A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Terminated

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

Inclusion Criteria

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
1. abrocitinib naive or,
2. 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

Exclusion Criteria

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
Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3	At Month 3	The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of body surface area \[BSA\] affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\score for head/neck + 0.3\score for trunk + 0.2\score for upper extremities + 0.4\score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD. EASI 75 response was defined as at least a 75% reduction in EASI relative to baseline.
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) at Month 3	At Month 3	The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study	From Baseline (Day 1) up to end of study (Month 12)	The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.
Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study	From Baseline (Day 1) up to end of study (Month 12)	The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\score for head/neck + 0.3\score for trunk + 0.2\score for upper extremities + 0.4\score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD. EASI 90 response was defined as at least a 90% reduction in EASI relative to baseline.
Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) and a Reduction of >= 2 Points From Baseline Until End of Study	From Baseline (Day 1) up to end of study (Month 12)	The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) and a reduction of \>=2 points from baseline according to IGA were reported in this outcome measure.
Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD.
Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study	From Baseline (Day 1) up to end of study (Month 12)	The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\score for head/neck + 0.3\score for trunk + 0.2\score for upper extremities + 0.4\score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD. EASI 75 response was defined as at least a 75% reduction in EASI relative to baseline.
Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	POEM was a participant-reported measure that assessed AD symptoms. The participants self-evaluated 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 from 0 ("at no day") to 4 ("at all days"). The total POEM score was summed over the symptoms and ranged from 0 (clear) to 28 points (very severe), where higher score indicated greater severity.
Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, Sleep short of breath and headache, sleep quantity (raw scores), optimal sleep, sleep adequacy, and sleep somnolence) as well as sleep problems index I and II and all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), where higher scores indicated more sleep problems, with exception of sleep adequacy which was scored as 0 (least sleep adequacy) to 100 (better sleep adequacy) where higher scores indicated higher sleep adequacy, and optimal sleep scored as 0 (less quantity of sleep) to 24 (greater quantity of sleep), where higher scores indicated higher quantity sleep.
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	SCORAD total score was a validated scoring index for AD that assessed severity by combining A: extent, B: severity and C: subjective symptoms. A: a rule of 9 was used to calculate BSA affected by AD as a % of whole-BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) was assessed as none =0, mild =1, moderate =2, severe =3, severity scores were added to give B (0-18). C: based on itching and sleep deprivation, each scored (0-10) where, 0= no itch/no sleeplessness and 10= worst imaginable itch/sleeplessness, scores for itch and sleeplessness were added to give C (0-20). The total score for an individual was calculated as A/5 + 7B/2 + C and ranged from 0-103; higher SCORAD scores = greater severity of AD.
Absolute EASI Total Score at Months 1, 3, 6, 9 and 12	At Months 1, 3, 6, 9 and 12	The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\score for head/neck + 0.3\score for trunk + 0.2\score for upper extremities + 0.4\score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD.
Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of BSA affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\score for head/neck + 0.3\score for trunk + 0.2\score for upper extremities + 0.4\score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD.
Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that typically ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD.
Percentage of Participants Who Achieved at Least 4 Point Improvement on Pruritus Numerical Rating Scale (NRS) From Baseline Until End of Study	From Baseline (Day 1) up to end of study (Month 12)	The pruritus-NRS comprised of one item and the score ranged from 0 ("no itch") to 10 ("worst imaginable itch"). Higher scores indicated greater severity. Participants were asked to rate the intensity of their average pruritus using this scale. Percentage of participants who achieved at least 4-point improvement on pruritus NRS are reported in this outcome measure.
Percentage of Participants With Pruritus NRS Score Less Than or Equal to (<=1)	From Baseline (Day 1) up to end of study (Month 12)	The pruritus-NRS was comprised of one item and the score ranged from 0 ("no itch") to 10 ("worst imaginable itch"). Higher scores indicated greater severity. Participants were asked to rate the intensity of their average pruritus using this scale. Percentage of participants with pruritus NRS score \<=1 are reported in this outcome measure.
Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	PP NRS evaluated itching in the last 24 hours on a scale ranging from no itching (0) to worst possible itching (10). Higher scores indicated greater severity.
Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	The DLQI was a 10-item participant-reported measure that rated how much a participant's skin problems had 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. Each question was scored from 0 to 3 where, 0=best quality of life and 3=greatest possible impairment of the quality of life (QoL). The total score was calculated as sum of scores and ranged from 0 (best QoL) to 30 (worst QoL), with higher scores indicating greater impairment of quality of life.
Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	HADS was a validated 14-item questionnaire to assess states of anxiety and depression. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, each of which comprised of 7 items among adults who were physically ill. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, with 0 denoting lowest and 3 denoting highest anxiety or depression level. For both subscales the total score was derived by summing up the respective 7 items with total score ranging from 0 (no presence of anxiety and depression) to 21 (severe feeling of anxiety and depression); higher score indicated greater severity of anxiety and depression.
Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12	Baseline (Day 1), Months 1, 3, 6, 9 and 12	EQ-5D-5L was an instrument for measuring quality of life, including health benefits and health status on a visual analogue scale (VAS). EQ-5D health state profile has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprise a health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) has a unique predefined utility index value assigned to it, by EuroQol. Higher (positive) scores = better health state. The VAS component rates current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state) ; higher scores indicate a better health state.
Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12	At Months 1, 3, 6, 9 and 12	PBI consisted of two one-sided questionnaires which were completed by participants before and after receiving a treatment. Total of 23 possible treatment goals were evaluated on importance scale from 0 ("not at all") to 4 ("very"). "Does not apply to me" was coded as "0". PBI was calculated by multiplying achieved benefits (respective PBI after baseline) with importance of the respective needs prior to therapy (PBI at baseline), dividing these products by sum of all importance items (PBI at baseline) and summing them up for all items. Total PBI score ranged from 0 (no benefit) to 4 (maximal benefit), where higher scores indicated more benefits. PBI questionnaire measured satisfaction at all points in time after baseline.
Number of Participants With Treatment Expectation Measured by PBI at Baseline	At Baseline (Day 1)	PBI consisted of two one-sided questionnaires which were completed by participants before and after receiving treatment. Total of 25 possible treatment goals were evaluated on importance scale from 0 (" not at all") to 4 ("very"), where higher scores indicated more important goals. The responses to each treatment goal included: somewhat, moderately, quite, very, does not apply to me, not answered and not at all. Treatment expectation was measured at baseline.
Number of Days With Topical Treatment Use	Months 1, 3, 6, 9 and 12	Topical treatments included topical corticosteroids and topical calcineurin inhibitors. Number of days with topical treatment use was reported in this outcome measure. Number of days was calculated as date of first topical treatment - date of last topical treatment + 1.
Number of Days of Emollients Use	Months 1, 3, 6, 9 and 12	Number of days with emollients use was calculated as: date of first emollients use - date of last emollients use + 1. The number of days with emollients use was reported in this outcome measure.

Trial Locations

Locations (38): Elbe Kliniken Stade - Buxtehude GmbH
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Buxtehude, Lower Saxony, Germany
ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka
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Gelsenkirchen, North Rhine-Westphalia, Germany
Dermatologische Gemeinschaftspraxis Dres. Quist PartG
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Mainz, Rhineland-Palatinate, Germany
"Magdeburger company for Medical studies & Services"
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Magdeburg, Saxony-Anhalt, Germany
Hautärztliche Gemeinschaftspraxis
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Ahaus, Germany
Hautarztpraxis Dr. Virgil Mihaescu
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Augsburg, Germany
Dermatologie Bad Kreuznach - Dr. med. Georg Mauer
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Bad Kreuznach, Germany
Praxis Dr. A. Magerl
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Bensheim, Germany
Hautzentrum
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Bergen, Germany
Dr. Christiane Handrick Hautarztpraxis
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Berlin, Germany
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Elbe Kliniken Stade - Buxtehude GmbH
🇩🇪Buxtehude, Lower Saxony, Germany