Evidence map›Paper›PMID 39347926›Full record

Trial reportAdvances in therapy2025

Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study.

Xia Li, Yangfeng Ding, Chunlei Zhang, Yan Lu, Fuqiu Li, Weili Pan, Shuping Guo, Jinnan Li, Bilian Zhao, Jie Zheng

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03364309 (A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03364309 phase3completednot on this map

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2020Enrolled438ConditionsPlaque PsoriasisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Xia LiDepartment of Dermatology, School of Medicine, Rui Jin Hospital, Shanghai Jiao Tong University, 197, Rui Jin Er Road, Shanghai, 200025, China.
Yangfeng DingDepartment of Dermatology, Shanghai Skin Disease Hospital, Shanghai, China.
Chunlei ZhangDepartment of Dermatology, Peking University Third Hospital, Beijing, China.
Yan LuDepartment of Dermatology, Jiangsu Province People's Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.
Fuqiu LiDepartment of Dermatology, The Second Norman Bethune Hospital of Jilin University, Jilin, China.
Weili PanDepartment of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, China.
Shuping GuoDepartment of Dermatology, First Hospital of Shanxi Medical University, Shanxi, China.
Jinnan LiEli Lilly and Company, Shanghai, China.
Bilian ZhaoEli Lilly and Company, Shanghai, China.
Jie ZhengDepartment of Dermatology, School of Medicine, Rui Jin Hospital, Shanghai Jiao Tong University, 197, Rui Jin Er Road, Shanghai, 200025, China. jie-zheng2001@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSpecial body area involvement is common in psoriasis and can be challenging to treat. We investigated the efficacy of ixekizumab (IXE) in Chinese patients with moderate-to-severe psoriasis and fingernail, scalp, or palmoplantar involvement.

methodsA post-hoc sub-analysis of a phase 3 trial, in which patients were randomized to receive placebo, IXE 80 mg every 2 (IXE Q2W) or 4 (IXE Q4W) weeks. At Week 12, patients classified as IXE responders [static Physician's Global Assessment (sPGA) score of 0 or 1 [0,1)] were re-randomized (2:1) to IXE Q4W or placebo until Week 60. Efficacy was assessed by body-region specific parameters including Nail Psoriasis Severity Index (NAPSI), Psoriasis Scalp Severity Index (PSSI), and Palmoplantar Psoriasis Area Severity Index (PPASI).

resultsOf 438 patients, 99.1% (434) had ≥ 1 special area involvement [fingernail (76.5%, 335), scalp (97.3%, 426), palmoplantar (27.9%, 122)]. Significantly greater improvements from baseline in NAPSI score were observed with IXE Q4W and Q2W at Week 12 versus placebo (p < 0.001 for both). These improvements were further increased and sustained over 60 weeks in IXE Q4W and Q2W responders who were re-randomized to IXE Q4W, who achieved a 77.9% and 89.7% improvement from baseline, respectively, at Week 60. Significantly higher proportions of patients receiving IXE Q4W and Q2W achieved NAPSI 50 at Week 12 versus placebo (44.4%, 36.6% vs. 14.1%; p < 0.001 and < 0.01, respectively). Similarly, significantly higher proportions of patients receiving IXE Q4W and Q2W achieved PSSI 100 and PPASI 100 at Week 12 versus placebo (60.6% and 65.1% vs. 1.2%, and 67.4%, 84.3% vs. 21.4%, respectively; p < 0.001 for all comparisons). Improvements across all outcomes were sustained in patients re-randomized to IXE Q4W until Week 60.

conclusionIXE led to a rapid onset of action and sustained efficacy over 60 weeks in Chinese patients with moderate-to-severe psoriasis and special body area involvement. CLINICALTRIALS: gov identifier, NCT03364309.

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsPsoriasisAdultChinaDouble-Blind MethodEast Asian PeopleFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic AgentsixekizumabChinese patientsIxekizumabPsoriasisSpecial area involvement

Identifiers

PMID39347926

What OpenQuestion holds

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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.