OLYMPIA 2
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
61.0% female
39.0% male
N = 274
274 patients (168 female, 106 male).
Inclusion criteria: adult patients with moderate-to-severe prurigo nodularis.
Key exclusion criteria: chronic pruritus resulting from an active condition other than prurigo nodularis; neuropathic or psychogenic pruritus; active atopic dermatitis.
Interventions
N=183 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=91 placebo (subcutaneous matching placebo every 4 weeks for 16 weeks).
Primary outcome
Improvement in itch response at week 16
56.3%
20.9%
56.3 %
42.2 %
28.1 %
14.1 %
0.0 %
Nemolizumab
Placebo
Significant
increase ▲
NNT = 2
Significantly greater improvement in itch response at week 16 (56.3% vs. 20.9%; AD 37.4%, 95% CI 26.3 to 48.5).
Secondary outcomes
Significant increase in Investigator's Global Assessment response at week 16 (37.7% vs. 11%; AD 28.5%, 95% CI 18.8 to 38.2).
Significantly greater improvement in Peak Pruritus Numerical Rating Scale score at week 4 (41% vs. 7.7%; AD 33.4%, 95% CI 24.3 to 42.4).
Significantly greater improvement in Sleep Disturbance Numerical Rating Scale score at week 16 (51.9% vs. 20.9%; AD 31.9%, 95% CI 20.7 to 43.2).
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 improvement in itch response at week 16.
Reference
Shawn G Kwatra, Gil Yosipovitch, Franz J Legat et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589.
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