Adalimumab Therapy maintains steroid-free remission and Fistula Closure in patients with moderate to severe Crohnʼs Disease: Results of an Open-Label Study in Canada (ACCESS)
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 been shown to induce and maintain remission in patients with CD. The ACCESS (Adalimumab in Canadian SubjeCts With ModErate to Severe Crohn's DiSease) study was a Canadian-based, multicenter, open-label trial of 304 patients with moderately or severely active CD. The objective of this analysis was to evaluate adalimumab's ability to induce and maintain steroid-free remission in patients receiving steroids at baseline and to induce complete fistula closure in patients with fistulas at baseline. The study population included patients naïve to biotherapy as well as patients who had failed infliximab therapy. Patients received induction therapy of 160-mg/80-mg adalimumab at Weeks 0/2, followed by 40-mg every-other-week maintenance dosing. If flare/nonresponse (as determined by the investigator) occurred during maintenance dosing, patients were allowed to change their regimen to 40 mg weekly at or after Week 8. Patients were to remain in the study for a minimum of 24 weeks or until adalimumab was commercially available for the treatment of CD in Canada. Endpoints included steroid-free remission (Harvey-Bradshaw Index [HBI] ≤4 and steroid-free), sustained steroid-free remission (steroid-free for at least 90 days and in remission), and complete fistula closure (closure of all fistulas that were draining at baseline). Data were analyzed using both nonresponder imputation (NRI) and as-observed methods. At baseline, 144 patients were receiving steroids and 68 patients had at least 1 draining fistula. Rates of steroid-free remission at Week 24 are summarized in Table 1, and fistula closure over time is summarized in Table 2. Steroid Free Remission (HBI ≤4) at Week 24 Fistula Closure Over Time In this 6-month, open-label trial, adalimumab maintenance therapy was effective in inducing and sustaining steroid-free remission and fistula healing in patients with moderate to severe CD. Adalimumab therapy was effective for both anti-TNF-naive and infliximab-experienced patients.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".