Evidence map›Paper›PMID 37191738›Full record

ArticleRheumatology and therapy2023

Effect of Upadacitinib on Quality of Life and Work Productivity in Active Non-radiographic Axial Spondyloarthritis: Results From Randomized Phase 3 Trial SELECT-AXIS 2.

Uta Kiltz, Mitsumasa Kishimoto, Jessica A Walsh, Percival Sampaio-Barros, Manish Mittal, Christopher D Saffore, Peter Wung, Fabiana Ganz, Ana Biljan, Denis Poddubnyy

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. 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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

10 authors at 6 institutions in 4 countries.

Uta KiltzRuhr-Universität Bochum, Bochum, Germany. uta.kiltz@elisabethgruppe.de.ORCID http://orcid.org/0000-0001-5668-4497
Mitsumasa KishimotoDepartment of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.
Jessica A WalshUniversity of Utah and Salt Lake City Veterans Affairs Health, Salt Lake City, UT, USA.
Percival Sampaio-BarrosDivision of Rheumatology, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.
Manish MittalAbbVie Inc, North Chicago, IL, USA.
Christopher D SafforeAbbVie Inc, North Chicago, IL, USA.
Peter WungAbbVie Inc, North Chicago, IL, USA.
Fabiana GanzAbbVie Inc, North Chicago, IL, USA.
Ana BiljanAbbVie Inc, North Chicago, IL, USA.
Denis PoddubnyyDepartment of Gastroenterology, Infectious Diseases and Rheumatology (Including Nutrition Medicine), Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
AbbVie (United States) · USHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHumboldt-Universität zu Berlin · DEKyorin University · JPRheumazentrum Ruhrgebiet · DEUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo evaluate the effect of upadacitinib vs. placebo on health-related quality of life (HRQoL) and work productivity in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) enrolled in the SELECT-AXIS 2 phase 3 randomized controlled trial.

methodsAdult patients with active nr-axSpA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized 1:1 to receive upadacitinib 15 mg once daily or placebo. Mean changes from baseline in measures of HRQoL (Ankylosing Spondylitis QoL [ASQoL], Assessment of SpondyloArthritis international Society Health Index [ASAS HI], Short-Form 36 Physical Component Summary [SF-36 PCS] score) and Work Productivity and Activity Impairment (WPAI) were assessed through 14 weeks based on mixed-effects repeated measures or analysis of covariance models. The proportions of patients with improvements ≥ minimum clinically important differences (MCID) were assessed in HRQoL measures at week 14 using non-responder imputation with multiple imputation.

resultsAt week 14, upadacitinib- vs. placebo-treated patients reported greater improvements from baseline in ASQoL and ASAS HI (ranked, P < 0.001) and in SF-36 PCS and WPAI overall work impairment (nominal P < 0.05). Improvements were observed as early as week 2 in ASAS HI. Greater proportions of upadacitinib vs. placebo-treated patients reported improvements ≥ MCID in ASQoL (62.6 vs. 40.9%), ASAS HI (44.8 vs. 28.8%), and SF-36 PCS (69.3 vs. 52.0%), with numbers needed to treat < 10 for all (nominal P ≤ 0.01). Improvements ≥ MCID were consistently observed irrespectively of prior exposure to tumor necrosis factor inhibitors.

conclusionsUpadacitinib provides clinically meaningful improvements in HRQoL and work productivity in patients with active nr-axSpA. CLINICAL REGISTRATION NUMBER: NCT04169373, SELECT-AXIS 2.

Indexed as

Non-radiographic axial spondyloarthritisPatient-reported outcomesQuality of lifeUpadacitinib

Identifiers

PMID37191738
PMCPMC10186301
OpenAlexW4376641168

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.