Evidence map›Paper›PMID 42342288›Full record

Trial reportRMD open2026

Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study.

Roy Fleischmann, Jerzy Swierkot, Patrick Durez, Louis Bessette, Ricardo Blanco, Filip Van den Bosch, Duke Geem, Lingfeng Luo, Lauren D Smith, Diane Caballero and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative StudyMulticenter Study
In one paragraph

Trial report in RMD open, 2026. 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. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Roy FleischmannUniversity of Texas Southwestern Medical Center, Dallas, Texas, USA rfleischmann@arthdocs.com.ORCID http://orcid.org/0000-0002-6630-1477
Jerzy SwierkotDepartment of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.
Patrick DurezInstitut de Recherche Expérimentale et Clinique, UCLouvain Saint-Luc, Pôle de Recherche en Rhumatologie, Brussels, Belgium.ORCID http://orcid.org/0000-0002-7156-2356
Louis BessetteCentre de recherche du CHU de Québec, Laval University, Quebec, Québec, Canada.
Ricardo BlancoRheumatology Division, Hospital University Marqués de Valdecilla, Immunopathology Group, IDIVAL, Santander, Spain.ORCID http://orcid.org/0000-0003-2344-2285
Filip Van den BoschDepartment of Internal Medicine and Pediatrics, VIB-UGent Center for Inflammation Research, Ghent University, Ghent, Belgium.ORCID http://orcid.org/0000-0002-3561-5932
Duke GeemImmunology, AbbVie, North Chicago, Illinois, USA.
Lingfeng LuoImmunology, AbbVie, North Chicago, Illinois, USA.
Lauren D SmithImmunology, AbbVie, North Chicago, Illinois, USA.
Diane CaballeroImmunology, AbbVie, North Chicago, Illinois, USA.
Sebastian MeerweinAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Charles PeterfySpire Sciences Inc, Boca Raton, Florida, USA.
Yoshiya TanakaDepartment of Molecular Targeted Therapeutics, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID http://orcid.org/0000-0002-0807-7139
Eduardo MyslerRheumatology, Organización Medica de Investigación, Buenos Aires, Argentina.ORCID http://orcid.org/0000-0002-8993-0313

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the safety and efficacy of upadacitinib versus adalimumab through 7 years in the ongoing SELECT-COMPARE study.

methodsPatients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) were randomised to placebo, upadacitinib 15 mg once daily or adalimumab 40 mg every other week (on background MTX). Inadequate responders were rescued to the alternate therapy, with placebo recipients switching to upadacitinib by week 26. Patients completing 48 weeks were eligible to enter the 10-year extension. Safety was assessed as treatment-emergent adverse events (TEAEs); efficacy was analysed by randomised group (non-responder imputation [NRI]) or treatment sequence (as observed [AO]).

resultsUpadacitinib was generally well tolerated, displaying TEAE rates comparable to adalimumab, but numerically higher rates of herpes zoster, creatine phosphokinase elevation, non-melanoma skin cancer, lymphopenia and hepatic disorders. Responses with continuous upadacitinib or adalimumab were maintained through 372 weeks; week 372 Clinical Disease Activity Index remission (≤2.8) and 28-joint Disease Activity Score based on C-reactive protein<2.6 were achieved by 145/230 (63.0%) and 178/204 (83.2%) (AO)/142/651 (21.8%) and 172/651 (26.4%) (NRI) of patients with upadacitinib versus 46/86 (53.5%) and 59/81 (72.8%) (AO)/43/327 (13.1%) and 55/327 (16.8%) (NRI) with adalimumab. Initial non-responders/incomplete responders benefited from switching, with improvements in efficacy endpoints maintained through week 336 post switch, without additional safety concerns.

conclusionThe safety profile of upadacitinib remained consistent with previous analyses, with no new safety concerns through 7 years. Upadacitinib and adalimumab (continuous or rescue treatment) maintained disease activity targets throughout the 7-year treatment period. Upadacitinib exhibited an acceptable benefit-risk profile for long-term RA treatment. TRIAL REGISTRATION NUMBER: NCT02629159.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, RheumatoidHeterocyclic Compounds, 3-RingAdultAgedFemaleHumansMaleMethotrexateMiddle AgedTreatment OutcomeAdalimumabAntirheumatic AgentsHeterocyclic Compounds, 3-RingMethotrexateupadacitinibAntirheumatic AgentsArthritis, RheumatoidBiological TherapyInflammation

Identifiers

PMID42342288
PMCPMC13296005

What Socratic holds

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LicenceCC BY
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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 Socratic graph.