Trial Outcomes & Findings for Topical Ruxolitinib Evaluation in Chronic Hand Eczema (NCT NCT05906628)

Last Updated: 2025-07-31

Results Overview

The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

186 participants

Primary outcome timeframe

Baseline; Week 16

Results posted on

2025-07-31

Participant Flow

This study was conducted at 30 study centers in Canada, Germany, Poland, and the United States.

Participant milestones

Participant milestones
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
16-Week DBVC Period STARTED	94	92
16-Week DBVC Period COMPLETED	84	77
16-Week DBVC Period NOT COMPLETED	10	15
16-Week OLE Period STARTED	84	77
16-Week OLE Period COMPLETED	76	71
16-Week OLE Period NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
16-Week DBVC Period Lack of Efficacy	0	1
16-Week DBVC Period Lost to Follow-up	2	1
16-Week DBVC Period Protocol Violation	4	2
16-Week DBVC Period Withdrawal by Subject	4	11
16-Week OLE Period Death	1	0
16-Week OLE Period Lost to Follow-up	1	1
16-Week OLE Period Protocol Violation	0	1
16-Week OLE Period Withdrawal by Subject	6	4

Baseline Characteristics

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.	Total n=186 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 15.11 • n=5 Participants	48.1 years STANDARD_DEVIATION 15.29 • n=7 Participants	48.0 years STANDARD_DEVIATION 15.16 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	83 Participants n=5 Participants	85 Participants n=7 Participants	168 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 16

Population: Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study treatment the participant might have applied during their participation in the study. Missing post-Baseline values were imputed as nonresponders.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16	53.2 percentage of participants Interval 42.6 to 63.6	10.9 percentage of participants Interval 5.3 to 19.1

SECONDARY outcome

Timeframe: Baseline; Weeks 4 and 16

Population: ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. Missing post-Baseline values were imputed as nonresponders at Weeks 4 and 16.

ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch).

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=91 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 Week 4	46.7 percentage of participants Interval 36.3 to 57.4	17.6 percentage of participants Interval 10.4 to 27.0
Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 Week 16	52.2 percentage of participants Interval 41.5 to 62.7	23.1 percentage of participants Interval 14.9 to 33.1

SECONDARY outcome

Timeframe: Baseline; Day 3; Week 1 (Day 7)

Population: ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=88 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=90 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) Day 3	12.9 percentage of participants Interval 6.6 to 22.0	6.0 percentage of participants Interval 2.0 to 13.5
Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) Week 1 (Day 7)	28.0 percentage of participants Interval 18.7 to 39.1	9.5 percentage of participants Interval 4.2 to 17.9

SECONDARY outcome

Timeframe: Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32

Population: ITT Population. Only participants with available data were analyzed.

The IGA-CHE is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 2	22.5 percentage of participants Interval 14.3 to 32.6	1.2 percentage of participants Interval 0.0 to 6.3
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 4	37.8 percentage of participants Interval 27.8 to 48.6	4.8 percentage of participants Interval 1.3 to 11.7
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 8	44.3 percentage of participants Interval 33.7 to 55.3	3.8 percentage of participants Interval 0.8 to 10.6
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 12	52.9 percentage of participants Interval 41.9 to 63.7	14.1 percentage of participants Interval 7.3 to 23.8
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 16	58.1 percentage of participants Interval 47.0 to 68.7	12.8 percentage of participants Interval 6.3 to 22.3
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 24	51.2 percentage of participants Interval 39.9 to 62.4	51.4 percentage of participants Interval 39.4 to 63.1
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Week 32	52.6 percentage of participants Interval 40.9 to 64.0	54.8 percentage of participants Interval 42.7 to 66.5

SECONDARY outcome

Timeframe: Baseline; Weeks 1-32

Population: ITT Population. Only participants with available data were analyzed.

