Evidence map›Paper›PMID 41359216›Full record

ArticleDermatology and therapy2026

A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study.

Adam Reich, Andrew Blauvelt, Stephan Weidinger, Vivian Y Shi, Norito Katoh, Charles Lynde, Xinghua Gao, Nicole M Armstrong, Charlotte Bernigaud, Kassim Rahawi

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05131477 (A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05131477 phase2completednot on this map

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorKymab LimitedRan2021 to 2024Enrolled390ConditionsEczema, Atopic DermatitisArmsAmlitelimab, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. OX40/OX40L modulation: A target for regulating T cells in cutaneous inflammatory disorders.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Review
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Adam ReichDepartment of Dermatology, University of Rzeszow, Rzeszow, Poland. adamandrzejreich@gmail.com.ORCID http://orcid.org/0000-0002-5573-1754
Andrew BlauveltBlauvelt Consulting LLC, Annapolis, MD, USA.ORCID http://orcid.org/0000-0002-2633-985X
Stephan WeidingerDepartment of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany.ORCID http://orcid.org/0000-0003-3944-252X
Vivian Y ShiDepartment of Dermatology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-7510-9428
Norito KatohNorth Campus, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID http://orcid.org/0000-0002-3498-2482
Charles LyndeUniversity of Toronto, Markham, ON, Canada.ORCID http://orcid.org/0000-0001-9163-5463
Xinghua GaoDepartment of Dermatology, The First Hospital of China Medical University, Shenyang, China.ORCID http://orcid.org/0000-0001-8809-8564
Nicole M ArmstrongSanofi, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-2479-1076
Charlotte BernigaudSanofi, Paris, France.ORCID http://orcid.org/0000-0002-4563-8927
Kassim RahawiSanofi, Cambridge, MA, USA.ORCID http://orcid.org/0009-0000-6700-9171

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAmlitelimab (SAR445229, KY1005), a nondepleting anti-OX40 ligand monoclonal antibody, reduced lesions and pruritus in phase 2a and 2b trials in adults with moderate-to-severe atopic dermatitis (AD). Here, efficacy and durability of amlitelimab across body regions were evaluated, given that unmet needs remain for treatment of head and neck AD.

methodsSTREAM-AD phase 2b trial data were used in this post hoc analysis. Patients were randomized 1:1:1:1:1 to receive amlitelimab subcutaneously (250 mg with 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg) or placebo every 4 weeks from weeks 0 to 24 (part 1). In part 2, clinical responders (patients achieving Investigator Global Assessment 0/1 and/or ≥ 75% reduction in Eczema Area and Severity Index [EASI-75] at week 24) were re-randomized 3:1 to withdraw from amlitelimab or continue their pre-week 24 amlitelimab dose through week 52. EASI subscores and signs were evaluated for head and neck, trunk, lower extremities, and upper extremities.

resultsPart 1 included 390 randomized patients; 190 continued to part 2. In part 1, all EASI body region subscores were reduced with all amlitelimab doses at week 24 (P ≤ 0.01). Additionally, the four EASI signs-erythema, edema, excoriation, and lichenification-were reduced with amlitelimab vs. placebo. Greater proportions of patients achieved EASI-75 per body region with all amlitelimab doses, compared to placebo (P ≤ 0.05). At week 52, clinical responders maintained improvements in each body region achieved in part 1, regardless of treatment continuation or withdrawal.

conclusionImprovements in AD signs and severity were observed with amlitelimab across all body regions. Notably, clinical responses were sustained following treatment withdrawal, supporting the potential for extended dosing intervals and durable off-treatment efficacy. Amlitelimab may be a treatment option for hard-to-treat head and neck AD that disproportionately impairs quality of life.

trial registrationClinicalTrials.gov Identifier NCT05131477.

Indexed as

AmlitelimabAtopic dermatitisBody regionEczema Area and Severity IndexEdemaErythemaExcoriationLichenificationOX40 ligand

Identifiers

PMID41359216
PMCPMC12873050

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Registered trials

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.