A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Registration Number
- NCT05250115
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):
* Are aged at least 18 years old
* Have a confirmed diagnosis of AD by a skin doctor
* Decide to start treatment with Abrocitinib as part of routine clinical practice
* Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects
Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 112
-
Patients aged ≥18 years
-
Confirmed diagnosis of AD by dermatologist prior to study inclusion
-
Patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being
- abrocitinib naive or,
- patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion
-
Patient is eligible for abrocitinib treatment according to Summary of Product Characteristics (SmPC)
-
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study
- Contraindications according to SmPC
- Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period
- Patients being treated with abrocitinib within a time period of <28 days prior to the timepoint of study inclusion
- Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the non-interventional study
- Patients who are unable to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response based on achieving the IGA of clear (0) or almost clear (1) Month 3 Response based on Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1). IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.
Response based on achieving the EASI-75 Month 3 Response based on achieving the EASI-75 (≥75% improvement from baseline). Eczema Area and Severity Index (EASI) Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
- Secondary Outcome Measures
Name Time Method Percentage change of IGA compared to baseline Baseline, month 1, month 3, month 6, month 9, month 12 Percentage change of IGA compared to baseline. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.
Change of Peak-Pruritus NRS over time Baseline, month 1, month 3, month 6, month 9, month 12 Change of Peak-Pruritus NRS over time. This numeric rating scale evaluates worst itching in the last 24 hours from no itching \[0\] to worst possible itching \[10\].
Number of days with emollients use Baseline, month 1, month 3, month 6, month 9, month 12 Number of days where non-medicated emollients are used.
Response based on achieving the IGA of clear (0) or almost clear (1) Baseline, month 1, month 6, month 9, month 12 Response based on IGA score of clear (0) or almost clear (1). IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.
Percentage change of EASI compared to baseline Baseline, month 1, month 3, month 6, month 9, month 12 Percentage change of EASI compared to baseline. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
Response based on achieving the EASI-75 Baseline, month 1, month 6, month 9, month 12 Response based on achieving the EASI-75 (≥75% improvement from baseline). EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
Percentage change of SCORAD compared to baseline Baseline, month 1, month 3, month 6, month 9, month 12 Percentage change of Scoring Atopic dermatitis (SCORAD) compared to baseline. SCORAD is a validated scoring index for AD for severity, combining A: extent (0-100), B: severity (0-18) and C: subjective symptoms (0-20) based on itching and sleep deprivation, each scored (0-10). The SCORAD for an individual is calculated using the formula A/5 + 7B/2 + C (may range from 0 to 103).
Response based on achieving the EASI-90 Baseline, month 1, month 3, month 6, month 9, month 12 Response based on achieving the EASI-90 (≥90% improvement from baseline). EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
Absolute EASI values over time Baseline, month 1, month 3, month 6, month 9, month 12 Absolute EASI values over time. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
Physician´s satisfaction with treatment Baseline, month 1, month 3, month 6, month 9, month 12 Physicians´ satisfaction with treatment based on a 5 point scale from 0 (very dissatisfied) to 4 (very confident).
Response based on achieving at least 4 points improvement of Pruritus NRS from baseline Baseline, month 1, month 3, month 6, month 9, month 12 The numeric rating scale (NRS) is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their average pruritus using this scale.
Change of POEM from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of Patient Oriented Eczema Measure (POEM) from baseline. This patient-reported measure assesses AD symptoms. The patient himself evaluates the frequency of occurrence and severity of 7 symptoms (such as itching and burning of the skin) within the last week, each according to a 5-point Likert scale. The maximum POEM score is 28 points.
Percentage of patients with EASI-75 response compared to baseline Baseline, month 1, month 3, month 6, month 9, month 12 Percentage of patients with EASI-75 (≥75% improvement from baseline) response. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.
Response based on achieving the IGA of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points Baseline, month 1, month 3, month 6, month 9, month 12 Response based on IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.
Change of DLQI from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of Dermatology Life Quality-Index (DLQI) from baseline. The DLQI is a 10-item patient-reported measure that rates how much a patient´s skin problems have affected their life over the last week assigned to the following 6 dimensions: symptoms, daily life, leisure/sport, work/school, social life/relationship and treatment. For each question, 0 to 3 points are given, whereby 3 points indicate the greatest possible impairment of the QoL in the queried area. The sum of scores ranges from 0 to 30, with higher scores indicating greater impairment of quality of life.
Change of EuroQol five-dimensional-five level (EQ-5D-5L) from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of EQ-5D-5L from baseline. This is a generic instrument for measuring quality of life, including health benefits and health status on a visual analogue scale (VAS), using the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Number of days with topical-treatment use (TCS, TCI) Baseline, month 1, month 3, month 6, month 9, month 12 Number of medicated topical background therapy (topical corticosteroid \[TCS\]), topical calcineurin inhibitors \[TCI\]) days.
