A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis

Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randoml...
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Autor*in:	Lin Cai [verfasserIn] Gen-Hui Chen [verfasserIn] Qian-Jin Lu [verfasserIn] Min Zheng [verfasserIn] Yu-Zhen Li [verfasserIn] Jin Chen [verfasserIn] Jie Zheng [verfasserIn] Fu-Ren Zhang [verfasserIn] Jian-Bin Yu [verfasserIn] Sen Yang [verfasserIn] Fu-Qiu Li [verfasserIn] Sheng-Xiang Xiao [verfasserIn] Qiu-Ning Sun [verfasserIn] Jin-Hua Xu [verfasserIn] Xing-Hua Gao [verfasserIn] Hong Fang [verfasserIn] Tian-Wen Gao [verfasserIn] Fei Hao [verfasserIn] Quan-Zhong Liu [verfasserIn] Ya-Ting Tu [verfasserIn] Ruo-Yu Li [verfasserIn] Bao-Xi Wang [verfasserIn] Dan-Qi Deng [verfasserIn] Qing-Shan Zheng [verfasserIn] Hong-Xia Liu [verfasserIn] Jian-Zhong Zhang [verfasserIn] Li-Shao Guo. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Übergeordnetes Werk:	In: Chinese Medical Journal - Wolters Kluwer, 2004, 133(2020), 24, Seite 2905-2909
Übergeordnetes Werk:	volume:133 ; year:2020 ; number:24 ; pages:2905-2909

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc Journal toc

DOI / URN:	10.1097/CM9.0000000000001221

Katalog-ID:	DOAJ050571044

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245	1	2	\|a A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
264		1	\|c 2020
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520			\|a Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
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700	0		\|a Qian-Jin Lu \|e verfasserin \|4 aut
700	0		\|a Min Zheng \|e verfasserin \|4 aut
700	0		\|a Yu-Zhen Li \|e verfasserin \|4 aut
700	0		\|a Jin Chen \|e verfasserin \|4 aut
700	0		\|a Jie Zheng \|e verfasserin \|4 aut
700	0		\|a Fu-Ren Zhang \|e verfasserin \|4 aut
700	0		\|a Jian-Bin Yu \|e verfasserin \|4 aut
700	0		\|a Sen Yang \|e verfasserin \|4 aut
700	0		\|a Fu-Qiu Li \|e verfasserin \|4 aut
700	0		\|a Sheng-Xiang Xiao \|e verfasserin \|4 aut
700	0		\|a Qiu-Ning Sun \|e verfasserin \|4 aut
700	0		\|a Jin-Hua Xu \|e verfasserin \|4 aut
700	0		\|a Xing-Hua Gao \|e verfasserin \|4 aut
700	0		\|a Hong Fang \|e verfasserin \|4 aut
700	0		\|a Tian-Wen Gao \|e verfasserin \|4 aut
700	0		\|a Fei Hao \|e verfasserin \|4 aut
700	0		\|a Quan-Zhong Liu \|e verfasserin \|4 aut
700	0		\|a Ya-Ting Tu \|e verfasserin \|4 aut
700	0		\|a Ruo-Yu Li \|e verfasserin \|4 aut
700	0		\|a Bao-Xi Wang \|e verfasserin \|4 aut
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700	0		\|a Hong-Xia Liu \|e verfasserin \|4 aut
700	0		\|a Jian-Zhong Zhang \|e verfasserin \|4 aut
700	0		\|a Li-Shao Guo. \|e verfasserin \|4 aut
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allfields	10.1097/CM9.0000000000001221 doi (DE-627)DOAJ050571044 (DE-599)DOAJ04f41d1851b94e88b9901be1e565abef DE-627 ger DE-627 rakwb eng Lin Cai verfasserin aut A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300. Medicine R Gen-Hui Chen verfasserin aut Qian-Jin Lu verfasserin aut Min Zheng verfasserin aut Yu-Zhen Li verfasserin aut Jin Chen verfasserin aut Jie Zheng verfasserin aut Fu-Ren Zhang verfasserin aut Jian-Bin Yu verfasserin aut Sen Yang verfasserin aut Fu-Qiu Li verfasserin aut Sheng-Xiang Xiao verfasserin aut Qiu-Ning Sun verfasserin aut Jin-Hua Xu verfasserin aut Xing-Hua Gao verfasserin aut Hong Fang verfasserin aut Tian-Wen Gao verfasserin aut Fei Hao verfasserin aut Quan-Zhong Liu verfasserin aut Ya-Ting Tu verfasserin aut Ruo-Yu Li verfasserin aut Bao-Xi Wang verfasserin aut Dan-Qi Deng verfasserin aut Qing-Shan Zheng verfasserin aut Hong-Xia Liu verfasserin aut Jian-Zhong Zhang verfasserin aut Li-Shao Guo. verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 133(2020), 24, Seite 2905-2909 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:133 year:2020 number:24 pages:2905-2909 https://doi.org/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/article/04f41d1851b94e88b9901be1e565abef kostenfrei http://journals.lww.com/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei https://doaj.org/toc/2542-5641 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 133 2020 24 2905-2909
