Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

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.

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata; Janus Kinase Inhibitors
• Intervention / Treatment: Drug: Tofacitinib; Drug: Baricitinib; Drug: Ruxolitinib; Drug: Upadacitinib; Drug: Abrocitinib; Drug: Ritlecitinib

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Ru Dai, MD; Phone Number: 15982215914; Email: dairu@zju.edu.cn
• Study Contact Backup: Name: Wu; Email: wuxianjie@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Ru Dai, Ph.D; Phone Number: 86 15982215914; Email: dairu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tofacitinib treated group; In the real-world settings, patients with AA treated with tofacitinib.	Drug: Tofacitinib; In the real-world settings, patients with AA treated with tofacitinib.
Baritinib treated group; In the real-world settings, patients with AA treated with baritinib.	Drug: Baricitinib; In the real-world settings, patients with AA treated with Baricitinib.
Ruxolitinib treated group; In the real-world settings, patients with AA treated with ruxolitinib	Drug: Ruxolitinib; In the real-world settings, patients with AA treated with Ruxolitinib.
Upadacitinib treated group; In the real-world settings, patients with AA treated with upadacitinib.	Drug: Upadacitinib; In the real-world settings, patients with AA treated with Upadacitinib.
Abrocitinib treated group; In the real-world settings, patients with AA treated with abhicitinib.	Drug: Abrocitinib; In the real-world settings, patients with AA treated with Abrocitinib.
Ritlecitinib treated group; In the real-world settings, patients with AA treated with ritlecitinib.	Drug: Ritlecitinib; In the real-world settings, patients with AA treated with Ritlecitinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean SALT	Reduction of Severity of Alopecia Tool (SALT) score compared with baseline	at week 24
SALT50	Percentage of patient with more than 50% improvement in SALT score	at week 24
SALT75	Percentage of patient with more than 70% improvement in SALT score	at week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean SALT	Reduction of Severity of Alopecia Tool (SALT) score compared with baseline	at week 12, 36, 48, 56
SALT50	Percentage of patient with more than 75% improvement in SALT score	at week 12, 36, 48, 56
SALT75	Percentage of patient with more than 50% improvement in SALT score	at week 12, 36, 48, 56
Safety profile	Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events.	at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Xianjie Wu, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib; Abrocitinib; Upadacitinib
• Other Study ID Numbers: 20240699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No