Updated Integrated Safety Analysis of Ritlecitinib Over 72 Months In Patients With Alopecia Areata From the ALLEGRO Clinical Trial Program
Bibliographic record
Abstract
Introduction: Ritlecitinib, an oral, selective JAK3/TEC family kinase inhibitor, demonstrated efficacy and safety up to 48 weeks in patients aged ≥12 years with alopecia areata (AA) in the ALLEGRO phase 2b/3 study (NCT03732807). This updated integrated safety analysis evaluated the safety of ritlecitinib over 72 months in patients with AA in two phase 2a studies (NCT04517864; NCT02974868), the phase 2b/3 study, and an ongoing long-term, phase 3, open-label study (NCT04006457) from the ALLEGRO program. Methods: Safety data were pooled from the 4 studies. Proportions and incidence rates (IRs; IR/100 patient-years [PYs]) of adverse events (AEs) are reported for the any-ritlecitinib (any dose) and ritlecitinib 50-mg ± 200-mg (50 mg ± 4-week 200-mg loading dose) groups. These analysis groups are not additive and are overlapping populations, with the any-ritlecitinib group including all patients. Results: In the any-ritlecitinib (n=1294) and 50-mg ± 200-mg (n=1228) groups, median duration of exposure was 1204 (3539.5 PYs) and 1197 (3261.5 PYs) days, respectively. AEs occurred in 1158 (89.5%; 167.9/100 PYs) and 1070 (87.1%; 148.1/100 PYs) patients in the any-ritlecitinib and 50-mg ± 200-mg groups, respectively. The most common AEs included headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs occurred in 88 (6.8%; 2.5/100 PYs) patients in the any-ritlecitinib group and 84 (6.8%; 2.6/100 PYs) patients in the 50-mg ± 200-mg group, and included 2 deaths (breast cancer and acute respiratory failure/cardiorespiratory arrest) in the 50-mg ± 200-mg group. Discontinuations due to AEs occurred in 7.0% and 6.6% in the any-ritlecitinib and 50-mg ± 200-mg groups, respectively. IRs for both groups were 0.1/100 PYs for opportunistic infections; 1.0/100 PYs for herpes zoster; 0.3/100 PYs for malignancies, excluding nonmelanoma skin cancer; and 0.2/100 PYs for major adverse cardiovascular events. Conclusion: Ritlecitinib was generally well tolerated over 72 months in patients with AA. Safety was consistent with previous data.
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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 | 0.015 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".