S1122 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Non-Complicated Crohn’s Disease: Results From the EVOLVE Expansion Study
Bibliographic record
Abstract
Introduction: Crohn’s disease (CD) complexity may affect treatment (Tx) outcomes. This analysis compared real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in bio-naïve patients with non-complicated CD. Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective study analyzing medical charts of bio-naïve patients with CD aged ≥ 18 who initiated VDZ or UST (index) from 2016 to 2021 in Australia, Belgium, or Switzerland. Outcomes in pts with non-complicated CD (defined as no active fistula at index, no prior CD-related surgeries, and no CD-related hospitalizations in 12 months prior to index) were evaluated in a subgroup analysis. Data were collected from index to chart abstraction initiation, Tx discontinuation, death, or loss to follow-up, whichever was first. Time-to-event analyses for clinical outcomes (clinical response, clinical remission, and mucosal healing, assessed using published algorithms1) and Tx persistence during 36 months of Tx were conducted using Kaplan-Meier method. Safety (serious adverse events [SAEs], serious infections [SIs]) and healthcare resource utilization (HCRU; CD exacerbations, CD-related hospitalizations, CD-related surgeries) were also analyzed. Baseline characteristics between cohorts were balanced using inverse probability of treatment weighting (IPTW). Results: Overall, 425 pts (VDZ 244, UST 181) were included in this analysis. After IPTW, baseline characteristics were similar between groups (Table 1). During 36 months of Tx, weighted cumulative rates of clinical response (VDZ 85.0%, UST 85.6%; P=0.70), clinical remission (VDZ 93.3%, UST 91.3%, P=0.80), mucosal healing (VDZ 90.6%, UST 91.7%, P=0.14), and Tx persistence (VDZ 71.8%, UST 83.7%, P=0.07) were similar between both cohorts. During 36 months, risks of SAEs (HR=1.23; 95% CI, 0.62-2.46; P=0.55), SIs (HR=1.26; 95% CI 0.22-7.24; P=0.80), CD exacerbations (HR=1.09; 95% CI 0.74-1.61; P=0.66), CD-related surgeries (HR=1.11; 95% CI 0.47-2.62; P=0.82), and CD-related hospitalizations (HR=0.71; 95% CI 0.33-1.56; P=0.40) were similar between VDZ and UST cohorts. Conclusion: Over 36 months in a real-world clinical setting, cumulative rates of clinical response, clinical remission, mucosal healing, and Tx persistence, and rates of SAEs, SIs, and HCRU outcomes were not significantly different in patients with non-complicated CD who initiated VDZ or UST as a first-line biologic. Reference: 1. Bressler B, et al. J Crohns Colitis. 2021;15(10):1694-1706. Table 1. - Baseline characteristics of bio-naïve patients with non-complicated CD initiating first-line biologic treatment with vedolizumab or ustekinumab Unweighted Weighted Baseline characteristic VDZn=244 USTn=181 p value* VDZn=210 USTn=215 Std Diff after IPTW Age, mean±SD, y 46.5±17.6 43.3±17.3 0.06 45.7±16.6 45.7±18.1 0.001 Male, n (%) 118 (48.4) 93 (51.4) 0.54 102 (48.7) 100 (46.7) 0.040 Smoking status, n (%) 0.27 0.190 Current 46 (18.9) 31 (17.1) 113 (53.8) 123 (57.1) Former 50 (20.5) 25 (13.8) 43 (20.6) 30 (13.8) Never 128 (52.5) 108 (59.7) 36 (17.0) 43 (19.9) Disease duration, n with available data 242 181 Median (min, max), y 3.5 (0.0–46.0) 2.5 (0.0–40.0) 0.40 3.5 (0.0–46.0) 3.7 (0.0–40.0) 0.139 CD location at Tx initiation, n (%) 0.03 Colonic with/without upper GI disease 65 (26.6) 28 (15.5) 43 (20.4) 48 (22.3) 0.029 Ileal with/without upper GI disease 106 (43.4) 86 (47.5) 94 (44.7) 93 (43.1) 0.012 Ileocolonic with/without upper GI disease 63 (25.8) 63 (34.8) 68 (32.2) 68 (31.7) 0.020 Disease behavior at Tx initiation, n (%) 0.11 < 0.001 Non-stricturing, non-penetrating 174 (71.3) 113 (62.4) 161 (76.6) 145 (67.6) Penetrating 7 (2.9) 11 (6.1) 9 (4.1) 12 (5.7) Stricturing 51 (20.9) 50 (27.6) 29 (14.0) 40 (18.6) Disease severity at Tx initiation, n (%) 0.03 Normal 21 (8.6) 13 (7.2) 17 (8.3) 22 (20.1) Mild 55 (22.5) 20 (11.0) 51 (24.1) 21 (9.6) 0.002 Moderate 123 (50.4) 114 (63.0) 106 (50.5) 131 (60.8) 0.022 Severe 22 (9.0) 16 (8.8) 19 (9.2) 20 (9.5) 0.037 History of fistula† prior to Tx initiation, n (%) 5 (2.0) 10 (5.5) 0.05 4 (1.7) 11 (5.3) 0.196 *Unadjusted p values are reported.†Enterocutaneous, perianal, rectovaginal, other, or unknown.CD, Crohn’s disease; GI, gastrointestinal; IPTW, inverse probability of treatment weighting; Std Diff, standardized difference; Tx, treatment, UST, ustekinumab; VDZ, vedolizumab; y, years.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.011 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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 source (direct Gemma or distilled Codex), 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".