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Nemolizumab

(Synonyms: CIM331) 目录号 : GC68341

Nemolizumab (CIM331) 是一种人源化的抗人白细胞介素-31 受体 a 单克隆抗体,可抑制白细胞介素-31 (IL-31) 与其受体的结合和随后的信号转导。Nemolizumab 可用于特应性皮炎 (AD) 的研究。

Nemolizumab Chemical Structure

Cas No.:1476039-58-3

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产品描述

Nemolizumab (CIM331) is a humanized antihuman interleukin-31 receptor A monoclonal antibody that inhibits the binding of interleukin-31 (IL-31) to its receptor and subsequent signal transduction. Nemolizumab can used be in research of atopic dermatitis (AD)[1].

[1]. Nakahara T, et, al. Nemolizumab and Atopic Dermatitis: the Interaction Between Interleukin-31 and Interleukin-31 Receptor as a Potential Therapeutic Target for Pruritus in Patients With Atopic Dermatitis. 2018;5:405-14.

Chemical Properties

Cas No. 1476039-58-3 SDF Download SDF
别名 CIM331
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Research Update

Nemolizumab: First Approval

Drugs 2022 Jul;82(10):1143-1150.PMID:35834124DOI:10.1007/s40265-022-01741-z.

Nemolizumab is a subcutaneously administered humanized anti-interleukin-31 (IL-31) receptor A (IL-31RA) monoclonal antibody that is being developed by Chugai Pharmaceutical Co. Ltd, Maruho Co. Ltd and Galderma Pharma S.A. for the treatment of skin diseases, including atopic dermatitis (AD), AD associated pruritus (ADaP), prurigo nodularis (PN), chronic kidney disease associated pruritus (CKDaP) and systemic sclerosis (SSc). IL-31 is a neuroimmune cytokine that induces itch, inflammation, keratinocyte differentiation and fibroblast activation in chronic pruritic skin diseases. Nemolizumab (Mitchga® Syringes) was approved in Japan on 28 March 2022 for use in adults and children over the age of 13 years for the treatment of itch associated with AD (only when existing treatment is insufficiently effective). This article summarizes the milestones in the development of Nemolizumab leading to this first approval.

Nemolizumab for atopic dermatitis

Drugs Today (Barc) 2022 Apr;58(4):159-173.PMID:35412530DOI:10.1358/dot.2022.58.4.3378056.

Atopic dermatitis (AD) is a common inflammatory skin disease that has emerging treatments targeting the underlying immunological mechanism. Interleukin-31 (IL-31) is associated with the pathobiological mechanism of AD, contributing to symptoms such as dermatitis and pruritus. Nemolizumab is an anti-IL-31 receptor α-chain (IL-31RA) monoclonal antibody agent that is efficacious in improving symptoms of AD in several phase II and phase III studies in recent years. Nemolizumab demonstrates great efficacy in reducing pruritus and to a lesser degree, dermatitis associated with AD. Additionally, one advantage of Nemolizumab is its quick speed of action. Adverse effects are mild and transient in nature, including exacerbation of AD, nasopharyngitis, upper respiratory tract infections, elevated creatine kinase and peripheral edema. Severe adverse effects were not common and consisted of exacerbation of AD and asthma exacerbation. Therefore, Nemolizumab has the potential to be an important treatment of choice for AD given its efficacy, mild side effect profile and rapid time of onset. In this review, we examine the preclinical and clinical studies of the novel drug Nemolizumab for the treatment of AD with a focus on its mechanism of action, pharmacokinetics, safety, efficacy, indications and drug interactions.

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus

N Engl J Med 2020 Jul 9;383(2):141-150.PMID:32640132DOI:10.1056/NEJMoa1917006.

Background: Nemolizumab is a subcutaneously administered humanized monoclonal antibody against interleukin-31 receptor A, which is involved in pruritus and inflammation in atopic dermatitis. In phase 2 studies, Nemolizumab lessened the severity of atopic dermatitis. Methods: In a 16-week, double-blind, phase 3 trial, we randomly assigned Japanese patients with atopic dermatitis and moderate-to-severe pruritus and an inadequate response to topical agents in a 2:1 ratio to receive subcutaneous Nemolizumab (60 mg) or placebo every 4 weeks until week 16, with concomitant topical agents. The primary end point was the mean percent change in the visual-analogue scale (VAS) score for pruritus (range, 0 to 100, with higher scores indicating worse pruritus) from baseline to week 16. Secondary end points included the time course of change in the VAS score for pruritus up to week 4, the change in the Eczema Area and Severity Index (EASI) score (range, 0 to 72, with higher scores indicating greater severity), a score of 4 or less on the Dermatology Life Quality Index (DLQI; range, 0 to 30, with higher scores indicating a greater effect on daily life), a score of 7 or less on the Insomnia Severity Index (ISI; range, 0 to 28, with higher scores indicating greater severity), and safety. Results: A total of 143 patients were randomly assigned to receive Nemolizumab and 72 to receive placebo. The median VAS score for pruritus at baseline was 75. At week 16, the mean percent change in the VAS score was -42.8% in the Nemolizumab group and -21.4% in the placebo group (difference, -21.5 percentage points; 95% confidence interval, -30.2 to -12.7; P<0.001). The mean percent change in the EASI score was -45.9% with Nemolizumab and -33.2% with placebo. The percentage of patients with a DLQI score of 4 or less was 40% in the Nemolizumab group and 22% in the placebo group; the percentage of patients with an ISI score of 7 or less was 55% and 21%, respectively. The incidence of injection-related reactions was 8% with Nemolizumab and 3% with placebo. Conclusions: In this 16-week trial, the use of subcutaneous Nemolizumab in addition to topical agents for atopic dermatitis resulted in a greater reduction in pruritus than placebo plus topical agents. The incidence of injection-site reactions was greater with Nemolizumab than with placebo. Longer and larger trials are necessary to determine whether Nemolizumab has a durable effect and is safe for atopic dermatitis. (Funded by Maruho; JapicCTI number, 173740.).

