Study: Long-Term Dupilumab Safe and Effective in Adolescents with Atopic Dermatitis

Treatment with dupilumab in adolescents with moderate-to-severe atopic dermatitis (AD) demonstrated long-term safety and efficacy that was comparable to the treatment’s use in adults, according to a new study.

The results reinforced findings from an earlier short-term study that showed dupilumab can significantly improve AD in adolescents. The study, published in the British Journal of Dermatology, examined the long-term efficacy and safety profile of dupilumab in adolescents with inadequately controlled, moderate-to-severe AD.

Up until recently, there was a high unmet medical need for adolescents with AD, for which treatments typically included topical therapies that did not have long-term applicability. AD can have substantial detrimental effects on health-related quality of life (QoL) in adolescents, often linked with depression, anxiety, and attention deficit-hyperactivity disorder as well as a greater risk of asthma, allergic rhinitis, and food allergy.

Dupilumab, a monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL13, has demonstrated a favorable benefit-to-risk safety profile, improved disease severity and symptoms, and improved scores for anxiety, depression, and QoL in adults with AD.

For this phase 2a study, 40 adolescents received 1 dupilumab dose and 8 weeks of pharmacokinetic sampling. Patients then received the same dose weekly for 4 weeks, with 8-week safety follow-up. Thereafter, 36 patients were enrolled in the ongoing phase 3 open-label extension (OLE) study.

Overall, mean ± SD trough dupilumab concentrations in serum at week 48 in the OLE trial were 74 ± 19 mg L^-1 and 161 ± 60 mg L^-1 for 2 mg kg^-1 and 4 mg kg^-1, respectively. Additionally, dupilumab was well tolerated over 52 weeks, with the most common treatment-emergent adverse effects being nasopharyngitis (week 52: 41% [2 mg kg^-1], 47% [4 mg kg^-1]) and AD exacerbation (29%, 42%). No new safety signals were observed and the safety profile was comparable with the known safety profile of dupilumab in adults.

The study also showed that, with continuing treatment, Eczema Area and Severity Index (EASI) scores improved [week 52: -85% ± 12% (2 mg k-¹) and -84% ± 20% (4mg kg-¹)].

“Adolescents with moderate-to-severe atopic dermatitis have a high disease burden that negatively affects quality of life, and patients are in need of therapies that can be used long-term,” senior author Ashish Bansal, MD, of Regeneron Pharmaceuticals, said in a statement. “Results from these trials show that dupilumab provides substantial and sustained clinical benefit to these patients with an acceptable safety profile.”

According to the study authors, in addition to the studies demonstrating the long-term efficacy and safety of dupilumab in adolescents for up to 52 weeks of treatment, the data also support the use of dupilumab in combination with topical corticosteroids.

“These 52-week safety and efficacy data support long-term use of dupilumab in this patient population,” the authors concluded.

References

Cork MJ, Thaci D, Eichenfield LF, et al. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase 2a open-label trial and subsequent phase 3 open-label extension. British Journal of Dermatology. 2019. https://doi.org/10.1111/bjd.18476

Long-Term Dupilumab Benefits Adolescents with Eczema [news release]. Wiley. https://newsroom.wiley.com/press-release/british-journal-dermatology/long-term-dupilumab-benefits-adolescents-eczema. Accessed October 9, 2019.