Evidence map›Paper›PMID 33590829›Full record

Trial reportRheumatology (Oxford, England)2021

Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE.

Vibeke Strand, Namita Tundia, Martin Bergman, Andrew Ostor, Patrick Durez, In-Ho Song, Jeffrey Enejosa, Casey Schlacher, Yan Song, Roy Fleischmann

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02629159 (A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT02629159 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

TypeinterventionalSponsorAbbVieRan2015 to 2027Enrolled1,629ConditionsRheumatoid ArthritisArmsPlacebo for Adalimumab, Adalimumab, Placebo for Upadacitinib, Upadacitinib
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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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 at 7 institutions in 3 countries.

Vibeke StrandDivision of Immunology/Rheumatology, Stanford University, Palo Alto, CA.
Namita TundiaAbbVie Inc, North Chicago, IL.ORCID 0000-0002-6294-1418
Martin BergmanDrexel University College of Medicine, Philadelphia, PA, USA.
Andrew OstorCabrini Medical Centre, Monash University, Melbourne, Australia.
Patrick DurezRheumatology, Cliniques Universitaires Saint-Luc-Université Catholique de Louvain-Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.
In-Ho SongAbbVie Inc, North Chicago, IL.
Jeffrey EnejosaAbbVie Inc, North Chicago, IL.
Casey SchlacherAbbVie Inc, North Chicago, IL.
Yan SongAnalysis Group, Inc, Boston, MA.
Roy FleischmannUniversity of Texas Southwestern Medical Center, MCRC, Dallas, TX, USA.
AbbVie (United States) · USAnalysis Group (United States) · USCliniques Universitaires Saint-Luc · BEDrexel University · USMonash Medical Centre · AUStanford University · USThe University of Texas Southwestern Medical Center · US

Funding

AbbVie
6 · The paper itself

Abstract

objectiveTo evaluate the impact of upadacitinib vs placebo and adalimumab treatment, on patient-reported outcomes (PROs) in SELECT-COMPARE in an active RA population with inadequate responses to MTX (MTX-IR).

methodsPROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA) and pain by visual analogue scale (VAS), the HAQ Disability Index (HAQ-DI), the 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and scores ≥ normative values were evaluated.

resultsUpadacitinib and adalimumab resulted in greater LSM changes from baseline vs placebo across all PROs (P < 0.05) at week 12, and pain and AM stiffness severity (P < 0.05) at week 2. More upadacitinib- vs placebo-treated (P < 0.05) and similar percentages of upadacitinib- vs adalimumab-treated patients reported improvements ≥ MCID across all PROs at week 12. Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and the SF-36 Physical Component Summary (PCS) (all P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients reported scores ≥ normative values in HAQ-DI and SF-36 PCS (P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients maintained clinically meaningful improvements in PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness through 48 weeks.

conclusionIn MTX-IR patients with RA, treatment with upadacitinib resulted in statistically significant and clinically meaningful improvements in PROs equivalent to or greater than with adalimumab.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT02629159.

Indexed as

Minimal Clinically Important DifferencePatient Reported Outcome MeasuresAdalimumabArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHeterocyclic Compounds, 3-RingHumansMaleMiddle AgedTime FactorsTreatment OutcomeAdalimumabHeterocyclic Compounds, 3-RingupadacitinibDMARDsinflammationoutcome measuresquality of liferheumatoid arthritis

Identifiers

PMID33590829
PMCPMC8645276
OpenAlexW3131272440

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.