Dupilumab Demonstrates Efficacy Across All Levels of Prurigo Nodularis Severity: Combined Results from Phase 3 Trials

In a comprehensive analysis pooling data from 2 pivotal phase 3 trials (LIBERTY-PN PRIME and PRIME2), researchers have shown that dupilumab effectively alleviates pruritus and reduces skin lesions in patients with prurigo nodularis (PN), irrespective of the severity of their baseline condition, according to a poster from the Revolutionizing Atopic Dermatitis (RAD) June 2024 meeting.

Prurigo nodularis is characterized by intensely itchy skin nodules that severely impact patients' quality of life. The severity of lesions can vary widely, from moderate cases with 20 to 100 nodules (IGA PN-S score of 3) to severe cases with over 100 nodules (IGA PN-S score of 4).

The study enrolled 311 adults who were inadequately controlled by topical therapies or for whom these treatments were unsuitable. Patients were randomly assigned to receive dupilumab 300 mg every 2 weeks or placebo. Efficacy was assessed using the Worst Itch Numerical Rating Scale (WI-NRS) and the Investigator’s Global Assessment for PN-Stage score (IGA PN-S) over 24 weeks.

Results demonstrated that significantly more patients treated with dupilumab achieved an IGA PN-S score of 0 (no nodules) or 1 (almost clear) at Week 24 compared to those receiving placebo, regardless of whether their PN was moderate (52.4% vs 24.5%) or severe (40.0% vs 7.4%) at baseline (nominal P = 0.0008 and P = 0.0014, respectively). Similar trends were observed in improvements in the WI-NRS scores, with higher percentages of dupilumab-treated patients experiencing clinically meaningful improvements compared to placebo in both severity groups (nominal P values ranging from 0.0002 to <0.0001).

While treatment-emergent adverse events (TEAEs) were more frequent in the dupilumab group compared to placebo in patients with moderate PN (71.6% vs 57.8%), the rates were comparable between groups in patients with severe PN (48.0% vs 55.6%). Importantly, the incidence of serious TEAEs, severe TEAEs, and specific adverse events such as conjunctivitis were consistent with dupilumab's known safety profile.

Reference:

Ständer S, Misery L, Yosipovitch G, Park CO, et al. Dupilumab is efficacious in patients with prurigo nodularis regardless of baseline lesion severity: pooled results from two phase 3 trials (LIBERTY-PN PRIME and PRIME2). Poster presented at: Revolutionizing Atopic Dermatitis; June 8-10, 2024; Chicago, IL.