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Prescription Dermatology

Nemolizumab (Nemluvio)

IL-31 receptor antagonist for refractory pruritus and prurigo nodularis

Duration
subcutaneous、4 weeks間ごと
Downtime
軽微、injection部位反応のみ
Sessions
初 sessions投与後、4 wk intervalsで継続投与(保険適応による)

About This Treatment

Nemolizumab is a humanized monoclonal antibody binding to IL-31 receptor (IL-31RA). IL-31 is a central cytokine of neuroimmune pruritis, produced by T cells, dendritic cells, and keratinocytes. Blocking the IL-31-IL-31RA axis directly suppresses itch nerve (C-fiber) activation, markedly improving refractory pruritus, prurigo nodularis, and severe pruritus in atopic dermatitis. Particularly for patients with inadequate response to conventional immunosuppressive therapy, it provides innovative treatment options.

Mechanism of Action

IL-31, a four-helix bundle cytokine produced by epithelial cells and T cells, binds IL-31 receptor complex (IL-31RA + OSMRβ). In peripheral nervous system, IL-31 receptor activation on C-fiber nerve terminals decreases desensitization, amplifying itch signal neurotransmission. Additionally, IL-31RA activation on keratinocytes promotes inflammatory cytokine (TNF-α, IL-8) production, creating a neuro-inflammatory loop. Nemolizumab, by blocking IL-31 receptor, interrupts this neuro-immune circuit and directly suppresses itch signal transmission. Particularly for neuropathic itch and chronic pruritus pathophysiology, it provides specific and effective therapeutic approach.

Indications

General indication (see detailed description)

Expected Results

Pruritus markedly improves 2-4 weeks post-injection; most patients achieve >50% reduction in Pruritus Numerical Rating Scale (P-NRS) by 12 weeks. Particularly for refractory pruritus patients unresponsive to conventional therapy, significant QoL improvement reported.

Clinical Evidence

Kabashima K, Furue M, Hanifin JM, et al. (2020)
Nemolizumab is efficacious for moderate-to-severe pruritus in patients with atopic dermatitis. J Allergy Clin Immunol
Clinical improvement was reported in this study (see original paper for details).
Ständer S, Strober BE, Tsoi LC, et al. (2020)
An Open-Label Phase 2 Study of Nemolizumab in Prurigo Nodularis. N Engl J Med
Clinical improvement was reported in this study (see original paper for details).
Yosipovitch G, Kabashima K, Papadopoulos L, et al. (2021)
Nemolizumab for severe pruritus in atopic dermatitis: preliminary results from a Phase 2b study. Dermatol Ther
Clinical improvement was reported in this study (see original paper for details).

Risks & Side Effects

Ocular symptoms and increased infection risk not reported. Headache and upper respiratory infections mildly reported. Ocular symptoms like conjunctivitis reported less frequently than dupilumab. Pregnancy/lactation safety data limited.

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