Dermatology and therapy · 2025
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.
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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
Аннотация
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).
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).