P329 Effect of adalimumab dose escalation on clinical, health-related quality of life, treatment satisfaction and work productivity outcomes among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA
Bibliographic record
Abstract
Background: Although adalimumab (ADA) has been shown to induce and maintain clinical remission in moderate to severe ulcerative colitis (UC), some patients (pts) may lose initial response and could benefit from dose escalation [1]. We assessed the effect of ADA dose escalation on various outcomes among pts with UC in clinical practice. Methods: INSPIRADA was a single-arm, multi-country, open-label study that evaluated the effect of ADA on clinical outcomes, costs of care, treatment satisfaction, and work productivity in pts with UC treated according to usual clinical practice. Adults with active UC, Physician's Global Assessment (PGA) of ≥2, and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤45 at baseline (BL) who failed conventional treatment and who had experienced rectal bleeding ≤7 days of BL were enrolled. Pts received ADA 160/80 mg at Wk 0/2 followed by ADA 40 mg every other week at Wk 4 through Wk 26. Pts who did not respond to ADA by Wk 8 were to discontinue ADA. Pts who lost response at or after Wk 8 could escalate to ADA 40 mg weekly. Outcomes were assessed for pts who dose escalated. Clinical outcomes included Simple Clinical Colitis Activity Index (SCCAI) response (SCCAI decrease ≥2) and remission (defined as an SCCAI ≤2). HRQoL was assessed using SIBDQ and the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) questionnaire. Satisfaction with medication was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Work Productivity and Activity Impairment (WPAI) outcomes were determined. Change from BL to Wk 26 in HRQoL, treatment satisfaction, and WPAI outcomes were calculated. Missing data were imputed using nonresponder imputation for response/remission and last observation carried forward for all other outcomes. Results: Data from 129 pts who dose escalated were analysed. At Wk 26, 64% of pts who dose escalated achieved SCCAI response and 33% achieved SCCAI remission (Table 1). Except for work time missed and convenience in TSQM among pts who dose escalated, statistically significant (p<0.001) improvements from BL to Wk 26 were seen in work productivity, performance of daily activities, SIBDQ, EQ-5D-5L, and treatment satisfaction. The safety profile of ADA among pts who dose escalated was consistent with that of pts who did not dose escalate. Conclusions: In pts with UC who lost response, ADA dose escalation was an effective option to recapture response and remission. Significant improvements in HRQoL, treatment satisfaction, and work productivity were also observed. References: [1] Wolf et al, (2014), APT, 40:486–97
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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 | 0.005 |
| 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 | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".