Evidence map›Paper›PMID 38747163›Full record

ArticleACR open rheumatology2024

Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial.

Filip Van den Bosch, Atul Deodhar, Denis Poddubnyy, Walter P Maksymowych, Désirée van der Heijde, Tae-Hwan Kim, Mitsumasa Kishimoto, Xenofon Baraliakos, Yihan Li, Kristin D'Silva and 2 more

Abstract read
In one paragraph

Article in ACR open rheumatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. 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

12 authors.

Filip Van den BoschDepartment of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium.ORCID https://orcid.org/0000-0002-3561-5932
Atul DeodharDivision of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.ORCID https://orcid.org/0000-0002-2130-1246
Denis PoddubnyyDepartment of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin, Berlin, Germany.ORCID https://orcid.org/0000-0002-4537-6015
Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.ORCID https://orcid.org/0000-0002-1291-1755
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID https://orcid.org/0000-0002-5781-158X
Tae-Hwan KimDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0002-3542-2276
Mitsumasa KishimotoDepartment of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4007-1589
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.ORCID https://orcid.org/0000-0002-9475-9362
Yihan LiAbbVie Inc., North Chicago, Illinois.
Kristin D'SilvaAbbVie Inc., North Chicago, Illinois.ORCID https://orcid.org/0000-0001-8370-4166
Peter WungAbbVie Inc., North Chicago, Illinois.
In-Ho SongAbbVie Inc., North Chicago, Illinois.

Funding

AbbVie
6 · The paper itself

Abstract

objectiveUpadacitinib improved the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) versus placebo over 14 weeks in the primary analysis of the SELECT-AXIS 2 nr-axSpA study. Here, we evaluated the efficacy and safety of upadacitinib through 1 year in patients with nr-axSpA in SELECT-AXIS 2.

methodsPatients aged at least 18 years diagnosed with nr-axSpA who fulfilled the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria and were receiving stable background therapy were randomized to upadacitinib 15 mg once daily or placebo for the 52-week double-blind period. Efficacy was assessed using non-responder imputation incorporating multiple imputation (NRI-MI) and as-observed analyses for binary endpoints, and mixed-effects model repeated measures for continuous endpoints.

resultsOf 314 randomized patients, 259 (upadacitinib, n = 129; placebo, n = 130) completed 52 weeks of treatment. More patients receiving upadacitinib versus placebo achieved ≥40% improvement in ASAS at week 52 (63% vs 43%, NRI-MI; nominal P < 0.001). Similar treatment effects were observed for the achievement of axSpA Disease Activity Score inactive disease (33% v 11%, NRI-MI; nominal P < 0.001). Overall, patients receiving upadacitinib versus placebo showed greater improvement in disease activity, inflammation, pain, function, enthesitis, and quality of life through 52 weeks. Adverse events were generally comparable between the treatment groups. No opportunistic infections, malignancies, major adverse cardiovascular events, venous thromboembolic events, inflammatory bowel disease, or deaths were reported in those receiving upadacitinib.

conclusionTreatment with upadacitinib showed sustained efficacy versus placebo with no new safety findings identified through 1 year. These results support the continued favorable benefit-risk profile of upadacitinib treatment for nr-axSpA.

Identifiers

PMID38747163
PMCPMC11319917

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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.