Evidence map›Paper›PMID 32876903›Full record

ArticleRheumatology and therapy2020

Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE.

Yue Yang, Xing-Fu Li, Xiao Zhang, Chun-De Bao, Jian-Kang Hu, Jian-Hua Xu, Xiang-Pei Li, Jian Xu, Dong-Yi He, Zhi-Jun Li and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02265705 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 8% of its field
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.

NCT02265705 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2017Enrolled290ConditionsRheumatoid ArthritisArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Efficacy of Janus kinase inhibitors in rheumatoid arthritis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2023
    Review
  8. Article
  9. 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

16 authors at 12 institutions in 2 countries.

Yue Yang *Peking University People's Hospital, Beijing, China.
Xing-Fu Li *Qilu Hospital of Shandong University, Jinan, China.
Xiao Zhang *Guangdong General Hospital, Guangzhou, China.
Chun-De BaoRenji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.
Jian-Kang HuJiangxi Pingxiang People's Hospital, Pingxiang, China.
Jian-Hua XuThe First Affiliated Hospital of Anhui Medical University, Hefei, China.
Xiang-Pei LiThe First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Jian XuFirst Affiliated Hospital of Kunming Medical University, Kunming, China.
Dong-Yi HeGuangHua Hospital, Shanghai, China.
Zhi-Jun LiFirst Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Guo-Chun WangChina-Japan Friendship Hospital, Beijing, China.
Han-Jun WuEli Lilly and Company, Shanghai, China.
Fei JiEli Lilly and Company, Shanghai, China.
Lu-Jing ZhanEli Lilly and Company, Shanghai, China.
Cristiano A F ZerbiniCEPIC-Centro Paulista de Investigação Clinica E Serviços Medicos, Ipiranga, São Paulo, Brazil.
Zhan-Guo LiPeking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com.
Lilly (China) · CNFirst Affiliated Hospital of Bengbu Medical College · CNUniversity of Science and Technology of China · CNCentro Paulista de Investigação Clinica · BRChina-Japan Friendship Hospital · CNFirst Affiliated Hospital of Anhui Medical University · CNGuangdong General Hospital · CNJiangxi Pingxiang People's Hospital · CNKunming Medical University · CNPeking University People's Hospital · CNRenji Hospital · CNShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBaricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). This analysis aims to describe the efficacy and safety of baricitinib in Chinese RA patients with an inadequate response to methotrexate (MTX-IR), and to analyze the effects of baseline characteristics on the efficacy of baricitinib treatment.

methodsIn this 52-week, randomized, double-blind, placebo-controlled study, 231 Chinese patients with moderately to severely active RA who had MTX-IR were randomly assigned to placebo (n = 115) or baricitinib 4 mg once daily (n = 116). The primary endpoint was American College of Rheumatology 20% (ACR20) response at week 12. Other efficacy measures included ACR50, ACR70, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, patient's assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain were analyzed. Additionally, subgroup analyses were performed across baseline characteristics.

resultsStatistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo. Most of the secondary objectives were met with statistically significant improvements. Efficacy of baricitinib was irrespective of patient demographics and baseline characteristics. Safety events were similar between the baricitinib and placebo groups.

conclusionsThe efficacy of baricitinib 4 mg in Chinese patients with moderately to severely active RA and prior MTX-IR was clinically significant compared to placebo regardless of baseline characteristics. Baricitinib was well tolerated with an acceptable safety profile during the full study period.

trial registrationNCT02265705.

Indexed as

ArthritisBaricitinibChinaRheumatoid

Identifiers

PMID32876903
PMCPMC7695798
OpenAlexW3081533594

What OpenQuestion holds

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LicenceCC BY-NC
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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.