spelling	10.1097/CM9.0000000000001221 doi (DE-627)DOAJ050571044 (DE-599)DOAJ04f41d1851b94e88b9901be1e565abef DE-627 ger DE-627 rakwb eng Lin Cai verfasserin aut A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300. Medicine R Gen-Hui Chen verfasserin aut Qian-Jin Lu verfasserin aut Min Zheng verfasserin aut Yu-Zhen Li verfasserin aut Jin Chen verfasserin aut Jie Zheng verfasserin aut Fu-Ren Zhang verfasserin aut Jian-Bin Yu verfasserin aut Sen Yang verfasserin aut Fu-Qiu Li verfasserin aut Sheng-Xiang Xiao verfasserin aut Qiu-Ning Sun verfasserin aut Jin-Hua Xu verfasserin aut Xing-Hua Gao verfasserin aut Hong Fang verfasserin aut Tian-Wen Gao verfasserin aut Fei Hao verfasserin aut Quan-Zhong Liu verfasserin aut Ya-Ting Tu verfasserin aut Ruo-Yu Li verfasserin aut Bao-Xi Wang verfasserin aut Dan-Qi Deng verfasserin aut Qing-Shan Zheng verfasserin aut Hong-Xia Liu verfasserin aut Jian-Zhong Zhang verfasserin aut Li-Shao Guo. verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 133(2020), 24, Seite 2905-2909 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:133 year:2020 number:24 pages:2905-2909 https://doi.org/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/article/04f41d1851b94e88b9901be1e565abef kostenfrei http://journals.lww.com/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei https://doaj.org/toc/2542-5641 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 133 2020 24 2905-2909
allfields_unstemmed	10.1097/CM9.0000000000001221 doi (DE-627)DOAJ050571044 (DE-599)DOAJ04f41d1851b94e88b9901be1e565abef DE-627 ger DE-627 rakwb eng Lin Cai verfasserin aut A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300. Medicine R Gen-Hui Chen verfasserin aut Qian-Jin Lu verfasserin aut Min Zheng verfasserin aut Yu-Zhen Li verfasserin aut Jin Chen verfasserin aut Jie Zheng verfasserin aut Fu-Ren Zhang verfasserin aut Jian-Bin Yu verfasserin aut Sen Yang verfasserin aut Fu-Qiu Li verfasserin aut Sheng-Xiang Xiao verfasserin aut Qiu-Ning Sun verfasserin aut Jin-Hua Xu verfasserin aut Xing-Hua Gao verfasserin aut Hong Fang verfasserin aut Tian-Wen Gao verfasserin aut Fei Hao verfasserin aut Quan-Zhong Liu verfasserin aut Ya-Ting Tu verfasserin aut Ruo-Yu Li verfasserin aut Bao-Xi Wang verfasserin aut Dan-Qi Deng verfasserin aut Qing-Shan Zheng verfasserin aut Hong-Xia Liu verfasserin aut Jian-Zhong Zhang verfasserin aut Li-Shao Guo. verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 133(2020), 24, Seite 2905-2909 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:133 year:2020 number:24 pages:2905-2909 https://doi.org/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/article/04f41d1851b94e88b9901be1e565abef kostenfrei http://journals.lww.com/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei https://doaj.org/toc/2542-5641 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 133 2020 24 2905-2909