The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Baseline	6.68 scores on a scale Standard Deviation 1.619	6.63 scores on a scale Standard Deviation 1.592
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 2	-3.03 scores on a scale Standard Deviation 2.346	-1.34 scores on a scale Standard Deviation 1.725
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 4	-3.88 scores on a scale Standard Deviation 2.275	-2.02 scores on a scale Standard Deviation 2.062
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 8	-4.23 scores on a scale Standard Deviation 2.437	-2.20 scores on a scale Standard Deviation 2.353
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 12	-4.41 scores on a scale Standard Deviation 2.315	-2.51 scores on a scale Standard Deviation 2.350
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 16	-4.24 scores on a scale Standard Deviation 2.279	-2.47 scores on a scale Standard Deviation 2.226
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 24	-4.23 scores on a scale Standard Deviation 2.400	-4.85 scores on a scale Standard Deviation 2.323
Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit Change from Baseline at Week 32	-4.41 scores on a scale Standard Deviation 2.163	-5.01 scores on a scale Standard Deviation 2.095

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. The 95% confidence interval was calculated based on the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=88 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=90 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score	15.0 days Interval 12.0 to 18.0	29.0 days Interval 17.0 to 73.0

SECONDARY outcome

Timeframe: Baseline; Weeks 1-32

Population: ITT Population. Only participants with available data were analyzed.

The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Baseline	6.14 scores on a scale Standard Deviation 2.164	6.06 scores on a scale Standard Deviation 1.754
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 2	-2.86 scores on a scale Standard Deviation 2.433	-1.27 scores on a scale Standard Deviation 1.671
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 4	-3.82 scores on a scale Standard Deviation 2.435	-1.83 scores on a scale Standard Deviation 1.929
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 8	-4.15 scores on a scale Standard Deviation 2.625	-1.95 scores on a scale Standard Deviation 2.118
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 12	-4.25 scores on a scale Standard Deviation 2.415	-2.21 scores on a scale Standard Deviation 2.206
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 16	-4.23 scores on a scale Standard Deviation 2.627	-2.32 scores on a scale Standard Deviation 2.036
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 24	-4.25 scores on a scale Standard Deviation 2.584	-4.47 scores on a scale Standard Deviation 2.261
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Change from Baseline at Week 32	-4.37 scores on a scale Standard Deviation 2.524	-4.61 scores on a scale Standard Deviation 2.112

SECONDARY outcome

Timeframe: Baseline; up to Week 16

Population: ITT Population. Participants with a Baseline Pain NRS Score ≥2 were analyzed. Only participants with available data were analyzed. The 95% confidence interval was calculated using the method by Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=91 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=89 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 2	59.0 percentage of participants Interval 47.693 to 69.715	34.1 percentage of participants Interval 24.027 to 45.449
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 4	76.7 percentage of participants Interval 66.394 to 85.179	47.5 percentage of participants Interval 36.213 to 58.977
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 8	74.4 percentage of participants Interval 63.555 to 83.396	52.0 percentage of participants Interval 40.151 to 63.686
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 12	84.0 percentage of participants Interval 73.719 to 91.45	53.5 percentage of participants Interval 41.287 to 65.452
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 16	81.9 percentage of participants Interval 71.106 to 90.021	58.6 percentage of participants Interval 46.166 to 70.228
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 24	83.3 percentage of participants Interval 72.133 to 91.375	90.2 percentage of participants Interval 79.81 to 96.304
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Week 32	86.8 percentage of participants Interval 76.356 to 93.765	88.3 percentage of participants Interval 77.428 to 95.179

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Participants with a Baseline Pain NRS Score ≥2 were analyzed. The 95% confidence interval was calculated using the method by Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=90 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score	5.0 days Interval 4.0 to 7.0	8.0 days Interval 5.0 to 12.0

SECONDARY outcome

Timeframe: Baseline; up to Week 16

Population: ITT Population. Only participants with available data were analyzed.

