P296 Effect of upadacitinib on patient-reported symptoms by the new Ulcerative Colitis Symptoms Questionnaire (UC-SQ) in patients with moderate to severe ulcerative colitis: data from the Phase 2b study U-ACHIEVE
Bibliographic record
Abstract
The Ulcerative Colitis Symptoms Questionnaire (UC-SQ) is a new disease-specific instrument developed to assess patient-reported outcomes in UC. We examined the impact of upadacitinib (UPA) on patient-reported outcomes utilising the UC-SQ in an 8-week (week) Phase 2b induction study (U-ACHIEVE, NCT02819635). Adults with moderate-to-severe UC (defined by adapted Mayo score [Mayo score without Physician Global Assessment] 5–9 points and Mayo endoscopy subscore 2–3) were randomised to receive extended-release UPA 7.5, 15, 30, 45 mg once daily (QD) or placebo (PBO) for 8 weeks. The UC-SQ contains a 17-item assessment of intestinal and extra-intestinal symptoms such as bowel movements, abdominal pain, blood/mucus in stool, fatigue, and difficulty sleeping. Items are rated on a five-point Likert scale to assess the frequency/intensity of individual symptoms. Overall scores of UC-SQ range from 17 to 85; higher scores indicate greater symptom burden. Patients at selected study sites completed the UC-SQ at baseline (BL) and Week 2, 4, and 8. Mean change from BL was calculated for UC-SQ total score and individual items at Week 2, 4, and 8; comparisons between UPA dosage groups and PBO were based on analysis of covariance, and missing data were imputed with the last observed value. A total of 110 patients completed the UC-SQ questionnaire. At BL, >50% of patients reported often or always having a sudden/intense need to have a bowel movement (73%), blood in stool (62%), diarrhoea (59%), difficulty sleeping (55%), mucus in stool (54%), or felt tired/lack of energy (53%). At Week 2, 4, and 8, respectively, significant improvement (decrease in mean score from BL, p < 0.05) was observed in UC-SQ total score in patients receiving UPA 15, 30, and 45 mg QD vs. PBO (table). Significant improvements were seen as early as Week 2 in the majority of the individual items of the UC-SQ in patients receiving UPA 30 and/or 45 mg QD vs. PBO, including intestinal symptoms of blood in stool, mucus in stool, bowel movement frequency, urgency for bowel movement, need for bowel movement even if bowel is empty, abdominal pain, and rectal pain. A positive impact on fatigue and sleep quality was also observed in patients receiving UPA vs. PBO. Table. Mean change from baseline in UC-SQ total score and individual items at Week 8 (LOCH). More than half of UC patients suffered in both intestinal and extraintestinal symptoms. Patients with moderate-to-severe UC treated with 8-week induction UPA therapy vs. PBO reported a reduction in UC-related symptoms and in the impact of these symptoms on their lives.
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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) | 0.002 | 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".