Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study
Bibliographic record
Abstract
BACKGROUND: Hidradenitis suppurativa is a disabling inflammatory skin disease. OBJECTIVE: To investigate the efficacy and safety of upadacitinib, a selective Janus kinase inhibitor. METHODS: In this phase 2, randomized, placebo-controlled, double-blind clinical trial (NCT04430855), adults with moderate-to-severe hidradenitis suppurativa were randomized 2:1 to once-daily upadacitinib 30 mg or placebo. At 12 weeks, placebo patients switched to blinded upadacitinib 15 mg, and patients receiving upadacitinib 30 mg continued assigned treatment through week 48. The primary endpoint was ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline (Hidradenitis Suppurativa Clinical Response [HiSCR50]) at week 12. RESULTS: Forty-seven patients received upadacitinib; 21 patients received placebo. At week 12, a significantly greater proportion of patients receiving upadacitinib achieved HiSCR50 vs a prespecified historical placebo rate (38.3% vs 25.0%; 1-sided P = .018). Comparison with the in-trial placebo group showed an adjusted difference of 14.7% (nominal P = .087). HiSCR50 achievement with upadacitinib was consistent across baseline Hurley stage and prior tumor necrosis factor inhibitor exposure and maintained through week 40. Upadacitinib's safety profile was consistent with previous reports on dermatologic conditions. LIMITATIONS: Sample size was small. CONCLUSION: Findings support further investigation of upadacitinib for moderate-to-severe hidradenitis suppurativa.
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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) | 0.003 | 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 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".