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis

N Engl J Med 2020 Feb 20;382(8):706-716.PMID:32074418DOI:10.1056/NEJMoa1908316.

Background: Prurigo nodularis is a chronic pruritic skin disease with multiple nodular skin lesions. Nemolizumab is a monoclonal antibody targeting the interleukin-31 receptor, which is involved in the pathogenesis of prurigo nodularis. Methods: We conducted a 12-week, randomized, double-blind, phase 2 trial of Nemolizumab (at a dose of 0.5 mg per kilogram of body weight) administered subcutaneously at baseline, week 4, and week 8, as compared with placebo, in patients with moderate-to-severe prurigo nodularis and severe pruritus. Moderate-to-severe prurigo nodularis was defined as 20 or more nodules, and severe pruritus was defined as a mean score of at least 7 for the worst daily intensity of pruritus on the numerical rating scale (scores range from 0 [no itch] to 10 [worst itch imaginable]). The primary outcome was the percent change from baseline in the mean peak score for pruritus on the numerical rating scale at week 4. Secondary outcomes included additional measures of itching and disease severity. Safety assessments were performed through week 18. Results: A total of 70 patients were randomly assigned in a 1:1 ratio to receive Nemolizumab (34 patients) or placebo (36). The initial pruritus score on the numerical rating scale was 8.4 in each group. At week 4, the peak pruritus score on the numerical rating scale was reduced from baseline by 4.5 points (change, -53.0%) in the Nemolizumab group, as compared with a reduction of 1.7 points (change, -20.2%) in the placebo group (difference, -32.8 percentage points; 95% confidence interval, -46.8 to -18.8; P<0.001). Results for secondary outcomes were in the same direction as for the primary outcome. Nemolizumab was associated with gastrointestinal symptoms (abdominal pain and diarrhea) and musculoskeletal symptoms. Conclusions: Nemolizumab resulted in a greater reduction in pruritus and severity of skin lesions than placebo in patients with prurigo nodularis but was associated with adverse events. Larger and longer trials are needed to determine the durability and safety of Nemolizumab for the treatment of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT03181503.).

Nemolizumab plus topical agents in patients with atopic dermatitis (AD) and moderate-to-severe pruritus provide improvement in pruritus and signs of AD for up to 68 weeks: results from two phase III, long-term studies

Br J Dermatol 2022 Apr;186(4):642-651.PMID:34726262DOI:10.1111/bjd.20873.

Background: Interleukin (IL)-31 affects the inflammatory response, is involved in epidermal barrier disruption in atopic dermatitis (AD) and plays a key role in pruritus. Nemolizumab, a humanized monoclonal antibody against IL-31 receptor A, reduced pruritus in patients with AD after a 16-week administration period. Objectives: To examine the long-term effectiveness and safety of Nemolizumab in patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus. Methods: In two long-term phase III studies, Nemolizumab 60 mg every 4 weeks (Q4W) was administered subcutaneously, concomitantly with topical treatments. Study-JP01 patients received double-blind Nemolizumab or placebo for 16 weeks, and then entered a 52-week extension period in which all patients received Nemolizumab (Nemolizumab/Nemolizumab and placebo/Nemolizumab groups). Study-JP02 patients received Nemolizumab for 52 weeks. Both studies included an 8-week follow-up period. Results: Study-JP01 Nemolizumab/Nemolizumab and placebo/Nemolizumab, and Study-JP02 Nemolizumab groups comprised 143, 72 and 88 patients, respectively. In the Nemolizumab/Nemolizumab group, there were clinically meaningful improvements from the start of treatment to week 68 in the pruritus visual analogue scale (66% decrease) and Eczema Area and Severity Index (78% decrease). Quality of life (QoL) indicators improved after the first Nemolizumab dose; improvements were maintained during the follow-up period. The long-term safety profile was consistent with previous studies, with no unexpected late-onset adverse events. Conclusions: Nemolizumab 60 mg Q4W with concomitant topical treatments in patients with AD and inadequately controlled moderate-to-severe pruritus produced a continuous improvement in pruritus, signs of AD, and QoL for up to 68 weeks, with a favourable safety profile.