Adalimumab Therapy maintains meaningful rates of steroid-free remission in patients with Crohnʼs Disease for up to 3 Years of Therapy: Results From an Open-Label Extension of CHARM
Bibliographic record
Abstract
Adalimumab, a fully human anti-tumor necrosis factor monoclonal antibody, is approved for the treatment of Crohn's disease (CD) and has been shown to induce and maintain remission in patients with CD. In CHARM, adalimumab demonstrated a steroid-sparing effect. Steroid-free remission was sustained through 1 year of adalimumab therapy in patients who were receiving steroids at baseline.1 The rates of steroid-free remission for patients who continued treatment with adalimumab for an additional 2 years (total length of therapy, 3 years) in ADHERE (Additional Long-Term Dosing With HUMIRA® to Evaluate Sustained Remission and Efficacy in CD), an ongoing, open-label extension trial of the CHARM (Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance) trial, are described here. In CHARM, a Phase III study of 854 patients with moderately to severely active CD, open-label 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, adalimumab 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 of prednisone (or equivalent) for ≥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 3 years from the CHARM baseline. Remission rates were calculated using nonresponder imputation (NRI) analysis. Of the patients randomized to adalimumab in CHARM, 206 were receiving steroids at baseline. At 2 and 3 years after CHARM baseline, 27% and 28% of these patients, respectively, were in steroid-free remission (table). Clinically meaningful rates of steroid-free remission were achieved in adalimumab-treated patients who were receiving steroids when they entered the CHARM study. Steroid-free remission rates were maintained after 3 years of adalimumab treatment.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".