Steroid-Free remission in response to Adalimumab therapy over 2 years in patients with Crohnʼs Disease: Results From open-label extension of the CHARM trial
Bibliographic record
Abstract
Adalimumab, a fully human monoclonal antibody targeting tumor necrosis factor (TNF), is approved for the treatment of adults with moderate to severe Crohn's disease (CD). In the Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance (CHARM), adalimumab demonstrated a steroid-sparing effect. Steroid-free remission was maintained through 1 year of adalimumab therapy in patients who were receiving steroids at baseline. The sustainability of steroid-free remission for more than 1 year in patients receiving a TNF antagonist in a clinical-trial setting has not been previously reported. This analysis assessed the rates of steroid-free remission among patients who continued treatment with adalimumab for an additional year (total length of therapy 2 years) in an ongoing, open-label extension (OLE) of the CHARM study. In CHARM, a Phase III study of 854 patients with moderate to severe CD, OL adalimumab was administered at Weeks 0 and 2 (80 mg and 40 mg, respectively); patients were then randomized to receive blinded therapy of adalimumab 40 mg every other week (eow), 40 mg weekly, or placebo for up to 56 weeks. Patients receiving steroids were included in the study if they had been on a stable dosage of <30 mg/d prednisone/equivalent for greater than or equal to 2 weeks prior to screening. The current post-hoc subanalysis evaluated data from the intention-to-treat population of patients receiving steroids at baseline who were randomized to adalimumab and assessed for steroid-free remission at 6, 12, 18, and 24 months from the start of CHARM. Patients with missing data were considered nonresponders (ie, not in steroidfree remission), regardless of the reason for the absence of data, including failure to enroll in the OLE. In CHARM, 206 patients receiving steroids at baseline were randomized to eow or weekly adalimumab treatment (table). Steroid-free remission rates were maintained over 2 years of adalimumab treatment, despite the strict nonresponder analysis methodology used. Steroid-Free Remission through 2 Years of Adalimumab Therapy in Randomized Patients Receiving Steroids at Baseline Adalimumab therapy resulted in clinically meaningful rates of steroidfree remission in patients who were receiving stable dosages of steroids when they entered the CHARM study. Responses were sustained over 2 years.
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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 | 0.006 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| 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".