Vixarelimab beneficial in prurigo nodularis

Treatment with vixarelimab yields clinically meaningful improvements in prurigo nodularis (PN) symptoms, while having a favourable safety profile, according to a phase 2b study.

Conducted at 72 centres across US, Canada, Europe, and Asia, the study included 189 adult patients (mean age 55.4 years, 60.3 percent female) with PN for at least 6 months of duration and moderate-to-severe pruritus.

These participants were randomly assigned to receive subcutaneous vixarelimab at 540 mg (high-dose group, n=47), 360 mg (mid-dose group, n=47), or 120 mg (low-dose group, n=47) or placebo (n=48), administered every 4 weeks for 16 weeks during the double-blind treatment period. All participants received vixarelimab 360 mg every 2 weeks during the subsequent 36-week open-label extension phase.

Outcomes included Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the proportion of patients achieving scores of 0 or 1 in the PN Investigator Global Assessment at week 16.

At week 16, the mean WI-NRS scores were significantly reduced with vixarelimab vs placebo across all doses (−56.2 percent with high dose, −51 percent with mid dose, and −33 percent with low dose vs −14.5 percent). A ≥4-point reduction in WI-NRS was observed in 66 percent, 61.7 percent, 29.8 percent, and 16.7 percent of participants in the respective treatment groups.

More vixarelimab-treated patients also achieved PN Investigator Global Assessment scores of 0 or 1 compared with those who received placebo (38.3 percent in the high-dose group, 29.8 percent in the mid-dose group, 14.9 percent in the low-dose group vs 10.4 percent in the placebo group).

There were no cases of fatal or serious drug-related treatment-emergent adverse events (TEAEs) documented during the study. Additionally, none of the participants experienced serious treatment-related TEAEs during the double-blind treatment period.