251 Treatment interruption did not impact efficacy or long-term safety of dupilumab: A phase 3 open-label trial

Treatment interruption may occur in clinical practice. The objective of this abstract is to present the effect of treatment interruption on long-term safety and efficacy of dupilumab. We present an interim analysis of an ongoing multicenter, open-label trial (NCT01949311) of dupilumab treatment for up to 3 years. Adults with moderate-to-severe atopic dermatitis (AD) were enrolled after participation in prior dupilumab trials. Safety and efficacy at Week [Wk] 52 for dupilumab naïve (previously unexposed) and retreated (>13 Wk gap between parent and open-label study) patients were evaluated. Of the 1,491 treated patients, 116 naïve and 290 retreated patients were included in this analysis (includes patients who finished to or withdrew before Wk52). Naïve and retreated patients had 432.5 and 371.0 adverse events/100 patient years (AEs/100PY), 11.7 and 5.4 serious AEs/100PY, and 2.6% and 2.8% treatment discontinuations due to AEs, respectively; there were no deaths. At Wk52, 49.1%/50.7% naïve/retreated patients had an Investigator’s Global Assessment score of 0 or 1, and 73.3%/80.7% achieved EASI-75 (from baseline of parent study); peak pruritus Numerical Rating Scale scores at Wk52 decreased by 64.9% and 60.6% from baseline of parent study for naïve and retreated patients. Overall, safety and efficacy assessments at all timepoints in the Wk52 analysis showed similar results between groups. In conclusion, safety and efficacy results were similar in the group of patients retreated with dupilumab after an interruption of ≥3 months, compared with patients who received dupilumab for the first time in this study and underwent uninterrupted treatment.