Dupilumab is the first biologic to show positive phase 3 results in patients with prurigo nodularis.
New data from the LIBERTY-PN PRIME2 trial presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting found that dupilumab significantly improved itch and skin lesions in patient with prurigo nodularis (PN).
Prurigo nodularis a chronic inflammatory skin disease with pruritic nodules on the extensor surfaces of the limbs and trunks of patients. Currently, there are no approved systemic therapies by the Food and Drug Administration (FDA) or European Medicines Agency (EMA).
Several off-label treatments such as topical treatments, ultraviolet light, and more have often resulted in inadequate control in patients with ≥20 lesions, and many off-label systemic therapies have limited evidence and various side effects and toxicities.
With the phase 3 LIBERTY-PN PRIME2 trial, adult patients with 20 or more nodules and severe itch were considered for dupilumab treatment.Among participants with PN, the mean WI-NRS of 8.5 (1.0) at baseline; 62% had ≥20 to 100 nodules, 38% had >100 nodules. Nearly two-thirds of these patients had previously used systemic therapies.
A total of 78 adults with PN were given a 600mg loading dose of dupilumab followed by 300mg doses every 2 weeks for a total of 24 weeks.
The primary endpoint was a proportion of patients experiencing a ≥4-point reduction on the Worst-Itch Numeric Rating Scale (WI-NRS, range: 0-10) from baseline to Week 12. Key secondary endpoints included proportions of patients with ≥4-point reduction in WI-NRS from baseline to week 24, and Investigator’s Global Assessment PN-Stage (IGA PN-S, range: 0-4] of 0 or 1 at week 24.
Regarding dupilumab and placebo-treated patients, 37.2% versus 22.0% achieved ≥4-point reduction in WI-NRS at W12 (P=0.0216) and 57.7% and 19.5% achieved a ≥4-point reduction at week 24 (P<0.0001).
Meanwhile, 44.9% of patients with PN achieved IGA PN-S of 0 or 1 at week 24 compate to 15.9% of the placebo group (P<0.0001), and the rate of treatment-emergent adverse events was 57.1% and 51.2% for dupilumab vs placebo, respectively.
Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch response and skin lesions vs placebo in adult patients with PN. The safety profile was consistent with the known safety profile of dupilumab.
The data showcases dupilumab as the first biologic to show positive phase 3 results in PN, with results being confirmed in a second positive trial announced in January 2022.