Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances.
J Eur Acad Dermatol Venereol
; 36(10): 1820-1825, 2022 Oct.
Article
em En
| MEDLINE
| ID: mdl-35766128
ABSTRACT
BACKGROUND:
Patients with prurigo nodularis (PN) have multiple itchy nodules, impaired quality of life and sleep deprivation. Prurigo nodularis patients have a high burden of disease, primarily due to the intensity of the itch. It is reasonable to expect that rapid relief of itch - and associated improvement of sleep - are highly valued clinical outcomes for patients. Nemolizumab is an IL-31A-receptor inhibitor that modulates the neuroimmune response with reported positive efficacy and safety data in a phase 2 study of PN.OBJECTIVES:
To evaluate the onset of action of nemolizumab on itch and sleep disturbances.METHODS:
Post hoc analysis of a phase 2 trial of nemolizumab 0.5 mg/kg SC vs. placebo in patients (n = 70) with moderate-to-severe PN (≥20 nodules) and severe pruritus (NRS ≥ 7). Time to significant reduction was assessed for peak pruritus (PP) and sleep disturbance (SD) using numerical rating scales (NRS), also assessed was scratching time during sleep.RESULTS:
Nemolizumab significantly reduced itch vs. placebo within 48 h (PP NRS -19.5% vs. -5.8%, respectively, P = 0.014). Significant difference between nemolizumab and placebo in reducing itch by ≥4 on PP NRS was achieved at Day 3 (23.5% vs. 0%, P < 0.001). A significant difference in SD NRS was reported by Day 4 (-24.0% vs. -4.3% placebo, P = 0.012). In addition, there was a separation between groups in SD responders (decrease of ≥4 points) in favour of nemolizumab by Day 2 (8.8% vs. 0%, P = 0.037). Sleep continued improving through Week 4, when there was a -56.0% reduction in SD NRS vs. -22.9% placebo (P < 0.001). Actigraphy data showed improvement in scratch/sleep duration for nemolizumab vs. placebo, respectively, by Week 1 (-32.15 vs. +28.15 min/h, P = 0.001).CONCLUSION:
Nemolizumab has a rapid and robust onset of action in PN with itch reduction and improvement of sleep within 48 h.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Prurigo
/
Transtornos do Sono-Vigília
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Humans
Idioma:
En
Revista:
J Eur Acad Dermatol Venereol
Assunto da revista:
DERMATOLOGIA
/
DOENCAS SEXUALMENTE TRANSMISSIVEIS
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Alemanha