Evidence map›Paper›PMID 39053948›Full record

Trial reportRMD open2024

Long-term sustainability of response to upadacitinib among patients with active rheumatoid arthritis refractory to biological treatments: results up to 5 years from SELECT-BEYOND.

Ronald F van Vollenhoven, Stephen Hall, Alvin F Wells, Sebastian Meerwein, Yanna Song, Oishi Tanjinatus, Roy Fleischmann

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
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 NCT02706847 (A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
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

7 authors.

Ronald F van VollenhovenAmsterdam University Medical Centres, Amsterdam, The Netherlands r.vanvollenhoven@amsterdamumc.nl.ORCID 0000-0001-6438-8663
Stephen HallRheumatology, Emeritus Research and Monash University, Melbourne, Victoria, Australia.
Alvin F WellsAurora Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA.
Sebastian MeerweinAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Yanna SongAbbVie, North Chicago, Illinois, USA.
Oishi TanjinatusAbbVie, North Chicago, Illinois, USA.
Roy FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-6630-1477

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the long-term sustainability of response to the Janus kinase inhibitor upadacitinib among patients with rheumatoid arthritis and an inadequate response or intolerance to biological disease-modifying antirheumatic drugs (bDMARD-IR) in the SELECT-BEYOND phase 3 trial.

methodsPatients on background conventional synthetic DMARDs (csDMARDs) were treated once daily with upadacitinib 15 mg or placebo. Patients who completed the week 24 visit could enter a long-term extension of up to 5 years. The sustainability of response was assessed based on achievement of Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and Disease Activity Score 28-joint count using C-reactive protein (DAS28 (CRP)) targets and evaluated up to week 260 in all patients receiving the approved upadacitinib 15 mg dose, including those randomised to upadacitinib 15 mg and those who switched from placebo to upadacitinib 15 mg at week 12.

resultsIn this bDMARD-IR population, 45% (n=104/229) and 79% (n=172/219) of patients treated with upadacitinib 15 mg plus background csDMARD(s) achieved CDAI remission or CDAI low disease activity (LDA) at any point during the 5-year study, respectively. Of those who achieved CDAI remission/LDA, 25%/43% maintained their initial response through 240 weeks of follow-up after first achieving response. Most patients who lost remission or LDA were able to recapture that response by the cut-off date. Similar overall results were observed for SDAI and DAS28 (CRP). No strong predictors of response were identified.

conclusionsOver three-quarters of bDMARD-IR patients achieved CDAI LDA with upadacitinib, and almost half of those maintained LDA through 240 weeks of follow-up. Remission was achieved by nearly half of all patients and maintained in approximately a quarter of those achieving remission. TRIAL REGISTRATION NUMBER: NCT02706847.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidHeterocyclic Compounds, 3-RingJanus Kinase InhibitorsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsHeterocyclic Compounds, 3-RingJanus Kinase InhibitorsupadacitinibAntirheumatic AgentsRheumatoid ArthritisTherapeutics

Identifiers

PMID39053948
PMCPMC11284904

What Socratic holds

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LicenceCC BY-NC
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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.