Long-Term Integrated Safety Summary of Ruxolitinib Cream in Phase 3 Clinical Trials of Patients with Vitiligo
Bibliographic record
Abstract
INTRODUCTION: Ruxolitinib cream demonstrated superior repigmentation versus vehicle at week 24 with continued improvement through week 104 in phase 3 studies of patients (aged ≥ 12 years) with nonsegmental vitiligo. Here, we evaluated long-term safety of ruxolitinib cream in an integrated analysis of phase 3 vitiligo studies. METHODS: Reported incidence and exposure-adjusted incidence rates (EAIRs) of treatment-emergent adverse events (TEAEs) were determined. RESULTS: Over 104 weeks, 673 patients with vitiligo applied either ruxolitinib cream (n = 637; 867.9 person-years [PY]) or vehicle (n = 270; 131.1 PY). TEAEs (EAIR, patients/100 PY) with ruxolitinib cream versus vehicle occurred in 62.6% (46.0) versus 37.0% (76.3) of patients, most commonly nasopharyngitis (7.2% [5.3] vs 2.6% [5.3]) and application site acne (6.0% [4.4] vs 1.1% [2.3]). No serious treatment-related TEAEs were reported with ruxolitinib cream. EAIRs (patients/100 PY) were low for acne-related TEAEs (7.1), skin and subcutaneous tissue infections (4.0), cytopenias (2.4), and liver enzyme elevations (2.2). Malignancies, serious infections, and thromboembolic events were rare (0.7, 0.5, and 0.2 patients/100 PY, respectively), and none were considered related to treatment. No major adverse cardiovascular events or deaths occurred. CONCLUSION: Ruxolitinib cream demonstrated tolerability, with no unexpected safety findings through 2 years in patients with vitiligo. Graphical Plain Language Summary available for this article. TRIAL REGISTRATION: Clinicaltrials.gov identifiers, NCT04052425 (registered on August 8, 2019), NCT04057573 (registered on August 14, 2019), and NCT04530344 (registered on August 25, 2020).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".