The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin. This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib. All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time. We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD. Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).
Study Type
OBSERVATIONAL
Enrollment
183
Study Drug for Observational Data Collection
CHU Amiens-Picardie - Site Nord
Amiens, Somme, France
RECRUITINGCHU Besancon - Hopital Jean Minjoz
Besançon, France
RECRUITINGPolyclinique Reims Bezannes
Bezannes, France
RECRUITINGChu Bordeaux Hopital Saint Andre
Bordeaux, France
RECRUITINGCHU Brest Hopital Morvan
Brest, France
RECRUITINGCHU de Caen
Caen, France
RECRUITINGCh de Calais
Calais, France
RECRUITINGCh William Morey
Chalon-sur-Saône, France
RECRUITINGCHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, France
RECRUITINGChu Estaing
Clermont-Ferrand, France
RECRUITING...and 20 more locations
Proportion of patients with an 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: 16 weeks
Proportion of patients with an 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: 12, 18 and 24 months
Change in Eczema Area and Severity Index (EASI) score from baseline
Time frame: 16 weeks and at 12, 18, and 24 months
Proportion of patients with an EASI75 and EASI90
Time frame: at 16 weeks and at 12, 18, and 24 months
Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)
Time frame: at 2, 16 weeks
PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)
Time frame: at 2, 16, 24 weeks and at 12 months
Absolute change from baseline in PP-NRS score
Time frame: at 2, 16, and 24 weeks, and at 12 months
Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score
Time frame: at 16 and 24 weeks, and at 12, 18, and 24 months
Absolute changes from baseline score of Epworth sleepiness scale
Time frame: at 2, 16, and 24 weeks, and at 12 months
Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks
Time frame: at 24 weeks and at 12 months
Duration of Drug Therapy
Time frame: Baseline to 24 months
Duration of each dosage
Time frame: Baseline to 24 months
Proportion of patients with each regimen and changes over the treatment period
Time frame: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation
Time frame: Baseline to 24 months
Proportion of patient with permanent treatment discontinuation with reason
Time frame: Baseline up to 24 months
Proportion of Participants Receiving Subsequent Treatment
Time frame: Baseline to 24 months
Number of Participants With Any Changes in Dosing
Time frame: Baseline to 24 months
Proportion of patient with temporary treatment discontinuation with reason
Time frame: Baseline to 24 months
Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)
Time frame: 16 and 24 weeks, and at 12 months
Demographic Characteristic of Participants: Age
Time frame: Baseline
Demographical Characteristics of Participants:sex
Time frame: Baseline
Demographic Characteristic of Participants: Body Mass Index
Time frame: Baseline
Disease Characteristics of Participants: IGA score
Time frame: Baseline
Disease Characteristics of Participants: EASI score
Time frame: Baseline
Disease Characteristics of Participants: % of BSA involvement
Time frame: Baseline
Disease Characteristics of Participants: PRO data
Time frame: Baseline
Demographic Characteristics of Participants: history of treatment for atopic dermatitis
Time frame: Baseline
Disease Characteristics of Participants: history of the disease
Time frame: baseline
Demographic Characteristic of Participants: Comorbidities
Time frame: Baseline
Hematological and lipid biological parameters
Time frame: At baseline and 16 weeks
Proportion of patients with serious events
Time frame: at 16 weeks, 12,18,24 months
Proportion of patients with non-serious adverse events
Time frame: at 16 weeks, 12,18,24 months
Number of scratching episodes during the evening sleep period that occur pre treatment versus on treatment
Data collection (scratch and sleep) from accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Duration of time scratching during the evening sleep period that occur pre treatment versus on treatment
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of sleep quantity
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Total sleep opportunity
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Sleep efficiency
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Total time asleep
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Sleep onset latency
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
Compare change from pre-treatment to on-treatment measures of Wake after sleep onset and Number of wake bouts
Measure by accelerometer monitor
Time frame: At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib
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