Evidence map›Paper›PMID 36820984›Full record

ArticleRheumatology and therapy2023

Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis.

Victoria Navarro-Compán, Xenofon Baraliakos, Marina Magrey, Andrew Östör, Christopher D Saffore, Manish Mittal, In-Ho Song, Fabiana Ganz, Jayne Stigler, Atul Deodhar

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 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.7field-weighted citation impact, top 6% 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

12 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
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  3. Review
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  12. Fatigue in Inflammatory Joint Diseases.International journal of molecular sciences · 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

10 authors at 6 institutions in 4 countries.

Victoria Navarro-CompánDepartment of Rheumatology, La Paz University Hospital, IdiPaz, Paseo de la Castellana, 261, 28046, Madrid, Spain. mvictoria.navarroc@gmail.com.ORCID http://orcid.org/0000-0002-4527-852X
Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Germany.ORCID http://orcid.org/0000-0002-9475-9362
Marina MagreyDivision of Rheumatology, Case Western Reserve University School of Medicine, University Hospital of Cleveland, Cleveland, OH, USA.ORCID http://orcid.org/0000-0002-6520-5619
Andrew ÖstörCabrini Medical Center, Monash University, Melbourne, Australia.
Christopher D SafforeAbbVie Inc, North Chicago, IL, USA.
Manish MittalAbbVie Inc, North Chicago, IL, USA.
In-Ho SongAbbVie Inc, North Chicago, IL, USA.
Fabiana GanzAbbVie Inc, North Chicago, IL, USA.
Jayne StiglerAbbVie Inc, North Chicago, IL, USA.
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0002-2130-1246
AbbVie (United States) · USAustralian National University · AUHospital Universitario La Paz · ESOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEUniversity Hospitals of Cleveland · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with ankylosing spondylitis (AS) have significant unmet treatment needs, despite advancements in biologic therapies. This study evaluated the impact of upadacitinib on clinically meaningful improvement in patient-reported outcomes (PROs) assessing disease activity, pain, fatigue, function, health-related quality of life (HRQoL), and work productivity in patients with AS with inadequate responses or intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR).

methodsPatients enrolled in the phase 3 SELECT-AXIS 2 AS bDMARD-IR study received blinded once-daily oral upadacitinib 15 mg or placebo for 14 weeks. The percentage of patients achieving improvements ≥ minimum clinically important differences (MCID) at week 14 were compared between treatment groups for disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), patient global assessment of disease activity (PtGA), total and nocturnal back pain, fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F), physical function (Bath Ankylosing Spondylitis Functional Index, BASFI), HRQoL (Assessment of SpondyloArthritis international Society Health Index [ASAS HI], Ankylosing Spondylitis Quality of Life [ASQoL], Short form-36 [SF-36] physical [PCS] and mental [MCS] component summary scores), and work productivity (Work Productivity and Activity Impairment [WPAI] Questionnaire). Mean changes from baseline through week 14 in fatigue and HRQoL were compared between treatment groups.

resultsA total of 420 patients with active AS who were bDMARD-IR were included. A higher proportion of patients reported MCIDs at week 14 across all PROs with upadacitinib compared with placebo (nominal p ≤ 0.05). Greater improvements in mean change from baseline through week 14 were reported with upadacitinib compared with placebo across FACIT-F, HRQoL, and WPAI, with improvements differentiated as early as week 1 for ASAS HI, ASQoL and SF-36 PCS and week 4 for SF-36 MCS.

conclusionsUpadacitinib 15 mg demonstrated rapid and clinically meaningful improvements in disease activity, pain, FACIT-F, function, HRQoL, and WPAI among bDMARD-IR patients with active AS. TRIAL REGISTRY: Clinical Registration number: NCT04169373, SELECT-AXIS 2.

Indexed as

Ankylosing spondylitisAxial spondyloarthritisHealth-related quality of lifePatient-reported outcomesUpadacitinib

Identifiers

PMID36820984
PMCPMC9948782
OpenAlexW4321611419

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.