Alopecia Areata, Janus Kinase Inhibitors
Conditions
Brief summary
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.
Interventions
DRUGRitlecitinib
In the real-world settings, patients with AA treated with Ritlecitinib.
DRUGTofacitinib
In the real-world settings, patients with AA treated with tofacitinib.
DRUGBaricitinib
In the real-world settings, patients with AA treated with Baricitinib.
DRUGRuxolitinib
In the real-world settings, patients with AA treated with Ruxolitinib.
DRUGUpadacitinib
In the real-world settings, patients with AA treated with Upadacitinib.
DRUGAbrocitinib
In the real-world settings, patients with AA treated with Abrocitinib.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with alopecia areata between 2 to 18 years old * Patients diagnosed with alopecia areata according to AA guideline * AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months
Exclusion criteria
* Patients had previously received hair implants * Other alopecia * Other diseases may induce alopecia including psoriasis, lichen planus, et al. * Unable to estimate SALT score at baseline or at follow-up * Patients are participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean SALT | at week 24 | Reduction of Severity of Alopecia Tool (SALT) score compared with baseline |
| SALT50 | at week 24 | Percentage of patient with more than 50% improvement in SALT score |
| SALT75 | at week 24 | Percentage of patient with more than 70% improvement in SALT score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean SALT | at week 12, 36, 48, 56 | Reduction of Severity of Alopecia Tool (SALT) score compared with baseline |
| Safety profile | at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 | Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events. |
| SALT50 | at week 12, 36, 48, 56 | Percentage of patient with more than 75% improvement in SALT score |
| SALT75 | at week 12, 36, 48, 56 | Percentage of patient with more than 50% improvement in SALT score |
Countries
China
Contacts
Primary ContactRu Dai, MD
Backup ContactWu
Outcome results
None listed