{"title":"基于中国银屑病患者真实世界数据的乌司替尼短期疗效和潜在因素。","authors":"Xingyu Li, Xiaowen Xie, Jiashuai Li, Jingjin Hu, Kun Hu, Minjia Tan, Jing Yang, Sichun Deng, Yijie Liu, Mi Zhang, Yehong Kuang, Junchen Chen, Liqiu Liao, Wu Zhu","doi":"10.1080/09546634.2024.2321188","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>As one of the most effective biologic treatments for psoriasis, the short-term effectiveness of ustekinumab has yet to be studied extensively.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the short-term effectiveness and potential factors within four weeks after the first-dose ustekinumab treatment based on real-world data.</p><p><strong>Methods: </strong>The study enrolled 98 patients with moderate-to-severe psoriasis, given ustekinumab 45 mg at week 0, week 4, and then every 12 weeks. Based on clinical data collected at baseline and week 4, we investigated the short-term effectiveness of ustekinumab after the first dose and potential factors associated with the treatment. For evaluation, we collected demographic information, body data, medical history, laboratory examination results, Psoriasis Area and Severity Index (PASI), body surface area (BSA), and dermatology life quality index (DLQI). Response rates were calculated based on the number of patients that achieved a 75/90/100% reduction in PASI (PASI 75/90/100), and the primary treatment goal was to achieve PASI 75.</p><p><strong>Results: </strong>The response rates for PASI 75/90/100 at week 4 were 30.5%, 18.9%, and 16.8%, respectively. For PASI 75, the response rate was higher in patients without metabolic syndrome (MS) (without MS vs. with MS: 36.9% vs. 5.9%, <i>p</i> = 0.013); the serum triglyceride (TG) level was significantly lower in patients achieving PASI 75 (expressed as mean ± standard deviation, achieved vs. unachieved: 1.82 ± 1.79 vs. 3.59 ± 8.89, <i>p</i> = 0.010). For PASI 100, the response rates were higher in female patients (female vs. male: 26.3% vs. 10.5%, <i>p</i> = 0.044) and patients with a family history of psoriasis (with family history vs. without family history: 44.4% vs. 13.9%, <i>p</i> = 0.042). In addition, the possibility of achieving PASI 75/90/100 went up along with the serum high-density lipoprotein cholesterol (HDL-C) level (expressed as adjusted odds ratio < 95% confidence interval>: PASI 75: 28.484 < 2.035-248.419>, <i>p</i> = 0.011; PASI 90: 28.226 < 2.828-281.729>, <i>p</i> = 0.004; PASI 100: 12.175 < 1.876-79.028>, <i>p</i> = 0.009).</p><p><strong>Conclusion: </strong>In this study, nearly one-third of patients achieved PASI 75 after only the first-dose ustekinumab treatment. Sex, family history of psoriasis, MS, serum TG level might affect the short-term effectiveness, and serum HDL-C level may be a potential factor. The possibility of achieving treatment goals (PASI 75/90/100) at week 4 increased along with serum HDL-C levels.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2321188"},"PeriodicalIF":0.0000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Short-term effectiveness and potential factors of ustekinumab based on real-world data in Chinese psoriasis patients.\",\"authors\":\"Xingyu Li, Xiaowen Xie, Jiashuai Li, Jingjin Hu, Kun Hu, Minjia Tan, Jing Yang, Sichun Deng, Yijie Liu, Mi Zhang, Yehong Kuang, Junchen Chen, Liqiu Liao, Wu Zhu\",\"doi\":\"10.1080/09546634.2024.2321188\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>As one of the most effective biologic treatments for psoriasis, the short-term effectiveness of ustekinumab has yet to be studied extensively.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the short-term effectiveness and potential factors within four weeks after the first-dose ustekinumab treatment based on real-world data.</p><p><strong>Methods: </strong>The study enrolled 98 patients with moderate-to-severe psoriasis, given ustekinumab 45 mg at week 0, week 4, and then every 12 weeks. Based on clinical data collected at baseline and week 4, we investigated the short-term effectiveness of ustekinumab after the first dose and potential factors associated with the treatment. For evaluation, we collected demographic information, body data, medical history, laboratory examination results, Psoriasis Area and Severity Index (PASI), body surface area (BSA), and dermatology life quality index (DLQI). Response rates were calculated based on the number of patients that achieved a 75/90/100% reduction in PASI (PASI 75/90/100), and the primary treatment goal was to achieve PASI 75.