Adalimumab maintains long-term remission through 2 years in patients with moderate to severe Crohnʼs Disease
Bibliographic record
Abstract
Adalimumab, a fully human antibody targeting tumor necrosis factor (TNF), is approved for treatment of adults with moderate to severe Crohn's disease (CD). Adalimumab has shown efficacy in the induction and maintenance of remission in CD for patients naive to and experienced with TNF-antagonist therapy. This analysis assessed the maintenance of remission in adalimumab-treated patients from the end of the 56-week Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance (CHARM) through an additional year in an ongoing open-label extension (OLE) study (total treatment, 2 years). As previously reported,1 854 patients enrolled in CHARM received OL induction adalimumab at Weeks 0 and 2. At Week 4, 778 of these patients were randomized to placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly. At/after Week 12, patients with flares (increase in CD Activity Index [CDAI] greater than or equal to 70 points compared with Week 4 and CDAI >220) or nonresponse (CDAI decrease <70 points from baseline) could receive OL adalimumab 40 mg eow and could subsequently change to OL weekly. At the end of CHARM (56 weeks), patients were eligible to enroll in an OLE, during which randomized patients received OL adalimumab 40 mg eow, and patients receiving OL adalimumab eow or weekly continued their regimens. Patients could switch to weekly dosage for flares/nonresponse. Posthoc analyses of maintenance of remission (CDAI <150) and response (decrease in CDAI greater than or equal to 70 [CR-70] or greater than or equal to 100 [CR-100] points) [data not shown] were performed for patients initially randomized to adalimumab who were in remission at CHARM Week 56. Both intention-to-treat (ITT) and randomized responder (RR; CR-70 at Week 4) populations were evaluated. Patients randomized to placebo were not analyzed. Remission rates were calculated using nonresponder imputation (NRI) and last observation carried forward (LOCF). A total of 467 patients enrolled in the OLE. Remission results are summarized in the table below. Of the 145 ITT patients initially randomized to adalimumab who were in remission at the end of CHARM, 111 (77%) remained in remission 2 years after CHARM enrollment (12-month OLE visit), and 97 (79%) of 123 RRs maintained remission at 2 years (NRI). Remission Rates for Adalimumab-Treated Patients Through 2 Years Adalimumab demonstrated sustained efficacy in maintaining CD remission through 2 years of therapy. The vast majority of adalimumab-treated patients in remission after 1 year in CHARM maintained remission for an additional year in an OLE.
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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) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 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".