OC-045 Efficacy & safety of dose adjustment & delayed response to ustekinumab in moderate–severe crohn’s disease patients: results from im-uniti maintenance study
Bibliographic record
Abstract
Introduction Ustekinumab (UST) induced/maintained clinical response (CR) and remission (CRM) in mod-severe Crohn’s disease (CD) as shown in 2 induction (UNITI-1 and 2) and 1 maintenance (IM-UNITI) RCT, placebo (PBO) controlled phIII trials. We evaluated UST efficacy in 2 more grps in IM-UNITI: pts undergoing dose adjustment after loss of response (LOR) and pts without a CR to IV UST during induction and had an additional SC dose. Method Pts achieving CR after single dose IV induction randomised to SC PBO, UST 90 mg/q12w or q8w. Pts meeting LOR criteria (i.e. CDAI ≥220 and a≥100 point ←from baseline maintenance CDAI score, between wks 8–32 of IM-UNITI trial) underwent a single dose adjustment as follows: PBO→q8w, q12w→q8w, and q8w→q8w (no dose adjustment) and assessed for CR (≥100 point ↓in CDAI) and CRM (CDAI <150) 16 wks later. Separately, UST pts not in CR 8 wks after IV dose given SC UST 90 mg and if CR 8 wks later stayed on q8w. Results 51 (39%), 29 (23%), and 28 (22%) pts in PBO, q12w and q8w grps, respectively, had dose adjustment after meeting LOR criteria. We observed CRM and CR in 39% and 71% of pts adjusting PBO→q8w (situation similar to drug holiday), 41%–55% in q12w→q8w grp and 32%–46% in q8w→q8w grp assessed 16 wks later respectively (Table 1). Median CDAI change after adjustment was −121,–141 and −78.5 in PBO→q8w, q12w→q8w and q8w→q8w grs, respectively. UST 467 pts not in response after IV dose,50.5%–28.9% had CR and CRM 8 wks after 1 extra UST dose (90 mg SC). Of 251 of these pts continued dosing at wk 8 of maintenance, 68.1% had CR and 50.2% CRM at wk 44. No ←or changes in AEs seen among dose adjustment pts. Conclusion Pts meeting LOR criteria, dose adjustment from UST 90 mg/q12w to q8w had some additional clinical benefit vs pts remaining on UST 90 mg/q8w. Initial induction non-responders pts can benefit from continued treatment with at least 1 SC UST dose 8 wks after IV induction. Disclosure of Interest B. Sands: None Declared, C. Gasink Conflict with: Janssen R and D, LLC, D. Jacobstein Conflict with: Janssen R and D, LLC, L. Gao Conflict with: Janssen R and D, LLC, J. Johanns Conflict with: Janssen R and D, LLC, P. Szapary Conflict with: Janssen R and D, LLC, J. Colombel: None Declared, S. Targan: None Declared, S. Ghosh: None Declared, W. Sandborn: None Declared
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".