Adalimumab Therapy maintains remission for up to 3 Years in patients with moderately to severely active Crohnʼs Disease: Results From an Open-Label Extension of CHARM
Bibliographic record
Abstract
Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) and has demonstrated efficacy in induction and maintenance of remission in CD for patients naïve to and experienced with anti-TNF therapy. The current analysis assessed the maintenance of remission in adalimumab-treated patients from the end of the 56-week CHARM (Crohn's Trial of the Fully Human Antibody Adalimumab for Remission Maintenance) trial through an additional 2 years of open-label therapy in the ADHERE (Additional Long-Term Dosing With HUMIRA® to Evaluate Sustained Remission and Efficacy in CD) study (total treatment length, 3 years). As previously reported,1 854 patients enrolled in CHARM and received open-label induction treatment with 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 or after Week 12, patients with flares or nonresponse could receive open-label adalimumab 40 mg eow and could subsequently change to weekly treatment. At the end of CHARM (56 weeks), patients were eligible to enroll in ADHERE, during which blinded patients received open-label adalimumab 40 mgeow and patients receiving open-label adalimumabeow or weekly continued their regimens. Patients could switch to weekly dosage for flares/nonresponse. Dosage decrease was not allowed. Post-hoc analyses of maintenance of remission (Crohn's Disease Activity Index [CDAI] <150) and response (drop in CDAI ≥70 [CR-70] or 100 [CR-100] points; data not shown) were performed for patients initially randomized to adalimumab who were in remission at Week 56 of CHARM. Patients randomized to placebo were not analyzed. Remission rates were calculated using nonresponder imputation (NRI) and last-observation-carried-forward (LOCF) analyses. Atotal of 467 patients enrolled in ADHERE. Remission results for the 145 patients initially randomized to adalimumab who were in remission at the end of CHARM are shown in the table. In the LOCF analysis, 83% (120/145) of patients were in remission 3 years after enrollment in CHARM (Week 108 of ADHERE). Using the more conservative NRI analysis, 64% of adalimumab-treated patients maintained remission at Year 3. Adalimumab therapy sustained clinical remission for up to 3 years in patients with moderate to severe CD. The majority of adalimumab-treated patients in remission after 1 year in CHARM maintained remission for an additional 2 years of open-label therapy in ADHERE.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| 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 | 0.003 |
| 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".