Dados do Trabalho

Título

Maintenance of Patient Well-Being and Perception of Treatment Effect in Dupilumab-Treated Patients Transitioning From Every Other Week to Monthly Doses

Resumo

Introduction: Patients with moderate-to-severe atopic dermatitis (AD) suffer from a high burden of disease and the patient’s assessment of response to treatment is an important factor in the long-term management and treatment adherance for this chronic condition.

Methods: Adults with moderate-to-severe AD that previously participated in SOLO 1/2 (NCT02277743/NCT02277769; 300mg every 2 weeks for 16 weeks) and achieved a 75% reduction from baseline in Eczema Area and Severity Index and/or an Investigator's Global Assessment score of 0/1 at Week 16 were enrolled in this phase 3 study (LIBERTY AD SOLO-CONTINUE, NCT02395133). Patients were randomized to dupilumab monotherapy 300mg every 4 weeks (q4w; n=41), dupilumab monotherapy 300mg every 8 weeks (q8w; n=39), or placebo (n=39) for an additional 36 weeks. Possible responses to perception of well-being and perception of treatment effect included: poor, fair, good, very good, and excellent.

Results: After 36 weeks on monotherapy with dupilumab q4w/q8w, 56.1%/38.5% of patients responded “very good” or “excellent” in their assessment of well-being, and 58.5%/48.7% considered the treatment effect “very good” or “excellent” compared with 12.8% and 15.4% of patients on placebo. The differences between dupilumab q4w/q8w and placebo at Week 52 were significant for well-being (P<0.0001/P<0.05) and treatment effect (P<0.0001/P<0.01). Overall safety was consistent with the known dupilumab safety profile.

Conclusions: Most optimally responding patients who were subsequently randomized to continue dupilumab 300mg q4w monotherapy for an additional 36 weeks rated both their well-being and perception of treatment effect as “very good” or “excellent” over 9 months of maintenance treatment.