S851 Health-Related Quality of Life With Ustekinumab vs Adalimumab for Induction and Maintenance Therapy in Biologic-Naïve Patients With Moderate-To-Severe Crohn’s Disease: PROMIS-29 in the SEAVUE Study
Bibliographic record
Abstract
Introduction: Patients (pts) with Crohn’s disease (CD) suffer from systemic symptoms, including fatigue, that negatively affect health-related quality of life (HRQoL). In SEAVUE, we evaluated the changes in systemic symptoms through 1 year with ustekinumab (UST) vs adalimumab (ADA) in biologic-naïve pts with CD using the Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) questionnaire. PROMIS-29 measures anxiety, depression, fatigue, sleep disturbance, pain interference, pain intensity, physical function, and ability to participate in social roles and activities. Methods: SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study in biologic-naïve adults with CD Activity Index (CDAI) scores ≥220/≤450. Pts were randomized 1:1 to UST (⁓6mg/kg IV at baseline then 90mg SC every 8 weeks) or ADA (160/80mg SC at baseline/Week 2, then 40mg SC every 2 weeks) per US-approved regimens. Dose modification was not allowed. Mean changes and clinically meaningful improvement from baseline were assessed for each PROMIS-29 domain. Results: Among 386 randomized pts, baseline mean PROMIS-29 scores were similar between treatment groups (anxiety: 60 UST, 60 ADA; depression: 57 UST, 57 ADA; fatigue: 62 UST, 61 ADA; sleep disturbance: 54 UST, 53 ADA; pain interference: 61 UST, 60 ADA; pain intensity: 6 UST, 5 ADA; physical function: 43 UST, 44 ADA; ability to participate in social roles and activities: 44 UST, 45 ADA). In both groups, improvements in all PROMIS-29 domain scores were observed as early as Week 8 (data not shown) and continued through Week 52 (Table). Improvements from baseline to Week 52 were similar between groups for all domains. When clinically meaningful improvement from baseline to Week 52 (change ≥5 points) was evaluated, significantly more pts in the UST vs ADA group achieved this endpoint for the fatigue (decrease ≥5 points: 58.6% UST, 47.7% ADA; nominal p=0.030) and ability to participate in social roles and activities (increase ≥5 points: 58.6% UST, 47.7% ADA; nominal p=0.032) domains; there was no significant difference between groups for the other domains. Conclusion: PROMIS-29 domain scores improved similarly with UST and ADA through Week 52 in biologic-naïve pts with moderate-to-severe CD. Clinically meaningful improvement in fatigue and ability to participate in social roles and activities scores was more commonly observed with UST vs ADA, potentially reflecting better HRQoL in biologic-naïve pts with CD.Table 1.: Change from baseline to Week 52 in PROMIS-29 domain scores and the percentage of pts who achieved a clinically meaningful improvement between baseline and Week 52.
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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 | 0.003 | 0.002 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".