Vixarelimab Shows Dose-Dependent Efficacy in Prurigo Nodularis Phase 2b Trial

KEY TAKEAWAYS

• A new study shows vixarelimab reduced itch severity and improved lesion outcomes in patients with moderate to severe prurigo nodularis (PN).

• The clincial effects appeared to be dose-dependenty, with the high-dose group achieving the most significant improvements.

• There were no treatment-related adverse events in the study period. 

Vixarelimab demonstrated dose-dependent improvements in itch severity and skin lesion clearance in patients with moderate to severe prurigo nodularis (PN), according to new results from a phase 2b randomized clinical trial.

Researchers for the double-blind, placebo-controlled study included 190 adults and looked at three monthly doses of subcutaneous vixarelimab (120 mg, 360 mg, and 540 mg) compared to placebo over a study period of 16 weeks, followed by a 36-week open-label extension. Participants had PN for at least 6 months and reported moderate to severe pruritus.

At week 16, patients in the vixarelimab group saw statistically and clinically meaningful reductions in the Worst Itch Numeric Rating Scale (WI-NRS) vs placebo. Two-thirds of patients in the high-dose group achieved at least a 4-point WI-NRS reduction (vs 16.7% with placebo), and Investigator Global Assessment (IGA) scores of 0 or 1 were also more frequent among vixarelimab-treated groups. Benefits were observed early and sustained throughout the double-blind period.

There were no fatal or serious drug-related adverse events reported, and the therapy was well-tolerated. 

"The clinical benefit of vixarelimab occurred rapidly and was sustained throughout the 16-week DB period and the 36-week open-label extension period," the authors concluded. "Additional studies examining the effectiveness of vixarelimab in ulcerative colitis and idiopathic pulmonary fibrosis are ongoing."

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