Study: Long-Term Dupilumab Safe and Effective in Adolescents with Atopic Dermatitis<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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)].<\/p>\n
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.<\/p>\n
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.<\/p>\n
These 52-week safety and efficacy data support long-term use of dupilumab in this patient population, the authors concluded.<\/p>\n
References<\/p>\n
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<\/a><\/p>\n 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<\/a>. Accessed October 9, 2019.<\/p>\n<\/p>\n <\/p>\n Continued here: Study: Long-Term Dupilumab Safe and Effective in Adolescents with Atopic Dermatitis 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 Continue reading
\nLong-Term Dupilumab Safe, Effective in Adolescents with Atopic Dermatitis - Pharmacy Times<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"