Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized, double-blind, controlled trial
Bibliographic record
Abstract
BACKGROUND: Alopecia areata (AA) is an autoimmune disease resulting in patchy or complete hair loss. OBJECTIVE: We report safety and efficacy results of deuruxolitinib, a selective Janus kinase 1/2 inhibitor, in adults with severe chronic AA. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial (NCT04797650). Patients aged 18 to 65 years with a Severity of Alopecia Tool (SALT) score ≥50 and an AA episode lasting ≥6 months at screening were randomized 1:2:1 to deuruxolitinib 12 mg twice daily (BID), 8 mg BID, or placebo between June 10 and December 13, 2021. The primary endpoint was the percentage of patients achieving a SALT score ≤20 (SALT20) at Week 24. RESULTS: Of 517 patients randomized, 515 received ≥1 dose of study drug. At Week 24, 33.0%, 38.3%, and 0.8% of patients receiving deuruxolitinib 8 mg BID, 12 mg BID, and placebo, respectively, achieved SALT20 (P < .0001 vs placebo for both doses). Deuruxolitinib was well tolerated, and most study drug-related treatment-emergent adverse events were mild or moderate in severity. LIMITATIONS: Long-term efficacy and safety or durability of treatment response were not assessed; further study is required. CONCLUSION: Efficacy and safety analyses support deuruxolitinib as a treatment option in adults with AA.
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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 | 0.002 | 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 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".