Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting
Bibliographic record
Abstract
INTRODUCTION: This 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. METHODS: This 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. RESULTS: Of 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). CONCLUSIONS: Patients 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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".