Trial results comparing upadacitinib (Rinvoq) to dupilumab for moderate to severe atopic dermatitis were posted on ClinicalTrials.gov on 2025-02-14. The study found that 19.9% of participants treated with upadacitinib achieved a ≥90% reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 16, compared to 8.9% of those treated with dupilumab.
Background
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by rash and intense itching. For adolescent and adult participants with moderate to severe AD who have an inadequate response to systemic therapies, systemic anti-inflammatory treatments are often required. Upadacitinib and dupilumab are both approved drugs for the treatment of moderate to severe atopic dermatitis.
Trial design
This completed Phase 3 trial (NCT05601882) enrolled 920 participants to evaluate adverse events and changes in disease activity in adolescent and adult participants with moderate to severe Atopic Dermatitis. The study compared oral upadacitinib to subcutaneous dupilumab.
Key results
Key results at Week 16 comparing upadacitinib to dupilumab included:
- For the percentage of participants achieving a ≥90% reduction from baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1), upadacitinib showed 19.9% compared to 8.9% for dupilumab. The adjusted response rate difference was 11.0% (95% Confidence Interval 6.6%-15.5%), with a p-value of 0.0001.
- For the percentage of participants achieving a ≥90% reduction from baseline in Eczema Area and Severity Index Score (EASI 90), upadacitinib showed 40.8% compared to 22.5% for dupilumab. The adjusted response rate difference was 18.4% (95% Confidence Interval 12.5%-24.2%), with a p-value of 0.0001.
- For the percentage of participants achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 among those with baseline WP-NRS > 1, upadacitinib showed 30.2% compared to 15.5% for dupilumab. The adjusted response rate difference was 14.7% (95% Confidence Interval 9.4%-20.0%), with a p-value of 0.0001.
- For the percentage of participants achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 among those with baseline WP-NRS ≥ 4, upadacitinib showed 54.7% compared to 38.1% for dupilumab. The adjusted response rate difference was 16.6% (95% Confidence Interval 10.2%-23.0%), with a p-value of 0.0001.
Early onset of pruritus relief was also observed:
- For the percentage of participants achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 among those with baseline WP-NRS > 1, upadacitinib showed 16.1% compared to 2.8% for dupilumab. The adjusted response rate difference was 13.2% (95% Confidence Interval 9.6%-16.9%), with a p-value of 0.0001.
- For the percentage of participants achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 among those with baseline WP-NRS > 1, upadacitinib showed 7.7% compared to 1.3% for dupilumab. The adjusted response rate difference was 6.4% (95% Confidence Interval 3.8%-9.1%), with a p-value of 0.0001.
What this means
The results indicate that upadacitinib demonstrated superior efficacy compared to dupilumab across several key measures of atopic dermatitis disease activity and pruritus relief. The significantly higher percentages of participants achieving EASI 90, combined EASI 90 and WP-NRS 0/1, and improvements in pruritus, along with the rapid onset of pruritus relief, suggest that upadacitinib may offer a more effective treatment option for adolescent and adult participants with moderate to severe atopic dermatitis who have had an inadequate response to prior systemic therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05601882, titled "A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis," were posted on 2025-02-14 on clinicaltrials.gov.