The purpose of this observation study is to learn about the safety and effects of the study medicine (called Litfulo) for the potential treatment of Severe Alopecia Areata.
To evaluate the safety of Litfulo Capsule after marketing, with regard to the following clauses in routine clinical practice. * Adverse Events (AEs)/ Adverse Drug Reactions (ADRs) * Unexpected Adverse Events (AEs)/ADRs that have not been reflected in the approved drug label * Serious Adverse Events (SAEs)/Serious Adverse Drug Reaction (SADRs) * Adverse Event of Special Interest(AESI) * Serious Infections, defined as any infection (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy or hospitalization for treatment or meeting other criteria that require the infection to be classified as serious adverse event * Opportunistic infections and Herpes Zoster * Malignancy
Study Type
OBSERVATIONAL
Enrollment
3,000
as provided in real world practice.
Pfizer
Seoul, South Korea
RECRUITINGFrequency and proportion of AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving 50% or above improvement in SALT score from baseline (SALT 50) at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving 75% or above improvement in SALT score from baseline (SALT 75) at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.