G. Yosipovitch, E. Simpson, H. Tan, R. Gerber, T. Luger, S. Ständer, W. Tom, J. Cappelleri, A. Bushmakin, W. Ports, A. Tallman
{"title":"crisaborole外用软膏(2%)治疗特应性皮炎相关瘙痒的效果:2项3期临床试验的扩展分析","authors":"G. Yosipovitch, E. Simpson, H. Tan, R. Gerber, T. Luger, S. Ständer, W. Tom, J. Cappelleri, A. Bushmakin, W. Ports, A. Tallman","doi":"10.1097/itx.0000000000000012","DOIUrl":null,"url":null,"abstract":"Introduction: Pruritus is an essential feature of atopic dermatitis (AD) and is widely considered the most distressing symptom. Crisaborole ointment is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate AD. The efficacy of crisaborole for AD-associated pruritus was assessed in 2 phase 3 trials using the Severity of Pruritus Scale (SPS). Post hoc validation of the SPS identified that 1 SPS observation provided inadequate test-retest reliability. Therefore, extended analyses were conducted using at least 2 SPS observations for robust assessment of pruritus in the phase 3 crisaborole trials. Methods: Data were analyzed from 2 identically designed, vehicle-controlled, double-blind, phase 3 trials designed to investigate the efficacy and safety of crisaborole in AD patients aged 2 years and above (AD-301: NCT02118766; AD-302: NCT02118792). At least 2 SPS observations were averaged for acceptable test-retest reliability. Results: At least 2 baseline observations were available for 569 patients in AD-301 and 561 patients in AD-302. Median time to pruritus improvement (SPS score ⩽1 with at least 1-point improvement from baseline) was shorter with crisaborole than with vehicle (AD-301: 5.0 vs. 10.0 d, P=0.0003; AD-302: 6.0 vs. 9.0 d, P=0.0087). At week 4, more crisaborole-treated patients than vehicle-treated patients experienced pruritus improvement (AD-301: 37% vs. 21%, P<0.0001; AD-302: 34% vs. 21%, P=0.0006), mean pruritus scores were lower with crisaborole than with vehicle (AD-301: 0.97 vs. 1.28, P<0.0001; AD-302: 1.08 vs. 1.35, P<0.0001), and more crisaborole-treated patients than vehicle-treated patients experienced a clinically important pruritus response (AD-301: 75% vs. 57%, P<0.0001; AD-302: 72% vs. 64%, P=0.0828). Conclusions: These extended analyses show that patients treated with crisaborole experienced rapid and clinically relevant improvement in AD-associated pruritus.","PeriodicalId":73523,"journal":{"name":"Itch (Philadelphia, Pa.)","volume":"226 24","pages":"e12"},"PeriodicalIF":0.0000,"publicationDate":"2018-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/itx.0000000000000012","citationCount":"6","resultStr":"{\"title\":\"Effect of crisaborole topical ointment, 2%, on atopic dermatitis–associated pruritus: an extended analysis of 2 phase 3 clinical trials\",\"authors\":\"G. Yosipovitch, E. Simpson, H. Tan, R. Gerber, T. Luger, S. Ständer, W. Tom, J. Cappelleri, A. Bushmakin, W. Ports, A. Tallman\",\"doi\":\"10.1097/itx.0000000000000012\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: Pruritus is an essential feature of atopic dermatitis (AD) and is widely considered the most distressing symptom. Crisaborole ointment is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate AD. The efficacy of crisaborole for AD-associated pruritus was assessed in 2 phase 3 trials using the Severity of Pruritus Scale (SPS). Post hoc validation of the SPS identified that 1 SPS observation provided inadequate test-retest reliability. Therefore, extended analyses were conducted using at least 2 SPS observations for robust assessment of pruritus in the phase 3 crisaborole trials. Methods: Data were analyzed from 2 identically designed, vehicle-controlled, double-blind, phase 3 trials designed to investigate the efficacy and safety of crisaborole in AD patients aged 2 years and above (AD-301: NCT02118766; AD-302: NCT02118792). At least 2 SPS observations were averaged for acceptable test-retest reliability. Results: At least 2 baseline observations were available for 569 patients in AD-301 and 561 patients in AD-302. Median time to pruritus improvement (SPS score ⩽1 with at least 1-point improvement from baseline) was shorter with crisaborole than with vehicle (AD-301: 5.0 vs. 10.0 d, P=0.0003; AD-302: 6.0 vs. 9.0 d, P=0.0087). At week 4, more crisaborole-treated patients than vehicle-treated patients experienced pruritus improvement (AD-301: 37% vs. 21%, P<0.0001; AD-302: 34% vs. 21%, P=0.0006), mean pruritus scores were lower with crisaborole than with vehicle (AD-301: 0.97 vs. 1.28, P<0.0001; AD-302: 1.08 vs. 1.35, P<0.0001), and more crisaborole-treated patients than vehicle-treated patients experienced a clinically important pruritus response (AD-301: 75% vs. 57%, P<0.0001; AD-302: 72% vs. 64%, P=0.0828). Conclusions: These extended analyses show that patients treated with crisaborole experienced rapid and clinically relevant improvement in AD-associated pruritus.\",\"PeriodicalId\":73523,\"journal\":{\"name\":\"Itch (Philadelphia, Pa.)\",\"volume\":\"226 24\",\"pages\":\"e12\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1097/itx.0000000000000012\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Itch (Philadelphia, Pa.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/itx.0000000000000012\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Itch (Philadelphia, Pa.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/itx.0000000000000012","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Effect of crisaborole topical ointment, 2%, on atopic dermatitis–associated pruritus: an extended analysis of 2 phase 3 clinical trials
Introduction: Pruritus is an essential feature of atopic dermatitis (AD) and is widely considered the most distressing symptom. Crisaborole ointment is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate AD. The efficacy of crisaborole for AD-associated pruritus was assessed in 2 phase 3 trials using the Severity of Pruritus Scale (SPS). Post hoc validation of the SPS identified that 1 SPS observation provided inadequate test-retest reliability. Therefore, extended analyses were conducted using at least 2 SPS observations for robust assessment of pruritus in the phase 3 crisaborole trials. Methods: Data were analyzed from 2 identically designed, vehicle-controlled, double-blind, phase 3 trials designed to investigate the efficacy and safety of crisaborole in AD patients aged 2 years and above (AD-301: NCT02118766; AD-302: NCT02118792). At least 2 SPS observations were averaged for acceptable test-retest reliability. Results: At least 2 baseline observations were available for 569 patients in AD-301 and 561 patients in AD-302. Median time to pruritus improvement (SPS score ⩽1 with at least 1-point improvement from baseline) was shorter with crisaborole than with vehicle (AD-301: 5.0 vs. 10.0 d, P=0.0003; AD-302: 6.0 vs. 9.0 d, P=0.0087). At week 4, more crisaborole-treated patients than vehicle-treated patients experienced pruritus improvement (AD-301: 37% vs. 21%, P<0.0001; AD-302: 34% vs. 21%, P=0.0006), mean pruritus scores were lower with crisaborole than with vehicle (AD-301: 0.97 vs. 1.28, P<0.0001; AD-302: 1.08 vs. 1.35, P<0.0001), and more crisaborole-treated patients than vehicle-treated patients experienced a clinically important pruritus response (AD-301: 75% vs. 57%, P<0.0001; AD-302: 72% vs. 64%, P=0.0828). Conclusions: These extended analyses show that patients treated with crisaborole experienced rapid and clinically relevant improvement in AD-associated pruritus.
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