cancers. Typical ADCs include trastuzumab emtansine for HER2-positive breast cancer, sacituzumab govitecan for triple-negative breast cancer (TNBC), and trastuzumab deruxtecan (T-DXd) for HER2-positive breast cancer, gastric cancer, and HER2 mutation-positive non-small cell lung cancer. Although they have shown therapeutic efficacy, almost all patients develop resistance via multiple mechanisms. In this article, we discuss the major mechanisms of resistance to ADCs, classifying them into five categories: mechanisms related to ‘target antigen,’ ‘decreased internalization,’ ‘lysosomal dysfunction,’ and ‘payload sensitivity’ and other resistance mechanisms [Figure 1]. We also discuss the strategies for overcoming ADC resistance.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 693-698"},"PeriodicalIF":2.4,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Treatment of small cell lung cancer; advances and future prospects","authors":"Seiji Niho","doi":"10.1016/j.resinv.2025.05.013","DOIUrl":"10.1016/j.resinv.2025.05.013","url":null,"abstract":"<div><div>For a long time, the standard chemotherapy for small cell lung cancer (SCLC) was a combination of platinum plus etoposide. In 2019, anti-PD-L1 antibodies atezolizumab or durvalumab were introduced for the treatment of extensive-stage (ES) SCLC in combination with chemotherapy. Two randomized phase III studies (IMpower 133 and CASPIAN) demonstrated that addition of atezolizumab or durvalumab to platinum plus etoposide prolonged the overall survival in ES-SCLC patients. In addition, consolidation therapy with durvalumab after chemoradiotherapy was also shown to prolong the overall survival in patients with limited-stage SCLC. Tarlatamab is a bispecific antibody that targets DLL3 and CD3. It binds to both DLL3 on cancer cells and CD3 on T cells, causing T-cell-mediated lysis of cancer cells. A phase II study (DeLLphi-301) showed a 40 % response rate and median progression-free survival of 4.9 months following tarlatamab administration in previously treated SCLC patients, which led to approval of this drug in Japan for the treatment of SCLC at the end of 2024. A molecular biological classification of SCLC was proposed in 2021. Four SCLC subtypes (SCLC-A, N, P, and I) were defined based on differential expression of some transcription factors. An exploratory subgroup analysis of data from IMpower 133 study demonstrated that patients with SCLC-I tumors derive the greatest benefit from the addition of atezolizumab to chemotherapy. Further development of effective treatments and additional biomarkers to predict efficacy is needed. Bispecific antibodies and/or antibody-drug conjugate could be the next candidates for breakthroughs in the treatment of SCLC.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 680-685"},"PeriodicalIF":2.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144170395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The hygiene environment during childhood may affect susceptibility to sarcoidosis: A case-control study of environmental risk factors","authors":"Michiru Sawahata , Naoto Arai , Ryohei Kamei , Hitokazu Tsukao , Noriharu Shijubo , Takeshi Hattori , Satoshi Konno , Koki Kosami , Masanari Kuwabara , Ryusuke Ae , Yosikazu Nakamura , Masashi Bando , Koichi Hagiwara , Makoto Maemondo","doi":"10.1016/j.resinv.2025.05.009","DOIUrl":"10.1016/j.resinv.2025.05.009","url":null,"abstract":"<div><h3>Background</h3><div>This study investigated the association between the development of sarcoidosis and environmental factors, focusing on the childhood hygiene environment.</div></div><div><h3>Methods</h3><div>This case-control study used a questionnaire administered to patients with sarcoidosis and residence-matched controls (age 18 to <90 years) in 7 prefectures between 2018 and 2020. Logistic regression analysis was performed to identify risk factors, including adulthood lifestyle history, childhood hygiene environment, and history of infections.