Trial Outcomes & Findings for A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT05601882)
NCT ID: NCT05601882
Last Updated: 2025-02-14
Results Overview
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
920 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2025-02-14
Participant Flow
Participants were randomized at 214 sites located in 28 countries (Australia, Belgium, Bulgaria, Canada, China, Croatia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United States/Puerto Rico).
Participants who met eligibility criteria were randomized in a 1:1 ratio to receive either upadacitinib 15 mg QD or dupilumab as per its label in Period 1. At Week 16, participants from both Period 1 arms with a \< EASI 75 response entered Period 2; those from the dupilumab arm were offered the option to receive upadacitinib 15 mg QD while those from the upadacitinib arm either continued (if already receiving 30 mg) or escalated to upadacitinib 30 mg QD (if receiving 15 mg QD) until Week 32.
Participant milestones
| Measure |
Dupilumab (Period 1)
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
Dupilumab -> Upadacitinib (Period 2)
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
|
Upadacitinib -> Upadacitinib 30 mg (Period 2)
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
|
|---|---|---|---|---|
|
Period 1 (Baseline - Week 16)
STARTED
|
462
|
458
|
0
|
0
|
|
Period 1 (Baseline - Week 16)
COMPLETED
|
423
|
418
|
0
|
0
|
|
Period 1 (Baseline - Week 16)
NOT COMPLETED
|
39
|
40
|
0
|
0
|
|
Period 2 (Week 16 - Week 32)
STARTED
|
0
|
0
|
208
|
147
|
|
Period 2 (Week 16 - Week 32)
COMPLETED
|
0
|
0
|
198
|
131
|
|
Period 2 (Week 16 - Week 32)
NOT COMPLETED
|
0
|
0
|
10
|
16
|
Reasons for withdrawal
| Measure |
Dupilumab (Period 1)
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
Dupilumab -> Upadacitinib (Period 2)
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
|
Upadacitinib -> Upadacitinib 30 mg (Period 2)
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
|
|---|---|---|---|---|
|
Period 1 (Baseline - Week 16)
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 16)
Withdrawal by Subject
|
21
|
24
|
0
|
0
|
|
Period 1 (Baseline - Week 16)
Other, not specified
|
16
|
16
|
0
|
0
|
|
Period 2 (Week 16 - Week 32)
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Period 2 (Week 16 - Week 32)
Withdrawal by Subject
|
0
|
0
|
3
|
4
|
|
Period 2 (Week 16 - Week 32)
Other, not specified
|
0
|
0
|
4
|
11
|
Baseline Characteristics
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
Total
n=920 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
508 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
421 Participants
n=5 Participants
|
414 Participants
n=7 Participants
|
835 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
137 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
296 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
599 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16
|
8.9 percentage of participants
Interval 6.3 to 11.5
|
19.9 percentage of participants
Interval 16.2 to 23.5
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16
|
22.5 percentage of participants
Interval 18.7 to 26.3
|
40.8 percentage of participants
Interval 36.3 to 45.3
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=459 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=454 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1
|
15.5 percentage of participants
Interval 12.2 to 18.8
|
30.2 percentage of participants
Interval 26.0 to 34.4
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=457 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=448 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4
|
38.1 percentage of participants
Interval 33.6 to 42.5
|
54.7 percentage of participants
Interval 50.1 to 59.3
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=459 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=454 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1
|
2.8 percentage of participants
Interval 1.3 to 4.3
|
16.1 percentage of participants
Interval 12.7 to 19.5
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=459 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=454 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1
|
1.3 percentage of participants
Interval 0.3 to 2.3
|
7.7 percentage of participants
Interval 5.3 to 10.2
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4
|
9.7 percentage of participants
Interval 7.0 to 12.4
|
23.8 percentage of participants
Interval 19.9 to 27.7
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2
|
8.2 percentage of participants
Interval 5.7 to 10.7
|
26.7 percentage of participants
Interval 22.7 to 30.8
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Outcome measures
| Measure |
Dupilumab (Period 1)
n=462 Participants
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 Participants
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
|---|---|---|
|
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16
|
5.6 percentage of participants
Interval 3.5 to 7.7
|
14.8 percentage of participants
Interval 11.6 to 18.1
|
Adverse Events
Dupilumab (Period 1)
Serious events: 5 serious events
Other events: 87 other events
Deaths: 0 deaths
Upadacitinib (Period 1)
Serious events: 4 serious events
Other events: 156 other events
Deaths: 0 deaths
Dupilumab -> Upadacitinib (Period 2)
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Upadacitinib -> Upadacitinib 30 mg (Period 2)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dupilumab (Period 1)
n=462 participants at risk
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 participants at risk
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
Dupilumab -> Upadacitinib (Period 2)
n=208 participants at risk
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
|
Upadacitinib -> Upadacitinib 30 mg (Period 2)
n=147 participants at risk
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.22%
1/458 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Infections and infestations
PNEUMONIA
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.68%
1/147 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Infections and infestations
SEPSIS
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Musculoskeletal and connective tissue disorders
JUVENILE IDIOPATHIC ARTHRITIS
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.68%
1/147 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Nervous system disorders
MIGRAINE WITHOUT AURA
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.68%
1/147 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Psychiatric disorders
DEPRESSION
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/458 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.22%
1/458 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.22%
1/458 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.22%
1/462 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.22%
1/458 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.68%
1/147 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
0.00%
0/462 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.22%
1/458 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/208 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.00%
0/147 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
Other adverse events
| Measure |
Dupilumab (Period 1)
n=462 participants at risk
Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.
Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.
|
Upadacitinib (Period 1)
n=458 participants at risk
Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.
|
Dupilumab -> Upadacitinib (Period 2)
n=208 participants at risk
At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.
|
Upadacitinib -> Upadacitinib 30 mg (Period 2)
n=147 participants at risk
At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.
|
|---|---|---|---|---|
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Infections and infestations
NASOPHARYNGITIS
|
7.6%
35/462 • Number of events 43 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
12.7%
58/458 • Number of events 74 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
8.7%
18/208 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
8.2%
12/147 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.8%
22/462 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
5.9%
27/458 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
5.8%
12/208 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
4.8%
7/147 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Nervous system disorders
HEADACHE
|
3.5%
16/462 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
5.9%
27/458 • Number of events 32 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
2.4%
5/208 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
0.68%
1/147 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
1.5%
7/462 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
12.0%
55/458 • Number of events 56 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
6.7%
14/208 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
3.4%
5/147 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
3.2%
15/462 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
5.0%
23/458 • Number of events 24 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
5.8%
12/208 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
|
6.1%
9/147 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was for 113 days for the Dupilumab (Period 1) group; 114 days for the Upadacitinib (Period 1) group; 225 days for the Dupilumab -> Upadacitinib (Period 2) group; and 224 days for the Upadacitinib -> Upadacitinib 30 mg (Period 2) group.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER