Dupilumab is efficacious in patients above and below 60 years old with prurigo nodularis: pooled results from two phase III trials (LIBERTY-PN PRIME and PRIME2)

Abstract

Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by itchy papulonodular lesions that substantially affect patient quality of life. The aim of this subgroup analysis was to evaluate the efficacy and safety of dupilumab for the treatment of PN in older patients (> 60 years). LIBERTY-PN PRIME and PRIME2 were randomized, double-blind, multicentre, parallel-group, 24-week, phase III trials in adults with PN with >= 20 nodules and severe itch, inadequately controlled with topical prescription therapies or for whom these therapies were inadvisable. This pooled subgroup analysis of LIBERTY-PN PRIME and PRIME2 (NCT04183335 and NCT04202679) included adults with moderate-to-severe PN receiving 300 mg dupilumab (n = 153) or matched placebo (n = 158) every 2 weeks for 24 weeks. We assessed the proportion of patients younger and older than 60 years who achieved >= 4-point reduction in Worst Itch Numerical Rating Scale (WI-NRS), or Investigator's Global Assessment for PN-Stage (IGA PN-S) score 0 or 1 at week 24. Reported P-values are nominal and not adjusted for multiplicity. The incidence of treatment-emergent adverse events (TEAEs) was also assessed. Baseline demographics and clinical characteristics were similar between groups (dupilumab = 60 years n = 47; placebo = 60 years n = 46). In the overall population, a greater proportion of dupilumab-treated patients reported improved WI-NRS by >= 4 points at week 24 (dupilumab vs. placebo; 63.4% vs. 23.4%; P = 60 years n = 46). In the overall population, a greater proportion of dupilumab-treated patients reported improved WI-NRS by >= 4 points at week 24 (dupilumab vs. placebo; 63.4% vs. 23.4%; P = 60 years n = 46). In the overall population, a greater proportion of dupilumab-treated patients reported improved WI-NRS by >= 4 points at week 24 (dupilumab vs. placebo; 63.4% vs. 23.4%; P = 60 years (64% vs. 17%; P= 4 points at week 24, vs. placebo. There was no difference in treatment efficacy between age groups (dupilumab = 60 years P = 0.61; placebo = 60 years P = 0.44). In the overall population, a greater proportion of dupilumab-treated than placebo-treated patients achieved IGA PN-S score 0 or 1 at week 24 (48.4% vs. 18.4%; P = 60 years P = 0.44). In the overall population, a greater proportion of dupilumab-treated than placebo-treated patients achieved IGA PN-S score 0 or 1 at week 24 (48.4% vs. 18.4%; P = 60 years (51% vs. 9%; P = 60 years (51% vs. 9%; P = 60 years P = 0.28; placebo = 60 years P=0.08). Incidences of TEAEs and severe TEAEs were similar in both age groups. Dupilumab-treated patients in the younger and older age groups experienced significant reductions in both itch and skin lesions. Safety was generally consistent with the known dupilumab safety profile and was similar between age groups. .