The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD). AD is a long-lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: 1. Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo 2. Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.
This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea. The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea. The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea. About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study. Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study. There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).
Study Type
OBSERVATIONAL
Enrollment
1,100
Tablets
Pfizer Tower
Seoul, South Korea
RECRUITINGNumber of participants with Adverse Events (AE's) according to frequency
Time frame: Up to 52 weeks from the time of first treatment
Number of participants with Adverse Drug Reactions (ADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected AE's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected ADR's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Events (SAE's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Adverse Events of Special Interest (AESI) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Proportion of participants achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >=2 points
Time frame: At 12 weeks, and 52 weeks after the first treatment
Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline
Time frame: At week 12 and 52 weeks after the first treatment
Proportion of Participants Achieving >=4 Points improvement in the severity of Pruritus Numerical Rating Scale (NRS) from baseline
Time frame: At week 12 and 52 weeks after the first treatment
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