Evidence map›Paper›PMID 38806190›Full record

Trial reportRMD open2024

Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study.

Roy Fleischmann, Jerzy Swierkot, Sara K Penn, Patrick Durez, Louis Bessette, Xianwei Bu, Nasser Khan, Yihan Li, Charles G Peterfy, Yoshiya Tanaka and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in RMD open, 2024. 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 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 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.

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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  17. Adverse effects of Janus kinase inhibitors with relevance for daily practice in dermatology.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
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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

11 authors.

Roy FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Med Center, Dallas, Texas, USA rfleischmann@arthdocs.com.ORCID 0000-0002-6630-1477
Jerzy SwierkotDepartment of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.
Sara K PennImmunology, AbbVie, North Chicago, Illinois, USA.
Patrick DurezPôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, UCLouvain Saint-Luc, Brussels, Belgium.ORCID 0000-0002-7156-2356
Louis BessetteRheumatology, Laval University, Quebec, Quebec, Canada.
Xianwei BuImmunology, AbbVie, North Chicago, Illinois, USA.
Nasser KhanImmunology, AbbVie, North Chicago, Illinois, USA.
Yihan LiImmunology, AbbVie, North Chicago, Illinois, USA.
Charles G PeterfySpire Sciences Inc, Boca Raton, Florida, USA.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Eduardo MyslerRheumatology, Organización Medica de Investigación, Buenos Aires, Argentina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the safety and efficacy of upadacitinib versus adalimumab from SELECT-COMPARE over 5 years.

methodsPatients with rheumatoid arthritis and inadequate response to methotrexate were randomised to receive upadacitinib 15 mg once daily, placebo or adalimumab 40 mg every other week, all with concomitant methotrexate. By week 26, patients with insufficient response to randomised treatment were rescued; patients remaining on placebo switched to upadacitinib. Patients completing the 48-week double-blind period could enter a long-term extension. Safety and efficacy were assessed through week 264, with radiographic progression analysed through week 192. Safety was assessed by treatment-emergent adverse events (TEAEs). Efficacy was analysed by randomised group (non-responder imputation (NRI)) or treatment sequence (as observed).

resultsRates of TEAEs were generally similar with upadacitinib versus adalimumab, although numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer were reported with upadacitinib. Numerically greater proportions of patients randomised to upadacitinib versus adalimumab achieved clinical responses (NRI); Clinical Disease Activity Index remission (≤2.8) and Disease Activity Score based on C reactive protein <2.6 were achieved by 24.6% vs 18.7% (nominal p=0.042) and 31.8% vs 23.2% (nominal p=0.006), respectively. Radiographic progression was numerically lower with continuous upadacitinib versus adalimumab at week 192.

conclusionThe safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit-risk profile for long-term rheumatoid arthritis treatment. TRIAL REGISTRATION NUMBER: NCT02629159.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, RheumatoidHeterocyclic Compounds, 3-RingAdultAgedDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedTreatment OutcomeAdalimumabAntirheumatic AgentsHeterocyclic Compounds, 3-RingMethotrexateupadacitinibAntirheumatic AgentsArthritis, RheumatoidBiological TherapyInflammation

Identifiers

PMID38806190
PMCPMC11138271

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.