OLYMPIA 1
Trial question
What is the role of nemolizumab, an anti-IL-31Ra monoclonal antibody, in patients with moderate-to-severe prurigo nodularis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 286
286 patients (166 female, 120 male).
Inclusion criteria: adult patients with moderate-to-severe prurigo nodularis.
Key exclusion criteria: body weight < 30 kg; chronic pruritus resulting from another active condition other than prurigo nodularis; neuropathic/psychogenic pruritus; active atopic dermatitis; COPD, uncontrolled asthma, and/or chronic bronchitis.
Interventions
N=190 nemolizumab (subcutaneous loading dose of 60 mg, followed by 30 mg every 4 weeks for < 90 kg or 60 mg every 4 weeks for ≥ 90 kg for 16 weeks).
N=96 placebo (subcutaneous matching placebo every 4 weeks for 16 weeks).
Primary outcome
≥ 4-point improvement in Peak Pruritus Numerical Rating Scale score at week 16
58.4%
16.7%
58.4 %
43.8 %
29.2 %
14.6 %
0.0 %
Nemolizumab
Placebo
Significant
increase ▲
NNT = 2
Significant increase in ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale score at week 16 (58.4% vs. 16.7%; AD 40.1%, 95% CI 29.4 to 50.8).
Secondary outcomes
Significant increase in Investigator Global Assessment success at week 16 (26.3% vs. 7.3%; AD 14.6%, 95% CI 6.7 to 22.6).
Significant increase in ≥ 4-point improvement in Sleep Disturbance Numerical Rating Scale score at week 16 (50% vs. 11.5%; AD 38%, 95% CI 27.8 to 48.2).
Significant increase in Peak Pruritus Numerical Rating Scale score < 2 at week 16 (34.2% vs. 4.2%; AD 30.5%, 95% CI 22.3 to 38.7).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with moderate-to-severe prurigo nodularis, nemolizumab was superior to placebo with respect to ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale score at week 16.
Reference
Sonja Ständer, Gil Yosipovitch, Franz J Legat et al. Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial. JAMA Dermatol. 2025 Feb 1;161(2):147-156.
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