阿达木单抗与乌司奴单抗治疗中重度斑块型银屑病的疗效及复发的比较 : = Comparison of Efficacy and Relapse of Adalimumab and Ustekinumab in Treatment of Moderate to Severe Psoriasis
目的比较两种生物制剂(乌司奴单抗UST和阿达木单抗ADA)治疗中重度斑块型银屑病的疗效、停药复发情况,探索复发先后相关的原因。方法对比两项Ⅲ期临床研究(UST 52例,ADA 40例):①治疗终点的疗效;②研究完成后,在最后一次注射试验药物后的12周±7天、24周±7天、36周±7天、48周±7天,四个停药访视点银屑病患者皮损面积和严重性指数(PASI)积分达到100%、90%、75%、50%的患者应答的人数用PASI100、PASI90、PASI75、PASI50表示;③停药复发先后与人口学及临床特征的相关性。结果①治疗终点两药PASI100、PASI90、PASI75应答率差异无统计学意义(PASI75的应答率ADA 92.16%和UST 100%);②停药后ADA比UST先失去PASI100、PASI90、PASI75、PASI50的应答;停药时间越长,ADA失去应答越多(停药48周时ADA组有2/3的患者复发,UST组不到1/4);③停药后复发者特征:UST皮损类型为混合型(即斑块型合并点滴型)的患者失去应答更快;ADA皮损颜色呈鲜红色、皮损瘙痒评分高、皮损面积大于30%、病程长的患者失去应答更快,复发早。结论两种生物制剂对中重度斑块型银屑病的疗效肯定,随着停药时间延长,UST治疗组皮损呈混合型者、ADA治疗组皮损颜色呈鲜红色者先失去疗效。.
Objective To compare two biological agents adalimumab(ADA) and ustekinumab(UST) in the treatment of moderate to severe plaque psoriasis in terms of efficacy and time to relapse after drug withdrawal,and to analyze the causes associated with relapse.Methods Two phase Ⅲ clinical studies(UST52,ADA40) were compared:① the efficacy of treatment endpoint;② the number of patients who achieved PASI100,PASI90,PASI75,and PASI50 responses in four drug withdrawal visits as follows:12 weeks ± 7 days,24 weeks ± 7 days,36 weeks ± 7 days,48 weeks ± 7 days after the last injection of the drug;③ analysis of the correlation of the recurrence of drug withdrawal and demographic and clinical features.Results ① At the end of the treatment,there were no significant differences in response rates;PASI75 was 92.16%(ADA) and 100%(UST),respectively.② After drug withdrawal loss of PASI100,PASI90,PASI75 and PASI50 responses were first seen for ADA compared to UST.The longer the drug withdrawal time,the more the ADA-treated patients lost the response,2/3 of ADA-treated patients relapsed at 48 weeks after drug withdrawal compared with 1/4 of UST-treated patients.③ Clinical features of relapse:patients with mixed(plaque with papules) type of lesion lost responses more quickly in UST group;patients with red color lesion,severe pruritus,longer duration of disease and larger skin lesion area(BSA)>30% lost responses more quickly in adalimumab group.Conclusion The efficacy of two biologics in the treatment of moderate to severe plaque psoriasis is certain.With the prolonged drug withdrawal time,patients with mixed(plaque with papules) type of skin lesion in UST group and red color skin lesion in ADA group lost its efficacy first..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019-11-06 16:30 2019 |
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| Erschienen: |
2019-11-06 16:30 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2019 |
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| Enthalten in: |
Zhong guo pi fu xing bing xue za zhi - (2019), 12 vom: 06 16:30. Nov., Seite 1376-1382 Original Letters: Enthalten in 中国皮肤性病学杂志 (DE-600)2994200-7 (DE-600)2994200-7 陕西省西安市 |
| Reihe: |
China Academic Journals (CAJ), E, 医药卫生科技 = Medicine & Public Health |
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| Sprache: |
Chinesisch |
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| Weiterer Titel: |
Comparison of Efficacy and Relapse of Adalimumab and Ustekinumab in Treatment of Moderate to Severe Psoriasis |
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| Beteiligte Personen: |
NINA Bhochhibhoya [VerfasserIn] |
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| Links: |
oversea.cnki.net [lizenzpflichtig] |
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| Anmerkungen: |
Author info:NINA Bhochhibhoya;ZHANG Lina;ZHENG Jie;LI Xia;Department of Dermatology,Ruijin Hospital,Shanghai Jiaotong University School of Medicine;Department of Biostatistics,Shanghai Jiaotong University School of Medicine |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CAJ645916811 |
