Evidence map›Paper›PMID 38689136›Full record

Observational studyDrug safety2024

The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study.

Ying Li, Lin Dang, Chengzhi Lv, Bingjiang Lin, Juan Tao, Nan Yu, Ya Deng, Huiping Wang, Xiaojing Kang, Hui Qin and 5 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. 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

15 authors.

Ying Li *Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, 200443, China.
Lin Dang *Department of Dermatology, Longgang Central Hospital of Shenzhen, Shenzhen, Guangdong, China.
Chengzhi LvDepartment of Dermatology, Dalian Skin Disease Hospital, Dalian , Liaoning, China.
Bingjiang LinDepartment of Dermatology, Ningbo First Hospital, Ningbo, Zhejiang, China.
Juan TaoDepartment of Dermatology, Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China.
Nan YuDepartment of Dermatology, General Hospital of Ningxia Medical Hospital, Yinchuan, Ningxia, China.
Ya DengDepartment of Dermatology, The Second Hospital Affiliated to Chongqing Medical University, Chongqing, China.
Huiping WangDepartment of Dermatology, Tianjin Medical University General Hospital, Tianjin, China.
Xiaojing KangDepartment of Dermatology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.
Hui QinDepartment of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, 200443, China.
Rong ChenEli Lilly and Company, Shanghai, China.
Jinnan LiEli Lilly and Company, Shanghai, China.
Yunsheng LiangDepartment of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, China. yunshengliang@aliyun.com.
Yanhua LiangDepartment of Dermatology, Cosmetology and Venereology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China. liangdoctor@163.com.
Yuling ShiDepartment of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, 200443, China. shiyuling1973@tongji.edu.cn.ORCID http://orcid.org/0000-0002-1273-7881

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIxekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis. However, there are limited data on the real-world safety of ixekizumab in Chinese patient populations. We performed an observational study of ixekizumab for the treatment of moderate-to-severe plaque psoriasis in routine clinical practice in China. Here we present a further safety analysis of this study.

methodsIn this prospective, observational, single-arm, multicenter, post-marketing safety study, adults (≥18 years) with moderate-to-severe plaque psoriasis receiving ixekizumab were enroled at dermatology departments in hospitals across China and prospectively followed for 12 weeks or until their last dose of ixekizumab. In this analysis, we evaluated adverse events (AEs) of special interest (AESIs) identified using MedDRA

resultsThis analysis included 663/666 patients enrolled in the primary study. At least one AESI was reported in 224 (33.8%) patients and considered related to ixekizumab in 181 (27.3%); the most common were injection site reactions (n = 131, 19.8%), infections (n = 80, 12.1%), and allergic reactions/hypersensitivity events (n = 59, 8.9%). The proportion of patients with ≥ 1 AE was higher for females versus males (99/186, 53.2% versus 184/477, 38.6%, p = 0.0006). The proportion of patients with ≥ 1 AE increased with the number of ixekizumab injections after baseline [61/188 (32.4%) for zero to one injection, 151/338 (44.7%) for two to four injections, and 61/106 (57.5%) for five to seven injections; p = 0.0001].

conclusionsIn this real-world study, ixekizumab was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis, with no difference in safety across most patient subgroups.

Indexed as

Antibodies, Monoclonal, HumanizedPsoriasisAdultAgedChinaDermatologic AgentsEast Asian PeopleFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesSeverity of Illness IndexAntibodies, Monoclonal, HumanizedDermatologic Agentsixekizumab

Identifiers

PMID38689136
PMCPMC11182850

What OpenQuestion holds

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Registered trials

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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.