A Phase 3 study evaluating upadacitinib (Rinvoq) for moderate-to-severe atopic dermatitis reached primary completion on 2021-03-11, with results showing significant efficacy. In the main study, 72.9% of participants receiving upadacitinib 30 mg QD achieved at least a 75% reduction in Eczema Area and Severity Index (EASI 75) score from baseline at Week 16, compared to 13.3% for placebo.
Background
Upadacitinib was investigated for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Trial design
The Phase 3 study (NCT03607422), titled "A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)", enrolled 912 participants. The study assessed the efficacy and safety of upadacitinib for adolescent and adult participants with moderate to severe atopic dermatitis. Participants were randomized to receive either upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo.
Key results
The trial demonstrated significant improvements across multiple efficacy endpoints at Week 16 for both upadacitinib doses compared to placebo.
- EASI 75 (≥75% reduction in Eczema Area and Severity Index score from baseline):
- Upadacitinib 30 mg QD: 72.9% of participants.
- Upadacitinib 15 mg QD: 60.1% of participants.
- Placebo: 13.3% of participants.
- vIGA-AD 0 or 1 (Validated Investigator Global Assessment for Atopic Dermatitis of 0 or 1 with ≥ 2 points reduction from baseline):
- Upadacitinib 30 mg QD: 52.0% of participants.
- Upadacitinib 15 mg QD: 38.8% of participants.
- Placebo: 4.7% of participants.
- Worst Pruritus NRS (≥4 points reduction from baseline in Worst Pruritus Numerical Rating Scale):
- Upadacitinib 30 mg QD: 59.6% of participants.
- Upadacitinib 15 mg QD: 41.9% of participants.
- Placebo: 9.1% of participants.
- EASI 90 (90% reduction from baseline in EASI score):
- Upadacitinib 30 mg QD: 58.5% of participants.
- Upadacitinib 15 mg QD: 42.4% of participants.
- Placebo: 5.4% of participants.
- For EASI 75, the difference was 59.6% (95% CI: 53.1%, 66.2%) for 30 mg QD and 46.9% (95% CI: 39.9%, 53.9%) for 15 mg QD.
- For vIGA-AD 0 or 1, the difference was 47.4% (95% CI: 41.0%, 53.7%) for 30 mg QD and 34.0% (95% CI: 27.8%, 40.2%) for 15 mg QD.
- For Worst Pruritus NRS, the difference was 50.4% (95% CI: 43.8%, 57.1%) for 30 mg QD and 32.6% (95% CI: 25.8%, 39.4%) for 15 mg QD.
What this means
The completion of this Phase 3 study and the reported efficacy results suggest that upadacitinib could be an effective treatment option for adolescents and adults with moderate to severe atopic dermatitis. The consistent and statistically significant improvements observed across multiple key endpoints, including skin clearance (EASI 75, EASI 90, vIGA-AD) and reduction in pruritus, indicate a robust therapeutic effect. The dose-dependent response, with the 30 mg QD dose generally showing higher efficacy rates, provides important information for potential dosing strategies. These findings support the clinical utility of upadacitinib in managing the symptoms of this chronic inflammatory skin condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03607422, titled "A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)", were posted on 2021-03-11 on clinicaltrials.gov.