allfieldsGer	10.1097/CM9.0000000000001221 doi (DE-627)DOAJ050571044 (DE-599)DOAJ04f41d1851b94e88b9901be1e565abef DE-627 ger DE-627 rakwb eng Lin Cai verfasserin aut A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300. Medicine R Gen-Hui Chen verfasserin aut Qian-Jin Lu verfasserin aut Min Zheng verfasserin aut Yu-Zhen Li verfasserin aut Jin Chen verfasserin aut Jie Zheng verfasserin aut Fu-Ren Zhang verfasserin aut Jian-Bin Yu verfasserin aut Sen Yang verfasserin aut Fu-Qiu Li verfasserin aut Sheng-Xiang Xiao verfasserin aut Qiu-Ning Sun verfasserin aut Jin-Hua Xu verfasserin aut Xing-Hua Gao verfasserin aut Hong Fang verfasserin aut Tian-Wen Gao verfasserin aut Fei Hao verfasserin aut Quan-Zhong Liu verfasserin aut Ya-Ting Tu verfasserin aut Ruo-Yu Li verfasserin aut Bao-Xi Wang verfasserin aut Dan-Qi Deng verfasserin aut Qing-Shan Zheng verfasserin aut Hong-Xia Liu verfasserin aut Jian-Zhong Zhang verfasserin aut Li-Shao Guo. verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 133(2020), 24, Seite 2905-2909 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:133 year:2020 number:24 pages:2905-2909 https://doi.org/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/article/04f41d1851b94e88b9901be1e565abef kostenfrei http://journals.lww.com/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei https://doaj.org/toc/2542-5641 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 133 2020 24 2905-2909
allfieldsSound	10.1097/CM9.0000000000001221 doi (DE-627)DOAJ050571044 (DE-599)DOAJ04f41d1851b94e88b9901be1e565abef DE-627 ger DE-627 rakwb eng Lin Cai verfasserin aut A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300. Medicine R Gen-Hui Chen verfasserin aut Qian-Jin Lu verfasserin aut Min Zheng verfasserin aut Yu-Zhen Li verfasserin aut Jin Chen verfasserin aut Jie Zheng verfasserin aut Fu-Ren Zhang verfasserin aut Jian-Bin Yu verfasserin aut Sen Yang verfasserin aut Fu-Qiu Li verfasserin aut Sheng-Xiang Xiao verfasserin aut Qiu-Ning Sun verfasserin aut Jin-Hua Xu verfasserin aut Xing-Hua Gao verfasserin aut Hong Fang verfasserin aut Tian-Wen Gao verfasserin aut Fei Hao verfasserin aut Quan-Zhong Liu verfasserin aut Ya-Ting Tu verfasserin aut Ruo-Yu Li verfasserin aut Bao-Xi Wang verfasserin aut Dan-Qi Deng verfasserin aut Qing-Shan Zheng verfasserin aut Hong-Xia Liu verfasserin aut Jian-Zhong Zhang verfasserin aut Li-Shao Guo. verfasserin aut In Chinese Medical Journal Wolters Kluwer, 2004 133(2020), 24, Seite 2905-2909 (DE-627)363772693 (DE-600)2108782-9 25425641 nnns volume:133 year:2020 number:24 pages:2905-2909 https://doi.org/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/article/04f41d1851b94e88b9901be1e565abef kostenfrei http://journals.lww.com/10.1097/CM9.0000000000001221 kostenfrei https://doaj.org/toc/0366-6999 Journal toc kostenfrei https://doaj.org/toc/2542-5641 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 133 2020 24 2905-2909
language	English
source	In Chinese Medical Journal 133(2020), 24, Seite 2905-2909 volume:133 year:2020 number:24 pages:2905-2909
sourceStr	In Chinese Medical Journal 133(2020), 24, Seite 2905-2909 volume:133 year:2020 number:24 pages:2905-2909
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Medicine R
isfreeaccess_bool	true
container_title	Chinese Medical Journal
authorswithroles_txt_mv	Lin Cai @@aut@@ Gen-Hui Chen @@aut@@ Qian-Jin Lu @@aut@@ Min Zheng @@aut@@ Yu-Zhen Li @@aut@@ Jin Chen @@aut@@ Jie Zheng @@aut@@ Fu-Ren Zhang @@aut@@ Jian-Bin Yu @@aut@@ Sen Yang @@aut@@ Fu-Qiu Li @@aut@@ Sheng-Xiang Xiao @@aut@@ Qiu-Ning Sun @@aut@@ Jin-Hua Xu @@aut@@ Xing-Hua Gao @@aut@@ Hong Fang @@aut@@ Tian-Wen Gao @@aut@@ Fei Hao @@aut@@ Quan-Zhong Liu @@aut@@ Ya-Ting Tu @@aut@@ Ruo-Yu Li @@aut@@ Bao-Xi Wang @@aut@@ Dan-Qi Deng @@aut@@ Qing-Shan Zheng @@aut@@ Hong-Xia Liu @@aut@@ Jian-Zhong Zhang @@aut@@ Li-Shao Guo. @@aut@@
publishDateDaySort_date	2020-01-01T00:00:00Z
