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Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind,
Stephen K Tyring1, Phoebe Rich2, Yayoi Tada3
1Department of Dermatology, McGovern Medical School, University of Texas Health Science Center, 6431 Fannin St, Houston, TX, 77030, USA. styring@ccstexas.com.
Dermatology and Therapy
|January 1, 2023
Summary
This study found that risankizumab did not significantly improve Eczema Area and Severity Index scores in moderate-to-severe atopic dermatitis patients compared to placebo. Risankizumab was well-tolerated, but the primary efficacy endpoint was not met.
Area of Science:
- Immunodermatology
- Clinical Trials
- Pharmacology
Background:
- Atopic dermatitis (AD) involves T-helper cell pathways (Th2, Th22, Th17), suggesting IL-23 and IL-22 blockade as potential treatments.
- Current therapeutic strategies for AD aim to modulate these inflammatory pathways.
Purpose of the Study:
- To evaluate the efficacy and safety of risankizumab, an IL-23 inhibitor, in adults and adolescents with moderate-to-severe atopic dermatitis.
- To determine if risankizumab treatment leads to a significant reduction in AD severity compared to placebo.
Main Methods:
- A phase 2, randomized, double-blind, placebo-controlled trial (NCT03706040) involving patients aged 12+ with moderate-to-severe AD.
- Patients received risankizumab (150 mg or 300 mg) or placebo for 16 weeks, with a subsequent 36-week treatment period.
- The primary endpoint was the proportion of patients achieving at least 75% reduction in EASI score (EASI 75) at week 16.
Main Results:
- Neither the 150 mg nor 300 mg risankizumab dose achieved a statistically significant higher proportion of patients reaching EASI 75 at week 16 compared to placebo.
- Treatment differences were 13.0% (P=0.084) for 150 mg and 10.0% (P=0.179) for 300 mg.
- Risankizumab was generally well-tolerated; most adverse events were mild to moderate, with five serious adverse events reported in the risankizumab group.
Conclusions:
- The primary efficacy endpoint of achieving EASI 75 at week 16 was not met for either risankizumab dose compared to placebo.
- Risankizumab demonstrated a favorable safety profile with no new safety concerns identified.
- Further investigation may be needed to explore the role of IL-23 inhibition in atopic dermatitis management.
