Introduction <p>Itch and pain are two of the most common and burdensome symptoms for moderate to severe Chronic Hand Eczema (CHE). Here, we assess changes in itch/pain in patients with moderate to severe CHE treated with delgocitinib cream 20&#xa0;mg/g or cream vehicle for 16&#xa0;weeks.</p> Methods <p>In a pooled DELTA&#xa0;1 (NCT04871711)/DELTA&#xa0;2 (NCT04872101) analysis (delgocitinib [<i>n</i> = 639]; cream vehicle [<i>n</i> = 321]; twice-daily), the Hand Eczema Symptom Diary captured patient-reported itch/pain severity on a numeric rating scale. Changes in itch/pain from baseline were assessed daily during week&#xa0;1 and weekly from week&#xa0;1 to 16.</p> Results <p>In delgocitinib-treated patients, a statistically significant least square mean reduction from baseline was observed for itch from day&#xa0;1 ([delgocitinib cream/cream vehicle] 0.75/0.32; <i>P</i> &lt; 0.001) and pain from day&#xa0;3 (0.98/0.58; <i>P</i> = 0.001) after the first application. Among patients with ≥ 4-point baseline itch/pain score, a significantly greater percentage of delgocitinib-treated patients achieved ≥ 4-point reduction from week&#xa0;2 (14.2%/17.3%) versus cream vehicle (6.3%/6.9%; <i>P</i> &lt; 0.001). Reductions were maintained up to week&#xa0;16 with delgocitinib cream treatment. Delgocitinib cream was well tolerated.</p> Conclusion <p>Early onset of itch/pain reduction was observed within week&#xa0;1 for delgocitinib-treated patients, thereby providing further support of the use and efficacy of delgocitinib cream in adults with moderate to severe CHE.</p>

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Delgocitinib Cream Reduces Itch and Pain in Moderate to Severe Chronic Hand Eczema: Phase 3 DELTA 1 and 2 Pooled Analyses

  • Andrea Bauer,
  • Marie-Louise Schuttelaar,
  • Keith Baranowski,
  • Ursula Plohberger,
  • Laura Sørensen,
  • Margitta Worm

摘要

Introduction

Itch and pain are two of the most common and burdensome symptoms for moderate to severe Chronic Hand Eczema (CHE). Here, we assess changes in itch/pain in patients with moderate to severe CHE treated with delgocitinib cream 20 mg/g or cream vehicle for 16 weeks.

Methods

In a pooled DELTA 1 (NCT04871711)/DELTA 2 (NCT04872101) analysis (delgocitinib [n = 639]; cream vehicle [n = 321]; twice-daily), the Hand Eczema Symptom Diary captured patient-reported itch/pain severity on a numeric rating scale. Changes in itch/pain from baseline were assessed daily during week 1 and weekly from week 1 to 16.

Results

In delgocitinib-treated patients, a statistically significant least square mean reduction from baseline was observed for itch from day 1 ([delgocitinib cream/cream vehicle] 0.75/0.32; P < 0.001) and pain from day 3 (0.98/0.58; P = 0.001) after the first application. Among patients with ≥ 4-point baseline itch/pain score, a significantly greater percentage of delgocitinib-treated patients achieved ≥ 4-point reduction from week 2 (14.2%/17.3%) versus cream vehicle (6.3%/6.9%; P < 0.001). Reductions were maintained up to week 16 with delgocitinib cream treatment. Delgocitinib cream was well tolerated.

Conclusion

Early onset of itch/pain reduction was observed within week 1 for delgocitinib-treated patients, thereby providing further support of the use and efficacy of delgocitinib cream in adults with moderate to severe CHE.