Evidence map›Paper›PMID 40971024›Full record

ArticleRheumatology and therapy2025

Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting.

Regan Arendse, Proton Rahman, Philip Baer, Derek Haaland, Louis Bessette, Dalton Sholter, Meagan Rachich, Emmanouil Rampakakis, Anne Marilise Marrache, Allen J Lehman and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00741793 (BioTRAC), which is not on this map. Cited by 1 paper.

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

NCT00741793 completednot on this map

BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

TypeobservationalSponsorJanssen Inc.Ran2002 to 2018Enrolled2,821ConditionsArthritis, Rheumatoid, Spondyloarthritis, Axial, Arthritis, Psoriatic
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Regan ArendseCollege of Medicine, University of Saskatchewan, Health Sciences Building, 107 Wiggins Road, Saskatoon, SK, S7N 5E5, Canada. regan@arendse.biz.ORCID http://orcid.org/0000-0003-3398-8476
Proton RahmanFaculty of Medicine, Memorial University, St. John's, NL, Canada.
Philip BaerBaer Weinberg MPC, Toronto, ON, Canada.
Derek HaalandThe Waterside Clinic, Orillia, ON, Canada.
Louis BessetteLaval University, Quebec, QC, Canada.ORCID http://orcid.org/0000-0002-6834-2731
Dalton SholterUniversity of Alberta, Edmonton, AB, Canada.ORCID http://orcid.org/0009-0005-4740-6811
Meagan RachichJohnson & Johnson, Toronto, ON, Canada.
Emmanouil RampakakisJSS Medical Research, Montréal, QC, Canada.ORCID http://orcid.org/0000-0002-7427-8246
Anne Marilise MarracheJohnson & Johnson, Toronto, ON, Canada.
Allen J LehmanJohnson & Johnson, Toronto, ON, Canada.ORCID http://orcid.org/0000-0003-2315-7919
Odalis Asin-MilanJohnson & Johnson, Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis work aims to describe the risk of major adverse cardiovascular events (MACE), malignancy, and mortality in real-world patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) treated with subcutaneous (SC) golimumab.

methodsThis post hoc analysis included patients treated with SC golimumab from the BioTRAC registry. Incidence rates (IR) per 100 patient-years (PYs) and time to onset of adverse events of special interest (AEoSI), including MACE, malignancies, mortality, serious AEs (SAEs), and serious infections (SIs), were assessed in subgroups based on age, sex, prior tumor necrosis factor inhibitor experience, smoking status, and baseline methotrexate and oral steroid use. All analyses were stratified by indication.

resultsOf 1231 patients included, 529 had RA, 281 had PsA, and 421 had axSpA. At baseline, mean patient age was 57.7, 52.8, and 45.7 years in the RA, PsA, and axSpA groups, respectively. Most patients with RA (76.2%) and PsA (53.7%); 40.9% of patients with axSpA were female. The IR (95% confidence interval) for MACE was 1.1 (0.6, 2.0) events/100 PYs in the RA group with no events in the PsA and axSpA groups. Malignancy IRs were 1.4 (0.8, 2.3), 0.4 (0.0, 1.3), and 1.0 (0.4, 2.1)/100 PYs. SAE incidence ranged from 7.6 (5.5, 10.3)/100 PYs in the PsA group to 11.4 (9.4, 13.6) in the RA group, and that of SIs from 1.3 (0.5, 2.7)/100 PYs in patients with PsA to 2.3 (1.4, 3.4) in patients with RA. IRs for mortality were 0.7 (0.3, 1.4; n = 7), 0.2 (0.0, 1.0; n = 1), and 0.3 (0.0, 1.1; n = 2)/100 PYs in RA, PsA, and axSpA, respectively. Older patients with RA had a significantly shorter time to MACE (p = 0.007).

conclusionsPatients with RA, PsA, and axSpA treated with SC golimumab in the real world had a low incidence of MACE, malignancy, and all-cause mortality, further confirming the safety of golimumab for the treatment of rheumatic diseases. TRIAL REGISTRATION NUMBER AND DATE: ClinicalTrials.gov identifier, NCT00741793, August 22, 2008.

Indexed as

Adverse eventAxial spondyloarthritisGolimumabIncidence rateMajor adverse cardiovascular eventsMalignancyPsoriatic arthritisReal-world studyRheumatoid arthritis

Identifiers

PMID40971024
PMCPMC12638567

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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.