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Introduction <p>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&#xa0;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> Methods <p>Patients were randomised to receive secukinumab 300&#xa0;mg every 2 (SECQ2W) or 4&#xa0;weeks (SECQ4W), or placebo until week&#xa0;16. At week&#xa0;16, the placebo group switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W), whereas the secukinumab groups continued their treatment, until week&#xa0;52. Pain was assessed using the Patient’s Global Assessment of skin pain‒at worst on a continuous numeric rating scale (NRS) through week&#xa0;52. Quartiles were used to categorise pain severity groups based on baseline NRS scores (NRS ≤ 3.3; NRS &gt; 3.3 to ≤ 5.4; NRS &gt; 5.4 to ≤ 7.2; NRS &gt; 7.2). Additional assessments included quality of life (QoL) and pain medication use.</p> Results <p>At week&#xa0;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 &gt; 7.2 at baseline, 20.0% and 12.7% had NRS ≤ 3.3 at week&#xa0;16, respectively. This improvement in pain was maintained through week&#xa0;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&#xa0;16 and 52 versus baseline in the secukinumab groups.</p> Conclusion <p>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> Trial Registration <p>ClinicalTrials.gov identifier: NCT03713619 (SUNSHINE) and NCT03713632 (SUNRISE).</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月15日

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  • 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

摘要

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).