</div></div><div><h3>Results</h3><div>One hundred sixty-four patients with sarcoidosis and 1779 controls (641 men, 1138 women) were enrolled. Multivariate analysis showed that smoking history during adulthood was associated with developing sarcoidosis (odds ratio [OR], 2.09; 95 % confidence interval [CI], 1.16–3.75). For the childhood hygiene environment, attending nursery school (OR, 2.76; 95 % CI, 1.57–4.84) and use of well water (OR, 2.89; 95 % CI, 1.65–5.07) at age 0–2 years were associated with developing sarcoidosis. The OR of attending nursery school at age 3–6 years (OR, 1.79; 95 % CI, 0.89–3.61) was lower than that at age 0–2 years, but the OR of use of well water at age 3–6 years (OR, 2.89; 95 % CI, 1.59–5.26) was still high. By contrast, the risk of developing sarcoidosis was lower for being breastfed (OR, 0.36; 95 % CI, 0.15–0.88). Development of sarcoidosis was associated with history of tuberculosis (OR, 5.82; 95 % CI, 1.28–26.53).</div></div><div><h3>Conclusions</h3><div>Both adulthood lifestyle history and childhood hygiene environment were associated with sarcoidosis. Daily direct exposure to diverse microorganisms during childhood may increase the likelihood of antigens for granuloma formation entering the body and also modify susceptibility to sarcoidosis.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 672-679"},"PeriodicalIF":2.4,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of the pleural fluid Rivalta test for diagnosing pleural effusion","authors":"Masafumi Shimoda, Yoshiaki Tanaka, Kozo Morimoto, Megumi Hirano, Kaori Nagao, Kozo Yoshimori, Ken Ohta","doi":"10.1016/j.resinv.2025.05.010","DOIUrl":"10.1016/j.resinv.2025.05.010","url":null,"abstract":"<div><h3>Introduction</h3><div>The Rivalta test is commonly used to differentiate exudates from transudates in body cavity effusions. However, its diagnostic utility for pleural effusion remains uncertain. This study aimed to evaluate the diagnostic performance of the Rivalta test in differentiating various types of pleural effusions.</div></div><div><h3>Methods</h3><div>Data were retrospectively collected from 1158 patients at Fukujuji Hospital between January 2012 and June 2024. The cohort included 202 patients with tuberculous pleurisy, 246 with pleural infection, 427 with malignant pleural effusion, 76 with transudative pleural effusion, and 207 with other diseases. Rivalta test-positive and Rivalta test-negative groups were compared, along with the Rivalta test results across five disease groups.</div></div><div><h3>Results</h3><div>Among all patients, 1099 (94.9 %) had a positive Rivalta test, while 59 (5.1 %) had a negative Rivalta test. Serum C-reactive protein and total pleural protein levels were significantly lower in the Rivalta test-negative group. A negative Rivalta test was significantly associated with transudative pleural effusion compared with exudative pleural effusion (tuberculous pleurisy, pleural infection, malignant pleural effusion, and other diseases) (<em>p</em> < 0.001), whereas no significant differences were observed among the exudative groups. The negative Rivalta test showed 35.5 % sensitivity and 97.0 % specificity for identifying transudative pleural effusion. The Rivalta test showed lower diagnostic accuracy than Light's criteria did (McNemar test, <em>p</em> < 0.001). When added to Light's criteria, the diagnostic accuracy decreased, with a net reclassification improvement of −65 %.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that the Rivalta test has lower diagnostic utility than Light's criteria and should not be incorporated into pleural effusion examinations.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 667-671"},"PeriodicalIF":2.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical impact of radiological pleuroparenchymal fibroelastosis-like lesions in fibrotic hypersensitivity pneumonitis and efficacy of antigen avoidance","authors":"Tadatsugu Yoshinaga , Hiroki Shoji , Shingo Imura , Yuhei Suzuki , Kenta Tanaka , Sae Takashima , Tomoko Kobori , Mototaka Hattori , Yumiko Ikubo , Shogo Kasai , Yasumi Okochi , Hitoshi Tokuda","doi":"10.1016/j.resinv.2025.05.008","DOIUrl":"10.1016/j.resinv.2025.05.008","url":null,"abstract":"<div><h3>Background</h3><div>Pleuroparenchymal fibroelastosis (PPFE)-like lesions are frequently observed on high-resolution computed tomography in patients with fibrotic hypersensitivity pneumonitis (f-HP). This study aimed to evaluate the association of these lesions with overall survival and disease progression in f-HP patients and to examine the efficacy of antigen avoidance.