{"title":"抗tnf - α生物仿制药的药物生存期、长期安全性和有效性:一项单中心回顾性研究","authors":"Giulia Nunziati, Antonella DI Cesare, Elia Rosi, Ilaria Scandagli, Gianmarco Silvi, Prisca Guerra, Francesca Prignano","doi":"10.23736/S2784-8671.25.08060-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated.</p><p><strong>Methods: </strong>We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period.</p><p><strong>Results: </strong>A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy.</p><p><strong>Conclusions: </strong>Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.</p>","PeriodicalId":14526,"journal":{"name":"Italian Journal of Dermatology and Venereology","volume":"160 3","pages":"204-211"},"PeriodicalIF":1.8000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study.\",\"authors\":\"Giulia Nunziati, Antonella DI Cesare, Elia Rosi, Ilaria Scandagli, Gianmarco Silvi, Prisca Guerra, Francesca Prignano\",\"doi\":\"10.23736/S2784-8671.25.08060-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated.</p><p><strong>Methods: </strong>We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period.</p><p><strong>Results: </strong>A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy.</p><p><strong>Conclusions: </strong>Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.</p>\",\"PeriodicalId\":14526,\"journal\":{\"name\":\"Italian Journal of Dermatology and Venereology\",\"volume\":\"160 3\",\"pages\":\"204-211\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Italian Journal of Dermatology and Venereology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.23736/S2784-8671.25.08060-0\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Italian Journal of Dermatology and Venereology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.23736/S2784-8671.25.08060-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study.
Background: In the current landscape of psoriasis therapeutic management, despite the more recent market introduction of highly targeted molecules such as anti-interleukins, anti-tumor necrosis factor alpha (anti-TNF-α) biologic agents still play a key role, partly due to the availability of cost-effective biosimilar alternatives. Retention rate, long-term safety and effectiveness of these drugs have rarely been investigated.
Methods: We carried out a retrospective monocentric study including patients treated with biosimilar adalimumab, biosimilar etanercept, and biosimilar infliximab to assess drug survival, safety and effectiveness of these drugs over an extended period.
Results: A total of 93 patients were included in this study, with a median treatment duration of 86 months. Drug survival at 12 months was 91.4%, declining to <50% at 86 months. Interestingly, no significant differences were observed among the three anti-TNF-α biosimilars in terms of drug survival. The presence of psoriatic arthritis (PsA) correlated with increased drug survival. Adverse drug reactions were reported in 61.3% of patients, with infections being the most common issue. Treatment discontinuation was predominantly due to loss of efficacy.
Conclusions: Despite certain limitations, such as the retrospective design and the monocentric nature of the study, our findings underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management, emphasizing the importance of considering disease characteristics in treatment decisions.