OP33 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
Bibliographic record
Abstract
Abstract Background Guselkumab (GUS) is a dual-acting IL-23p19 subunit inhibitor that was efficacious in phase 3 trials (GALAXI 2/3) of pts with CD using IV induction and SC maintenance. We evaluated the efficacy and safety of GUS SC induction/maintenance in GRAVITI, a phase 3 treat-through trial in pts with moderately to severely active CD. Methods Eligible pts had a history of inadequate response or intolerance to oral corticosteroids, AZA, 6-MP, MTX, or biologics (BIO-IR). Randomization was stratified by baseline (BL) CDAI, SES-CD, and BIO-IR status, with 347 pts allocated 1:1:1 to GUS 400mg SC q4w (x3)→GUS 200mg SC q4w (N=115), GUS 400mg SC q4w (x3)→GUS 100mg SC q8w (N=115), or PBO (N=117). Pts were rescued at Wk16: PBO pts switched to GUS, and GUS pts stayed on GUS per treat-through design (sham rescue). The co-primary endpoints were clinical remission at Wk12 and endoscopic response at Wk12. Other multiplicity-controlled endpoints were clinical remission at Wk24, PRO-2 remission at Wk12, clinical response at Wk12, clinical remission at Wk48, and endoscopic response at Wk48. All endpoints assessed through Wk12 compared the combined GUS 400mg SC treatment arm to PBO; assessments after Wk12 compared each GUS SC maintenance regimen to PBO. All pts who met rescue criteria were considered not to have met efficacy endpoints after Wk16. Safety was assessed through Wk48. Results BL characteristics were similar across groups (overall mean age, 37.5yrs; mean CD disease duration, 8.0yrs; mean CDAI, 296.9; mean SES-CD, 12.0; BIO-IR, 46.4%). The co-primary and all multiplicity-controlled endpoints were met. GUS 400mg SC induction demonstrated superiority to PBO at Wk12. Both SC maintenance dose regimens were also superior to PBO at Wks 24 and 48 (Figure). In prespecified analyses of subpopulations defined by prior biologic history, greater proportions of GUS-treated pts achieved the endpoints than PBO. Key safety event rates per 100 pt years through Wk48 were similar among groups (Table). Proportions of GUS-treated pts experiencing ≥1 serious AE or AE leading to discontinuation of study agent were not greater than PBO. The numbers of GUS-treated pts with serious infections or AEs of special interest were low. Conclusion GRAVITI established the efficacy of GUS SC induction followed by SC maintenance in CD. These results build on the GALAXI 2/3 data and demonstrate that both IV and SC induction are efficacious. Safety findings were consistent with the known safety profile of GUS in approved indications.
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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) | 0.000 | 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 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 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".