Evidence map›Paper›PMID 42518036›Full record

Trial reportClinical rheumatology2026

Ivarmacitinib in patients with active ankylosing spondylitis: subgroup analysis based on key baseline features from a phase II/III trial.

Bei Xu, Yini Ke, Liqin Xu, Chuanyin Sun, Weiqian Chen, Danyi Xu, Yiduo Sun, Heng Cao, Jin Lin

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04481139 (A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects), which is not on this map. Not yet cited in PubMed.

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

NCT04481139 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2020 to 2023Enrolled504ConditionsAnkylosing SpondylitisArmsSHR0302, SHR0302 placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Bei XuDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Yini KeDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Liqin XuDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Chuanyin SunDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Weiqian ChenDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Danyi XuDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Yiduo SunDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
Heng CaoDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China. caohengzju@zju.edu.cn.
Jin LinDepartment of Rheumatology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China. linjinzju@zju.edu.cn.ORCID http://orcid.org/0000-0002-9970-9380

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aimed to evaluate the efficacy of ivarmacitinib in patients with active ankylosing spondylitis (AS) according to baseline characteristics.

methodsData were derived from a phase II/III trial (NCT04481139). Patients with active AS who received either ivarmacitinib 4 mg (n = 187) or placebo (n = 186) were included. Subgroup analyses were performed based on age, sex, body mass index (BMI), AS duration, history of biological or Janus kinase (JAK) inhibitor use, C-reactive protein (CRP) level, total back pain visual analogue scale (VAS) score, and night pain VAS score.

resultsAt week 12 (W12), Assessment of SpondyloArthritis international Society 20% improvement (ASAS20) response rates were significantly higher in the ivarmacitinib arm compared to the placebo arm across subgroups stratified by sex, BMI, AS duration, history of biological/JAK inhibitor use, total back pain VAS score, and night pain VAS score. ASAS5/6 response rates at W12 were higher in the ivarmacitinib arm across all subgroups. Greater improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores at W12 were observed in the ivarmacitinib arm across subgroups defined by age, sex, BMI, AS duration, total back pain VAS score, and night pain VAS score. The ivarmacitinib arm achieved greater improvements in Ankylosing Spondylitis Disease Activity Score (ASDAS) at W12 across all subgroups. Efficacy outcomes improved through W24 across all subgroups with continuous ivarmacitinib treatment and after switching from placebo at W12.

conclusionIvarmacitinib 4 mg demonstrated consistent efficacy in patients with active AS across diverse demographic and clinical subgroups. Key Points • Ivarmacitinib improved treatment response rates vs. placebo at W12 across multiple subgroups. • Efficacy benefits were sustained through 24 weeks after treatment with ivarmacitinib. • Efficacy improvements were observed after switching from placebo to ivarmacitinib.

Indexed as

Spondylitis, AnkylosingAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementSeverity of Illness IndexTreatment OutcomeAnkylosing spondylitisDemographicsDisease characteristicsEfficacyIvarmacitinib

Identifiers

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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.