The HECSI divides the hand into 5 areas for assessment (fingertips, fingers \[except the tips\], palms, back of hands, and wrists). Each of the 5 areas of the hand are assessed separately for erythema, induration/papulation, vesicles, fissuring, scaling, and edema using the following scale: 0, no skin changes; 1, mild disease; 2, moderate disease; and 3, severe disease. To determine the HECSI score, the affected area for each location (total of both hands) is given a score from 0 to 4 (0, 0%; 1, 1%-25%; 2, 26%-50%; 3, 51%-75%; and 4, 76%-100%) based on the extent of clinical symptoms. Finally, the score given for the extent at each location is multiplied by the total sum of the intensity of each clinical feature to calculate the total HECSI score, varying from 0 to a maximum severity score of 360 points. Percentage change was calculated as the (\[post-Baseline value minus the Baseline value\]/\[Baseline value\]) \* 100.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=90 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Week 2	-54.93 percentage change Standard Deviation 34.148	-16.68 percentage change Standard Deviation 50.066
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Week 4	-69.58 percentage change Standard Deviation 37.852	-26.00 percentage change Standard Deviation 58.790
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Week 8	-77.25 percentage change Standard Deviation 29.583	-33.81 percentage change Standard Deviation 62.468
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Week 12	-78.65 percentage change Standard Deviation 37.390	-41.00 percentage change Standard Deviation 50.605
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Week 16	-84.88 percentage change Standard Deviation 22.971	-37.61 percentage change Standard Deviation 54.760

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Only participants with available data were analyzed.

The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE. Participants were asked to select 1 response from the response options that best described the overall change in their CHE since they started study treatment: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse, and 7, very much worse.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 32	1.57 scores on a scale Standard Deviation 0.932	1.67 scores on a scale Standard Deviation 0.877
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 2	1.85 scores on a scale Standard Deviation 0.824	3.21 scores on a scale Standard Deviation 1.309
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 4	1.74 scores on a scale Standard Deviation 0.897	3.09 scores on a scale Standard Deviation 1.288
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 8	1.64 scores on a scale Standard Deviation 0.784	3.04 scores on a scale Standard Deviation 1.344
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 12	1.60 scores on a scale Standard Deviation 0.851	3.04 scores on a scale Standard Deviation 1.399
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 16	1.61 scores on a scale Standard Deviation 0.893	3.00 scores on a scale Standard Deviation 1.308
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Week 24	1.61 scores on a scale Standard Deviation 0.750	1.73 scores on a scale Standard Deviation 0.931

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Only participants with available data were analyzed.

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The questionnaire was analyzed under 6 subscales as follows: symptoms and feelings (Questions 1 and 2); daily activities (Questions 3 and 4); leisure (Questions 5 and 6); work and school (Question 7); personal relations (Questions 8 and 9); and treatment (Question 10). Scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0 (Question 7: "Prevented work or studying" = Yes = 3). The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Baseline	13.17 scores on a scale Standard Deviation 6.277	11.84 scores on a scale Standard Deviation 5.896
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 2	-7.95 scores on a scale Standard Deviation 5.046	-3.62 scores on a scale Standard Deviation 4.065
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 4	-8.68 scores on a scale Standard Deviation 5.517	-4.78 scores on a scale Standard Deviation 5.116
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 8	-9.11 scores on a scale Standard Deviation 5.837	-5.32 scores on a scale Standard Deviation 4.977
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 12	-9.38 scores on a scale Standard Deviation 5.905	-5.88 scores on a scale Standard Deviation 5.964
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 16	-9.62 scores on a scale Standard Deviation 6.055	-5.36 scores on a scale Standard Deviation 5.441
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 24	-8.97 scores on a scale Standard Deviation 6.457	-8.71 scores on a scale Standard Deviation 5.517
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 32	-9.71 scores on a scale Standard Deviation 5.675	-9.34 scores on a scale Standard Deviation 5.550

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Only participants with available data were analyzed.

The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems; Level 2 = slight problems; Level 3 = moderate problems; Level 4 = severe problems; and Level 5 = extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score).

