Evidence map›Paper›PMID 33313898›Full record

Trial reportRheumatology (Oxford, England)2021

Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY.

Vibeke Strand, Namita Tundia, Alvin Wells, Maya H Buch, Sebastiao C Radominski, Heidi S Camp, Alan Friedman, Jessica L Suboticki, Kendall Dunlap, Debbie Goldschmidt and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized 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 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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.

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
NCT02706951 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

TypeinterventionalSponsorAbbVieRan2016 to 2022Enrolled648ConditionsRheumatoid ArthritisArmsMethotrexate, Upadacitinib, Placebo Upadacitinib, Placebo Methotrexate
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 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

11 authors at 5 institutions in 3 countries.

Vibeke StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
Namita TundiaHEOR Immunology, AbbVie Inc., North Chicago, IL, USA.
Alvin WellsAurora Rheumatology and Immunotherapy Center, Franklin, WI, USA.
Maya H BuchCentre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK.
Sebastiao C RadominskiUniversidade Federal do Paraná, Curitiba, Brazil.
Heidi S CampClinical Immunology, AbbVie Inc., North Chicago, IL, USA.
Alan FriedmanClinical Immunology, AbbVie Inc., North Chicago, IL, USA.
Jessica L SubotickiUS Medical Affairs, AbbVie Inc., North Chicago, IL, USA.
Kendall DunlapUS Medical Affairs, AbbVie Inc., North Chicago, IL, USA.
Debbie GoldschmidtAnalysis Group Inc., New York, NY, USA.
Martin BergmanDepartment of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.
AbbVie (United States) · USDrexel University · USNIHR Manchester Biomedical Research Centre · GBStanford University · USUniversidade Federal do Paraná · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve or who had an inadequate response to MTX (MTX-IR).

methodsPROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined.

resultsIn 945 MTX-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naïve and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values.

conclusionAmong MTX-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone. CLINICAL TRIAL REGISTRATION NUMBER: SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.

Indexed as

Quality of LifeActivities of Daily LivingAdultAgedAntirheumatic AgentsArthritis, RheumatoidEfficiencyFatigueFemaleHeterocyclic Compounds, 3-RingHumansJanus Kinase InhibitorsLeast-Squares AnalysisMaleMethotrexateMiddle AgedAntirheumatic AgentsHeterocyclic Compounds, 3-RingJanus Kinase InhibitorsMethotrexateupadacitinibDMARDsinflammationoutcome measuresquality of lifeRA

Identifiers

PMID33313898
PMCPMC8516509
OpenAlexW3111661627

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.