P0670 Efficacy of subcutaneous guselkumab induction therapy by baseline demographics and concomitant medications in participants with moderately to severely active Crohn’s disease: Results from the phase 3 GRAVITI study
Bibliographic record
Abstract
Abstract Background The GRAVITI study established the efficacy and safety of subcutaneous (SC) induction with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in participants (pts) with moderately to severely active Crohn’s disease (CD) through 48 weeks of treatment.1 Here, we evaluated the efficacy of GUS SC induction in GRAVITI subgroups based on baseline demographics and concomitant CD-related medications. Methods Eligible pts had a history of inadequate response or intolerance to oral corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX), or biologics (ie, TNF antagonists or vedolizumab). Randomization was stratified by baseline CDAI, SES-CD, and history of inadequate response or intolerance to biologics, with 347 pts allocated 1:1:1 to GUS 400 mg SC q4w (x3) → GUS 200 mg SC q4w, GUS 400 mg SC q4w (x3) → GUS 100 mg SC q8w, or placebo (PBO). The co-primary endpoints assessed at Week 12 compared the combined GUS 400 mg SC q4w group (N=230) to PBO (N=117). Clinical remission at Week 12 (CDAI<150) and endoscopic response at Week 12 (≥50% improvement from baseline SES-CD) were evaluated for predefined subgroups based on sex (ie, male or female), race (ie, white, non-white, black or African American, Asian, other, or not reported/missing), ethnicity (ie, Hispanic or Latino, not Hispanic or Latino, or not reported/missing), age in years (ie, ≤36 [median], >36, <65, or ≥65), weight in kg by quartile (ie, <57.5, ≥57.5 to <68.5, ≥68.5 to <80.5, or ≥80.5), disease duration in years (ie, ≤5, >5 to ≤15, or >15), and concomitant CD-related medications (ie, receiving or not receiving 5-ASA compounds, oral corticosteroids, and AZA/6-MP/MTX as discrete categories). Results Clinical remission at Week 12 and endoscopic response at Week 12 were achieved by greater proportions of GUS- than PBO-treated pts across all subgroups (Figures 1 and 2). Treatment differences of GUS vs PBO for clinical remission at Week 12 and endoscopic response at Week 12 were similar for each subgroup of sex, race, ethnicity, age, and disease duration. Treatment differences of GUS vs PBO for clinical remission at Week 12 and endoscopic response at Week 12 were similar across all weight quartile subgroups and for each subgroup of concomitant CD-related medications. Conclusion In GRAVITI, GUS SC induction was effective in inducing clinical remission at Week 12 and endoscopic response at Week 12 across predefined subgroups of sex, race, age, weight quartile, and concomitant CD-related medications among pts with moderately to severely active CD. References 1)Panaccione R, Hart A, Steinwurz F, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with moderately to severely active Crohn’s disease: Results through week 48 from the phase 3 GRAVITI study. Presented at American College of Gastroenterology 2024.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".