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 2, Level 4	2 Participants	11 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 2, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 4, Level 1	37 Participants	15 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 4, Level 2	38 Participants	38 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 4, Level 3	9 Participants	25 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 4, Level 4	2 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 4, Level 5	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 8, Level 1	46 Participants	22 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 8, Level 2	29 Participants	36 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 8, Level 3	10 Participants	13 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 8, Level 4	0 Participants	7 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 8, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 12, Level 1	40 Participants	20 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 12, Level 2	30 Participants	37 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 12, Level 3	9 Participants	16 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 12, Level 4	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 12, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 16, Level 1	42 Participants	20 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 16, Level 2	28 Participants	38 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 16, Level 3	6 Participants	14 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 16, Level 4	4 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 16, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 24, Level 1	42 Participants	40 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 24, Level 2	26 Participants	22 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 24, Level 3	7 Participants	7 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 24, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 24, Level 5	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 32, Level 1	35 Participants	39 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 32, Level 2	27 Participants	22 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 32, Level 3	7 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 32, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 32, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Baseline, Level 1	39 Participants	41 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Baseline, Level 2	28 Participants	28 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Baseline, Level 3	16 Participants	11 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Baseline, Level 4	5 Participants	9 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Baseline, Level 5	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 2, Level 1	56 Participants	43 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 2, Level 2	22 Participants	29 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 2, Level 3	6 Participants	8 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 2, Level 4	2 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 2, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 4, Level 1	53 Participants	46 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 4, Level 2	24 Participants	24 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 4, Level 3	7 Participants	6 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 4, Level 4	2 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 4, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 8, Level 1	57 Participants	46 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 8, Level 2	23 Participants	24 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 8, Level 3	3 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 8, Level 4	1 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 8, Level 5	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 12, Level 1	58 Participants	46 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 12, Level 2	15 Participants	19 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 12, Level 3	5 Participants	7 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 12, Level 4	1 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 12, Level 5	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 16, Level 1	54 Participants	46 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 16, Level 2	19 Participants	23 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 16, Level 3	4 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 16, Level 4	3 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 16, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 24, Level 1	54 Participants	50 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 24, Level 2	17 Participants	15 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 24, Level 3	3 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 24, Level 4	1 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 24, Level 5	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 32, Level 1	44 Participants	54 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 32, Level 2	20 Participants	11 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 32, Level 3	3 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 32, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Anxiety/depression; Week 32, Level 5	2 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 12, Level 2	7 Participants	9 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 12, Level 3	5 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 12, Level 4	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 12, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 16, Level 1	69 Participants	64 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Baseline, Level 1	70 Participants	73 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Baseline, Level 2	14 Participants	8 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Baseline, Level 3	5 Participants	6 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Baseline, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Baseline, Level 5	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 2, Level 1	74 Participants	70 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 2, Level 2	4 Participants	9 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 2, Level 3	4 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 2, Level 4	2 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 2, Level 5	2 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 4, Level 1	69 Participants	68 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 4, Level 2	13 Participants	9 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 4, Level 3	4 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 4, Level 4	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 4, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 8, Level 1	71 Participants	70 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 8, Level 2	14 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 8, Level 3	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 8, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 8, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 12, Level 1	67 Participants	63 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 16, Level 2	7 Participants	9 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 16, Level 3	4 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 16, Level 4	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 16, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 24, Level 1	65 Participants	60 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 24, Level 2	6 Participants	8 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 24, Level 3	4 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 24, Level 4	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 24, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 32, Level 1	61 Participants	55 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 32, Level 2	5 Participants	7 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 32, Level 3	3 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 32, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Mobility; Week 32, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Baseline, Level 1	55 Participants	61 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Baseline, Level 2	24 Participants	21 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Baseline, Level 3	5 Participants	6 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Baseline, Level 4	5 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Baseline, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 2, Level 1	73 Participants	64 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 2, Level 2	10 Participants	13 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 2, Level 3	3 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 2, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 2, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 4, Level 1	69 Participants	57 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 4, Level 2	14 Participants	19 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 4, Level 3	3 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 4, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 4, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 8, Level 1	76 Participants	57 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 8, Level 2	6 Participants	15 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 8, Level 3	3 Participants	6 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 8, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 8, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 12, Level 1	72 Participants	61 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 12, Level 2	8 Participants	10 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 12, Level 3	0 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 12, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 12, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 16, Level 1	72 Participants	59 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 16, Level 2	8 Participants	16 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 16, Level 3	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 16, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 16, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 24, Level 1	70 Participants	64 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 24, Level 2	4 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 24, Level 3	1 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 24, Level 4	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 24, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 32, Level 1	64 Participants	62 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 32, Level 2	3 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 32, Level 3	2 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 32, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Self-care; Week 32, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Baseline, Level 1	25 Participants	38 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Baseline, Level 2	39 Participants	28 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Baseline, Level 3	16 Participants	18 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Baseline, Level 4	8 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Baseline, Level 5	1 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 2, Level 1	51 Participants	37 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 2, Level 2	27 Participants	32 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 2, Level 3	6 Participants	11 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 2, Level 4	2 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 2, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 4, Level 1	53 Participants	42 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 4, Level 2	27 Participants	24 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 4, Level 3	6 Participants	14 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 4, Level 4	0 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 4, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 8, Level 1	65 Participants	47 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 8, Level 2	18 Participants	22 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 8, Level 3	2 Participants	6 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 8, Level 4	0 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 8, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 12, Level 1	60 Participants	45 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 12, Level 2	17 Participants	26 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 12, Level 3	3 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 12, Level 4	0 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 12, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 16, Level 1	61 Participants	42 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 16, Level 2	16 Participants	25 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 16, Level 3	3 Participants	8 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 16, Level 4	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 16, Level 5	0 Participants	1 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 24, Level 1	55 Participants	54 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 24, Level 2	18 Participants	13 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 24, Level 3	2 Participants	3 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 24, Level 4	1 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 24, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 32, Level 1	57 Participants	61 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 32, Level 2	8 Participants	4 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 32, Level 3	4 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 32, Level 4	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Usual activities; Week 32, Level 5	0 Participants	0 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Baseline, Level 1	3 Participants	5 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Baseline, Level 2	28 Participants	28 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Baseline, Level 3	37 Participants	36 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Baseline, Level 4	20 Participants	19 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Baseline, Level 5	1 Participants	2 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 2, Level 1	33 Participants	17 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 2, Level 2	37 Participants	35 Participants
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Pain/discomfort; Week 2, Level 3	14 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline; up to Week 32

