Real-World Safety Data from Patients With Rheumatic Diseases Treated With CT-P13, An Infliximab Biosimilar: An Interim Analysis from an Observational Study
Bibliographic record
Abstract
<p><strong>Background</strong> CT-P13, an infliximab biosimilar, has been available in Europe and Canada since 2015, and real-world experience with CT-P13 is important to support the safety of this medication. PERSIST is an ongoing, observational cohort study evaluating CT-P13 as treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in a real-world setting.</p> <p><strong>Objectives</strong> This interim analysis reports safety outcomes for patients who received CT-P13 as their first biologic (Biologic-naïve) or who switched from infliximab reference product (IFX-RP) to CT-P13 (Switched) based on data collected from September 2015 to December 2017.</p> <p><strong>Methods</strong> Patients were recruited during usual care at 38 academic and community sites in 6 European countries and Canada. Adult RA, AS or PsA patients prescribed CT-P13 or locally-sourced IFX-RP at the investigator’s discretion and according to the approved label were eligible. Data were analysed descriptively.</p> <p><strong>Results</strong> This analysis included 329 patients (RA, n=134; AS, n=110; PsA, n=85). Of these, 6 (1.8%) were not treated, 3 (0.9%) completed study treatment, 244 (74.2%) were ongoing and 76 (23.1%) discontinued study treatment, most commonly due to lack of response (30 [9.1%]). Demographics and baseline characteristics were generally similar between groups (Table 1). Most treatment-emergent adverse events (TEAEs; Table 2) were of mild or moderate intensity; 7/129 events were severe. Most commonly reported adverse events were related to infection (n=33; 10.2%); most frequently reported infection-related TEAEs were nasopharyngitis (n=6; 1.9%), respiratory tract infection (n=5; 1.5%) and pneumonia (n=4; 1.2%). No case of tuberculosis was reported. Eight (2.5%) patients reported infusion related reactions.</p>
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.002 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".