</div></div><div><h3>Methods</h3><div>A retrospective observational study of patients with f-HP was conducted in a single center. High-resolution computed tomography was used to assess the presence of radiological PPFE-like lesions.</div></div><div><h3>Results</h3><div>Radiological PPFE-like lesions were detected in 48 of the 107 patients analyzed (44.9 %). Lesions were significantly associated with death from any cause (hazard ratio, 2.32; 95 % confidence interval [CI], 1.13–4.95; p = 0.024) and disease progression (odds ratio, 2.90; 95 % CI, 1.17–7.50; p = 0.024). Antigen non-avoidance was a significant predictor of worse overall survival (hazard ratio, 2.67; 95 % CI, 1.31–5.76; p = 0.008) and disease progression (odds ratio, 3.62; 95 % CI, 1.52–8.96; p = 0.004). Overall survival was significantly better (p = 0.116) and annual decline in forced vital capacity was significantly smaller (p = 0.002) in patients with radiological PPFE-like lesions who achieved antigen avoidance than in those who did not.</div></div><div><h3>Conclusions</h3><div>Radiological PPFE-like lesions were associated with worse survival and decline in forced vital capacity in patients with f-HP. Antigen avoidance may improve survival and prevent disease progression in f-HP patients with lesions.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 660-666"},"PeriodicalIF":2.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-term safety and effectiveness of mepolizumab for patients with bronchial asthma in routine clinical practice in Japan — final report of special drug use investigation","authors":"Eriko Tsuboi , Hironobu Aoki , Kiyomi Aizawa , Masaki Komatsubara , Peter Howarth","doi":"10.1016/j.resinv.2025.05.003","DOIUrl":"10.1016/j.resinv.2025.05.003","url":null,"abstract":"<div><h3>Background</h3><div>Mepolizumab is an anti-interleukin-5 (IL-5) monoclonal antibody that blocks IL-5-driven airway inflammation, including eosinophilia. Mepolizumab is well tolerated and effective in reducing exacerbations in patients with bronchial asthma. However, limited real-world data are available for treatment outcomes of mepolizumab in patients with bronchial asthma in Japan. Therefore, this large-scale study aimed to assess the long-term safety and effectiveness of mepolizumab in patients with bronchial asthma in Japan.</div></div><div><h3>Methods</h3><div>In this real-world observational study conducted between January 2017 and September 2023, patients with bronchial asthma who had available data in an electronic data capture system for at least 52 weeks prior to subcutaneous mepolizumab treatment were monitored for 52 weeks from their first dose of mepolizumab. Safety was evaluated based on patient-reported adverse drug reactions (ADRs), and effectiveness was evaluated by frequency of asthma exacerbations, changes in Asthma Control Test (ACT) scores, and peak expiratory flow (PEF).</div></div><div><h3>Results</h3><div>Overall, 1061 patients were enrolled. ADRs were reported by 4.1 % of patients in the safety population (n = 1027). No new safety concerns were identified. The overall effectiveness was evaluated in 959 patients in the effectiveness population. Post-mepolizumab initiation, asthma exacerbations were reduced from 3.8 to 1.0 per person-year; mean (standard deviation [SD]) ACT scores improved from 15.9 (4.6) to 21.4 (3.9); mean (SD) PEF improved from 304.4 L/min (146.8) to 349.5 L/min (134.7) compared with pre-mepolizumab initiation.</div></div><div><h3>Conclusions</h3><div>This analysis of real-world data demonstrates that mepolizumab was well tolerated and effective in patients with bronchial asthma in Japan.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 4","pages":"Pages 651-659"},"PeriodicalIF":2.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144090231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}