Population: ITT Population. Only participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Baseline	74.21 scores on a scale Standard Deviation 18.373	73.93 scores on a scale Standard Deviation 19.255
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 2	8.85 scores on a scale Standard Deviation 18.544	4.05 scores on a scale Standard Deviation 13.191
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 4	10.73 scores on a scale Standard Deviation 19.904	5.38 scores on a scale Standard Deviation 15.042
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 8	10.75 scores on a scale Standard Deviation 19.292	6.92 scores on a scale Standard Deviation 13.006
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 12	10.82 scores on a scale Standard Deviation 20.557	8.80 scores on a scale Standard Deviation 13.343
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 16	10.97 scores on a scale Standard Deviation 20.567	7.67 scores on a scale Standard Deviation 14.160
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 24	12.22 scores on a scale Standard Deviation 21.223	10.00 scores on a scale Standard Deviation 12.444
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Change from Baseline at Week 32	12.34 scores on a scale Standard Deviation 21.430	11.95 scores on a scale Standard Deviation 14.807

SECONDARY outcome

Timeframe: Baseline; up to Week 36

Population: ITT Population. Only participants with available data were analyzed.

The QOLHEQ is a validated disease-specific instrument to assess disease-specific health-related quality of life in participants suffering from CHE over the past 7 days. It consists of 30 items that are summarized according to impairments for 4 subscales: symptoms, emotions, limitations in functioning, and treatment and prevention. Each item is scored on a scale of never, rarely, sometimes, often, and all the time. The overall score is calculated by summing all items and ranges from 0 to 117. Higher scores indicate a greater impact on quality of life. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 24	-54.97 scores on a scale Standard Deviation 25.757	-46.60 scores on a scale Standard Deviation 24.862
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 32	-55.59 scores on a scale Standard Deviation 23.885	-50.04 scores on a scale Standard Deviation 24.931
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Safety Follow-up	-48.07 scores on a scale Standard Deviation 26.886	-40.67 scores on a scale Standard Deviation 27.454
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 12	-55.00 scores on a scale Standard Deviation 24.109	-28.95 scores on a scale Standard Deviation 24.322
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 16	-55.76 scores on a scale Standard Deviation 26.741	-29.56 scores on a scale Standard Deviation 25.060
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Baseline	75.19 scores on a scale Standard Deviation 23.864	66.52 scores on a scale Standard Deviation 23.224
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 2	-43.16 scores on a scale Standard Deviation 24.337	-21.98 scores on a scale Standard Deviation 18.408
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 4	-50.22 scores on a scale Standard Deviation 23.579	-25.10 scores on a scale Standard Deviation 21.021
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Change from Baseline at Week 8	-53.69 scores on a scale Standard Deviation 25.377	-28.44 scores on a scale Standard Deviation 22.570

