Evidence map›Paper›PMID 38180720›Full record

ArticleRheumatology and therapy2024

Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years.

Christina Charles-Schoeman, Jon T Giles, Nancy E Lane, Ernest Choy, Daniel E Furst, Jiří Vencovský, Anthony G Wilson, Gerd R Burmester, Derek Coombs, Sara K Penn and 4 more

Open access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Potential Role of Upadacitinib in Cytomegalovirus Colitis Recurrence.European journal of case reports in internal medicine · 2025
    Article
  9. 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

14 authors at 9 institutions in 5 countries.

Christina Charles-SchoemanUniversity of California, 1000 Veteran Avenue, Rm 32-59, Los Angeles, CA, 90095, USA. ccharles@mednet.ucla.edu.ORCID http://orcid.org/0000-0002-1768-7019
Jon T GilesColumbia University, New York, NY, USA.ORCID http://orcid.org/0000-0002-8792-0402
Nancy E LaneUniversity of California Davis, Sacramento, CA, USA.ORCID http://orcid.org/0000-0002-0177-2198
Ernest ChoyCREATE Centre, Cardiff University, Cardiff, UK.ORCID http://orcid.org/0000-0003-4459-8609
Daniel E FurstDivision of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0002-4018-7629
Jiří VencovskýDepartment of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic.ORCID http://orcid.org/0000-0002-0851-0713
Anthony G WilsonCenter for Arthritis Research, Conway Institute, University College Dublin, Dublin, Ireland.ORCID http://orcid.org/0000-0003-4855-3926
Gerd R BurmesterCharité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7518-1131
Derek CoombsAbbVie Inc., North Chicago, IL, USA.
Sara K PennAbbVie Inc., North Chicago, IL, USA.
Nasser KhanAbbVie Inc., North Chicago, IL, USA.
Jillian B YeeAbbVie Inc., North Chicago, IL, USA.
Kassim RahawiAbbVie Inc., North Chicago, IL, USA.
Iain B McInnesCollege of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-6462-4280
AbbVie (United States) · USUniversity of California, Los Angeles · USCardiff University · GBCharité - Universitätsmedizin Berlin · DECharles University · CZColumbia University · USUniversity College Dublin · IEUniversity of California, Davis · USUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUpadacitinib (UPA) is a Janus kinase inhibitor that has demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA) with an acceptable safety profile. We investigated laboratory parameter changes in UPA RA clinical trials.

methodsPooled data from six randomized trials in the SELECT phase 3 program were included. Key laboratory parameters and safety data were measured for UPA 15 and 30 mg once daily (QD), adalimumab (ADA) 40 mg every other week + methotrexate (MTX), and MTX monotherapy. Exposure-adjusted event rates (EAERs) of adverse events were calculated.

resultsA total of 3209 patients receiving UPA 15 mg QD (10 782.7 patient-years [PY]), 1204 patients receiving UPA 30 mg QD (3162.5 PY), 579 patients receiving ADA + MTX (1573.2 PY), and 314 patients receiving MTX monotherapy (865.1 PY) were included, representing up to 6.5 years of total exposure. Decreases in mean levels of hemoglobin, neutrophils, and lymphocytes, and increases in mean levels of liver enzymes and creatinine phosphokinase were observed with UPA, with grade 3 or 4 changes observed in some patients. Mean low- and high-density lipoprotein cholesterol ratios remained stable for patients receiving UPA 15 mg QD. EAERs of anemia and neutropenia occurred at generally consistent rates between UPA and active comparators (3.1-4.3 and 1.7-5.0 events [E]/100 PY across treatment groups, respectively). Rates of hepatic disorder were higher with MTX monotherapy, UPA 15 mg and UPA 30 mg (10.8, 9.7, and 11.0 E/100 PY, respectively) versus ADA + MTX (6.4 E/100 PY). Rates of lymphopenia were highest with MTX monotherapy (3.2 E/100 PY). Treatment discontinuations due to laboratory-related events were rare, occurring in 1.1% and 2.2% of patients treated with UPA 15 and 30 mg QD, respectively.

conclusionsThe results of this integrated long-term analysis of laboratory parameters continue to support an acceptable safety profile of UPA 15 mg QD for moderate-to-severe RA.

Indexed as

JAK inhibitorLaboratory parametersRheumatoid arthritisUpadacitinib

Identifiers

PMID38180720
PMCPMC10796877
OpenAlexW4390618867

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.