BACKGROUND: Nemolizumab is a humanized anti-IL-31 receptor blocker in phase 3 
for atopic dermatitis (AD).
OBJECTIVE: Analyse onset of action of nemolizumab 30 mg and compare efficacy and 
safety vs placebo (SC q4wk plus loading dose) in moderate-to-severe AD.
METHODS: Post hoc analysis of patients with Eczema Area and Severity Index 
(EASI) scores ≥ 16 from a phase 2b trial of moderate-to-severe AD. Endpoints 
were change in EASI score at week 16, peak pruritus numeric rating scale 
(PP-NRS), Investigator's Global Assessment (IGA), changes in sleep and 
responders with ≥ 4-point improvement on PP-NRS.
RESULTS: There was a significantly greater itch relief apparent by Day 2 (-22.8% 
vs -12.3% PP-NRS; P = 0.005) which continued to improve through week 16 (-68.5% 
vs -30.9% PP-NRS; P < 0.001). At week 16, PP-NRS ≥ 4-point response of itch was 
observed in 68.0% nemolizumab vs 15.9% placebo patients (P ≤ 0.001). There was 
also a rapid improvement of sleep disturbance with nemolizumab 30 mg, with a 
significant separation from placebo by Day 3 (-26.6% vs -9.0%; P < 0.001) which 
further improved till week 16 (-76.0% vs -36.5%; P < 0.001). Also for the EASI 
score a separation between groups in favour of nemolizumab was observed by week 
1 (P ≤ 0.001), which increased through week 16 (-68.6% vs. -42.6%; P = 0.002). 
Finally, the degree of response was greater in nemolizumab-treated patients; 
clinically relevant reductions of 75% EASI were observed in 50.0% of nemolizumab 
patients versus 15.9% of placebo patients, while 90% reductions were reported 
for 36.0% and 6.8% of patients, respectively (P < 0.001 for both). IGA success 
(score of 0/1) was 32.0% for nemolizumab vs 6.8% for placebo (P = 0.002). 
Nemolizumab was safe and well-tolerated in this population; nasopharyngitis and 
upper respiratory tract infection were the most common adverse events.
CONCLUSIONS: Nemolizumab resulted in very rapid, sustained improvements of 
inflammation, pruritus and sleep in patients with EASI ≥ 16 at baseline.