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Peer-reviewedCC BY-NC 4.0American Journal of Clinical Dermatology

Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program

  • Maryanne Senna1
  • Sameh Hanna2
  • Rie Ueki3
  • Xingqi Zhang4
  • Crystal Aguh5
  • Bianca Maria Piraccini6
  • Dalia Wajsbrot7
  • Edward Nagy8
  • Mojgan Sadrarhami9
  • Simon Chen9
  • Robert Wolk7
  • Helen Tran9
1 more authors
  • Alexandre Lejeune10
10 affiliations
  1. 1Lahey Hospital and Medical Center, Burlington, MA USA
  2. 2University of Toronto, Toronto, ON Canada
  3. 3Juntendo University, Tokyo, Japan
  4. 4The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  5. 5Department of Dermatology, Johns Hopkins Medicine, Baltimore, MD USA
  6. 6Piraccini Medical Center, Bologna, Italy
  7. 7Pfizer Inc, Groton, CT USA
  8. 8Pfizer Inc UK, Sandwich, Kent UK
  9. 9Pfizer Inc, New York, NY USA
  10. 10Pfizer Inc, 23 Av. du Dr Lannelongue, 75014 Paris, France
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Abstract

Background: Ritlecitinib, an oral Janus kinase (JAK) 3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, demonstrated safety in patients aged 12 years and older with alopecia areata (AA) in an initial integrated analysis of 4 clinical studies for up to 2 years.

Objective: This updated integrated safety analysis evaluated the safety of ritlecitinib up to ~ 5 years in patients aged ≥ 12 years with AA from the ALLEGRO clinical trial program.

Methods: Safety data were pooled from 4 studies. Two groups were analyzed: patients who received any dose of ritlecitinib (30 mg or 50 mg with or without a 4-week 200 mg loading dose, or 10 mg daily) (“any-ritlecitinib” group) and a subset of the any-ritlecitinib group including only patients who received ritlecitinib 50 mg daily with or without a 4-week 200 mg daily loading dose (ritlecitinib 50 mg ± 200-mg group). Safety data were summarized descriptively. Proportions and incidence rates (IRs; IR/100 patient-years [PYs]) of adverse events (AEs) were evaluated.

Results: In the ritlecitinib 50-mg ± 200-mg (N = 1228) and any-ritlecitinib (N = 1294) groups, median duration of exposure was 1197 days (3261.5 PYs) and 1204 days (3539.5 PYs), respectively. AEs occurred in 1070 patients (87.1%; 148.1/100 PYs) in the 50-mg ± 200-mg group and 1158 patients (89.5%; 167.9/100 PYs) in the any-ritlecitinib group. The most common AEs included headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs were reported in 6.8% of patients (2.6/100 PYs) in the 50-mg ± 200-mg group and 6.8% of patients (2.5/100 PYs) in the any-ritlecitinib group. There were two deaths. Overall, 8.1% of patients (3.0/100 PYs) and 8.4% of patients (3.0/100 PYs) in the 50-mg ± 200-mg and any-ritlecitinib groups, respectively, had an AE that led to discontinuation from the study or study drug. 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.

Conclusions: In this updated integrated safety analysis of the ALLEGRO clinical trials, long-term ritlecitinib treatment was generally well tolerated up to ~ 5 years in patients aged ≥ 12 years with AA. The overall safety profile was consistent with previously reported data.

Clinical Trial Registration: NCT03732807, NCT04006457, NCT04517864, NCT02974868.

Graphical Abstract:

Video Abstract: Video AbstractUpdated integrated safety analysis of ritlecitinib up to ~ 5 years in patients with alopecia areata from the ALLEGRO clinical trial program (MP4 407314 KB)

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40257-026-01062-x.

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Cite

BibTeXRIS
BibTeX
@article{senna2026updated,
  title = {{Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program}},
  author = {Maryanne Senna and Sameh Hanna and Rie Ueki and Xingqi Zhang and Crystal Aguh and Bianca Maria Piraccini and Dalia Wajsbrot and Edward Nagy and Mojgan Sadrarhami and Simon Chen and Robert Wolk and Helen Tran and Alexandre Lejeune},
  journal = {American Journal of Clinical Dermatology},
  year = {2026},
  month = jul,
  doi = {10.1007/s40257-026-01062-x},
  url = {https://doi.org/10.1007/s40257-026-01062-x},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program
AU  - Maryanne Senna
AU  - Sameh Hanna
AU  - Rie Ueki
AU  - Xingqi Zhang
AU  - Crystal Aguh
AU  - Bianca Maria Piraccini
AU  - Dalia Wajsbrot
AU  - Edward Nagy
AU  - Mojgan Sadrarhami
AU  - Simon Chen
AU  - Robert Wolk
AU  - Helen Tran
AU  - Alexandre Lejeune
PY  - 2026
DA  - 2026/07/22
JO  - American Journal of Clinical Dermatology
DO  - 10.1007/s40257-026-01062-x
UR  - https://doi.org/10.1007/s40257-026-01062-x
AB  - Background: Ritlecitinib, an oral Janus kinase (JAK) 3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, demonstrated safety in patients aged 12 years and older with alopecia areata (AA) in an initial integrated analysis of 4 clinical studies for up to 2 years.  Objective: This updated integrated safety analysis evaluated the safety of ritlecitinib up to ~ 5 years in patients aged ≥ 12 years with AA from the ALLEGRO clinical trial program.  Methods: Safety data were pooled from 4 studies. Two groups were analyzed: patients who received any dose of ritlecitinib (30 mg or 50 mg with or without a 4-week 200 mg loading dose, or 10 mg daily) (“any-ritlecitinib” group) and a subset of the any-ritlecitinib group including only patients who received ritlecitinib 50 mg daily with or without a 4-week 200 mg daily loading dose (ritlecitinib 50 mg ± 200-mg group). Safety data were summarized descriptively. Proportions and incidence rates (IRs; IR/100 patient-years [PYs]) of adverse events (AEs) were evaluated.  Results: In the ritlecitinib 50-mg ± 200-mg (N = 1228) and any-ritlecitinib (N = 1294) groups, median duration of exposure was 1197 days (3261.5 PYs) and 1204 days (3539.5 PYs), respectively. AEs occurred in 1070 patients (87.1%; 148.1/100 PYs) in the 50-mg ± 200-mg group and 1158 patients (89.5%; 167.9/100 PYs) in the any-ritlecitinib group. The most common AEs included headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs were reported in 6.8% of patients (2.6/100 PYs) in the 50-mg ± 200-mg group and 6.8% of patients (2.5/100 PYs) in the any-ritlecitinib group. There were two deaths. Overall, 8.1% of patients (3.0/100 PYs) and 8.4% of patients (3.0/100 PYs) in the 50-mg ± 200-mg and any-ritlecitinib groups, respectively, had an AE that led to discontinuation from the study or study drug. 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.  Conclusions: In this updated integrated safety analysis of the ALLEGRO clinical trials, long-term ritlecitinib treatment was generally well tolerated up to ~ 5 years in patients aged ≥ 12 years with AA. The overall safety profile was consistent with previously reported data.  Clinical Trial Registration: NCT03732807, NCT04006457, NCT04517864, NCT02974868.  Graphical Abstract:  Video Abstract: Video AbstractUpdated integrated safety analysis of ritlecitinib up to ~ 5 years in patients with alopecia areata from the ALLEGRO clinical trial program (MP4 407314 KB)  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40257-026-01062-x.
SN  - 1175-0561
SN  - 1179-1888
ER  -