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| 245 | 1 | 0 | |a 阿达木单抗与乌司奴单抗治疗中重度斑块型银屑病的疗效及复发的比较 |b = Comparison of Efficacy and Relapse of Adalimumab and Ustekinumab in Treatment of Moderate to Severe Psoriasis |
| 246 | 3 | 1 | |a Comparison of Efficacy and Relapse of Adalimumab and Ustekinumab in Treatment of Moderate to Severe Psoriasis |
| 264 | 1 | |c 2019-11-06 16:30 | |
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| 500 | |a Author info:NINA Bhochhibhoya;ZHANG Lina;ZHENG Jie;LI Xia;Department of Dermatology,Ruijin Hospital,Shanghai Jiaotong University School of Medicine;Department of Biostatistics,Shanghai Jiaotong University School of Medicine | ||
| 520 | |a 目的比较两种生物制剂(乌司奴单抗UST和阿达木单抗ADA)治疗中重度斑块型银屑病的疗效、停药复发情况,探索复发先后相关的原因。方法对比两项Ⅲ期临床研究(UST 52例,ADA 40例):①治疗终点的疗效;②研究完成后,在最后一次注射试验药物后的12周±7天、24周±7天、36周±7天、48周±7天,四个停药访视点银屑病患者皮损面积和严重性指数(PASI)积分达到100%、90%、75%、50%的患者应答的人数用PASI100、PASI90、PASI75、PASI50表示;③停药复发先后与人口学及临床特征的相关性。结果①治疗终点两药PASI100、PASI90、PASI75应答率差异无统计学意义(PASI75的应答率ADA 92.16%和UST 100%);②停药后ADA比UST先失去PASI100、PASI90、PASI75、PASI50的应答;停药时间越长,ADA失去应答越多(停药48周时ADA组有2/3的患者复发,UST组不到1/4);③停药后复发者特征:UST皮损类型为混合型(即斑块型合并点滴型)的患者失去应答更快;ADA皮损颜色呈鲜红色、皮损瘙痒评分高、皮损面积大于30%、病程长的患者失去应答更快,复发早。结论两种生物制剂对中重度斑块型银屑病的疗效肯定,随着停药时间延长,UST治疗组皮损呈混合型者、ADA治疗组皮损颜色呈鲜红色者先失去疗效。 | ||
| 520 | |a Objective To compare two biological agents adalimumab(ADA) and ustekinumab(UST) in the treatment of moderate to severe plaque psoriasis in terms of efficacy and time to relapse after drug withdrawal,and to analyze the causes associated with relapse.Methods Two phase Ⅲ clinical studies(UST52,ADA40) were compared:① the efficacy of treatment endpoint;② the number of patients who achieved PASI100,PASI90,PASI75,and PASI50 responses in four drug withdrawal visits as follows:12 weeks ± 7 days,24 weeks ± 7 days,36 weeks ± 7 days,48 weeks ± 7 days after the last injection of the drug;③ analysis of the correlation of the recurrence of drug withdrawal and demographic and clinical features.Results ① At the end of the treatment,there were no significant differences in response rates;PASI75 was 92.16%(ADA) and 100%(UST),respectively.② After drug withdrawal loss of PASI100,PASI90,PASI75 and PASI50 responses were first seen for ADA compared to UST.The longer the drug withdrawal time,the more the ADA-treated patients lost the response,2/3 of ADA-treated patients relapsed at 48 weeks after drug withdrawal compared with 1/4 of UST-treated patients.③ Clinical features of relapse:patients with mixed(plaque with papules) type of lesion lost responses more quickly in UST group;patients with red color lesion,severe pruritus,longer duration of disease and larger skin lesion area(BSA)>30% lost responses more quickly in adalimumab group.Conclusion The efficacy of two biologics in the treatment of moderate to severe plaque psoriasis is certain.With the prolonged drug withdrawal time,patients with mixed(plaque with papules) type of skin lesion in UST group and red color skin lesion in ADA group lost its efficacy first. | ||
| 610 | 2 | 4 | |a 上海交通大学医学院附属瑞金医院皮肤科 |
| 610 | 2 | 4 | |a 上海交通大学医学院生物统计教研室 |
| 650 | 4 | |a 皮肤病学与性病学 | |
| 650 | 4 | |a 医药、卫生 | |
| 650 | 4 | |a Dermatosis and Venereal Disease | |
| 650 | 4 | |a 医药卫生科技 | |
| 650 | 4 | |a Medicine & Public Health | |
| 650 | 4 | |a 银屑病 | |
| 650 | 4 | |a 生物制剂 | |
| 650 | 4 | |a 阿达木单抗 | |
| 650 | 4 | |a 乌司奴单抗 | |
| 650 | 4 | |a 停药复发 | |
| 650 | 4 | |a Psoriasis | |
| 650 | 4 | |a Biologic agent | |
| 650 | 4 | |a Adalimumab | |
| 650 | 4 | |a Ustekinumab | |
| 650 | 4 | |a Relapse after drug withdrawal | |
| 700 | 0 | |a 张莉娜 |4 oth | |
| 700 | 0 | |a 郑捷 |4 oth | |
| 700 | 0 | |a 李霞 |4 oth | |
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