OP010 Long term efficacy and safety of Ustekinumab for Crohn's disease: results from IM-UNITI long-term extension through 2 years
Bibliographic record
Abstract
Background: Ustekinumab (UST) is a fully human IGG1 mAB to human IL 12/23p40 approved for treatment of moderate to severe active Crohn's disease (CD). The ongoing IM-UNITI long-term extension (LTE) evaluates efficacy & safety of subcutaneous (SC) UST through approximately 5 years of treatment, with results through wk96 reported herein. Methods: 1281 patients (pts) entered the maintenance study, including 397 UST induction responders in the primary population (randomized to SC placebo (PBO); n=133, UST 90mg q12w (q12w); n=132, or UST 90mg q8w (q8w); n=132). A one-time dose adjustment to 90mg q8w occurred in pts in the randomized group who met loss of response criteria between wks8 & 32. Non-randomized pts included: PBO induction responders who continued on PBO, non-responders to PBO induction who received a single UST 130mg IV dose then UST 90mg SC q12w if in clinical response at wk8, & non-responders to UST induction who received UST 90mg SC & if in clinical response at wk8 continued on UST 90 mg q8w. All pts completing wk44 were eligible to enter LTE continuing on the treatment they were on at wk44. This included 567 UST treated pts of which 237 were from the primary population. Pts receiving PBO were discontinued following the unblinding of the entire study, which occurred after the Week 44 DBL. Results: Table 1 presents analyses for randomized pts where pts with missing data or who discontinued are assumed not to be in response or remission at wk92, with 72.6% of q12w pts & 74.4% of q8w pts (non-dose adjusted) achieving remission at wk92. Based on observed data analyses, among randomized pts who continued to receive UST through wk96, 79.2% of q12w & 87.1% of q8w pts (non-dose adjusted) were in remission & 90.9% & 94.3% were in response at wk92, respectively. Among all UST treated pts who continued to receive UST through wk96, remission & response rates at wk92 were 70.7% & 84.7%. Safety events (per hundred subject years) were not higher among all UST treated pts compared to PBO from wk44 through wk96, including overall AE's (82.9 vs 91), SAE's (14.16 vs 18.2), & serious infections (3.73 vs 4.33), with 536.8 subject years of follow-up among UST treated pts & 115.4 subject years among PBO pts. Among all UST treated pts, there were 2 deaths (sudden death, asphyxia). There were two non-NMSC malignancies reported between wks44 & 96, a seminoma (UST) & a papillary thyroid cancer (PBO only). Conclusions: SC UST maintained clinical response & remission through two years. No new safety signals were observed.
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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".