P0843 Efficacy by baseline disease characteristics of subcutaneous guselkumab induction therapy in patients with moderately to severely active Crohn’s disease: Results at Week 12 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, a dual-acting IL-23p19 subunit inhibitor, in participants with moderately to severely active Crohn’s disease through 48 weeks of treatment.1 Here, we evaluated the efficacy of guselkumab SC induction in GRAVITI subgroups based on baseline disease characteristics. Methods Eligible participants had a history of inadequate response or intolerance to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, 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 participants allocated 1:1:1 to guselkumab 400 mg SC q4w (x3) → guselkumab 200 mg SC q4w, guselkumab 400 mg SC q4w (x3) → guselkumab 100 mg SC q8w, or placebo. The co-primary endpoints assessed at Week 12 compared the combined guselkumab 400 mg SC group (N=230) to placebo (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 disease duration in years (ie, ≤5, >5 to ≤15, or >15), involved disease location as assessed by central reader (ie, ileum, colon, or both), CDAI (ie, ≤300 or >300), C-reactive protein (ie, ≤5 or >5; CRP), fecal calprotectin (ie, ≤250 or >250; FeCal), and SES-CD (≤12 or >12). Results Clinical remission at Week 12 and endoscopic response at Week 12 were achieved by greater proportions of guselkumab- than placebo-treated participants across all subgroups (Figures 1 and 2). Treatment differences of guselkumab vs placebo for clinical remission at Week 12 were similar for each subgroup of disease duration, involved disease location, and FeCal. Guselkumab difference from placebo in clinical remission at Week 12 was greatest for participants with CRP>5 vs CRP≤5 (adjusted treatment difference: 42.8% vs 24.7%) and participants with SES-CD>12 vs SES-CD≤12 (adjusted treatment difference: 45.3% vs 28.2%). Treatment differences of guselkumab vs placebo for endoscopic response at Week 12 were similar for each subgroup of disease duration, involved disease location, CDAI score, CRP, FeCal, and SES-CD. Conclusion In GRAVITI, guselkumab SC induction was effective in inducing clinical remission at Week 12 and endoscopic response at Week 12 across predefined subgroups based on disease characteristics among participants with moderately to severely active Crohn’s disease. 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 | 0.001 |
| 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 | 0.000 | 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".