LONG-TERM SAFETY IN ADULTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS TREATED WITH DUPILUMAB UP TO 4 YEARS

Abstract

<h3>Introduction</h3> In patients with atopic dermatitis (AD), classical immunosuppressive treatments are not recommended for continuous use due to safety concerns. This analysis reports long-term safety of dupilumab up to 4 years in adults with moderate-to-severe AD. <h3>Methods</h3> In the LIBERTY AD OLE (NCT01949311) study, adult patients ≥18 years old with AD initially received dupilumab 300mg weekly. 226 ongoing patients transitioned to 300mg every other week (q2w) to align with approved dosing. Use of topical corticosteroids (TCS) or calcineurin inhibitors was permitted. Treatment-emergent adverse events (TEAE) are reported as number of patients per 100-patient years (nP/100PY). Due to the lack of a control arm, LIBERTY AD CHRONOS (NCT02260986) 52-week safety results are provided. <h3>Results</h3> 2,207/1,065/557/362/352 patients completed up to 52/100/148/172/204 weeks of treatment. Mean (SD) treatment exposure was 103.4±57.8 weeks. Of the 2,677 patients included in the analysis, 2,273 experienced ≥1 TEAE (167.5 nP/100PY), which were mainly mild or moderate, and were lower than in the 300mg weekly + TCS arm of the 1-year CHRONOS trial (322.4 nP/100PY). 99 patients (1.8 nP/100PY) experienced TEAEs leading to treatment discontinuation. Of 536 patients reporting ≥1 event of conjunctivitis, 95% had mild (4.7 nP/100PY) or moderate (5.0 nP/100PY) severity. 89% of conjunctivitis events were resolved or resolving, and 0.5% (0.2 nP/100PY) led to treatment discontinuation. Efficacy was sustained and consistent with previous reports of this study. <h3>Conclusion</h3> The overall safety profile of dupilumab up to 4 years was consistent with the known safety profile and demonstrated sustained efficacy in adult patients with moderate-to-severe AD.