LIBERTY-PN PRIME
Trial question
What is the role of dupilumab in patients with prurigo nodularis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
66.0% female
34.0% male
N = 151
151 patients (100 female, 51 male).
Inclusion criteria: adult patients with prurigo nodularis with ≥ 20 nodules and severe itch uncontrolled with topical therapies.
Key exclusion criteria: prurigo nodularis secondary to medications or medical conditions; severe renal conditions; uncontrolled thyroid disease; active tuberculosis or NTM infection.
Interventions
N=75 dupilumab (at a dose of 300 mg SC every 2 weeks for 24 weeks).
N=76 placebo (matching placebo SC every 2 weeks for 24 weeks).
Primary outcome
Reduction in Worst Itch Numeric Rating Scale by ≥ 4-point at week 24
60%
18.4%
60.0 %
45.0 %
30.0 %
15.0 %
0.0 %
Dupilumab
Placebo
Significant
increase ▲
NNT = 2
Significantly greater reduction in Worst Itch NRS by ≥ 4-point at week 24 (60% vs. 18.4%; AD 42.7%, 95% CI 27.8 to 57.7).
Secondary outcomes
Significant increase in Investigator's Global Assessment for Prurigo Nodularis-Stage score of 0 or 1 at week 24 (48% vs. 18.4%; AD 28.3%, 95% CI 13.4 to 43.2).
Significantly greater reduction in Worst Itch NRS by ≥ 4-point at week 12 (44% vs. 15.8%; AD 29.2%, 95% CI 14.5 to 43.8).
Significant increase in concomitant reduction in Worst Itch NRS by ≥ 4 points and Investigator's Global Assessment for Prurigo Nodularis-Stage score of 0 or 1 at week 24 (38.7% vs. 9.2%; AD 29.6%, 95% CI 16.4 to 42.8).
Safety outcomes
No significant difference in treatment-emergent serious adverse events.
Conclusion
In adult patients with prurigo nodularis with ≥ 20 nodules and severe itch uncontrolled with topical therapies, dupilumab was superior to placebo with respect to reduction in Worst Itch NRS by ≥ 4-point at week 24.
Reference
Gil Yosipovitch, Nicholas Mollanazar, Sonja Ständer et al. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190.
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