The Journal of clinical and aesthetic dermatology · 2026
The Impact of Dupilumab on Psychological Wellbeing in Moderate-to-Severe Atopic Dermatitis Patients: A Phase IV Clinical Trial.
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Johnson Chandler E, Elhage Kareem G, Spencer Riley K, Jin Joy Q, Yeroushalmi Samuel, Davis Mitchell S, Hakimi Marwa, Liao Wilson, Bhutani Tina
Аннотация
OBJECTIVE: This study aims to prospectively evaluate the emotional impact of dupliumab treatment on patients with atopic dermatitis (AD) using a validated psychometric instrument, the Psychological General Wellbeing (PGWB) index. This index is widely used in nondermatologic conditions and assesses self-representations of intrapersonal affective and emotional states reflecting a sense of subjective wellbeing or distress.
METHODS: This was a Phase IV, open-label clinical trial using dupilumab for the treatment of moderate-to-severe AD. The primary endpoint was the change in PGWB score at Week 16 of dupilumab treatment compared to baseline.
RESULTS: A total of 24 participants completed the study. The change in average PGWB score after 16 weeks of treatment with dupilumab compared to baseline was not statistically significant (5.8±19.7; P=0.15). There was significant improvement in PGWB score at Week 52 of treatment (8.5±17.4; P=0.03). Mean Eczema Area and Severity Index (EASI) improvements at Weeks 16 and 52 were 60.3% and 76.8%, respectively. Regarding Investigator Global Assessment (IGA), 29.2% and 41.7% of participants achieved a score of 0 or 1 at Weeks 16 and 52, respectively.
LIMITATIONS: This study did not have a control arm and was limited by small sample size.
CONCLUSION: Treatment with dupilumab for 52 weeks was associated with improvement of psychological wellbeing, suggesting that intervention with this interleukin (IL) 4/IL-13 inhibitor is capable of restoring quality of life in these patients.
TRIAL ADMINISTRATION: NCT03667014.
METHODS: This was a Phase IV, open-label clinical trial using dupilumab for the treatment of moderate-to-severe AD. The primary endpoint was the change in PGWB score at Week 16 of dupilumab treatment compared to baseline.
RESULTS: A total of 24 participants completed the study. The change in average PGWB score after 16 weeks of treatment with dupilumab compared to baseline was not statistically significant (5.8±19.7; P=0.15). There was significant improvement in PGWB score at Week 52 of treatment (8.5±17.4; P=0.03). Mean Eczema Area and Severity Index (EASI) improvements at Weeks 16 and 52 were 60.3% and 76.8%, respectively. Regarding Investigator Global Assessment (IGA), 29.2% and 41.7% of participants achieved a score of 0 or 1 at Weeks 16 and 52, respectively.
LIMITATIONS: This study did not have a control arm and was limited by small sample size.
CONCLUSION: Treatment with dupilumab for 52 weeks was associated with improvement of psychological wellbeing, suggesting that intervention with this interleukin (IL) 4/IL-13 inhibitor is capable of restoring quality of life in these patients.
TRIAL ADMINISTRATION: NCT03667014.