Evidence map›Paper›PMID 31791386›Full record

Trial reportArthritis research & therapy2019

Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs.

Vibeke Strand, Michael Schiff, Namita Tundia, Alan Friedman, Sebastian Meerwein, Aileen Pangan, Arijit Ganguli, Mahesh Fuldeore, Yan Song, Janet Pope

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02706847 (A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 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.

NCT02706847 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

TypeinterventionalSponsorAbbVieRan2016 to 2022Enrolled499ConditionsRheumatoid ArthritisArmsPlacebo, Upadacitinib
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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.

Vibeke StrandStanford University, 306 Ramona Road, Portola Valley, CA, 94028, USA.
Michael SchiffUniversity of Colorado School of Medicine, Denver, CO, 80045, USA.
Namita TundiaAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. namita.tundia@abbvie.com.
Alan FriedmanAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Sebastian MeerweinAbbVie Deutschland GmbH & Co., KG, Mainzer Strasse 81, 65189, Wiesbaden, Germany.
Aileen PanganAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Arijit GanguliAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Mahesh FuldeoreAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Yan SongAnalysis Group Inc., 14th Floor, 111 Huntington Avenue, Boston, MA, 02199, USA.
Janet PopeUniversity of Western Ontario, St. Joseph's Health Care, 268 Grosvenor Street, London, ON, N6A 4V2, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient-reported outcomes (PROs) are important when evaluating treatment benefits in rheumatoid arthritis (RA). We compared upadacitinib, an oral, selective JAK-1 inhibitor, with placebo to assess clinically meaningful improvements in PROs in patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR).

methodsPRO responses between upadacitinib 15 mg or 30 mg and placebo were evaluated at week 12 from the SELECT-BEYOND trial. Improvement was determined by measuring Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI). Least squares mean changes and percentage of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores greater than or equal to normative values were determined. The number needed to treat (NNT) to achieve clinically meaningful improvements was calculated.

resultsIn 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity. Compared with placebo, more upadacitinib-treated patients reported improvements ≥ MCID in PtGA, pain, HAQ-DI, SF-36 PCS, 7 of 8 SF-36 domains (15 mg), 5 of 8 SF-36 domains (30 mg), AM stiffness duration and severity, and ISI (30 mg) and scores ≥ normative values in HAQ-DI and SF-36 domains. Across most PROs, NNTs to achieve MCID with upadacitinib ranged from 4 to 7 patients.

conclusionsIn bDMARD-IR RA patients, upadacitinib (15 mg or 30 mg) improved multiple aspects of quality of life, and more patients reached clinically meaningful improvements approaching normative values compared with placebo.

trial registrationThe trial is registered with ClinicalTrials.gov (NCT02706847), registered 6 March 2016.

Indexed as

AgedAntirheumatic AgentsArthritis, RheumatoidFemaleHeterocyclic Compounds, 3-RingHumansMaleMiddle AgedPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeAntirheumatic AgentsHeterocyclic Compounds, 3-RingupadacitinibFatigueHAQJAK inhibitorMCIDPainPatient-reported outcome measuresQuality of lifeRheumatoid arthritisSF-36Treatment outcomesUpadacitinib

Identifiers

PMID31791386
PMCPMC6889334

What OpenQuestion holds

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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.