Evidence map›Paper›PMID 38169057›Full record

SynthesisAdvances in therapy2024

Safety of Upadacitinib in Immune-Mediated Inflammatory Diseases: Systematic Literature Review of Indirect and Direct Treatment Comparisons of Randomized Controlled Trials.

Eduardo Mysler, Gerd R Burmester, Christopher D Saffore, John Liu, Lani Wegrzyn, Chelsey Yang, Keith A Betts, Yan Wang, Alan D Irvine, Remo Panaccione

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
8.0field-weighted citation impact, top 2% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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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

10 authors at 4 institutions in 4 countries.

Eduardo MyslerRheumatology, Organización Medica de Investigación, Buenos Aires, Argentina.
Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Christopher D SafforeAbbVie Inc, North Chicago, IL, USA. christopher.saffore@abbvie.com.
John LiuAbbVie Inc, North Chicago, IL, USA.
Lani WegrzynAbbVie Inc, North Chicago, IL, USA.
Chelsey YangAnalysis Group Inc., Beijing, China.
Keith A BettsAnalysis Group Inc., Los Angeles, CA, USA.
Yan WangAnalysis Group Inc., Los Angeles, CA, USA.
Alan D IrvineDepartment of Clinical Medicine, Trinity College Dublin, Dublin, Ireland.
Remo PanaccioneDivision of Gastroenterology and Hepatology, Inflammatory Bowel Disease Unit, Cumming School of Medicine, University of Calgary, Calgary, Canada.
AbbVie (United States) · USCharité - Universitätsmedizin Berlin · DETrinity College Dublin · IEUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImmune-mediated inflammatory diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondylarthritis (nr-axSpA), atopic dermatitis (AD), ulcerative colitis (UC), and Crohn's disease (CD) pose a substantial burden on patients and their quality of life. Upadacitinib is an orally administered, selective, and reversible Janus kinase inhibitor indicated for seven conditions, but data on its safety versus other active treatments are limited. A systematic literature review of indirect and direct treatment comparisons of randomized controlled trials (RCTs) was conducted to assess the safety profile of upadacitinib.

methodsMEDLINE, Embase, and Cochrane Library databases were searched for indirect and direct treatment comparisons of RCTs that (1) included licensed upadacitinib dosages; (2) studied any of the seven conditions; (3) reported any adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, major adverse cardiovascular event, venous thromboembolism, malignancies, infections or serious infections, and death; and (4) were published between January 2018 and August 2022.

resultsA total of 25 studies were eligible for inclusion. SAEs, AEs leading to discontinuation, and any AEs were commonly studied. RA was the most studied condition, followed by AD and UC. Most studies (16/25, 64%) reported no statistically significant difference in the studied safety outcomes between upadacitinib and other active treatments (e.g., tumor necrosis factor blockers, interleukin receptor antagonists, integrin receptor antagonists, T cell co-stimulation modulator), or placebo (placebo ± methotrexate or topical corticosteroids). Other studies (9/25, 36%) reported mixed results of no statistically significant difference and either statistically higher (8/25, 32%) or lower rates (1/25, 4%) on upadacitinib.

conclusionMost studies suggested that upadacitinib has no statistically significant difference in the studied safety outcomes compared to active treatments or placebo in patients with RA, PsA, AS, AD, UC, and CD. A few studies reported higher rates, but findings were inconsistent with limited interpretation.

Indexed as

Arthritis, PsoriaticArthritis, RheumatoidColitis, UlcerativeHeterocyclic Compounds, 3-RingSpondylitis, AnkylosingHumansMethotrexateRandomized Controlled Trials as TopicHeterocyclic Compounds, 3-RingMethotrexateupadacitinibDermatologyDirect treatment comparisonGastroenterologyIndirect treatment comparisonRheumatologySafetySystematic literature reviewUpadacitinib

Identifiers

PMID38169057
PMCPMC10838816
OpenAlexW4390498067

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.