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Introduction <p>In pooled LIBERTY-PN PRIME/PRIME2 trials on prurigo nodularis (PN), at week&#xa0;24, the stringent composite endpoint of a ≥ 4-point reduction from baseline in Worst Itch Numeric Rating Scale (WI-NRS) score combined with an Investigator’s Global Assessment for PN-Stage (IGA PN-S) score of 0/1 (clear/almost clear skin) was achieved by 35.3% of dupilumab versus 8.9% of placebo-treated patients. This optimal response may not capture the full experience of treatment in the remaining patients. This study assessed additional efficacy endpoints in the remaining dupilumab (64.7%) and placebo (91.1%) PRIME/PRIME2 recipients without optimal response at week&#xa0;24.</p> Methods <p>Additional week&#xa0;24 endpoints included ≥ 9-point reduction from baseline in Dermatology Life Quality Index (DLQI) score, Patient Global Impression of Severity (PGIS) score of “none”/”mild,” ≥ 75% healed lesions from Prurigo Activity and Severity (PAS-75), and a concomitant reduction from baseline of ≥ 3 points in WI-NRS score and ≥ 1 point in IGA PN-S score.</p> Results <p>Data from 99 dupilumab-treated and 144 placebo-treated patients without optimal response were analyzed. Among dupilumab-treated patients, 61.1% achieved a ≥ 9-point reduction from baseline in DLQI score, 55.8% a PGIS score of “none” or “mild,” 53.7% PAS-75, and 45.7% the less stringent itch and skin lesion composite endpoint (nominal <i>P</i> vs placebo significant for all).</p> Conclusion <p>Dupilumab treatment versus placebo resulted in nominally significant improvements in signs, symptoms, and quality of life in patients with PN without optimal response by week&#xa0;24, supporting the benefits of continued treatment. These results highlight the need to develop a treat-to-target strategy for the long-term management of PN.</p> Trial Registration <p>ClinicalTrial.gov Identifiers: NCT04183335 and NCT04202679 (registered December 2019).</p>

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Dupilumab Treatment Provides Multidimensional Benefits in Patients with Prurigo Nodularis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月13日

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  • Sonja Ständer,
  • Gil Yosipovitch,
  • Shawn G. Kwatra,
  • Pedro Mendes-Bastos,
  • Tsen-Fang Tsai,
  • Saeko Nakajima,
  • Amy H. Praestgaard,
  • Joseph Zahn,
  • Simmi Wiggins

摘要

Introduction

In pooled LIBERTY-PN PRIME/PRIME2 trials on prurigo nodularis (PN), at week 24, the stringent composite endpoint of a ≥ 4-point reduction from baseline in Worst Itch Numeric Rating Scale (WI-NRS) score combined with an Investigator’s Global Assessment for PN-Stage (IGA PN-S) score of 0/1 (clear/almost clear skin) was achieved by 35.3% of dupilumab versus 8.9% of placebo-treated patients. This optimal response may not capture the full experience of treatment in the remaining patients. This study assessed additional efficacy endpoints in the remaining dupilumab (64.7%) and placebo (91.1%) PRIME/PRIME2 recipients without optimal response at week 24.

Methods

Additional week 24 endpoints included ≥ 9-point reduction from baseline in Dermatology Life Quality Index (DLQI) score, Patient Global Impression of Severity (PGIS) score of “none”/”mild,” ≥ 75% healed lesions from Prurigo Activity and Severity (PAS-75), and a concomitant reduction from baseline of ≥ 3 points in WI-NRS score and ≥ 1 point in IGA PN-S score.

Results

Data from 99 dupilumab-treated and 144 placebo-treated patients without optimal response were analyzed. Among dupilumab-treated patients, 61.1% achieved a ≥ 9-point reduction from baseline in DLQI score, 55.8% a PGIS score of “none” or “mild,” 53.7% PAS-75, and 45.7% the less stringent itch and skin lesion composite endpoint (nominal P vs placebo significant for all).

Conclusion

Dupilumab treatment versus placebo resulted in nominally significant improvements in signs, symptoms, and quality of life in patients with PN without optimal response by week 24, supporting the benefits of continued treatment. These results highlight the need to develop a treat-to-target strategy for the long-term management of PN.

Trial Registration

ClinicalTrial.gov Identifiers: NCT04183335 and NCT04202679 (registered December 2019).