Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study
AuthorDeleuran, M; Thaci, D; Beck, LA; de Bruin-Weller, M; Blauvelt, A; Forman, S; Bissonnette, R; Reich, K; Soong, W; Hussain, I; ...
Source TitleJournal of the American Academy of Dermatology
University of Melbourne Author/sFoley, Peter
AffiliationMedicine (St Vincent's)
Document TypeJournal Article
CitationsDeleuran, M., Thaci, D., Beck, L. A., de Bruin-Weller, M., Blauvelt, A., Forman, S., Bissonnette, R., Reich, K., Soong, W., Hussain, I., Foley, P., Hide, M., Bouaziz, J. -D., Gelfand, J. M., Sher, L., Schuttelaar, M. L. A., Wang, C., Chen, Z., Akinlade, B. ,... Ardeleanu, M. (2020). Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 82 (2), pp.377-388. https://doi.org/10.1016/j.jaad.2019.07.074.
Access StatusOpen Access
BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
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