Absolute change of IGA compared to baseline Baseline, month 1, month 3, month 6, month 9, month 12 Absolute change of IGA compared to baseline. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.
Change of MOS from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of Medical Outcomes Study Sleep Scale (MOS) from baseline. Medical Outcomes Study Sleep Scale (MOS)-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.
Change of HADS from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of Hospital Anxiety and Depression Scale (HADS) from baseline. HADS is a 14-item measure that identifies anxiety (7 items) and depression (7 items) among adults who are physically ill with lower scores indicating lower levels of anxiety and depression.
Change of PBI from baseline Baseline, month 1, month 3, month 6, month 9, month 12 Change of Patient Benefit Index (PBI) from baseline. Measurement of patient defined treatment benefits according to German and international standards, contains two one-sided questionnaires which are to be completed by the patient before and after receiving a treatment. A total of 23 possible treatment goals are evaluated on an importance scale from 0 ("not at all") to 5 ("very").
Patients satisfaction with treatment At all scheduled time points (Baseline, month 1, month 3, month 6, month 9, month 12) Patients satisfaction with treatment based on a 5-point scale from 0 (very dissatisfied) to 4 (very confident).
Trial Locations
- Locations (38)
Elbe Kliniken Stade - Buxtehude GmbH
🇩🇪Buxtehude, Niedersachsen, Germany
ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka
🇩🇪Gelsenkirchen, Nordrhein-westfalen, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist PartG
🇩🇪Mainz, Rheinland-pfalz, Germany
"Magdeburger company for Medical studies & Services"
🇩🇪Magdeburg, Sachsen-anhalt, Germany
Hautärztliche Gemeinschaftspraxis
🇩🇪Ahaus, Germany
Hautarztpraxis Dr. Virgil Mihaescu
🇩🇪Augsburg, Germany
Dermatologie Bad Kreuznach - Dr. med. Georg Mauer
🇩🇪Bad Kreuznach, Germany
Praxis Dr. A. Magerl
🇩🇪Bensheim, Germany
Hautzentrum
🇩🇪Bergen, Germany
Dr. Christiane Handrick Hautarztpraxis
🇩🇪Berlin, Germany
Dres. Ziethen-Stavermann GbR
🇩🇪Berlin, Germany
Hautarztpraxis Dr. med. Thomas Schirmer
🇩🇪Berlin, Germany
Hautzentrum Weißensee
🇩🇪Berlin, Germany
Hautarztpraxis Weid
🇩🇪Bingen, Germany
Hautarztpraxis an der Hase Studienzentrum
🇩🇪Bramsche, Germany
Hautärzte Braunschweig
🇩🇪Braunschweig, Germany
Hautarztpraxis Dr. med. Daniela Kasche
🇩🇪Buxtehude, Germany
BAG Freitag und Knöll
🇩🇪Falkensee, Germany
Haut- und Laserzentrum Freisung Prof. Kurzen
🇩🇪Freising, Germany
Hautarztpraxis Dr. med Michael Loth
🇩🇪Gernsbach, Germany
Hautarztpraxis Dr. Brinkmann, Schult & Samimi-Fard
🇩🇪Gladbeck, Germany
Cutaneum Praxis Dr. Buck
🇩🇪Hamburg, Germany
Hautarztpraxis Dr. med. Matthias Lütten
🇩🇪Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
dermaSANA
🇩🇪Karlsruhe, Germany
Kosmedikulm
🇩🇪Kulmbach, Germany
Praxis Dr. Voth
🇩🇪Köln, Germany
Dr. Beate Schwarz
🇩🇪Langenau, Germany
Hautarztpraxis Dr. Susanne Gißler-Walter
🇩🇪Mutterstadt, Germany
Dermatologie Mölln, Praxis Dr Segert
🇩🇪Mölln, Germany
ZENTderma, Dr. Rolf Ostendorf
🇩🇪Mönchengladbach, Germany
Hautarztpraxis Dorittke / Kardorff
🇩🇪Mönchengladbach, Germany
Praxis Dr. Quack
🇩🇪München, Germany
Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel
🇩🇪Nürnberg, Germany
Hautarztpraxis Mortazawi
🇩🇪Remscheid, Germany
Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski
🇩🇪Selters, Germany
Dermatologisches Studienzentrum Hunsrück - DSH
🇩🇪Simmern/Hunsrück, Germany
Hautarztpraxis Dr. Hoffmann
🇩🇪Witten, Germany