Johan Sieborg, Julia-Tatjana Maul, Jashin J Wu, Nikolai Nguyen Loft, Lone Skov, Lars Erik Bryld, Mads Kirchheiner Rasmussen, Tomas Norman Dam, Trine Bertelsen, Kawa Khaled Ajgeiy, Simon Francis Thomsen, Jacob P Thyssen, Alexander Egeberg, David Thein
{"title":"银屑病生物仿制药SB5与GP2017在阿达木单抗起始药强制非医疗转换后的实际药物生存期:一项全国队列研究","authors":"Johan Sieborg, Julia-Tatjana Maul, Jashin J Wu, Nikolai Nguyen Loft, Lone Skov, Lars Erik Bryld, Mads Kirchheiner Rasmussen, Tomas Norman Dam, Trine Bertelsen, Kawa Khaled Ajgeiy, Simon Francis Thomsen, Jacob P Thyssen, Alexander Egeberg, David Thein","doi":"10.2340/actadv.v105.42572","DOIUrl":null,"url":null,"abstract":"<p><p>Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study's objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58-2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.</p>","PeriodicalId":6944,"journal":{"name":"Acta dermato-venereologica","volume":"105 ","pages":"adv42572"},"PeriodicalIF":3.5000,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898103/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study.\",\"authors\":\"Johan Sieborg, Julia-Tatjana Maul, Jashin J Wu, Nikolai Nguyen Loft, Lone Skov, Lars Erik Bryld, Mads Kirchheiner Rasmussen, Tomas Norman Dam, Trine Bertelsen, Kawa Khaled Ajgeiy, Simon Francis Thomsen, Jacob P Thyssen, Alexander Egeberg, David Thein\",\"doi\":\"10.2340/actadv.v105.42572\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study's objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58-2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.</p>\",\"PeriodicalId\":6944,\"journal\":{\"name\":\"Acta dermato-venereologica\",\"volume\":\"105 \",\"pages\":\"adv42572\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-03-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11898103/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta dermato-venereologica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2340/actadv.v105.42572\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta dermato-venereologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2340/actadv.v105.42572","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study.
Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study's objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58-2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.
期刊介绍:
Acta Dermato-Venereologica publishes high-quality manuscripts in English in the field of Dermatology and Venereology, dealing with new observations on basic dermatological and venereological research, as well as clinical investigations. Each volume also features a number of Review articles in special areas, as well as short Letters to the Editor to stimulate debate and to disseminate important clinical observations. Acta Dermato-Venereologica has rapid publication times and is amply illustrated with a large number of colour photographs.