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Real-world review finds Black patients report fewer dupilumab-related adverse events than White patients.
A recent study suggests that Black patients on dupilumab for atopic dermatitis may experience fewer treatment-related adverse events than White patients.1
Research has reported racial differences in atopic dermatitis prevalence, incidence, severity, and persistence in the United States, with African American and Latinx people having greater rates.2 Recently, findings have shown ethic differences in immunophenotype characterization; FLG mutations are 6 times less common in African American patients compared to European American patients with atopic dermatitis. Additionally, Asian patients with atopic dermatitis have stronger TH17/TH22 activation, and African American patients with atopic dermatitis have the greatest serum IgE levels and often lack TH1 and TH17 activation.3
The US Food and Drug Administration (FDA) approved dupilumab, an IgE-based monoclonal specific for IL-4Ra, for adults with atopic dermatitis in March 2017.4 Long-term adverse events of dupilumab often include ocular and cutaneous reactions.1
Given the ethic differences in immunophenotype characterization, investigators wanted to see whether dupilumab-associated adverse events differed by ethnicity. Thus, the team, led by Ikenna Anusionwu, BA, MD candidate, from the Perelman School of Medicine at the University of Pennsylvania, conducted a single-center, retrospective chart review to identify the most frequently reported dupilumab-associated adverse events and the prevalence of these events among different races.1
The sample included participants aged ≥ 18 years with a past or current dupilumab prescription for atopic dermatitis. Participants visited a clinic at the University of Pennsylvania Health System between January 1, 2017, and January 1, 2022. The study excluded those who were on dupilumab for an investigational trial or an off-label indication.
Although the team primarily aimed to assess the prevalence of dupilumab-associated adverse events in Black or African American individuals (29.21%; n = 130), nearly half of the sample was White (49.21%; n = 219), followed by other skin of color such as Asian, Hispanic/Latinx American Indian (17.30%; n = 77) and unknown or not reported race (4.27%; n = 19). This study had a greater representation of Black or African American patients with dupilumab-treated atopic dermatitis compared with prior clinical trials.
Like other clinical trials, this review showed a similar safety profile, with 79% of the sample not reporting dupilumab-associated adverse events. The most frequently reported dupilumab-associated adverse event was ocular manifestations, followed by injection site and dermatologic reactions.
Black participants reported the following events: ocular (60%), injection site (16%), dermatologic (12%), MSK (8%)—with 4% malignant. White participants reported ocular (67%), dermatologic (12%), injection site (10%), MSK (8%), and other (8%). Participants with other skin colors reported ocular (75%), dermatologic (17%), and other (1%).1
Among White participants, 1 in 2 reported dupilumab-associated adverse events (n = 51). Moreover, only 1 in 3 Black or African Americans reported dupilumab-associated adverse events (n = 25).1
The analysis showed that Black or African Americans experienced a lower risk of having a dupilumab-associated adverse event, although this was not significant (RR, 0.78; 95% CI, 0.46 – 1.34). Investigators noted that the lack of statistical significance may be due to the small sample size.1
The risk of ocular adverse events may be driven by the TH-1 response, caused by blocking TH2 cytokines (IL-4/IL-13). The lower level of ocular adverse events in Black or African Americans may be due to the relative scarcity of TH-1 activation.
“Considering that diverse racial/ethnic representation is low in many dermatologic clinical trials, it is important to assess real-life outcomes of medication efficacy and safety outcomes in [skin of color] patients,” investigators wrote.1 “Larger datasets from multiple institutions are needed to assess whether these findings are statistically significant.”
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