A106 USTEKINUMAB IS EFFECTIVE FOR MAINTAINING CLINICAL RESPONSE IN REFRACTORY MODERATE-TO-SEVERE CROHN’S DISEASE: A MULTICENTRE COHORT STUDY
Bibliographic record
Abstract
Ustekinumab is a monoclonal antibody targeting interleukins 12 and 23. Ustekinumab has recently been approved for treatment of Crohn’s disease by the United States Food and Drug Administration but long-term maintenance of clinical response in the real-world setting is unclear. To assess the efficacy of ustekinumab for maintaining clinical response in CD A retrospective multicentre cohort study was performed at two institutions (University of Calgary, University of Alberta). CD patients achieving clinical response to ustekinumab induction between 2011 and 2016 were eligible for inclusion. The primary outcome was loss of clinical response, defined as ustekinumab dose escalation, ustekinumab re-induction, rescue corticosteroids, surgery, or drug discontinuation. Multivariate Cox proportional hazards regression analysis was used to assess predictors of loss of response, expressed as hazard ratios (HR) with 95% confidence intervals (CI). We identified 98 CD patients responding to ustekinumab induction. Median follow-up was 56.1 weeks (IQR 31.6–105.0). 30 patients (30.6%) lost clinical response during maintenance therapy at a median time of 48.7 weeks (IQR 34.4–84.3). 15 patients (15.3%) required dose escalation, 7 patients (7.1%) required reinduction, 9 patients (9.2%) required rescue corticosteroids, and 7 patients (7.1%) underwent surgical resection. 10 patients (10.2%) discontinued ustekinumab due to loss of response. In Cox proportional hazards regression, high dose induction at 6mg/kg (HR 0.16 [95% CI: 0.03–0.79]) and concurrent immunomodulator use were protective against loss of response (adjusted HR 0.35 [95% CI: 0.14–0.91]) In this large multicentre cohort of CD patients with initial response to induction therapy, ustekinumab was effective for maintaining clinical response in 70% of patients over long-term follow-up. Long-term maintenance may be improved in patients receiving higher dose induction regimens and using concomitant therapy. Table 1 – Baseline patient demographic Figure 1 – Survival curves for the proportion of Crohn’s disease patients experiencing loss of response to ustekinumab maintenance therapy, stratified by concurrent immunomodulator (red line) and no concurrent immunomodulator (blue line) therapy at ustekinumab induction CAG
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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 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 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 | 0.001 |
| 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".