Assessing Long-Term Pain Reduction with Secukinumab in Moderate to Severe Hidradenitis Suppurativa: A Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Trials.
John R Ingram, Jacek C Szepietowski, Lukasz Matusiak, Georgios Kokolakis, Magdalena B Wozniak, Christine-Elke Ortmann, Angela Llobet Martinez, Shoba Ravichandran, Nicolas Thomas, Ivette Alarcon, Christelle C Pieterse, Maryam Shayesteh Alam, Dimitrios Ioannides, Alexa B Kimball
{"title":"Assessing Long-Term Pain Reduction with Secukinumab in Moderate to Severe Hidradenitis Suppurativa: A Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Trials.","authors":"John R Ingram, Jacek C Szepietowski, Lukasz Matusiak, Georgios Kokolakis, Magdalena B Wozniak, Christine-Elke Ortmann, Angela Llobet Martinez, Shoba Ravichandran, Nicolas Thomas, Ivette Alarcon, Christelle C Pieterse, Maryam Shayesteh Alam, Dimitrios Ioannides, Alexa B Kimball","doi":"10.1007/s13555-025-01426-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) is a chronic, painful skin disease associated with a high disease burden. Disease-related pain is frequently reported as the most troublesome symptom of HS. The SUNSHINE and SUNRISE phase 3 trials previously reported that secukinumab improved control of pain in patients with moderate to severe HS. The objective of this analysis was to evaluate the impact of secukinumab on multiple aspects of pain in patients with HS from SUNSHINE and SUNRISE.</p><p><strong>Methods: </strong>Patients were randomised to receive secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W), or placebo until week 16. At week 16, the placebo group switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W), whereas the secukinumab groups continued their treatment, until week 52. Pain was assessed using the Patient's Global Assessment of skin pain‒at worst on a continuous numeric rating scale (NRS) through week 52. Quartiles were used to categorise pain severity groups based on baseline NRS scores (NRS ≤ 3.3; NRS > 3.3 to ≤ 5.4; NRS > 5.4 to ≤ 7.2; NRS > 7.2). Additional assessments included quality of life (QoL) and pain medication use.</p><p><strong>Results: </strong>At week 16, a greater mean (standard deviation) absolute change from baseline in skin pain was observed for patients treated with secukinumab [SECQ2W (- 1.35 (2.16)); SECQ4W (- 1.05 (2.02))] versus placebo [- 0.47 (2.07)]. In the SECQ2W and SECQ4W groups, in patients with NRS > 7.2 at baseline, 20.0% and 12.7% had NRS ≤ 3.3 at week 16, respectively. This improvement in pain was maintained through week 52. Moreover, patients in the NRS ≤ 3.3 category generally experienced better QoL. The proportion of patients reporting pain medication use was generally reduced at weeks 16 and 52 versus baseline in the secukinumab groups.</p><p><strong>Conclusion: </strong>This analysis highlights the sustained benefits of secukinumab in reducing pain in patients with moderate to severe HS. These pain reductions were associated with QoL improvements.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT03713619 (SUNSHINE) and NCT03713632 (SUNRISE).</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1833-1849"},"PeriodicalIF":4.2000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12126416/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01426-x","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Hidradenitis suppurativa (HS) is a chronic, painful skin disease associated with a high disease burden. Disease-related pain is frequently reported as the most troublesome symptom of HS. The SUNSHINE and SUNRISE phase 3 trials previously reported that secukinumab improved control of pain in patients with moderate to severe HS. The objective of this analysis was to evaluate the impact of secukinumab on multiple aspects of pain in patients with HS from SUNSHINE and SUNRISE.
Methods: Patients were randomised to receive secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W), or placebo until week 16. At week 16, the placebo group switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W), whereas the secukinumab groups continued their treatment, until week 52. Pain was assessed using the Patient's Global Assessment of skin pain‒at worst on a continuous numeric rating scale (NRS) through week 52. Quartiles were used to categorise pain severity groups based on baseline NRS scores (NRS ≤ 3.3; NRS > 3.3 to ≤ 5.4; NRS > 5.4 to ≤ 7.2; NRS > 7.2). Additional assessments included quality of life (QoL) and pain medication use.
Results: At week 16, a greater mean (standard deviation) absolute change from baseline in skin pain was observed for patients treated with secukinumab [SECQ2W (- 1.35 (2.16)); SECQ4W (- 1.05 (2.02))] versus placebo [- 0.47 (2.07)]. In the SECQ2W and SECQ4W groups, in patients with NRS > 7.2 at baseline, 20.0% and 12.7% had NRS ≤ 3.3 at week 16, respectively. This improvement in pain was maintained through week 52. Moreover, patients in the NRS ≤ 3.3 category generally experienced better QoL. The proportion of patients reporting pain medication use was generally reduced at weeks 16 and 52 versus baseline in the secukinumab groups.
Conclusion: This analysis highlights the sustained benefits of secukinumab in reducing pain in patients with moderate to severe HS. These pain reductions were associated with QoL improvements.
Trial registration: ClinicalTrials.gov identifier: NCT03713619 (SUNSHINE) and NCT03713632 (SUNRISE).
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
