Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to \<18 years old in Japan in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
Study Type
OBSERVATIONAL
Enrollment
167
Takeo Skin Clinic /ID# 248095
Asahi Owari, Aichi-ken, Japan
Ichinomiya Municipal Hospital /ID# 245070
Ichinomiya-shi, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 245069
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 250809
Nagoya, Aichi-ken, Japan
Aichi Children's Health and Medical Center /ID# 245357
Obu-shi, Aichi-ken, Japan
Percentage of Participants with Serious Infection
Serious infection is defined as any infection identified as an Infection Company MedDRA Query that meets seriousness criteria
Time frame: 2 Years
Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification
An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. Safety specification is defined as: serious infections (including TB, pneumonia, pneumocystis pneumonia, pulmonary hemorrhage and opportunistic infections), herpes zoster, VTE (deep venous thrombosis and pulmonary embolus), gastrointestinal perforation, hepatic function disorder, Interstitial lung disease, neutrophil count decreased, lymphocyte count decreased and hemoglobin decreased, hepatitis B virus reactivation, malignancies, major adverse cardiac events, rhabdomyolysis and myopathy, and renal impairment, and safety in pediatric patients and weighing \<40 kg.
Time frame: 2 Years
Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth
An AE/ADR is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs/treatment-emergent SAEs (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: 2 Years
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: 2 Years
Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Time frame: Up to 2 Years
Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Time frame: Up to 2 Years
Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Time frame: 2 Years
Percentage of Participants Achieving Worst Pruritus-NRS 0/1
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Time frame: 2 Years
Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.
Time frame: 2 Years
Percent Change from Baseline in POEM Score
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD.
Time frame: 2 Years
Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale with a higher score denoting worse AD. Minimal Clinically Important Difference=4
Time frame: 2 Years
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Noriko Dermatology Clinic /ID# 246626
Akita, Akita, Japan
Nippon Medical Chiba Hokusoh Hospital /ID# 246627
Inzai-shi, Chiba, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 245064
Yotsukaido-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 248739
Matsuyama, Ehime, Japan
Aso Iizuka Hospital /ID# 252145
Iizuka-shi, Fukuoka, Japan
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