Findings from a Phase 3 trial evaluating dupilumab (Dupixent; Sanofi and Regeneron) in the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12 to 17 years showed the trial met its primary and key secondary endpoints.
The randomized, double-blind, placebo-controlled trial evaluated dupilumab in 251 teens aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical medications or for whom topical treatment was medically inadvisable.
The primary endpoint was the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) at Week 16. A key secondary endpoint was the proportion of patients who achieved ≥75% skin improvement as measured by the EASI-75 at Week 16. Enrolled patients were randomized to: weight-based dupilumab subcutaneous (SC) injection 200mg or 300mg every 2 weeks, dupilumab SC 300mg every 4 weeks, or placebo every 2 weeks.
More patients who received weight-based dupilumab every 2 weeks or fixed-dose dupilumab every 4 weeks achieved the primary endpoint vs placebo (24% and 18% vs 2%; P <.0001 and P <.0007, respectively). In addition, a greater improvement in EASI-75 was seen with dupilumab vs placebo (41.5% [every 2 weeks] and 38% [every 4 weeks] vs 8% [placebo]; P <.0001).
Moreover, a 66% and 65% improvement in average percent change from baseline in EASI score was seen for dupilumab every 2 weeks and dupilumab every 4 weeks, respectively, compared with a 24% improvement in the placebo group (P <.0001). The two dupilumab arms also demonstrated a greater average percent change from baseline in the pruritus numerical rating scale (NRS) (48% [every 2 week] and 45.5% [every 4 weeks] vs 19% [placebo] (P< .0001).
Regarding safety, the overall rate of adverse events was comparable between the dupilumab groups and placebo (72% [every 2 weeks], 64% [every 4 weeks] vs 69% [placebo]).
Dupixent, an interleukin-4 receptor alpha antagonist, is currently approved for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
“Moderate-to-severe atopic dermatitis can place a particularly significant burden on adolescents, who have to deal with oozing skin lesions with unrelenting, intense itching during their formative years,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Dupixent blocks the IL-4/IL-13 pathway, which is emerging as a central driver of Type 2 allergic inflammation.”
For more information call (800) 633-1610 or visit Dupixent.com.