Trial Outcomes & Findings for Apremilast for Atopic Dermatitis - A Pilot Study in Adults (NCT NCT01393158)

Results Overview

The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

Results posted on

2020-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Apremilast 20mg Apremilast: 20 mg by mouth twice daily for a total of 12 weeks.	Apremilast 30mg Apremilast: 30 mg by mouth twice daily for a total of 24 weeks.
Overall Study STARTED	6	10
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Apremilast 20mg Apremilast: 20 mg by mouth twice daily for a total of 12 weeks.	Apremilast 30mg Apremilast: 30 mg by mouth twice daily for a total of 24 weeks.
Overall Study Adverse Event	1	0

Baseline Characteristics

Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apremilast 20mg n=6 Participants Apremilast: 20 mg by mouth twice daily for a total of 12 weeks.	Apremilast 30mg n=10 Participants Apremilast: 30 mg by mouth twice daily for a total of 24 weeks.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
EASI	30.9 units on a scale STANDARD_DEVIATION 12.0 • n=5 Participants	21.4 units on a scale STANDARD_DEVIATION 7.6 • n=7 Participants	24.8 units on a scale STANDARD_DEVIATION 10.3 • n=5 Participants

PRIMARY outcome

Timeframe: Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.

Outcome measures

Outcome measures
Measure	Apremilast 20 BID n=6 Participants Subjects received 20mg of Apremilast BID for 12 weeks	Apremilast 30mg BID n=10 Participants Subjects received 30mg of Apremilast BID for 24 weeks
Change in EASI Scores	-8.8 units on a scale Standard Deviation 11.6	-8.2 units on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.

Outcome measures

Outcome measures
Measure	Apremilast 20 BID n=6 Participants Subjects received 20mg of Apremilast BID for 12 weeks	Apremilast 30mg BID n=10 Participants Subjects received 30mg of Apremilast BID for 24 weeks
Number of Participants in Each IGA Category Mild	0 participants	1 participants
Number of Participants in Each IGA Category Moderate	2 participants	8 participants
Number of Participants in Each IGA Category Severe	3 participants	1 participants
Number of Participants in Each IGA Category Very Severe	1 participants	0 participants

SECONDARY outcome

Timeframe: Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant.

Outcome measures

Outcome measures
Measure	Apremilast 20 BID n=6 Participants Subjects received 20mg of Apremilast BID for 12 weeks	Apremilast 30mg BID n=10 Participants Subjects received 30mg of Apremilast BID for 24 weeks
Change in Pruritus (Visual Analog Scale) Score	-32.2 units on a scale Standard Deviation 24.0	-13.4 units on a scale Standard Deviation 22.0

SECONDARY outcome

Timeframe: Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)

The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-"not at all", 1-"a little", 2-" a lot", 3- "very much" with some questions having the option of "not relevant". The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.

Outcome measures

Outcome measures
Measure	Apremilast 20 BID n=6 Participants Subjects received 20mg of Apremilast BID for 12 weeks	Apremilast 30mg BID n=10 Participants Subjects received 30mg of Apremilast BID for 24 weeks
Change In DLQI Scores	-8.3 units on a scale Standard Deviation 4.0	-6.3 units on a scale Standard Deviation 5.6

Adverse Events

Apremalist 20mg BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Apremalist 30mg BID

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apremalist 20mg BID n=6 participants at risk Patients receiving 20mg BID for 12 weeks	Apremalist 30mg BID n=10 participants at risk Patients receiving 30mg BID for 24 weeks
Gastrointestinal disorders Nausea	33.3% 2/6 • 4 Months in the 20 mg BID arm, and 7 months in the 30mg BID arm. All-cause mortality was not monitored/assessed.	90.0% 9/10 • 4 Months in the 20 mg BID arm, and 7 months in the 30mg BID arm. All-cause mortality was not monitored/assessed.

Additional Information

Dr. Eric Simpson,

Oregon Health & Science University

Phone: 503-494-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place