Christos C Zouboulis, Athanassios Kyrgidis, Afsaneh Alavi, Gregor B E Jemec, Antonio Martorell, Angelo V Marzano, Hessel H van der Zee, Magdalena B Wozniak, Angela Llobet Martinez, Torben Kasparek, Teresa Bachhuber, Christine-Elke Ortmann, Iryna Lobach, Nicolas Thomas, Shoba Ravichandran, Thrasyvoulos Tzellos
{"title":"用国际化脓性扁平苔癣严重程度评分系统（IHS4）评估塞库单抗对化脓性扁平苔癣患者的疗效：SunSHINE 和 SUNRISE 试验的事后分析。","authors":"Christos C Zouboulis, Athanassios Kyrgidis, Afsaneh Alavi, Gregor B E Jemec, Antonio Martorell, Angelo V Marzano, Hessel H van der Zee, Magdalena B Wozniak, Angela Llobet Martinez, Torben Kasparek, Teresa Bachhuber, Christine-Elke Ortmann, Iryna Lobach, Nicolas Thomas, Shoba Ravichandran, Thrasyvoulos Tzellos","doi":"10.1111/jdv.20369","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).</p><p><strong>Objective: </strong>To evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.</p><p><strong>Methods: </strong>Data from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300 mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4-55, IHS4-75, IHS4-90 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4-55 and HS clinical response (HiSCR), at Weeks 16 and 52.</p><p><strong>Results: </strong>In total, 1084 patients (SECQ2W = 361; SECQ4W = 360; placebo = 363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: -10.80 [-12.30 to -9.30] and -9.46 [-10.96 to -7.96] vs. -4.92 [-6.43 to -3.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4-55 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4-75 and IHS4-90 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (>85%) was observed between IHS4-55 and HiSCR.</p><p><strong>Conclusions: </strong>Both SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings.</p>","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4000,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials.\",\"authors\":\"Christos C Zouboulis, Athanassios Kyrgidis, Afsaneh Alavi, Gregor B E Jemec, Antonio Martorell, Angelo V Marzano, Hessel H van der Zee, Magdalena B Wozniak, Angela Llobet Martinez, Torben Kasparek, Teresa Bachhuber, Christine-Elke Ortmann, Iryna Lobach, Nicolas Thomas, Shoba Ravichandran, Thrasyvoulos Tzellos\",\"doi\":\"10.1111/jdv.20369\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).</p><p><strong>Objective: </strong>To evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.</p><p><strong>Methods: </strong>Data from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300 mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4-55, IHS4-75, IHS4-90 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4-55 and HS clinical response (HiSCR), at Weeks 16 and 52.</p><p><strong>Results: </strong>In total, 1084 patients (SECQ2W = 361; SECQ4W = 360; placebo = 363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: -10.80 [-12.30 to -9.30] and -9.46 [-10.96 to -7.96] vs. -4.92 [-6.43 to -3.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4-55 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4-75 and IHS4-90 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (>85%) was observed between IHS4-55 and HiSCR.</p><p><strong>Conclusions: </strong>Both SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings.</p>\",\"PeriodicalId\":17351,\"journal\":{\"name\":\"Journal of the European Academy of Dermatology and Venereology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.4000,\"publicationDate\":\"2024-10-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the European Academy of Dermatology and Venereology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/jdv.20369\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the European Academy of Dermatology and Venereology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jdv.20369","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
导言：国际化脓性扁桃体炎严重程度评分系统（IHS4）是一种经过验证的工具，用于测量化脓性扁桃体炎（HS）的炎性病变，包括引流隧道：目的：使用 IHS4 评估 secukinumab 对中度至重度 HS 患者的疗效：方法：分析SUNSHINE和SUNRISE试验的数据，这两项试验评估了中重度HS成人患者每2周（SECQ2W）和4周（SECQ4W）皮下注射300毫克secukinumab的疗效。评估内容包括：IHS4从基线到第52周的变化和严重程度分类；第16周和第52周的IHS4-55、IHS4-75、IHS4-90反应（IHS4下降55%、75%和90%）以及IHS4-55与HS临床反应（HiSCR）的一致性：共分析了1084名患者（SECQ2W=361人；SECQ4W=360人；安慰剂=363人）。第16周时，SECQ2W和SECQ4W与安慰剂相比，IHS4从基线降低的幅度更高（调整后的平均值[95% CI]：-10.80 [-12.30 to -9.30]和-9.46 [-10.96 to -7.96]对-4.92 [-6.43 to -3.41]）；两种剂量方案的IHS4降低幅度均保持到第52周。与安慰剂（31.5%）相比，使用SECQ2W（43.4%）和SECQ4W（39.5%）的患者在第16周达到IHS4-55的比例更高，在第52周进一步提高。IHS4-75和IHS4-90的反应也呈类似趋势。虽然根据IHS4，基线时没有患者病情轻微（80.7%为重度HS，19.3%为中度HS），但在第16周时，SECQ2W组（25.9%）和SECQ4W组（24.0%）与安慰剂组（16.4%）相比，有更大比例的患者被归类为病情轻微；这两种剂量方案的这一趋势一直持续到第52周。IHS4-55和HiSCR之间的一致性很强（>85%）：结论：与安慰剂相比，SECQ2W和SECQ4W在第16周均显示出改善IHS4测量的治疗反应和降低疾病严重程度的疗效，而且这些改善一直持续到第52周。这些研究结果证明，动态二分法 IHS4 可以在临床试验中有效检测治疗反应的变化。
Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials.
Introduction: The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).
Objective: To evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.
Methods: Data from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300 mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4-55, IHS4-75, IHS4-90 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4-55 and HS clinical response (HiSCR), at Weeks 16 and 52.
Results: In total, 1084 patients (SECQ2W = 361; SECQ4W = 360; placebo = 363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: -10.80 [-12.30 to -9.30] and -9.46 [-10.96 to -7.96] vs. -4.92 [-6.43 to -3.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4-55 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4-75 and IHS4-90 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (>85%) was observed between IHS4-55 and HiSCR.
Conclusions: Both SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings.
期刊介绍：
The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV).
The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology.
The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.
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