Evidence map›Paper›PMID 35896281›Full record

Trial reportRMD open2022

Upadacitinib in active ankylosing spondylitis: results of the 2-year, double-blind, placebo-controlled SELECT-AXIS 1 study and open-label extension.

Désirée van der Heijde, Atul Deodhar, Walter P Maksymowych, Joachim Sieper, Filip Van den Bosch, Tae-Hwan Kim, Mitsumasa Kishimoto, Andrew J Östör, Bernard Combe, Yunxia Sui and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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.

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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Selective JAK-Inhibitors in Spondyloarthritis.Mediterranean journal of rheumatology · 2024
    Review
  18. Review
  19. Osteoimmunology of Spondyloarthritis.International journal of molecular sciences · 2023
    Review
  20. JAK Inhibitors for the Treatment of Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2023
    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

13 authors at 10 institutions in 9 countries.

Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, Netherlands mail@dvanderheijde.nl.ORCID 0000-0002-5781-158X
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-1291-1755
Joachim SieperDepartment of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-0285-9890
Filip Van den BoschDepartment of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium.
Tae-Hwan KimDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.ORCID 0000-0002-3542-2276
Mitsumasa KishimotoDepartment of Nephrology and Rheumatology, Kyorin University, School of Medicine, Tokyo, Japan.ORCID 0000-0002-4007-1589
Andrew J ÖstörCabrini Medical Centre and Monash University, Melbourne, Victoria, Australia.ORCID 0000-0002-7929-4827
Bernard CombeDepartment of Rheumatology, Montpellier University, Montpellier, France.
Yunxia SuiAbbVie Inc, North Chicago, Illinois, USA.
Yuanyuan DuanAbbVie Inc, North Chicago, Illinois, USA.
Peter K WungAbbVie Inc, North Chicago, Illinois, USA.
In-Ho SongAbbVie Inc, North Chicago, Illinois, USA.
AbbVie (United States) · USCharité - Universitätsmedizin Berlin · DEGhent University · BEHanyang University Seoul Hospital · KRKyorin University · JPLeiden University Medical Center · NLMonash Medical Centre · AUOregon Health & Science University · USUniversité de Montpellier · FRUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLong-term safety and efficacy of upadacitinib in patients with active ankylosing spondylitis (AS) has not been previously reported.

methodsIn SELECT-AXIS 1, patients receiving placebo were switched to upadacitinib 15 mg once daily at week 14 while patients initially randomised to upadacitinib continued their regimen through week 104. Efficacy was assessed using as-observed (AO) and non-responder imputation (NRI).

resultsOf 187 patients randomised, 144 patients (77%) completed week 104. Among patients receiving continuous upadacitinib, 85.9% (AO) and 65.6% (NRI) achieved Assessment of SpondyloArthritis international Society 40 response (ASAS40) at week 104. Similar magnitude of ASAS40 responses were observed among patients who switched from placebo to upadacitinib (88.7% and 63.8%, respectively). The mean change from baseline to week 104 in Spondyloarthritis Research Consortium of Canada MRI spine and sacroiliac joint inflammation scores were -7.3 and -5.3, respectively, in the continuous upadacitinib group and -7.9 and -4.9 in the placebo-to-upadacitinib switch group. The mean (95% CI) change from baseline to week 104 in the modified Stoke Ankylosing Spondylitis Spine Score was 0.7 (0.3, 1.1) in the total group. Adverse event rate was 242.7/100 patient-years. No serious infections, adjudicated major adverse cardiovascular events, lymphoma, non-melanoma skin cancer, or gastrointestinal perforations were observed.

conclusionsUpadacitinib 15 mg once daily showed sustained and consistent efficacy over 2 years for ASAS40 and other clinically relevant endpoints. A low rate of radiographic progression was observed and no new safety findings were observed.

Indexed as

Antirheumatic AgentsSpondylarthritisSpondylitis, AnkylosingHeterocyclic Compounds, 3-RingHumansTreatment OutcomeAntirheumatic AgentsHeterocyclic Compounds, 3-Ringupadacitinibinflammationmagnetic resonance imagingspondylitis, ankylosing

Identifiers

PMID35896281
PMCPMC9335045
OpenAlexW4288459194

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.