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Dupilumab Effective Up to 5 Years in Adults with Moderate-to-Severe Atopic Dermatitis in Open-Label Extension Study
AAAAI 2024. Reduction of AD signs and symptoms was significant among approximately half of study participants at 4 weeks and continuously rose through week 260, investigators report.
Among adults with moderate-to-severe atopic dermatitis (AD) treatment with dupilumab was associated with sustained reduction of disease signs and symptoms for up to 5 years. The findings come from an open-label extension (OLE) study that enrolled adults with AD who had participated in any of the dupilumab phase 3 parent studies in AD.
Results were presented by study lead author Lisa Beck, MD, Dean’s Professor of Dermatology and Medicine at the University of Rochester Medical Center, in Rochester, NY, at the 2024 American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting, February 23-26, 2024, in Washington, DC.
Drawing from the total study population of 2677 participants, Beck and colleagues selected a subpopulation of adults with moderate to severe AD who were treated with dupilumab 300 mg either weekly or every 2 weeks during the OLE study and who had been naïve to dupilumab treatment before entering the OLE.
The investigators assessed efficacy using 2 measures of change in disease severity: the Eczema Area Severity Index (EASI) and the Pruritis Numerical Rating Scale (Pruritis NRS). Specifically, they reported the proportion of participants that achieved 75%/90% reduction from parent study baseline in EASI (EASEI-75/EASI-90) and the proportion of those with reduction on the Pruritis NRS of ≥4 from parent study baseline or score = 0 (≥4-point Pruritus NRS reduction).
Beck et al observed both early and sustained improvement in signs of AD. Compared with OLE baseline values of 16.6%/7.8% of participants with EASI-75/EASI-90, researchers reported:
- Week 4: 55.1%/27.2%
- Week 8: 70.6%/ 44.1%
- Week 260: 91.3%/72.8%
The team found similar improvements, both early and sustained at 5 years, for AD symptoms. When they compared the proportion of participants with ≥4-point Pruritus NRS reduction at baseline OLE (17.4%), they reported:
- Week 4: 46.1%
- Week 8: 55.7%
- Week 260: 60.7%
All the safety data were consistent with the known dupilumab safety profile in individuals with AD. The findings support dupilumab as effective continuous long-term therapy for adults with moderate-to-severe AD, concluded the team.
