Annunziata Dattola, Nicoletta Bernardini, Francesca Svara, Anna Balato, Giacomo Caldarola, Domenico D'Amico, Clara De Simone, Eugenia Veronica Di Brizzi, Maria Esposito, Claudia Giofrè, Domenico Giordano, Claudio Guarneri, Francesco Loconsole, Viviana Lora, Gaia Moretta, Diego Orsini, Severino Persechino, Concetta Potenza, Simone Ragonesi, Giovanni Pellacani, Ketty Peris, Maria Concetta Fargnoli, Antonio Giovanni Richetta
{"title":"替雷珠单抗 200 毫克的疗效:一项意大利多中心研究。","authors":"Annunziata Dattola, Nicoletta Bernardini, Francesca Svara, Anna Balato, Giacomo Caldarola, Domenico D'Amico, Clara De Simone, Eugenia Veronica Di Brizzi, Maria Esposito, Claudia Giofrè, Domenico Giordano, Claudio Guarneri, Francesco Loconsole, Viviana Lora, Gaia Moretta, Diego Orsini, Severino Persechino, Concetta Potenza, Simone Ragonesi, Giovanni Pellacani, Ketty Peris, Maria Concetta Fargnoli, Antonio Giovanni Richetta","doi":"10.1080/09546634.2024.2420825","DOIUrl":null,"url":null,"abstract":"<p><p><b>Introduction:</b> Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden.</p><p><p><b>Methods:</b> This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks.</p><p><p><b>Results:</b> Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred.</p><p><p><b>Conclusions:</b> Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2420825"},"PeriodicalIF":0.0000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness of tildrakizumab 200 mg: an Italian multicenter study.\",\"authors\":\"Annunziata Dattola, Nicoletta Bernardini, Francesca Svara, Anna Balato, Giacomo Caldarola, Domenico D'Amico, Clara De Simone, Eugenia Veronica Di Brizzi, Maria Esposito, Claudia Giofrè, Domenico Giordano, Claudio Guarneri, Francesco Loconsole, Viviana Lora, Gaia Moretta, Diego Orsini, Severino Persechino, Concetta Potenza, Simone Ragonesi, Giovanni Pellacani, Ketty Peris, Maria Concetta Fargnoli, Antonio Giovanni Richetta\",\"doi\":\"10.1080/09546634.2024.2420825\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Introduction:</b> Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden.</p><p><p><b>Methods:</b> This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks.</p><p><p><b>Results:</b> Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred.</p><p><p><b>Conclusions:</b> Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.</p>\",\"PeriodicalId\":94235,\"journal\":{\"name\":\"The Journal of dermatological treatment\",\"volume\":\"35 1\",\"pages\":\"2420825\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Journal of dermatological treatment\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/09546634.2024.2420825\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of dermatological treatment","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/09546634.2024.2420825","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/27 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
简介:银屑病是一种慢性免疫介导疾病,治疗难度很大,尤其是病情严重或体重较重的患者。Tildrakizumab是一种抑制IL-23的单克隆抗体,已被批准用于治疗中度至重度银屑病,标准剂量为100毫克。对于体重超过90公斤或疾病负担较重的患者,200毫克的剂量可能会有更好的疗效:这项多中心、前瞻性研究评估了替雷珠单抗 200 毫克对中重度银屑病患者的有效性和安全性,重点关注那些面临特殊挑战的患者:体重超过 90 千克、基线 PASI ≥20 和难以治疗的区域。研究还比较了无生物反应和有生物反应经验的患者,以及男性和女性患者。成人患者在第0周和第4周皮下注射200毫克替雷珠单抗,然后每12周注射一次:使用 PASI、DLQI、生殖器 PASI 和 NAPSI 评分评估临床改善情况。24 周后,PASI 平均分从 14.6 分降至 0.4 分,PASI 90 分和 PASI 100 分超过 80%(分别为 100.0% 和 80.3%)。DLQI评分从14.2分降至1.8分,生殖器PASI和NAPSI评分也有显著改善。未发生重大不良事件:Tildrakizumab 200已被证明是一种有效的治疗选择,尤其适用于体重较重、疾病负担较重、敏感部位受累的患者,且没有出现新的安全信号。
Effectiveness of tildrakizumab 200 mg: an Italian multicenter study.
Introduction: Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden.
Methods: This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks.
Results: Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred.
Conclusions: Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.