Short communication: Comments on hair disorders associated with dupilumab based on VigiBase

Abstract

Background Dupilumab is a human antibody that blocks the signaling of both interleukin-4 and interleukin-13 receptors. It has been approved for the treatment of moderate-to-severe atopic dermatitis. However, several case reports have reported conflicting effects of dupilumab on alopecia. Objectives This study aimed to examine dupilumab-related hair disorders using the large real-world database, VigiBase. Methods All individual case safety reports associated with dupilumab in the Uppsala Monitoring Center VigiBase until December 29, 2019, were analyzed. Hair disorder-related terms were defined in High Level Terms with “alopecias,” “pilar disorders NEC (not elsewhere classified),” and “hypertrichoses,” using the Medical Dictionary for Regulatory Activities Hierarchy. Hair disorder reports associated with dupilumab and other biologics that inhibit the Th2 axis (omalizumab, mepolizumab, reslizumab, and benralizumab) were analyzed to determine their association with hair disorders. Disproportionality analysis was performed based on the proportional reporting ratio, reporting odds ratio, and information components. Results Among the 20,548 total dupilumab adverse event (AE) reports, hair disorders were reported in 462 dupilumab cases (2.2%), most of which reported hair loss, and only eight cases reported an increase in hair growth. The paradoxical trend in hair loss and growth after dupilumab use was confirmed using a disproportionality analysis. Among the other investigated biologics on Th2 immunity, only omalizumab was associated with hair loss. Additionally, hair disorders after dupilumab treatment were more frequently reported in women than in men. The proportion of hair disorder cases was high in Europe, accounting for 20.8% of hair disorder reports, whereas only 9.7% of all dupilumab-related AEs were reported in Europe. In conclusion, our analysis using a large real-world database confirmed that dupilumab is associated with hair disorders.

Complete hair regrowth in a young male with severe atopic dermatitis and alopecia areata after dupilumab: probably more than a coincidence

“…A study using the VigiBase, a real-world pharmacovigilance database concluded that hair disorders corresponded to 2.2% of total dupilumab adverse events. This study concluded that dupilumab was associated with both hair growth and loss and overall, the paradoxical results of dupilumab in hair disorders might be caused by complex disease factors, such as IgE and IL-4 levels and the complexity of AA pathogenesis 14 .…”

“…However, the relationship between dupilumab and alopecia areata remains controversial as some patients experience improvement after starting treatment while others develop dupilumab-induced alopecia 13 with some studies suggesting that Th2 inhibition may amplify alternate pathways such as Th1 and Th17 resulting in hair loss 14 . Moreover, alopecia associated with dupilumab tends to follow an androgenetic pattern and usually has an eczematous pattern upon histopathological examination 15 .…”

Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

“…Hair loss is listed among the side effects in the omalizumab package insert, but unlisted for the other study drugs. Several published case reports and a previous analysis based on VigiBase considered the potential correlation between the onset of hair disorders and dupilumab therapy [ 62 – 64 ]. Nevertheless, a paradoxical effect of dupilumab as a beneficial treatment for alopecia areata has been reported [ 65 ].…”