</p><p><strong>Results: </strong>The response rates for PASI 75/90/100 at week 4 were 30.5%, 18.9%, and 16.8%, respectively. For PASI 75, the response rate was higher in patients without metabolic syndrome (MS) (without MS vs. with MS: 36.9% vs. 5.9%, <i>p</i> = 0.013); the serum triglyceride (TG) level was significantly lower in patients achieving PASI 75 (expressed as mean ± standard deviation, achieved vs. unachieved: 1.82 ± 1.79 vs. 3.59 ± 8.89, <i>p</i> = 0.010). For PASI 100, the response rates were higher in female patients (female vs. male: 26.3% vs. 10.5%, <i>p</i> = 0.044) and patients with a family history of psoriasis (with family history vs. without family history: 44.4% vs. 13.9%, <i>p</i> = 0.042). In addition, the possibility of achieving PASI 75/90/100 went up along with the serum high-density lipoprotein cholesterol (HDL-C) level (expressed as adjusted odds ratio < 95% confidence interval>: PASI 75: 28.484 < 2.035-248.419>, <i>p</i> = 0.011; PASI 90: 28.226 < 2.828-281.729>, <i>p</i> = 0.004; PASI 100: 12.175 < 1.876-79.028>, <i>p</i> = 0.009).</p><p><strong>Conclusion: </strong>In this study, nearly one-third of patients achieved PASI 75 after only the first-dose ustekinumab treatment. Sex, family history of psoriasis, MS, serum TG level might affect the short-term effectiveness, and serum HDL-C level may be a potential factor. The possibility of achieving treatment goals (PASI 75/90/100) at week 4 increased along with serum HDL-C levels.</p>\",\"PeriodicalId\":94235,\"journal\":{\"name\":\"The Journal of dermatological treatment\",\"volume\":\"35 1\",\"pages\":\"2321188\"},\"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/10.1080/09546634.2024.2321188\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/26 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/10.1080/09546634.2024.2321188","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/26 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景:乌斯特库单抗是治疗银屑病最有效的生物制剂之一:作为治疗银屑病最有效的生物制剂之一,乌斯特库单抗的短期疗效尚未得到广泛研究:本研究的目的是根据真实世界的数据,评估首剂乌司替库单抗治疗后四周内的短期疗效和潜在因素:该研究招募了98名中度至重度银屑病患者,分别在第0周、第4周和每12周给予45毫克的乌斯特库单抗。根据基线和第 4 周收集的临床数据,我们调查了乌斯特库单抗首次用药后的短期疗效以及与治疗相关的潜在因素。为了进行评估,我们收集了人口统计学信息、身体数据、病史、实验室检查结果、银屑病面积和严重程度指数(PASI)、体表面积(BSA)和皮肤科生活质量指数(DLQI)。应答率根据 PASI 减少 75/90/100% (PASI 75/90/100)的患者人数计算,主要治疗目标是达到 PASI 75:第 4 周时,PASI 75/90/100 的应答率分别为 30.5%、18.9% 和 16.8%。就 PASI 75 而言,无代谢综合征(MS)患者的应答率更高(无代谢综合征与有代谢综合征患者相比:36.9% 对 5.9%,P = 0.013);达到 PASI 75 的患者血清甘油三酯(TG)水平显著降低(以平均值±标准差表示,达到与未达到:1.82 ± 1.79 对 1.82 ± 1.79,P = 0.013):1.82 ± 1.79 vs. 3.59 ± 8.89,p = 0.010)。就 PASI 100 而言,女性患者(女性对男性:26.3% 对 10.5%,p = 0.044)和有银屑病家族史的患者(有家族史对无家族史:44.4% 对 13.9%,p = 0.042)的应答率更高。此外,达到 PASI 75/90/100 的可能性随着血清高密度脂蛋白胆固醇(HDL-C)水平的升高而升高(以调整后的几率<95%置信区间>表示:PASI 75:28.484,p = 0.011;PASI 90:28.226,p = 0.004;PASI 100:12.175,p = 0.009):结论:在这项研究中,近三分之一的患者仅在接受第一剂乌司替尼治疗后就达到了 PASI 75。性别、银屑病家族史、多发性硬化症、血清 TG 水平可能会影响短期疗效,而血清 HDL-C 水平可能是一个潜在因素。第 4 周达到治疗目标(PASI 75/90/100)的可能性随着血清 HDL-C 水平的升高而增加。
Short-term effectiveness and potential factors of ustekinumab based on real-world data in Chinese psoriasis patients.
Background: As one of the most effective biologic treatments for psoriasis, the short-term effectiveness of ustekinumab has yet to be studied extensively.
Objective: The purpose of this study was to evaluate the short-term effectiveness and potential factors within four weeks after the first-dose ustekinumab treatment based on real-world data.
Methods: The study enrolled 98 patients with moderate-to-severe psoriasis, given ustekinumab 45 mg at week 0, week 4, and then every 12 weeks. Based on clinical data collected at baseline and week 4, we investigated the short-term effectiveness of ustekinumab after the first dose and potential factors associated with the treatment. For evaluation, we collected demographic information, body data, medical history, laboratory examination results, Psoriasis Area and Severity Index (PASI), body surface area (BSA), and dermatology life quality index (DLQI). Response rates were calculated based on the number of patients that achieved a 75/90/100% reduction in PASI (PASI 75/90/100), and the primary treatment goal was to achieve PASI 75.
Results: The response rates for PASI 75/90/100 at week 4 were 30.5%, 18.9%, and 16.8%, respectively. For PASI 75, the response rate was higher in patients without metabolic syndrome (MS) (without MS vs. with MS: 36.9% vs. 5.9%, p = 0.013); the serum triglyceride (TG) level was significantly lower in patients achieving PASI 75 (expressed as mean ± standard deviation, achieved vs. unachieved: 1.82 ± 1.79 vs. 3.59 ± 8.89, p = 0.010). For PASI 100, the response rates were higher in female patients (female vs. male: 26.3% vs. 10.5%, p = 0.044) and patients with a family history of psoriasis (with family history vs. without family history: 44.4% vs. 13.9%, p = 0.042). In addition, the possibility of achieving PASI 75/90/100 went up along with the serum high-density lipoprotein cholesterol (HDL-C) level (expressed as adjusted odds ratio < 95% confidence interval>: PASI 75: 28.484 < 2.035-248.419>, p = 0.011; PASI 90: 28.226 < 2.828-281.729>, p = 0.004; PASI 100: 12.175 < 1.876-79.028>, p = 0.009).
Conclusion: In this study, nearly one-third of patients achieved PASI 75 after only the first-dose ustekinumab treatment. Sex, family history of psoriasis, MS, serum TG level might affect the short-term effectiveness, and serum HDL-C level may be a potential factor. The possibility of achieving treatment goals (PASI 75/90/100) at week 4 increased along with serum HDL-C levels.