Dermatitis, Atopic
Conditions
Keywords
Atopic Dermatitis, Abrocitinib, JAK inhibitors
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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 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. |
Countries
Germany
Participant flow
Recruitment details
A total of 112 participants who were diagnosed with moderate to severe atopic dermatitis (AD) and received abrocitinib treatment were included, of which 2 participants violated the inclusion/exclusion criteria, and a total 110 participants were included in the full analysis set (FAS). Participants were followed up for 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Abrocitinib Participants with moderate to severe AD who received treatment with oral abrocitinib were observed in this prospective study. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Other | 7 |
| Overall Study | Premature study end | 40 |
| Overall Study | Withdrawal by Subject | 6 |
| Overall Study | Withdrawal of informed consent | 1 |
Baseline characteristics
| Characteristic | Abrocitinib |
|---|---|
| Age, Continuous | 39.59 Years STANDARD_DEVIATION 15.45 |
| Race/Ethnicity, Customized Ethnicity Caucasian | 86 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Caucasian | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 7 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 112 |
| other Total, other adverse events | 33 / 112 |
| serious Total, serious adverse events | 4 / 112 |
Outcome results
Primary
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) 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.
Time frame: At Month 3
Population: The FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) at Month 3 | 35.71 Percentage of participants |
Primary
Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) 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.
Time frame: At Month 3
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3 | 47.62 Percentage of participants |
Secondary
Absolute Change From Baseline in IGA Total Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 1 | -1.31 Units on a scale | Standard Deviation 1.16 |
| Abrocitinib | Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 3 | -1.66 Units on a scale | Standard Deviation 1.11 |
| Abrocitinib | Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 6 | -1.51 Units on a scale | Standard Deviation 1.12 |
| Abrocitinib | Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 9 | -1.39 Units on a scale | Standard Deviation 1.06 |
| Abrocitinib | Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 12 | -1.38 Units on a scale | Standard Deviation 1.3 |
Secondary
Absolute EASI Total Score 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.
Time frame: At Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 1 | 5.09 Units on a scale | Standard Deviation 6.57 |
| Abrocitinib | Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 3 | 4.37 Units on a scale | Standard Deviation 7.03 |
| Abrocitinib | Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 6 | 3.65 Units on a scale | Standard Deviation 4.5 |
| Abrocitinib | Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 9 | 4.70 Units on a scale | Standard Deviation 5.47 |
| Abrocitinib | Absolute EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 12 | 5.11 Units on a scale | Standard Deviation 8.09 |
Secondary
Number of Days of Emollients Use
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.
Time frame: Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Number of Days of Emollients Use | At Month 1 | 17.22 Days | Standard Deviation 14.41 |
| Abrocitinib | Number of Days of Emollients Use | At Month 3 | 52.76 Days | Standard Deviation 43.39 |
| Abrocitinib | Number of Days of Emollients Use | At Month 6 | 95.61 Days | Standard Deviation 74.54 |
| Abrocitinib | Number of Days of Emollients Use | At Month 9 | 155.35 Days | Standard Deviation 105.94 |
| Abrocitinib | Number of Days of Emollients Use | At Month 12 | 219.93 Days | Standard Deviation 135.11 |
Secondary
Number of Days With Topical Treatment Use
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.
Time frame: Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Number of Days With Topical Treatment Use | At Month 1 | 6.66 Days | Standard Deviation 10.12 |
| Abrocitinib | Number of Days With Topical Treatment Use | At Month 3 | 19.59 Days | Standard Deviation 31.57 |
| Abrocitinib | Number of Days With Topical Treatment Use | At Month 6 | 31.52 Days | Standard Deviation 52.98 |
| Abrocitinib | Number of Days With Topical Treatment Use | At Month 9 | 41.08 Days | Standard Deviation 71.48 |
| Abrocitinib | Number of Days With Topical Treatment Use | At Month 12 | 62.71 Days | Standard Deviation 97.25 |
Secondary
Number of Participants With Treatment Expectation Measured by PBI at Baseline
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.
