Evidence map›Paper›PMID 39535685›Full record

Trial reportAdvances in therapy2025

Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab.

Xinghua Gao, Weili Pan, Min Zheng, Fuqiu Li, Xiuqin Dong, Dong Lv, Zaipei Guo, Jinnan Li, Xuan Wang, Songmei Geng

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
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. 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 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
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.

Xinghua GaoDepartment of Dermatology, The First Hospital of China Medical University, Shenyang, 110001, China.
Weili PanDepartment of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, 314408, Zhejiang, China.
Min ZhengDepartment of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310003, Zhejiang, China.
Fuqiu LiDepartment of Dermatology, The Second Hospital of Jilin University, Changchun, 130041, Jilin, China.
Xiuqin DongDepartment of Dermatology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Dong LvDepartment of Dermatology, Yancheng First People's Hospital, Yancheng, Jiangsu Province, China.
Zaipei GuoDepartment of Dermatology, West China Hospital, Sichuan University, Chengdu, China.
Jinnan LiEli Lilly and Company, Shanghai, China.
Xuan WangEli Lilly and Company, Shanghai, China.
Songmei GengDepartment of Dermatology, Northwest Hospital, The Second Hospital Affiliated to Xi'an Jiaotong University, 157 Xiwu Road, Xi'an, 710004, China. gengsongmei73@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn China, approximately 2.3 million people have psoriasis. Continuous treatment is recommended for moderate-to-severe psoriasis. This study aimed to evaluate the outcomes of continuous versus interrupted ixekizumab (IXE) treatment and retreatment with IXE after disease worsening in Chinese patients.

methodsIn this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized to IXE or placebo at Week 0. At Week 12, IXE responders (static Physician's Global Assessment [sPGA] score, 0 or 1 [0,1]) were re-randomized (2:1) to IXE (IXE/IXE, continuous treatment) or placebo (IXE/PBO, interrupted treatment). After re-randomization, treatment in IXE/PBO patients with disease worsening (relapse, sPGA ≥ 3) was switched to IXE every 4 weeks (IXE/PBO + IXEQ4W, retreatment). Efficacy was assessed by evaluating the response rates of Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1), Dermatology Life Quality Index (DLQI) (0,1), mean PASI, and Itch Numerical Rating Scale (NRS) scores and improvements of special body areas. Safety was evaluated by assessing treatment-emergent adverse events (AEs) and serious AEs.

resultsAt Week 12, 289 IXE responders were re-randomized to the IXE/IXE group (192 patients) and IXE/PBO group (97 patients). High rates of PASI 75 and sPGA (0, 1) responses were maintained in the IXE/IXE group until Week 60. At Week 60, 88 (90.7%) patients in the IXE/PBO group had disease relapse; the median time to relapse was approximately 20 weeks. After 24 weeks of retreatment, PASI 75 and sPGA (0, 1) were recaptured (97.2% and 74.6%, respectively, in the IXE/PBO + IXEQ4W group). AEs were comparable in patients who received continuous treatment and retreatment.

conclusionIn Chinese patients who received continuous IXE treatment, high response rates were maintained through 60 weeks. Most patients had disease relapse after treatment withdrawal. After retreatment, most of these patients had regained and maintained response since Week 12. TRIAL REGISTRATION NUMBER: NCT03364309.

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsPsoriasisAdultChinaDouble-Blind MethodEast Asian PeopleFemaleHumansMaleMiddle AgedRetreatmentSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic AgentsixekizumabChinese populationIxekizumabPASIPsoriasissPGA

Identifiers

PMID39535685
PMCPMC11782330

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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.