Time to Onset of a Minimal Clinically Important Difference in DLQI with Guselkumab Treatment in VOYAGE 1
Bibliographic record
Abstract
Introduction Psoriasis (PsO) is a chronic inflammatory disease of the skin. While skin clearance, as measured by the Psoriasis Area and Severity Index (PASI), is a clinical goal, PsO patients also suffer from reduced health-related quality of life (HRQoL). In the Phase 3 VOYAGE 1 trial, guselkumab (GUS) demonstrated improvements on patient reported outcomes compared with placebo (PBO) and adalimumab (ADA). Here we report an analysis of the estimated time to onset of the minimal clinically important difference (MCID) in HRQoL, as measured by the Dermatology Quality of Life Index (DLQI) and associated PASI response in GUS-treated patients from VOYAGE 1. Methods The VOYAGE 1 trial enrolled patients with moderate-to-severe PsO who were randomized to receive PBO, GUS, or ADA. The DLQI is a self-report measure for HRQoL ranging from 0 (no impact) to 30 (maximum impact) that assesses the effect of skin problems on 6 HRQoL domains. An accepted MCID in DLQI is 4, previously reported as the smallest difference in DLQI total score that patients’ rate as beneficial. DLQI score and PASI improvement (percent change from baseline) were analyzed at Weeks 0, 8, 16, and 24 for the subset of VOYAGE 1 patients with a baseline DLQI score >4. Earliest time to onset of MCID in mean DLQI and corresponding mean PASI improvement were estimated using linear interpolation for the GUS group between Weeks 0 and 8. Results Among patients randomized to GUS, n=279 (85%) had DLQI >4 at baseline. By first assessment at Week 8 (W8), we observed a reduction in the mean DLQI score from 15.6 (baseline) to 5.0 (W8) with median DLQI decreasing from 15.0 (baseline) to 3.0 (W8). The interpolated onset of MCID in DLQI occurred at 21.1 days (W3) following the initial GUS dose. In GUS-treated patients, the estimated mean PASI improvement corresponding to the onset of MCID in mean DLQI occurring at Week 3 was 29.2%. Conclusions These data indicate that the onset of clinically meaningful improvements in mean DLQI occur as early as after the first dose of GUS in patients with moderate-to-severe PsO.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 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 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".