Ingram John R, Szepietowski Jacek C, Matusiak Lukasz, Kokolakis Georgios, Wozniak Magdalena B, Ortmann Christine-Elke, Martinez Angela Llobet, Ravichandran Shoba, Thomas Nicolas, Alarcon Ivette, Pieterse Christelle C, Alam Maryam Shayesteh, Ioannides Dimitrios, Kimball Alexa B
Department of Dermatology & Academic Wound Healing, Division of Infection and Immunity, Cardiff University, Cardiff, UK.
Division of Dermatology, Venereology and Clinical Immunology, Faculty of Medicine, Wroclaw University of Science and Technology, Wroclaw, Poland.
Dermatol Ther (Heidelb). 2025 May 15. doi: 10.1007/s13555-025-01426-x.
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).
引言：化脓性汗腺炎（HS）是一种慢性疼痛性皮肤病，疾病负担较高。与疾病相关的疼痛常被报告为HS最困扰人的症状。阳光（SUNSHINE）和日出（SUNRISE）3期试验先前报告称，司库奇尤单抗可改善中度至重度HS患者的疼痛控制。本分析的目的是评估司库奇尤单抗对阳光和日出试验中HS患者疼痛多个方面的影响。 方法：患者被随机分为每2周（SECQ2W）或4周（SECQ4W）接受300mg司库奇尤单抗治疗，或接受安慰剂治疗直至第16周。在第16周时，安慰剂组转而接受SECQ2W（安慰剂-SECQ2W）或SECQ4W（安慰剂-SECQ4W）治疗，而司库奇尤单抗组继续其治疗，直至第52周。通过第52周使用患者对皮肤疼痛的整体评估——最差情况采用连续数字评定量表（NRS）来评估疼痛。根据基线NRS评分（NRS≤3.3；NRS>3.3至≤5.4；NRS>5.4至≤7.2；NRS>7.2）将四分位数用于对疼痛严重程度组进行分类。额外的评估包括生活质量（QoL）和止痛药物使用情况。 结果：在第16周时，与安慰剂组[-0.47（2.07）]相比，接受司库奇尤单抗治疗的患者[SECQ2W（-1.35（2.16））；SECQ4W（-1.05（2.02））]从基线开始的皮肤疼痛平均（标准差）绝对变化更大。在SECQ
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