Evidence map›Paper›PMID 34726262›Full record

Trial reportThe British journal of dermatology2022

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.

K Kabashima, T Matsumura, H Komazaki, M Kawashima, Nemolizumab JP01 andJP02 Study Group

Open access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed
15.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 119 citations in OpenAlex.

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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

K KabashimaDepartment of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID 0000-0002-0773-0554
T MatsumuraClinical Development Department, Maruho Co. Ltd, Kyoto, Japan.
H KomazakiClinical Development Department, Maruho Co. Ltd, Kyoto, Japan.
M KawashimaTokyo Women's Medical University, Tokyo, Japan.
Nemolizumab JP01 andJP02 Study Group
Maruho (Japan) · JPKyoto University · JPTokyo Women's Medical University · JP

Funding

Maruho Co. Ltd.
6 · The paper itself

Abstract

backgroundInterleukin (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.

objectivesTo examine the long-term effectiveness and safety of nemolizumab in patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus.

methodsIn 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.

resultsStudy-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.

conclusionsNemolizumab 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.

Indexed as

Dermatitis, AtopicEczemaAdolescentAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPruritusQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizednemolizumab

Identifiers

PMID34726262
PMCPMC9305216
OpenAlexW3208491758

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.