S0725 Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-Up Results From an Observational Real World Study Among Patients With Inflammatory Bowel Disease (ONWARD Study)
Bibliographic record
Abstract
INTRODUCTION: The objective of this study was to describe the effects of infliximab-dyyb, a biosimilar to reference product (RP) infliximab, on clinical and patient-reported outcomes (PROs) in inflammatory bowel disease (IBD) including Crohn’s disease (CD) and ulcerative colitis (UC) patients in a real-world setting. METHODS: In this prospective, observational study, patients with IBD in the US and Canada were recruited to begin treatment with infliximab-dyyb. Patients, divided into biological naive users of infliximab-dyyb (naive users) and those switching from RP infliximab to infliximab-dyyb, were followed for 1 year. Clinical outcomes assessed were partial Mayo score (PMS) and Harvey Bradshaw Index (HBI) for the UC and CD cohort, respectively. Clinical response (PMS/HBI reduction ≥3 points) and remission (PMS <3 or HBI <5) were measured. Patient reported outcomes (PROs) included: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and EuroQol Visual Analog Scale (EQ-VAS). Changes from baseline were assessed using mixed models for repeated measures. Adverse events (overall/treatment-related) were assessed. RESULTS: A total of 67 CD and 48 UC patients initiating treatment with infliximab-dyyb were enrolled (51% female; mean age 44 years; 87% Caucasian; mean BMI 27.9). Of them, 39 patients were naive users, 57 were switched from RP infliximab, and 19 were switched from other biologics. Among UC naïve users, PMS improved (P < 0.0001) and remission rate increased from baseline (P = 0.0015; Table 1). For UC patients switching from RP infliximab to infliximab-dyyb, PMS improved from baseline (P = 0.0103; Table 1). CD naive users and patients switching from RP infliximab had low baseline HBI scores which where maintained over time (Table 2). Among all naïve users, SIBDQ and EQ-VAS scores improved from baseline (P < 0.0001 and 0.0135; Table 3). Patients switching from RP infliximab maintained SIBDQ and EQ-VAS scores (P = 0.1416 and 0.0675; Table 3). Regarding adverse events, 22 occurred related to treatment (including 5 lack of response, 4 infusion reaction, 2 immunogenicity, and 2 hypersensitivity reaction). Overall, 19 (17%) patients discontinued infliximab-dyyb. CONCLUSION: Clinical outcomes among naive users of infliximab-dyyb improved for UC and were maintained for CD patients. Naive users of infliximab-dyyb showed significant improvements in PROs. Patients switching from RP infliximab to infliximab-dyyb maintained their clinical outcomes and quality of life.Table 1Table 2Table 3
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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 | 0.001 |
| 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 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".