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Introduction <p>Prurigo nodularis (PN/chronic prurigo) is characterised by intensely pruritic, symmetrically distributed nodules. In the PRIME (NCT04183335) and PRIME2 (NCT04202679) clinical trials, dupilumab demonstrated clinically meaningful and statistically significant improvements in itch versus placebo in patients with uncontrolled PN on topical therapies. This post hoc analysis evaluated the efficacy of dupilumab versus placebo in reducing the daily symptom burden (DSB) with respect to itch, skin pain, and sleep disturbance in patients with PN.</p> Methods <p>Pooled data from the PRIME and PRIME2 trials (<i>N</i> = 311) were utilised. DSB was assessed with three patient-reported outcomes (PROs): Worst Itch Numeric Rating Scale (WI-NRS), Skin Pain-NRS, and Sleep-NRS. Each PRO utilised a scale of 0–10 (0: no pruritus/no skin pain/worst possible sleep; 10: worst pruritus/worst skin pain/best possible sleep). The symptom intensity was categorised as no symptoms (0 for WI-NRS and Skin Pain-NRS; 10 for Sleep-NRS), mild (1–2 or 8–9), moderate (3–6 or 4–7), severe (7–8 or 2–3), and very severe (9–10 or 0–1). The proportion of patients experiencing only none-to-mild symptoms and the mean frequency of days with only such symptoms in the week before week&#xa0;24 were compared between treatment arms.</p> Results <p>In the week before week&#xa0;24, significantly higher proportions of patients treated with dupilumab had only none-to-mild symptom days than those receiving placebo with respect to WI-NRS (26.8% vs 7.6%), Skin Pain-NRS (38.6% vs 19.0%), and Sleep-NRS (28.8% vs 10.1%), with <i>p</i> &lt; 0.0001. At week&#xa0;24, patients treated with dupilumab had more days per week with none-to-mild itch (mean 2.4 vs 0.9), skin pain (3.4 vs 1.9), and sleep disturbance (2.7 vs 1.4) versus placebo.</p> Conclusion <p>Patients treated with dupilumab showed greater improvement in DSB with respect to itch, skin pain, and sleep disturbance than those receiving placebo.</p>

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Dupilumab Improves Daily Symptom Burden in Adult Patients with Prurigo Nodularis: Post Hoc Analysis from LIBERTY PN-PRIME and PRIME2 Studies

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月2日

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  • Shawn G. Kwatra,
  • Sonja Ständer,
  • Brian S. Kim,
  • Jerome Msihid,
  • Ashish Bansal,
  • Melanie Makhija,
  • Simmi Wiggins,
  • Joseph Zahn,
  • Ryan B. Thomas,
  • Donia Bahloul

摘要

Introduction

Prurigo nodularis (PN/chronic prurigo) is characterised by intensely pruritic, symmetrically distributed nodules. In the PRIME (NCT04183335) and PRIME2 (NCT04202679) clinical trials, dupilumab demonstrated clinically meaningful and statistically significant improvements in itch versus placebo in patients with uncontrolled PN on topical therapies. This post hoc analysis evaluated the efficacy of dupilumab versus placebo in reducing the daily symptom burden (DSB) with respect to itch, skin pain, and sleep disturbance in patients with PN.

Methods

Pooled data from the PRIME and PRIME2 trials (N = 311) were utilised. DSB was assessed with three patient-reported outcomes (PROs): Worst Itch Numeric Rating Scale (WI-NRS), Skin Pain-NRS, and Sleep-NRS. Each PRO utilised a scale of 0–10 (0: no pruritus/no skin pain/worst possible sleep; 10: worst pruritus/worst skin pain/best possible sleep). The symptom intensity was categorised as no symptoms (0 for WI-NRS and Skin Pain-NRS; 10 for Sleep-NRS), mild (1–2 or 8–9), moderate (3–6 or 4–7), severe (7–8 or 2–3), and very severe (9–10 or 0–1). The proportion of patients experiencing only none-to-mild symptoms and the mean frequency of days with only such symptoms in the week before week 24 were compared between treatment arms.

Results

In the week before week 24, significantly higher proportions of patients treated with dupilumab had only none-to-mild symptom days than those receiving placebo with respect to WI-NRS (26.8% vs 7.6%), Skin Pain-NRS (38.6% vs 19.0%), and Sleep-NRS (28.8% vs 10.1%), with p < 0.0001. At week 24, patients treated with dupilumab had more days per week with none-to-mild itch (mean 2.4 vs 0.9), skin pain (3.4 vs 1.9), and sleep disturbance (2.7 vs 1.4) versus placebo.

Conclusion

Patients treated with dupilumab showed greater improvement in DSB with respect to itch, skin pain, and sleep disturbance than those receiving placebo.