EFFICACY ASSESSMENT OF NATALIZUMAB IN PATIENTS WITH CROHNʼS DISEASE AND PRIOR HISTORY OF INFLIXIMAB THERAPY
Bibliographic record
Abstract
Purpose: To determine the ability of Antegren™ (natalizumab) in maintaining clinical response/remission in patients with Crohn's disease (CD) who had previously received (and/or failed) infliximab (IFX) therapy. Methods: A total of 339 adult patients with CD who achieved response (≥70-point reduction in baseline Crohn's Disease Activity Index [CDAI]) and/or remission (< 150) and had a CDAI score of <220 following 3 intravenous infusions of natalizumab in the induction of response or remission study (ENACT-1), were re-randomized to natalizumab (n = 168) or placebo (PLC) (n = 171) in ENACT-2. The primary endpoint was the proportion of patients who did not lose clinical response from ENACT-1 for an additional 6 months. Results: Natalizumab responders from ENACT-1 previously exposed to IFX therapy (n = 108) and re-randomized to natalizumab (n = 48) in ENACT-2 demonstrated significantly higher response rates (58% vs 10%; p <0.001) following 6 monthly infusions than those re-randomized to PLC (n = 60). The subset of patients that previously failed IFX therapy (n = 57) and were re-randomized to natalizumab (n = 24) in ENACT-2 also had higher response rates (54% vs 15%; p = 0.002) following 6 monthly infusions compared with patients re-randomized to PLC (n = 33). Patients in remission in ENACT-1, previously exposed to IFX (n = 75) and re-randomized to natalizumab (n = 40) in ENACT-2, showed significantly higher remission rates (43% vs 6%; p = 0.002) following 6 infusions compared with the PLC group (n = 35). Patients who were in remission and had previously failed IFX therapy (n = 41) and were re-randomized to natalizumab in ENACT-2 (n = 19) had significantly higher remission rates (37% vs 9%; p = 0.031) following 6 monthly infusions than patients re-randomized to PLC (n = 22). In addition to clinical efficacy, data from this study showed similar safety profiles between natalizumab and PLC groups. Conclusions: Natalizumab responders, previously treated with (or having failed) IFX, demonstrated statistically significant differences in maintaining clinical response/remission compared with PLC. Natalizumab may offer a novel therapeutic option for patients with CD who have previously received and/or failed IFX therapy.
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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 | 0.002 | 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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".