SECONDARY outcome

Timeframe: Baseline; up to Week 36

Population: ITT Population. Only participants with available data were analyzed.

The WPAI-ChHD questionnaire is a patient-reported quantitative assessment of the amount of absenteeism (measured as percentage of work time missed \[PWTM\] due to CHE), presentism, and daily activity impairment (percentage of impairment while working \[PIWW\] due to CHE, percentage of overall work impairment \[POWI\] due to CHE, percentage of activity impairment \[PAI\] due to CHE) attributable to a specific health problem. The WPAI-ChHD is a 6-item questionnaire used to assess the impact of chronic hand dermatitis (ChHD, the same as CHE in this context) on job performance and productivity in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Scores range from 0% (no impairment) to 100% (complete impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Baseline	5.68 percentage Standard Deviation 16.541	2.32 percentage Standard Deviation 7.736
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 2	-4.90 percentage Standard Deviation 12.817	-0.90 percentage Standard Deviation 5.858
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 4	-3.15 percentage Standard Deviation 16.734	0.82 percentage Standard Deviation 11.469
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 8	-3.92 percentage Standard Deviation 19.340	0.03 percentage Standard Deviation 11.714
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 12	-0.72 percentage Standard Deviation 14.356	-1.40 percentage Standard Deviation 9.591
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 16	-0.57 percentage Standard Deviation 22.398	0.06 percentage Standard Deviation 12.294
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 24	-3.09 percentage Standard Deviation 12.916	-0.36 percentage Standard Deviation 13.845
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Week 32	-0.80 percentage Standard Deviation 16.359	-0.83 percentage Standard Deviation 15.108
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PWTM, Change from Baseline at Safety Follow-up	-0.23 percentage Standard Deviation 9.681	-0.67 percentage Standard Deviation 14.285
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Baseline	46.52 percentage Standard Deviation 28.171	38.82 percentage Standard Deviation 26.176
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 2	-26.56 percentage Standard Deviation 26.888	-12.22 percentage Standard Deviation 21.285
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 4	-27.87 percentage Standard Deviation 28.642	-13.87 percentage Standard Deviation 21.375
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 8	-32.22 percentage Standard Deviation 25.365	-13.00 percentage Standard Deviation 22.944
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 12	-32.81 percentage Standard Deviation 27.500	-11.72 percentage Standard Deviation 23.998
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 16	-35.44 percentage Standard Deviation 28.162	-14.33 percentage Standard Deviation 20.031
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 24	-32.96 percentage Standard Deviation 27.584	-28.52 percentage Standard Deviation 24.984
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Week 32	-35.51 percentage Standard Deviation 26.775	-30.21 percentage Standard Deviation 24.796
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PIWW, Change from Baseline at Safety Follow-up	-30.20 percentage Standard Deviation 30.672	-21.67 percentage Standard Deviation 23.730
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Baseline	47.82 percentage Standard Deviation 28.060	40.02 percentage Standard Deviation 26.651
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 2	-27.50 percentage Standard Deviation 26.315	-10.85 percentage Standard Deviation 20.548
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 4	-25.78 percentage Standard Deviation 28.135	-11.08 percentage Standard Deviation 22.539
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 8	-32.66 percentage Standard Deviation 25.633	-10.82 percentage Standard Deviation 21.500
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 12	-32.55 percentage Standard Deviation 29.872	-11.99 percentage Standard Deviation 25.552
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 16	-33.67 percentage Standard Deviation 30.196	-14.10 percentage Standard Deviation 21.897
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 24	-33.95 percentage Standard Deviation 29.526	-28.35 percentage Standard Deviation 29.678
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Week 32	-34.73 percentage Standard Deviation 28.130	-29.59 percentage Standard Deviation 29.227
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up POWI, Change from Baseline at Safety Follow-up	-29.88 percentage Standard Deviation 32.391	-21.20 percentage Standard Deviation 26.726
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Baseline	56.40 percentage Standard Deviation 26.079	49.45 percentage Standard Deviation 24.466
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 2	-30.37 percentage Standard Deviation 26.667	-11.43 percentage Standard Deviation 21.236
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 4	-34.81 percentage Standard Deviation 26.651	-16.71 percentage Standard Deviation 22.611
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 8	-36.25 percentage Standard Deviation 26.259	-17.18 percentage Standard Deviation 24.169
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 12	-39.21 percentage Standard Deviation 26.671	-20.13 percentage Standard Deviation 27.680
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 16	-41.07 percentage Standard Deviation 27.439	-18.70 percentage Standard Deviation 22.381
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 24	-38.47 percentage Standard Deviation 27.304	-35.71 percentage Standard Deviation 26.842
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Week 32	-39.12 percentage Standard Deviation 25.553	-38.36 percentage Standard Deviation 25.382
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up PAI, Change from Baseline at Safety Follow-up	-32.06 percentage Standard Deviation 27.782	-26.27 percentage Standard Deviation 28.542

