Efficacy and Safety of Vedolizumab With Advancing Age in Patients With Crohnʼs Disease: Results From the GEMINI 2 Study
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ) is a gut-selective monoclonal antibody to a4b7 integrin for the treatment of patients (pts) with Crohn's disease (CD). The efficacy and safety of VDZ have been demonstrated in the GEMINI 2 study.1 Here we report post hoc analyses of data from GEMINI 2 that evaluate the effects of VDZ with advancing age in pts with CD. Methods: In GEMINI 2, pts received double-blind (DB) VDZ or placebo (PBO) (induction intent-totreat [ITT] population) or open-label VDZ at weeks 0 and 2. At week 6, responders to VDZ induction treatment were re-randomized to receive DB VDZ every 8 weeks (Q8W) or 4 weeks (Q4W) or PBO up to week 52 (maintenance ITT population). Efficacy endpoints and adverse events (AEs) were analyzed by baseline (week 0) age category (55 years). Results: At baseline, 178 (48%), 161 (44%), and 29 (8%) pts in the induction and 246 (53%), 179 (39%), and 36 (8%) pts in the maintenance ITT populations were aged 55 years, respectively. At week 6, 31 (28%) VDZ-treated pts aged 55 years had an enhanced clinical response (≥100-point reduction in CD Activity Index [CDAI] score from baseline). Clinical remission (CDAI total score ≤150) was achieved by 16 (14%), 15 (16%), and 1 (8%) VDZ-treated pts in each age category, respectively. At week 52, remission was achieved by 65 (38%), 42 (37%), and 9 (41%) VDZ-treated pts aged 55 years, respectively. AEs occurred at similar rates across the ages (Table). Three malignancies ( < 1%) were reported in VDZtreated pts aged 20 years (carcinoid tumor of the appendix), 45 years (breast cancer), and 52 years (squamous cell carcinoma [skin]). Five deaths were reported: 3 VDZ-treated pts aged < 35 years (myocarditis; CD and sepsis; septic shock), 1 VDZ-treated pt aged 46 years (intentional overdose), and 1 PBO-treated pt aged 75 years (bronchopneumonia). Conclusion: These data suggest that the safety and efficacy of VDZ were generally similar in CD pts across all the age categories analyzed. Data interpretation is limited by the small pt population aged >55 years; these findings should be further evaluated in prospective studies.Table 1: Adverse Events Reported in Patients with CD by Baseline Age Category (GEMINI 2)
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".