Evidence map›Paper›PMID 35788492›Full record

Trial reportAnnals of the rheumatic diseases2022

Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial.

Désirée van der Heijde, Xenofon Baraliakos, Joachim Sieper, Atul Deodhar, Robert D Inman, Hideto Kameda, Xiaofeng Zeng, Yunxia Sui, Xianwei Bu, Aileen L Pangan and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04169373 (A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period), which is not on this map. Cited by 75 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 11 pooled it
19.2field-weighted citation impact, top 1% 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.

NCT04169373 phase3completednot on this map

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period

TypeinterventionalSponsorAbbVieRan2019 to 2025Enrolled734ConditionsSpondyloarthritisArmsUpadacitinib, Placebo
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 11 syntheses or guidelines pooled it, 123 citations in OpenAlex.

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  2. Management of sacroiliac joint pain: current concepts.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2025
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15 more citing papers are in PubMed but not listed here.

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

12 authors at 8 institutions in 6 countries.

Désirée van der HeijdeRheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.ORCID http://orcid.org/0000-0002-5781-158X
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.ORCID http://orcid.org/0000-0002-9475-9362
Joachim SieperGastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-0285-9890
Atul DeodharDivision of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.ORCID http://orcid.org/0000-0002-2130-1246
Robert D InmanSchroeder Arthritis Institute, University Health Network, and University of Toronto, Toronto, Ontario, Canada.
Hideto KamedaInternal Medicine, Toho University, Tokyo, Japan.ORCID http://orcid.org/0000-0002-4330-5782
Xiaofeng ZengRheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China.
Yunxia SuiImmunology, AbbVie Inc, North Chicago, Illinois, USA.
Xianwei BuImmunology, AbbVie Inc, North Chicago, Illinois, USA.
Aileen L PanganImmunology, AbbVie Inc, North Chicago, Illinois, USA.
Peter WungImmunology, AbbVie Inc, North Chicago, Illinois, USA.
In-Ho SongImmunology, AbbVie Inc, North Chicago, Illinois, USA.
AbbVie (United States) · USCharité - Universitätsmedizin Berlin · DEChinese Academy of Medical Sciences & Peking Union Medical College · CNLeiden University Medical Center · NLOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEToho University · JPUniversity Health Network · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of upadacitinib, a Janus kinase inhibitor, in patients with active ankylosing spondylitis (AS) with an inadequate response (IR) to biological disease-modifying antirheumatic drugs (bDMARDs).

methodsAdults with active AS who met modified New York criteria and had an IR to one or two bDMARDs (tumour necrosis factor or interleukin-17 inhibitors) were randomised 1:1 to oral upadacitinib 15 mg once daily or placebo. The primary endpoint was Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 14. Sequentially tested secondary endpoints included Ankylosing Spondylitis Disease Activity score, Spondyloarthritis Research Consortium of Canada MRI spine inflammation score, total back pain, nocturnal back pain, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index and Maastricht Ankylosing Spondylitis Enthesitis Score. Results are reported from the 14-week double-blind treatment period.

resultsA total of 420 patients with active AS were randomised (upadacitinib 15 mg, n=211; placebo, n=209). Significantly more patients achieved the primary endpoint of ASAS40 at week 14 with upadacitinib vs placebo (45% vs 18%; p<0.0001). Statistically significant improvements were observed with upadacitinib vs placebo for all multiplicity-controlled secondary endpoints (p<0.0001). Adverse events were reported for 41% of upadacitinib-treated and 37% of placebo-treated patients through week 14. No events of malignancy, major adverse cardiovascular events, venous thromboembolism or deaths were reported with upadacitinib.

conclusionUpadacitinib 15 mg was significantly more effective than placebo over 14 weeks of treatment in bDMARD-IR patients with active AS. No new safety risks were identified with upadacitinib. TRIAL REGISTRATION NUMBER: NCT04169373.

Indexed as

Antirheumatic AgentsJanus Kinase InhibitorsSpondylarthritisSpondylitis, AnkylosingAdultBiological TherapyDouble-Blind MethodHeterocyclic Compounds, 3-RingHumansInterleukin-17Treatment OutcomeTumor Necrosis FactorsAntirheumatic AgentsHeterocyclic Compounds, 3-RingInterleukin-17Janus Kinase InhibitorsTumor Necrosis Factorsupadacitinibantirheumatic agentsinflammationMagnetic Resonance Imagingspondylitis, ankylosing

Identifiers

PMID35788492
PMCPMC9606523
OpenAlexW4283798749

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.