Time frame: At Baseline (Day 1)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Very | 39 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Somewhat | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Does not apply to me | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Very | 16 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Not at all | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Somewhat | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Moderately | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Quite | 21 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Moderately | 8 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Quite | 12 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Very | 27 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Does not apply to me | 13 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have a normal sex life | Not at all | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Moderately | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Quite | 19 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Very | 37 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Does not apply to me | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less dependent on doctor and clinic visits | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Moderately | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Very | 33 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Does not apply to me | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Somewhat | 7 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Moderately | 10 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Quite | 12 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Very | 30 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Does not apply to me | 6 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer out-of-pocket treatment expenses | Not at all | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Moderately | 7 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Quite | 17 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Very | 31 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Does not apply to me | 10 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have fewer side effects | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Moderately | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Quite | 14 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Does not apply to me | 6 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Quite | 19 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Very | 44 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Does not apply to me | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Somewhat | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Moderately | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Quite | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Very | 54 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Does not apply to me | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Get better skin quickly | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Very | 60 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Moderately | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Quite | 12 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Very | 45 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Does not apply to me | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of pain | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Somewhat | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Moderately | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Quite | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Does not apply to me | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Not answered | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be free of itching | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Somewhat | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Moderately | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Quite | 10 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Very | 54 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Does not apply to me | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Not answered | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | No longer have burning sensations on your skin | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Moderately | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Quite | 12 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Very | 49 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Does not apply to me | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be healed of all skin defects | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Somewhat | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Moderately | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Quite | 13 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Very | 38 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Does not apply to me | 6 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to sleep better | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Somewhat | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Moderately | 8 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Quite | 17 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Very | 31 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Does not apply to me | 8 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Feel less depressed | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Moderately | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Quite | 20 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Very | 37 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Does not apply to me | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Experience a greater enjoyment of life | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Somewhat | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Moderately | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Quite | 19 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Very | 36 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Does not apply to me | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have no fear that the disease will become worse | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Moderately | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Quite | 17 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Very | 44 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Does not apply to me | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal everyday life | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Somewhat | 4 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Moderately | 8 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Quite | 11 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Does not apply to me | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be more productive in everyday life | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Moderately | 11 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Quite | 19 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Very | 24 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Does not apply to me | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less of a burden to relatives and friends | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Somewhat | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Moderately | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Quite | 14 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Very | 41 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to engage in normal leisure activities | Not answered | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Moderately | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Quite | 15 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Very | 31 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Does not apply to me | 13 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to lead a normal working life | Not at all | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Somewhat | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Moderately | 9 