M Ayano, K Tsubouchi, K Suzuki, Y Kimoto, Y Arinobu, K Akashi, T Horiuchi, I Okamoto, H Niiro
{"title":"比较宁替达尼起始剂量对结缔组织病相关间质性肺疾病患者的安全性和有效性。","authors":"M Ayano, K Tsubouchi, K Suzuki, Y Kimoto, Y Arinobu, K Akashi, T Horiuchi, I Okamoto, H Niiro","doi":"10.1080/03009742.2024.2327159","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to analyse whether initiating nintedanib treatment at a reduced dose could improve the treatment continuation rate while maintaining efficacy in patients with connective tissue disease (CTD)-associated interstitial lung disease.</p><p><strong>Method: </strong>In total, 51 patients (age 61.6 ± 13.2 years; 38 women, 13 men) were retrospectively analysed. The primary endpoint was the cumulative discontinuation rate due to adverse events. Secondary endpoints included changes in drug dosage, efficacy evaluated based on annual changes in forced vital capacity (FVC), and safety assessed based on the frequency of adverse events.</p><p><strong>Results: </strong>Eighteen patients who started treatment at the standard dose of 300 mg (standard dosage group) were compared with 33 patients who started treatment at a reduced dose (reduced dosage group). Systemic sclerosis was the most common CTD (n = 32), followed by idiopathic inflammatory myopathies and, rarely, rheumatoid arthritis. Both groups exhibited comparable cumulative discontinuation rates due to adverse events and similar frequencies of adverse events. No significant differences were observed in maintenance doses between the two groups; however, patients in the reduced dosage group had a lower cumulative dose for up to 52 weeks than those in the standard dosage group. No significant differences were observed in changes in FVC between the two groups.</p><p><strong>Conclusion: </strong>There was no evidence for a difference between the two groups in terms of discontinuation rates, efficacy, and safety. To provide further evidence, future studies using more precise dose-escalation protocols are warranted.</p>","PeriodicalId":21424,"journal":{"name":"Scandinavian Journal of Rheumatology","volume":" ","pages":"255-262"},"PeriodicalIF":2.2000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparing the safety and efficacy of nintedanib starting dose in patients with connective tissue disease-associated interstitial lung diseases.\",\"authors\":\"M Ayano, K Tsubouchi, K Suzuki, Y Kimoto, Y Arinobu, K Akashi, T Horiuchi, I Okamoto, H Niiro\",\"doi\":\"10.1080/03009742.2024.2327159\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aimed to analyse whether initiating nintedanib treatment at a reduced dose could improve the treatment continuation rate while maintaining efficacy in patients with connective tissue disease (CTD)-associated interstitial lung disease.</p><p><strong>Method: </strong>In total, 51 patients (age 61.6 ± 13.2 years; 38 women, 13 men) were retrospectively analysed. The primary endpoint was the cumulative discontinuation rate due to adverse events. Secondary endpoints included changes in drug dosage, efficacy evaluated based on annual changes in forced vital capacity (FVC), and safety assessed based on the frequency of adverse events.</p><p><strong>Results: </strong>Eighteen patients who started treatment at the standard dose of 300 mg (standard dosage group) were compared with 33 patients who started treatment at a reduced dose (reduced dosage group). Systemic sclerosis was the most common CTD (n = 32), followed by idiopathic inflammatory myopathies and, rarely, rheumatoid arthritis. Both groups exhibited comparable cumulative discontinuation rates due to adverse events and similar frequencies of adverse events. No significant differences were observed in maintenance doses between the two groups; however, patients in the reduced dosage group had a lower cumulative dose for up to 52 weeks than those in the standard dosage group. No significant differences were observed in changes in FVC between the two groups.</p><p><strong>Conclusion: </strong>There was no evidence for a difference between the two groups in terms of discontinuation rates, efficacy, and safety. To provide further evidence, future studies using more precise dose-escalation protocols are warranted.</p>\",\"PeriodicalId\":21424,\"journal\":{\"name\":\"Scandinavian Journal of Rheumatology\",\"volume\":\" \",\"pages\":\"255-262\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Scandinavian Journal of Rheumatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/03009742.2024.2327159\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/4/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Scandinavian Journal of Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/03009742.2024.2327159","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/4/2 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Comparing the safety and efficacy of nintedanib starting dose in patients with connective tissue disease-associated interstitial lung diseases.
Objective: This study aimed to analyse whether initiating nintedanib treatment at a reduced dose could improve the treatment continuation rate while maintaining efficacy in patients with connective tissue disease (CTD)-associated interstitial lung disease.
Method: In total, 51 patients (age 61.6 ± 13.2 years; 38 women, 13 men) were retrospectively analysed. The primary endpoint was the cumulative discontinuation rate due to adverse events. Secondary endpoints included changes in drug dosage, efficacy evaluated based on annual changes in forced vital capacity (FVC), and safety assessed based on the frequency of adverse events.
Results: Eighteen patients who started treatment at the standard dose of 300 mg (standard dosage group) were compared with 33 patients who started treatment at a reduced dose (reduced dosage group). Systemic sclerosis was the most common CTD (n = 32), followed by idiopathic inflammatory myopathies and, rarely, rheumatoid arthritis. Both groups exhibited comparable cumulative discontinuation rates due to adverse events and similar frequencies of adverse events. No significant differences were observed in maintenance doses between the two groups; however, patients in the reduced dosage group had a lower cumulative dose for up to 52 weeks than those in the standard dosage group. No significant differences were observed in changes in FVC between the two groups.
Conclusion: There was no evidence for a difference between the two groups in terms of discontinuation rates, efficacy, and safety. To provide further evidence, future studies using more precise dose-escalation protocols are warranted.
期刊介绍:
Scandinavian Journal of Rheumatology is the official journal of the Scandinavian Society for Rheumatology, a non-profit organization following the statutes of the Scandinavian Society for Rheumatology/Scandinavian Research Foundation. The main objective of the Foundation is to support research and promote information and knowledge about rheumatology and related fields. The annual surplus by running the Journal is awarded to young, talented, researchers within the field of rheumatology.pasting
The Scandinavian Journal of Rheumatology is an international scientific journal covering clinical and experimental aspects of rheumatic diseases. The journal provides essential reading for rheumatologists as well as general practitioners, orthopaedic surgeons, radiologists, pharmacologists, pathologists and other health professionals with an interest in patients with rheumatic diseases.
The journal publishes original articles as well as reviews, editorials, letters and supplements within the various fields of clinical and experimental rheumatology, including;
Epidemiology
Aetiology and pathogenesis
Treatment and prophylaxis
Laboratory aspects including genetics, biochemistry, immunology, immunopathology, microbiology, histopathology, pathophysiology and pharmacology
Radiological aspects including X-ray, ultrasonography, CT, MRI and other forms of imaging.