Evidence map›Paper›PMID 34897366›Full record

Trial reportRheumatology (Oxford, England)2022

Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program.

Charles G Peterfy, Vibeke Strand, Alan Friedman, Stephen Hall, Eduardo Mysler, Patrick Durez, Xenofon Baraliakos, Jeffrey V Enejosa, Tim Shaw, Yihan Li and 2 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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
NCT02706873 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorAbbVieRan2016 to 2022Enrolled1,002ConditionsRheumatoid ArthritisArmsPlacebo to Upadacitinib, Methotrexate, Placebo to Methotrexate, Upadacitinib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. 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 at 5 institutions in 4 countries.

Charles G PeterfySpire Sciences, Boca Raton, FL.
Vibeke StrandDivision of Immunology and Rheumatology, Stanford University, Palo Alto, CA.
Alan FriedmanAbbVie, North Chicago, IL, USA.
Stephen HallCabrini Health and Emeritus Research, Monash University, Malvern, VIC, Australia.
Eduardo MyslerDepartment of Rheumatology, Organización Médica de Investigación, Buenos Aires, Argentina.
Patrick DurezRheumatology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium.
Xenofon BaraliakosRheumatology, Herne and Ruhr-University Bochum, Herne, Germany.ORCID 0000-0002-9475-9362
Jeffrey V EnejosaAbbVie, North Chicago, IL, USA.
Tim ShawAbbVie, North Chicago, IL, USA.
Yihan LiAbbVie, North Chicago, IL, USA.
Su ChenAbbVie, North Chicago, IL, USA.
In-Ho SongAbbVie, North Chicago, IL, USA.
AbbVie (United States) · USCabrini Hospital · AUCliniques Universitaires Saint-Luc · BERuhr University Bochum · DEStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the inhibition of progression of structural joint damage through week 48 in patients with moderately to severely active RA receiving upadacitinib as monotherapy or in combination with MTX.

methodsRadiographic progression was assessed in two phase 3 randomized controlled trials. MTX-naïve patients were randomized to upadacitinib 15 or 30 mg once daily or MTX monotherapy (SELECT-EARLY, n = 945), while MTX inadequate responders (IRs) were randomized to upadacitinib 15 mg once daily or adalimumab 40 mg every other week or placebo added to background MTX (SELECT-COMPARE, n = 1629). The mean changes from baseline in modified total Sharp score (mTSS), joint space narrowing and erosion scores were determined. Data were analysed both by linear extrapolation for missing data imputation and treatment switching and as observed.

resultsIn patients naïve or with limited exposure to MTX (SELECT-EARLY), mean changes from baseline to week 48 in mTSS were 0.03 for upadacitinib 15 mg, 0.14 for upadacitinib 30 mg and 1.00 for MTX based on linear extrapolation (P < 0.001 for both upadacitinib doses vs MTX). Among patients with an inadequate response to MTX (SELECT-COMPARE), the mean change from baseline in mTSS was significantly reduced in the upadacitinib 15 mg plus MTX group vs placebo plus MTX (0.28 vs 1.73; P < 0.001). The mean change from baseline in the adalimumab plus MTX group was 0.39.

conclusionUpadacitinib monotherapy or in combination with background MTX was effective in inhibiting the progression of structural joint damage through week 48 in MTX-naïve and MTX-IR patients with RA.

trial registrationClinicalTrials.gov (https://clinicaltrials.gov), NCT02706873 and NCT02629159.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdalimumabDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationHeterocyclic Compounds, 3-RingHumansMethotrexateTreatment OutcomeAdalimumabAntirheumatic AgentsHeterocyclic Compounds, 3-RingMethotrexateupadacitinibbiological therapiesDMARDsoutcome measuresradiologyrheumatoid arthritis

Identifiers

PMID34897366
PMCPMC9348768
OpenAlexW4200039992

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.