hierarchy_top_id	363772693
id	DOAJ050571044
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ050571044</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230308153641.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2020 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1097/CM9.0000000000001221</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ050571044</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ04f41d1851b94e88b9901be1e565abef</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Lin Cai</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="2"><subfield code="a">A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medicine</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">R</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Gen-Hui Chen</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Qian-Jin Lu</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Min Zheng</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Yu-Zhen Li</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" 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author	Lin Cai
spellingShingle	Lin Cai misc Medicine misc R A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
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topic_title	A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
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title	A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
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title_full	A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
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author_browse	Lin Cai Gen-Hui Chen Qian-Jin Lu Min Zheng Yu-Zhen Li Jin Chen Jie Zheng Fu-Ren Zhang Jian-Bin Yu Sen Yang Fu-Qiu Li Sheng-Xiang Xiao Qiu-Ning Sun Jin-Hua Xu Xing-Hua Gao Hong Fang Tian-Wen Gao Fei Hao Quan-Zhong Liu Ya-Ting Tu Ruo-Yu Li Bao-Xi Wang Dan-Qi Deng Qing-Shan Zheng Hong-Xia Liu Jian-Zhong Zhang Li-Shao Guo.
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title_sort	double-blind, randomized, placebo- and positive-controlled phase iii trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
title_auth	A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
abstract	Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
abstractGer	Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
abstract_unstemmed	Abstract. Background. Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. Methods. We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. Results. The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
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title_short	A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
url	https://doi.org/10.1097/CM9.0000000000001221 https://doaj.org/article/04f41d1851b94e88b9901be1e565abef http://journals.lww.com/10.1097/CM9.0000000000001221 https://doaj.org/toc/0366-6999 https://doaj.org/toc/2542-5641
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author2Str	Gen-Hui Chen Qian-Jin Lu Min Zheng Yu-Zhen Li Jin Chen Jie Zheng Fu-Ren Zhang Jian-Bin Yu Sen Yang Fu-Qiu Li Sheng-Xiang Xiao Qiu-Ning Sun Jin-Hua Xu Xing-Hua Gao Hong Fang Tian-Wen Gao Fei Hao Quan-Zhong Liu Ya-Ting Tu Ruo-Yu Li Bao-Xi Wang Dan-Qi Deng Qing-Shan Zheng Hong-Xia Liu Jian-Zhong Zhang Li-Shao Guo
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The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. Conclusion. During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. Trial Registration. 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A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis

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