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Quite | 19 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be able to have more contact with other people | Does not apply to me | 15 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Very | 28 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Does not apply to me | 5 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Not answered | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be comfortable showing yourself more in public | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Somewhat | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Moderately | 6 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Quite | 11 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Very | 30 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Be less burdened in your partnership | Does not apply to me | 17 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Need less time for daily treatment | Quite | 20 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Very | 42 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Not answered | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Find a clear diagnosis and therapy | Not at all | 0 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Have confidence in the therapy | Moderately | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Somewhat | 2 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Moderately | 3 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Quite | 17 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Very | 44 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Does not apply to me | 1 Participants |
| Abrocitinib | Number of Participants With Treatment Expectation Measured by PBI at Baseline | Regain control of the disease | Not answered | 0 Participants |
Secondary
Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12 | Month 1 | -58.09 Percentage change | Standard Deviation 33.22 |
| Abrocitinib | Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12 | Month 3 | -55.40 Percentage change | Standard Deviation 54.83 |
| Abrocitinib | Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12 | Month 6 | -49.54 Percentage change | Standard Deviation 73.27 |
| Abrocitinib | Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12 | Month 9 | -40.73 Percentage change | Standard Deviation 85.53 |
| Abrocitinib | Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12 | Month 12 | -55.37 Percentage change | Standard Deviation 70.83 |
Secondary
Percentage Change From Baseline in EASI Total Score 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 1 | -57.00 Percentage change | Standard Deviation 64.37 |
| Abrocitinib | Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 3 | -70.11 Percentage change | Standard Deviation 31.71 |
| Abrocitinib | Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 6 | -67.89 Percentage change | Standard Deviation 47.82 |
| Abrocitinib | Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 9 | -69.16 Percentage change | Standard Deviation 32.03 |
| Abrocitinib | Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12 | Month 12 | -71.58 Percentage change | Standard Deviation 35.79 |
Secondary
Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 1: Index score | 26.76 Percentage change | Standard Deviation 50.9 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 1: VAS | 36.15 Percentage change | Standard Deviation 51.76 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 3: Index score | 29.86 Percentage change | Standard Deviation 56.71 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 3: VAS | 45.73 Percentage change | Standard Deviation 54.75 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 6: Index score | 30.36 Percentage change | Standard Deviation 51.44 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 6: VAS | 51.50 Percentage change | Standard Deviation 60.27 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 9: Index score | 25.37 Percentage change | Standard Deviation 56.25 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 9: VAS | 36.76 Percentage change | Standard Deviation 43.67 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 12: Index score | 32.44 Percentage change | Standard Deviation 66.76 |
| Abrocitinib | Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12 | Month 12: VAS | 61.61 Percentage change | Standard Deviation 63.38 |
Secondary
Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 1: HADS anxiety score | -18.15 Percentage change | Standard Deviation 43.84 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 1: HADS depression score | -26.09 Percentage change | Standard Deviation 55.72 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 3: HADS anxiety score | -25.67 Percentage change | Standard Deviation 51.18 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 3: HADS depression score | -31.41 Percentage change | Standard Deviation 78.54 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 6: HADS anxiety score | -19.24 Percentage change | Standard Deviation 60.19 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 6: HADS depression score | -21.27 Percentage change | Standard Deviation 75.52 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 9: HADS anxiety score | -17.88 Percentage change | Standard Deviation 78.76 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 9: HADS depression score | -15.77 Percentage change | Standard Deviation 89.51 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 12: HADS anxiety score | -32.25 Percentage change | Standard Deviation 54.02 |
| Abrocitinib | Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12 | Month 12: HADS depression score | -36.70 Percentage change | Standard Deviation 58.61 |
Secondary
Percentage Change From Baseline in IGA Total Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 12 | -38.97 Percentage change | Standard Deviation 40.45 |
| Abrocitinib | Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 1 | -38.79 Percentage change | Standard Deviation 33.55 |
| Abrocitinib | Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 3 | -50.37 Percentage change | Standard Deviation 31.06 |
| Abrocitinib | Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 6 | -46.05 Percentage change | Standard Deviation 33.15 |
| Abrocitinib | Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12 | Month 9 | -41.86 Percentage change | Standard Deviation 32.07 |
Secondary
Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep disturbance | -30.42 Percentage change | Standard Deviation 40.76 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Snoring | -15.80 Percentage change | Standard Deviation 52.09 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep short of breath and headache | -34.57 Percentage change | Standard Deviation 51.46 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep Adequacy | 46.52 Percentage change | Standard Deviation 108.77 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep Somnolence | -14.23 Percentage change | Standard Deviation 56.05 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep Quantity (raw scores) | 13.94 Percentage change | Standard Deviation 39.4 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Optimal Sleep Scale | -27.78 Percentage change | Standard Deviation 46.09 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep Problems Index I | -15.45 Percentage change | Standard Deviation 56.08 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 1: Sleep Problems Index II | -20.91 Percentage change | Standard Deviation 39.67 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Disturbance | -39.93 Percentage change | Standard Deviation 31.15 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Snoring | -13.61 Percentage change | Standard Deviation 52.77 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep short of breath and headache | -54.90 Percentage change | Standard Deviation 46.68 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Adequacy | 81.69 Percentage change | Standard Deviation 141.71 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Somnolence | -15.71 Percentage change | Standard Deviation 68.76 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Quantity (raw scores) | 23.31 Percentage change | Standard