S1040 Relationship Between Health-Related Quality of Life and Work Productivity in Patients With Ulcerative Colitis in the Tofacitinib OCTAVE Phase 3 Induction and Maintenance Studies
Bibliographic record
Abstract
Introduction: Tofacitinib is an oral small molecule JAK inhibitor for the treatment of UC. Tofacitinib induction treatment has been shown to improve work productivity in patients (pts) with UC. However, the relationship between health-related quality of life (HRQoL) and work productivity in the tofacitinib OCTAVE clinical program has not been described. Methods: We aimed to evaluate the relationship between Inflammatory Bowel Disease Questionnaire (IBDQ) domains and Work Productivity and Activity Impairment-Ulcerative Colitis (WPAI-UC) components among pts in Phase 3 studies evaluating tofacitinib as induction or maintenance therapy for UC (OCTAVE Induction 1&2 [NCT01465763; NCT01458951]; OCTAVE Sustain [NCT01458574]). Relationships between IBDQ (total and domain scores) and WPAI-UC components (absenteeism, presenteeism, productivity loss, and activity impairment) were estimated using a repeated measures longitudinal model in which IBDQ domain score was a continuous anchor and WPAI-UC component score was the outcome (i.e., a linear relationship was imposed between the outcome and anchor). In sensitivity analyses, IBDQ domain score was used as a categorical anchor to assess the linearity assumption (which did not impose any functional relationship between outcome and anchor). Productivity loss includes absenteeism and presenteeism and thus is the most comprehensive WPAI-UC component. Analyses used all available pooled data from pts receiving tofacitinib or placebo. Results: Relationships between IBDQ total score and WPAI-UC components were very similar when using the IBDQ total score as a continuous anchor, compared with a categorical anchor, supporting the linearity assumption. The relationship between IBDQ total score and productivity loss was robust, with IBDQ total scores of 224 and 32 (higher score = better HRQoL) corresponding to a 5.6% (95% CI 3.4, 7.8) and 100.7% (97.3, 104.1) impact, respectively (Table). For every 16-point increase in IBDQ total score, productivity loss (0–100%) improved by 7.9% (7.5, 8.4; Table). Similar trends were observed between IBDQ total score and activity impairment and presenteeism; the relationship with absenteeism was weak. Similar relationships were observed between IBDQ domains and WPAI-UC components. Conclusion: In induction and maintenance studies, robust relationships between IBDQ (total and domain scores) and productivity loss were observed. These post hoc clinical trial data may not be fully generalizable to clinical practice. Table 1. - Percentage of productivity loss at IBDQ total scores in patients with UC in OCTAVE Phase 3 induction and maintenance studies (main model with IBDQ total score as a continuous anchor) Productivity loss, least squares mean, % (95% CI) IBDQ total score 32 100.7 (97.3, 104.1) 40 96.8 (93.6, 99.9) 60 86.9 (84.2, 89.5) 80 76.9 (74.7, 79.2) 100 67.0 (65.3, 68.8) 120 57.1 (55.7, 58.5) 140 47.2 (46.1, 48.4) 160 37.3 (36.2, 38.4) 180 27.4 (26.1, 28.8) 200 17.5 (15.8, 19.2) 220 7.6 (5.5, 9.7) 224 5.6 (3.4, 7.8) Point decrease in IBDQ total score 1 0.5 (0.5, 05) 16 7.9 (7.5, 8.4) The WPAI-UC is a self-administered six-item survey that generates four metrics: absenteeism (work time missed), presenteeism (impairment whilst working), productivity loss (overall work impairment from the combination of absenteeism and presenteeism), and activity impairment (non-work activity impairment). WPAI component scores are expressed as percentages, with a higher percentage indicating greater impairment and less productivityThe IBDQ evaluates disease-related quality of life by 32 items over four domains: bowel (total domain score ranges from 10 to 70), emotional (total domain score ranges from 12 to 84), social (total domain score ranges from 5 to 35), and systemic (total domain score ranges from 5 to 35). For the total score (ranges from 32 to 224) and each domain, a higher score indicates a better quality of lifeCI, confidence interval; IBDQ, Inflammatory Bowel Disease Questionnaire; UC, ulcerative colitis; WPAI-UC, Work Productivity and Activity Impairment-Ulcerative Colitis
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 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".