Long-Term Efficacy and Safety of Dupixent in Moderate-to-Severe Atopic Dermatitis: 5-Year Open-Label Extension Study Results¹

Study Overview

This open-label extension study followed adult patients with moderate-to-severe atopic dermatitis for up to 5 years, building upon the initial 52-week study. The primary objective was to assess the long-term safety and secondary objective was to assess efficacy of dupilumab in this patient population from September 2013 to June 2022 at 550 sites in 28 countries. A total of 2677 patients were enrolled and treated in the open-label extension study; 1611 (60.2%) were male, and the mean (SD) age was 39.2 (13.4) years, with mean EASI score of 16.39 and IGA 3-4 with 65.2% of patients at OLE baseline. Concomitant TCSs and TCIs, as well as other AD treatments, were permitted. The primary end points were the incidence and rate of treatment-emergent adverse events (TEAEs).

Long-Term Efficacy Results

The study demonstrated sustained efficacy of Dupixent over the 5-year period:

1. Skin Clearance: At end of the study, 67.5% of patients achieved an Investigator's Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin.
2. Eczema Severity Reduction: 88.9% of patients experienced at least a 75% improvement in their Eczema Area and Severity Index (EASI-75) score.
3. Sustained Improvements: The study showed consistent improvements in AD signs, symptoms, and quality of life measures throughout the 5-year period.

These results suggest that Dupixent provides durable efficacy in managing moderate-to-severe atopic dermatitis, offering long-term relief for patients struggling with this chronic condition.

Long-Term Safety Profile

The 5-year safety data provides evidence for the long-term use of Dupixent:

1. Acceptable Safety Profile: Dupixent demonstrated an acceptable long-term safety profile with no new safety signals identified over the 5-year period.
2. Stable or Decreasing Adverse Event Rates: The exposure-adjusted rate of overall TEAEs decreased or remained stable over time (including conjunctivitis) and was lower at 5 years compared with both the dupilumab and placebo arms in the 52-week CHRONOS trial.
3. Conjunctivitis Management: Most cases of conjunctivitis resolved during treatment (87,7%). Treatment discontinuation was due to conjunctivitis was rare (0,5%) suggesting that this side effect can be effectively managed while patients continue Dupixent therapy.

Implications for Clinical Practice

These long-term results have potential implications for dermatologists managing patients with moderate-to-severe atopic dermatitis:

1. Sustained Efficacy: The study provides evidence that Dupixent can offer long-term control of AD symptoms. Use of rescue treatment (1.6%) was uncommon, suggesting well-controlled disease throughout the trial.
2. Patient Selection: Dermatologists can consider Dupixent for patients requiring long-term management of their AD, given its sustained efficacy and acceptable safety profile.
3. Safety Monitoring: While the overall safety profile is favorable on the long-term, dermatologists should continue to monitor patients for common adverse events.
4. Quality of Life Improvements: The sustained efficacy in managing AD signs and symptoms suggests that Dupixent may offer long-term improvements in patients' quality of life.

Conclusion