Deviation 48.74 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Optimal Sleep Scale | -12.50 Percentage change | Standard Deviation 35.36 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Problems Index I | -33.27 Percentage change | Standard Deviation 30.21 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 3: Sleep Problems Index II | -34.49 Percentage change | Standard Deviation 25.42 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Disturbance | -32.02 Percentage change | Standard Deviation 52.68 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Snoring | -8.10 Percentage change | Standard Deviation 63.01 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep short of breath and headache | -44.44 Percentage change | Standard Deviation 48.51 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Adequacy | 59.83 Percentage change | Standard Deviation 81.33 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Somnolence | -18.15 Percentage change | Standard Deviation 68.23 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Quantity (raw scores) | 30.17 Percentage change | Standard Deviation 52.08 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Optimal Sleep Scale | -14.29 Percentage change | Standard Deviation 37.8 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Problems Index I | -29.01 Percentage change | Standard Deviation 37.19 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 6: Sleep Problems Index II | -27.61 Percentage change | Standard Deviation 37.6 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Disturbance | 4.54 Percentage change | Standard Deviation 179.32 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Snoring | -18.18 Percentage change | Standard Deviation 52.02 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep short of breath and headache | -57.14 Percentage change | Standard Deviation 43.71 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Adequacy | 52.55 Percentage change | Standard Deviation 113.18 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Somnolence | 7.55 Percentage change | Standard Deviation 115.13 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Quantity (raw scores) | 9.33 Percentage change | Standard Deviation 24.88 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Optimal Sleep Scale | -22.22 Percentage change | Standard Deviation 44.1 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Problems Index I | -13.61 Percentage change | Standard Deviation 61.78 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 9: Sleep Problems Index II | -16.82 Percentage change | Standard Deviation 49.82 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Disturbance | -16.56 Percentage change | Standard Deviation 87.57 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Snoring | -7.97 Percentage change | Standard Deviation 81.28 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep short of breath and headache | -58.33 Percentage change | Standard Deviation 42.34 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Adequacy | 86.83 Percentage change | Standard Deviation 142.51 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Somnolence | 0.59 Percentage change | Standard Deviation 127.53 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Quantity (raw scores) | 22.50 Percentage change | Standard Deviation 39.81 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Optimal Sleep Scale | -20.00 Percentage change | Standard Deviation 44.72 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Problems Index I | -19.99 Percentage change | Standard Deviation 93.75 |
| Abrocitinib | Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12 | Month 12: Sleep Problems Index II | -21.23 Percentage change | Standard Deviation 66.11 |
Secondary
Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12 | Month 1 | -54.53 Percentage change | Standard Deviation 35.86 |
| Abrocitinib | Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12 | Month 3 | -49.90 Percentage change | Standard Deviation 39.39 |
| Abrocitinib | Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12 | Month 6 | -49.54 Percentage change | Standard Deviation 38.25 |
| Abrocitinib | Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12 | Month 9 | -42.42 Percentage change | Standard Deviation 45.5 |
| Abrocitinib | Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12 | Month 12 | -44.74 Percentage change | Standard Deviation 63.31 |
Secondary
Percentage Change From Baseline in Peak-Pruritus (PP) NRS at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12 | Month 1 | -53.15 Percentage change | Standard Deviation 36.81 |
| Abrocitinib | Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12 | Month 3 | -43.17 Percentage change | Standard Deviation 39.01 |
| Abrocitinib | Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12 | Month 6 | -48.41 Percentage change | Standard Deviation 47.88 |
| Abrocitinib | Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12 | Month 9 | -39.11 Percentage change | Standard Deviation 74.06 |
| Abrocitinib | Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12 | Month 12 | -37.41 Percentage change | Standard Deviation 65.89 |
Secondary
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at 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.
Time frame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 | Month 1 | -48.53 Percentage change | Standard Deviation 28.43 |
| Abrocitinib | Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 | Month 3 | -50.60 Percentage change | Standard Deviation 27.6 |
| Abrocitinib | Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 | Month 6 | -53.41 Percentage change | Standard Deviation 29.64 |
| Abrocitinib | Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 | Month 9 | -43.46 Percentage change | Standard Deviation 31.86 |
| Abrocitinib | Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12 | Month 12 | -50.08 Percentage change | Standard Deviation 30.81 |
Secondary
Percentage of Participants Who Achieved at Least 4 Point Improvement on Pruritus Numerical Rating Scale (NRS) From Baseline Until End of Study
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants Who Achieved at Least 4 Point Improvement on Pruritus Numerical Rating Scale (NRS) From Baseline Until End of Study | 42.57 Percentage of participants |
Secondary
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
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | 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 | 47.52 Percentage of participants |
Secondary
Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study | 51.49 Percentage of participants |
Secondary
Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study | 63.37 Percentage of participants |
Secondary
Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study | 42.57 Percentage of participants |
Secondary
Percentage of Participants With Pruritus NRS Score Less Than or Equal to (<=1)
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.
Time frame: From Baseline (Day 1) up to end of study (Month 12)
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abrocitinib | Percentage of Participants With Pruritus NRS Score Less Than or Equal to (<=1) | 29.70 Percentage of participants |
Secondary
Treatment Satisfaction Measured by Patient Benefit Index (PBI) 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.
Time frame: At Months 1, 3, 6, 9 and 12
Population: FAS included all participants with informed consent who met the eligibility criteria and received at least one dose of abrocitinib. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib | Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12 | Month 1 | 2.79 Units on a scale | Standard Deviation 0.99 |
| Abrocitinib | Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12 | Month 3 | 2.92 Units on a scale | Standard Deviation 0.88 |
| Abrocitinib | Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12 | Month 6 | 3.12 Units on a scale | Standard Deviation 0.66 |
| Abrocitinib | Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12 | Month 9 | 2.92 Units on a scale | Standard Deviation 0.94 |
| Abrocitinib | Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12 | Month 12 | 3.07 Units on a scale | Standard Deviation 0.82 |