Natalizumab Does Not Require the Concomitant Use of Immunosuppressants or Corticosteriods for the Induction of Sustained Response and Remission in Patients with Crohnʼs Disease
Bibliographic record
Abstract
Purpose: This post-hoc analysis assessed the need for concomitant immunosuppressants (IMM) or corticosteroids (CS) for induction of response and remission with natalizumab (NAT) in the ENCORE and ENACT2 trials. Methods: In the ENCORE induction trial, 509 patients (pts) with CDAI scores ≥220 and ≤450 and CRP levels > 2.87 mg/L were randomized 1:1 to receive NAT 300 mg (N = 259) or placebo (PBO; N = 250) infusions at Mths 0, 1, and 2. In the ENACT2 maintenance trial, NAT-treated pts who responded in ENACT1 and had a CDAI score <220 were re-randomized 1:1 to receive monthly NAT (300 mg; N = 168) or placebo (N = 171) infusions for up to 12 mths. Results: In ENCORE, 188 pts were not receiving IMM or CS at baseline, with 90 and 98 randomized to receive NAT and PBO, respectively. A significantly greater proportion of NAT-treated pts were in clinical response at both Months 2 and 3, and, individually, at Mths 1 through 3, compared to the PBO group (Table 1). NAT treatment also resulted in a significantly greater proportion of pts in clinical remission at both Mths 2 and 3 and, individually, at Mths 1 and 3 compared to PBO (Table 1). In ENACT2, 138 pts were not receiving IMM or CS at baseline, and following randomization, 70 and 68 pts received NAT and PBO, respectively. At Mths 6 through 12, a significantly greater proportion of NAT-treated patients were in clinical response and remission, compared to the PBO group (Table 2).Table 1: ENCORE (Induction)Table 2: ENACT2 (Maintenance)Conclusion: Analyses of these trials suggest that NAT was effective in inducing response and sustaining remission in CD pts in the absence of concomitant IMM or CS 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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| 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 | 0.000 | 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 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".