LIBERTY-PN PRIME2
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
64.0% female
36.0% male
N = 160
160 patients (103 female, 57 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=78 dupilumab (at a dose of 300 mg SC every 2 weeks for 24 weeks).
N=82 placebo (matching placebo SC every 2 weeks for 24 weeks).
Primary outcome
Reduction in Worst Itch Numeric Rating Scale by ≥ 4-point at week 12
37.2%
22%
37.2 %
27.9 %
18.6 %
9.3 %
0.0 %
Dupilumab
Placebo
Significant
increase ▲
NNT = 6
Significantly greater reduction in Worst Itch NRS by ≥ 4-point at week 12 (37.2% vs. 22%; AD 16.8%, 95% CI 2.3 to 31.2).
Secondary outcomes
Significant increase in Investigator's Global Assessment for Prurigo Nodularis-Stage score of 0 or 1 at week 24 (44.9% vs. 15.9%; AD 30.8%, 95% CI 16.4 to 45.2).
Significantly greater reduction in Worst Itch NRS by ≥ 4-point at week 24 (57.7% vs. 19.5%; AD 42.6%, 95% CI 29.1 to 56.1).
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 (32.1% vs. 8.5%; AD 25.5%, 95% CI 13.1 to 37.9).
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 12.
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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