Maintenance of Remission over 1 Year in Patients with Active Crohnʼs Disease Treated with Adalimumab
Bibliographic record
Abstract
Purpose: To assess the long-term efficacy and safety of adalimumab (ADA)—a fully human anti-TNF monoclonal antibody approved for the treatment of rheumatoid arthritis (RA)—in maintaining remission in patients (pts) with Crohn's disease (CD). Methods: Patients with moderate to severely active CD who completed CLASSIC, a 4-week, placebo-controlled, multi-center study of ADA, were eligible to enter a long-term study of ADA (CLASSIC II). All pts in CLASSIC II received ADA 40 mg sc at Week 0 (Week 4 of CLASSIC) and Week 2. Patients in remission (CDAI < 150) at both Week 0 and Week 4 were randomized to receive ADA 40 mg eow, ADA 40 mg/wk, or placebo for up to 1 year. Patients with CDAI≥150 entered an open-label ADA cohort (results reported elsewhere). CDAI and adverse events (AE) were assessed at each study visit. Results: Of 275 pts entering CLASSIC II, 55 had CDAI < 150 at both Week 0 and Week 4 and were randomized. Remission was maintained over time in ADA-treated pts but not in pts receiving placebo (table). AE were generally mild to moderate in severity and similar to those previously reported in studies of ADA in pts with RA. Serious AE occurred in 2 pts in the placebo group (intestinal obstruction, back pain) and in 1 pt in the 40-mg-eow group (non-critical coronary artery disease.)Table: Maintenance of Remission, N (%)Conclusions: In this small exploratory cohort, remission was maintained in pts with CD treated with ADA 40 mg/wk or 40 mg eow for 1 year. ADA was safe and well-tolerated in this study. A larger study, powered to definitively assess the long-term efficacy of ADA, is ongoing.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| 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 | 0.001 |
| 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".