Dupilumab Safety Profile in Atopic Dermatitis, Prurigo Nodularis, and Chronic Spontaneous Urticaria

Overview

This correction clarifies the safety data presentation for dupilumab in treating atopic dermatitis (AD), prurigo nodularis (PN), and chronic spontaneous urticaria (CSU). The corrected Table 2 provides accurate treatment-emergent adverse event (TEAE) rates across placebo and dupilumab groups in clinical trials.

Background

Dupilumab is a monoclonal antibody used to alleviate itching and inflammation in various dermatological conditions including AD, PN, and CSU. Safety and tolerability are critical for its clinical use, especially when combined with topical corticosteroids (TCS) or antihistamines. Clinical trials have assessed TEAEs and serious adverse events to establish dupilumab's risk profile.

Data Highlights

Key Findings

• Dupilumab plus TCS showed a slightly higher overall TEAE rate in AD (88%) compared to placebo plus TCS (84%).
• In PN, dupilumab treatment had a higher TEAE rate (59.9%) than placebo (51%).
• For CSU, TEAE rates were similar between dupilumab (54.3%) and placebo (58.8%).
• Serious adverse events (TESAEs) were low across all groups, ranging from 2.9% to 7.4%.
• TEAEs leading to treatment discontinuation were fewer in dupilumab groups compared to placebo in AD and PN.
• No deaths occurred in AD or PN groups; one death was reported in the CSU placebo group.

Clinical Implications

Dupilumab demonstrates an acceptable safety profile across dermatological conditions when used with background therapies such as TCS or H1 antihistamines. Clinicians should monitor for common TEAEs including nasopharyngitis and injection-site reactions but can be reassured by the low rates of serious adverse events and treatment discontinuations. This supports dupilumab's continued use in managing AD, PN, and CSU.

Conclusion

The corrected safety data confirm dupilumab's tolerability in multiple dermatologic indications, reinforcing its role as a therapeutic option with manageable adverse events. Accurate safety reporting is essential for informed clinical decision-making.

References

1. Dermatol Ther (Heidelb) 2025 -- Amendment: Dupilumab Alleviates Itching in Various Dermatological Conditions