Evidence map›Paper›PMID 42701929›Full record

ArticleDermatology and therapy2026

Efficacy and Safety of the First Adalimumab Biosimilar in Chinese Children with Severe Plaque Psoriasis: The PISCES Study, a Multicenter Prospective Study.

Yirong Huang, Ting Pan, Xin Shi, Guoqiang Zhang, Fang Cheng, Songmei Geng, Heng Gu, Shanshan Li, Qingchun Diao, Xiaohua Wang and 6 more

Registry-linked trialAbstract read
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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 NCT05803187 (A Prospective, Observaional Multi-Center Phase IV Study to Evaluate the Efficacy and Safety of QLETLI), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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.

NCT05803187 completednot on this map

A Prospective, Observaional Multi-Center Phase IV Study to Evaluate the Efficacy and Safety of QLETLI (Adalimumab Biosimilar) in Pediatric and Juvenile Subjects With Severe Plaque Psoriasis (PISCES Trials)

TypeobservationalSponsorBio-Thera SolutionsRan2023 to 2025Enrolled80ConditionsPlaque Psoriasis
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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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

16 authors.

Yirong Huang *Department of Dermatology, The Affiliated Suzhou Hospital of Nanjing Medical University, 215002, Suzhou, China.
Ting Pan *Department of Dermatology, The Affiliated Suzhou Hospital of Nanjing Medical University, 215002, Suzhou, China.
Xin ShiDepartment of Dermatology, The Second Affiliated Hospital of Soochow University, 215004, Suzhou, China.
Guoqiang ZhangDepartment of Dermatology, The First Hospital of Hebei Medical University, 050031, Shijiazhuang, China.
Fang ChengDepartment of Dermatology, Xingtai People's Hospital, 054001, Xingtai, China.
Songmei GengDepartment of Dermatology, The Second Affiliated Hospital of Xi'an Jiaotong University, 710004, Xi'an, China.
Heng GuDepartment of Dermatology, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, 210042, Nanjing, China.
Shanshan LiDepartment of Dermatology, The First Hospital of Jilin University, 130021, Changchun, China.
Qingchun DiaoDepartment of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, 400021, Chongqing, China.
Xiaohua WangDepartment of Dermatology, Dermatology Hospital of Southern Medical University, 510091, Guangzhou, China.
Yonghong LuDepartment of Dermatology, Chengdu Second People's Hospital, 610017, Chengdu, China.
Chao JiDepartment of Dermatology, The First Affiliated Hospital of Fujian Medical University, 350005, Fuzhou, China.
Yuzhen LiDepartment of Dermatology and Venereology, The Second Affiliated Hospital of Harbin Medical University, 150001, Harbin, China.
Yuling ShiDepartment of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, 200443, Shanghai, China.
Jun GuDepartment of Dermatology, The Affiliated Suzhou Hospital of Nanjing Medical University, 215002, Suzhou, China.
Lingling ChenDepartment of Dermatology, The Affiliated Suzhou Hospital of Nanjing Medical University, 215002, Suzhou, China. chenlingling031@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAdalimumab, a monoclonal antibody targeting tumor necrosis factor-alpha, has been approved for the treatment of severe plaque psoriasis in children aged 4 years and older. Data on its use in the clinical management of pediatric psoriasis in China remains limited. This study is the first prospective analysis of the adalimumab biosimilar (GELELI®, the first biosimilar of adalimumab approved in China, and QLETLI® in the UK) safety and effectiveness for severe pediatric plaque psoriasis in China.

methodsWeight-based dosage was administered to 80 patients (ages 4-18 years) from multiple centers. Primary endpoints included the proportions of patients achieving PASI75 and PGA 0/1 at week 16.

resultsThe mean psoriasis area and severity index (PASI) score decreased from 15.31 ± 8.375 at baseline to 6.29 ± 4.208 at week 4. PASI 50/90/100 response rates were 91.1%, 49.4%, and 21.5% at week 12. At week 16, 81.0% and 68.4% of patients attained PASI75 and PGA 0/1, respectively. The incidence of adverse events was 82.5%. Adverse drug reactions accounted for 62.5%. No serious adverse events were reported.

conclusionsThe biosimilar demonstrates efficacy and safety in the treatment of Chinese children with severe plaque psoriasis, consistent with clinical trial data for the originator drug.

trial registrationClinicaltrials.gov: NCT05803187.

Indexed as

AdalimumabChildrenEfficacyProspectivePsoriasisSafety

Identifiers

PMID42701929

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