LAUSR

BACKGROUND Significant unmet need exists for long-term treatment of moderate-to-severe atopic dermatitis (AD). OBJECTIVE To assess long-term safety and efficacy of dupilumab in AD patients. METHODS This ongoing, multicenter, open-label extension (OLE) study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1-3 dupilumab clinical trials in AD. This analysis examined patients given 300mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS Of 1,491 enrolled patients (1,042.9 patient-years), 92.9% remained on treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events [AEs]/100 patient-years [100PY] and 8.5 serious AEs/100PY), with no new safety signals; common AEs 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 of treatment (median follow-up: 24 weeks), and patients not receiving the approved 300mg every 2 weeks dose regimen. 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.