P1169 Guselkumab maintenance treatment improves health-related quality of life in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR maintenance study
Bibliographic record
Abstract
Abstract Background Ulcerative colitis (UC) symptoms are associated with impaired health-related quality of life (HRQoL). The Phase 3 QUASAR maintenance study (NCT04033445) evaluated the efficacy and safety of guselkumab (GUS) in participants (pts) with moderately to severely active UC who demonstrated a clinical response to GUS intravenous (IV) induction. GUS is a selective dual-acting IL-23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. Here we report the effect of GUS subcutaneous (SC) maintenance therapy on HRQoL at Week (W) 44 in QUASAR pts as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Methods At maintenance baseline (BL), GUS IV induction W12 responders and placebo (PBO)→GUS IV induction W24 responders were randomized 1:1:1 to SC GUS 200 mg every 4 W (q4w; N=190), GUS 100 mg every 8 W (q8w; N=188), or PBO (GUS withdrawal; N=190) maintenance therapy. PROMIS-29 consists of 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and social participation) and a pain intensity numeric rating scale (NRS, range 0-10). The raw score of each domain is converted into a standardized T-score with a general population mean of 50 and standard deviation of 10. Physical component summary (PCS) and mental component summary (MCS) scores are derived from physical and mental domain T-scores, respectively. Higher scores indicate better outcomes for physical function and social participation domains and PCS and MCS scores and worse outcomes for all other symptom domains. Depending on the domain/score, improvement of ≥3 to ≥9 points from induction BL was identified as clinically meaningful.1 Results At maintenance BL, mean PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores in all treatment groups reflected values in-line with the general population, as expected for clinical responders to GUS IV induction (Table). At W44, the PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores observed at maintenance BL were sustained in both GUS SC maintenance groups but had worsened in the PBO group (Table). The proportion of pts achieving clinically meaningful improvement from induction BL at W44 was greater with GUS vs PBO for each PROMIS-29 domain T-score, pain intensity NRS score, and PCS/MCS scores (Figure). Conclusion Among pts with moderately to severely active UC who responded to GUS IV induction, GUS SC maintenance therapy sustained clinically meaningful improvements in HRQoL at W44 as measured by the PROMIS-29. This study was funded by Janssen Research & Development, LLC. References 1.Sands BE, et al. Value Health 2024;27:1225-1234.
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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 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| 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".