SECONDARY outcome

Timeframe: up to Week 16

Population: Safety Population: all randomized participants who applied study treatment at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned study treatment.

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period	36 Participants	29 Participants

SECONDARY outcome

Timeframe: up to Week 16

Population: Safety Population

A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period	2 Participants	1 Participants

SECONDARY outcome

Timeframe: up to Week 36

Population: Open-label Evaluable Population: all participants who applied study treatment at least once during the OLE Period

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=84 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=77 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Any TEAE in the OLE Period	10 Participants	25 Participants

SECONDARY outcome

Timeframe: up to Week 36

Population: Open-label Evaluable Population

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=84 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=77 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Any ≥Grade 3 TEAE in the OLE Period	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to Week 16

Population: Safety Population

The investigator determined whether a change was clinically meaningful.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=94 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=92 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to Week 36

Population: Open-label Evaluable Population

The investigator determined whether a change was clinically meaningful.

Outcome measures

Outcome measures
Measure	Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=84 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period.	Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=77 Participants Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period	0 Participants	0 Participants

Adverse Events

Vehicle Cream BID

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Ruxolitinib 1.5% Cream BID

Serious events: 5 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle Cream BID n=92 participants at risk Participants applied matching vehicle cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks.	Ruxolitinib 1.5% Cream BID n=171 participants at risk Participants applied ruxolitinib 1.5% cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks in the DBVC Period and for 16 weeks in the OLE Period. Participants who applied matching vehicle cream BID to CHE for 16 weeks during the DBVC Period and completed the Week 16 assessments with no safety concerns applied ruxolitinib 1.5% cream for 16 weeks during the OLE Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/92 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.58% 1/171 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Cardiac disorders Cardiac arrest	0.00% 0/92 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.58% 1/171 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/92 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.58% 1/171 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/92 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.58% 1/171 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Eye disorders Retinal artery embolism	1.1% 1/92 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.00% 0/171 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Cardiac disorders Sinus node dysfunction	0.00% 0/92 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	0.58% 1/171 • Number of events 1 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.

Other adverse events

Other adverse events
Measure	Vehicle Cream BID n=92 participants at risk Participants applied matching vehicle cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks.	Ruxolitinib 1.5% Cream BID n=171 participants at risk Participants applied ruxolitinib 1.5% cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks in the DBVC Period and for 16 weeks in the OLE Period. Participants who applied matching vehicle cream BID to CHE for 16 weeks during the DBVC Period and completed the Week 16 assessments with no safety concerns applied ruxolitinib 1.5% cream for 16 weeks during the OLE Period.
Infections and infestations Nasopharyngitis	9.8% 9/92 • Number of events 10 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.	5.8% 10/171 • Number of events 13 • up to Week 36 For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER