Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

Abstract

Background Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4%) at week 148. Limitations No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration ClinicalTrials.gov: NCT01949311. Video abstract Electronic supplementary material The online version of this article (10.1007/s40257-020-00527-x) contains supplementary material, which is available to authorized users.

Dupilumab provides favourable long‐term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open‐label phase IIa study and subsequent phase III open‐label extension study

“…20,24 For comparison with exposure-adjusted incidence of skin infections in the OLE study reported here (17-25 patients per 100 PYs), a 1-year open-label study in adolescents observed skin infections in 18-34 patients per 100 PYs 14 and a 3-year open-label study in adults found the incidence to be five patients per 100 PYs. 25 The rates of conjunctivitis in the phase IIa study were small, an observation also made in a similar analysis of adolescents, 14 which could be explained in part by the short study duration and low number of dupilumab doses. Furthermore, the studies reported here were conducted before investigators developed a heightened awareness of conjunctivitis as an AE associated with dupilumab, which may lead to higher reporting in more recent studies.…”

Biological drugs in the treatment of atopic dermatitis – recommendations of the Polish Dermatological Society, the Polish Society of Allergology, the Polish Pediatric Society and the Polish Society of Family Medicine

“…Long-term safety of up to 3 years of use of dupilumab has been established for adults [37,38]. In the group of children aged 12-17 years, safety data covers up to 52 weeks of treatment with dupilumab [39].…”

“…Bezpieczeństwo długoterminowej terapii dupilumabem u dzieci od 6. roku życia, młodzieży i dorosłych Długoterminowe bezpieczeństwo do 3 lat stosowania dupilumabu zostało określone dla dorosłych [37,38]. U dzieci w wieku 12-17 lat dane dotyczące bezpieczeństwa obejmują czas do 52 tygodni leczenia dupilumabem [39].…”

T2-associated diseases: focus on the comorbid patient

“…[47]. В открытом продленном исследовании LIBERTY AD OLE (open-label extension) дупилумаб продемонстрировал благоприятный профиль безопасности и устойчивой эффективности на протяжении 3 лет наблюдений [48].…”