Evidence map›Paper›PMID 38907104›Full record

ArticleRheumatology and therapy2024

Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis.

Xiaoxia Zhu, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Lingyun Sun, Lie Dai, Chunyu Tan, Zhijun Li, Zhengyu Xiao and 5 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04285229 (A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT04285229 phase3completednot on this map

A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2022Enrolled147ConditionsSpondyloarthritisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Observational
  2. Article
  3. 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

15 authors.

Xiaoxia ZhuDepartment of Rheumatology, Huashan Hospital Affiliated to Fudan University, 12 Wulumuqi Zhong Rd, Shanghai, 200040, China.
Jiankang HuPingxiang People's Hospital, Pingxiang, Jiangxi, China.
Dongzhou LiuShenzhen People's Hospital, The Second Clinical Medical College of Jinan University, Shenzhen, China.
Jingyang LiThe Affiliated Zhuzhou Hospital Xiangya Medical College Central South University, Zhuzhou, Hunan, China.
Huaxiang WuThe Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Lingyun SunNanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.
Lie DaiSun Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Chunyu TanWest China Hospital of Sichuan University, Chengdu, Sichuan, China.
Zhijun LiThe First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China.
Zhengyu XiaoThe First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China.
Xiaomei LiThe First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, Anhui, China.
Yan YanEli Lilly and Company, Shanghai, China.
Guanshen DouEli Lilly and Company, Shanghai, China.
Yuzi SunEli Lilly and Company, Shanghai, China.
Hejian ZouDepartment of Rheumatology, Huashan Hospital Affiliated to Fudan University, 12 Wulumuqi Zhong Rd, Shanghai, 200040, China. mail@hjzou.md.ORCID http://orcid.org/0000-0001-9762-2663

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIxekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China.

methodsIn this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc.

resultsCompared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level.

conclusionIXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed.

trial registrationClinicalTrials.gov identifier NCT04285229.

Indexed as

FatigueIxekizumabPatient-reported outcomeRadiographic axial spondyloarthritisSpinal painStiffness

Identifiers

PMID38907104
PMCPMC11264586

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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.