Natalizumab Maintains Remission for 2 Years in Patients with Moderately to Severely Active Crohnʼs Disease and in Those with Prior Infliximab Exposure
Bibliographic record
Abstract
Purpose: Natalizumab has been demonstrated as effective therapy for moderately to severely active Crohn's disease (CD) in both induction and long-term maintenance trials. Fifty-five percent of patients who responded to natalizumab induction therapy were in remission (Crohn's Disease Activity Index [CDAI] score < 150) after 15 months of continuous natalizumab therapy in the ENACT trials, compared with 22% in the placebo group (p < 0.001). This analysis was undertaken to assess the ability of natalizumab to maintain remission for up to an additional year (>2 yrs total). Methods: Patients who completed the ENACT-2 trial were eligible to enroll in an open-label extension (OLE) study. The primary objective of this 2-year study was to examine the long-term safety and tolerability of natalizumab. Secondary efficacy endpoints included evaluation of the ability of natalizumab to maintain remission. This analysis includes patients who were in remission after 15 months of continuous natalizumab therapy in the ENACT trials who enrolled in the OLE study and received an additional 12 months of natalizumab therapy. Eighty-seven patients met the criteria for analysis, 22 of whom had previous exposure to anti-TNF. Remission rates were calculated using last observation carried forward. Results: Patients in this analysis had a mean CDAI score of 151 (median, 150) after a single natalizumab infusion in ENACT-1. Ninety-three percent (81/87) of patients who were in remission at Month 12 of ENACT-2 were in remission following 6 additional natalizumab infusions in the OLE study. After 12 additional infusions, 86% (75/87) were in remission. In the subpopulation of patients with prior exposure to infliximab, 91% (20/22) were in remission after an additional 6 and 12 infusions of natalizumab in the OLE study. Similarly, 82% (9/11) who had previously failed therapy with infliximab were in remission at the same timepoints. Conclusions: Natalizumab maintained remission for >2 years (27 months) when administered as continuous therapy. Patients who entered remission with natalizumab induction therapy were highly likely to maintain long-term remission, including patients who had previously failed therapy with infliximab.
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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 | 0.001 | 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".