Trial Outcomes & Findings for Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (NCT NCT02134210)
NCT ID: NCT02134210
Last Updated: 2019-06-28
Results Overview
The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
COMPLETED
PHASE3
521 participants
12-weeks
2019-06-28
Participant Flow
Participant milestones
| Measure |
Enbrel (Etanercept)
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
CHS-0214
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
|---|---|---|
|
Part One: Weeks 0-12
STARTED
|
260
|
261
|
|
Part One: Weeks 0-12
COMPLETED
|
241
|
255
|
|
Part One: Weeks 0-12
NOT COMPLETED
|
19
|
6
|
|
Part Two: Weeks 13-48
STARTED
|
241
|
255
|
|
Part Two: Weeks 13-48
COMPLETED
|
211
|
227
|
|
Part Two: Weeks 13-48
NOT COMPLETED
|
30
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Baseline characteristics by cohort
| Measure |
Enbrel (Etanercept)
n=260 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
CHS-0214
n=261 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Total
n=521 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12.86 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
240 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
236 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-weeksThe Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
|
147 participants
|
142 participants
|
PRIMARY outcome
Timeframe: 12 WeeksMean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=226 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
|
-76.7 percentage of change
Standard Deviation 21.1
|
-73.4 percentage of change
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 24, 36, and 48Population: Part 2 of the study took place from week 13-48 and not all subjects that started the study were included in analysis
Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 4
|
-43.2 percentage of change
Standard Deviation 22.63
|
-42.1 percentage of change
Standard Deviation 24.93
|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 8
|
-65.7 percentage of change
Standard Deviation 22.16
|
-62.8 percentage of change
Standard Deviation 24.23
|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 12
|
-77.0 percentage of change
Standard Deviation 20.74
|
-76.0 percentage of change
Standard Deviation 21.96
|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 24
|
-80.8 percentage of change
Standard Deviation 20.43
|
-83.3 percentage of change
Standard Deviation 17.5
|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 36
|
-81.9 percentage of change
Standard Deviation 18.55
|
-82.8 percentage of change
Standard Deviation 20.44
|
|
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Week 48
|
-80.9 percentage of change
Standard Deviation 25.08
|
82.9 percentage of change
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 24, 36, and 48The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48.
Outcome measures
| Measure |
CHS-0214
n=261 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=260 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 8
|
225 Participants
|
213 Participants
|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 12
|
225 Participants
|
213 Participants
|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 24
|
221 Participants
|
204 Participants
|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 36
|
211 Participants
|
195 Participants
|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 48
|
203 Participants
|
178 Participants
|
|
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Week 4
|
228 Participants
|
221 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 24, 36, and 48The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 4 PASI-50
|
89 participants
|
86 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 4 PASI-90
|
6 participants
|
8 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 8 PASI-50
|
173 participants
|
155 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 8 PASI-90
|
28 participants
|
25 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 12 PASI-50
|
200 participants
|
184 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 12 PASI-90
|
69 participants
|
57 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 24 PASI-50
|
201 participants
|
194 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 24 PASI-90
|
99 participants
|
89 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 36 PASI-50
|
197 participants
|
183 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 36 PASI-90
|
93 participants
|
92 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 48 PASI-50
|
189 participants
|
169 participants
|
|
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Week 48 PASI-90
|
91 participants
|
81 participants
|
SECONDARY outcome
Timeframe: 4, 8, 12, 24, 36, and 48Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48. Minimum Value: 0 Maximum Value: 5 The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 4
|
-1.2 score on a scale
Standard Deviation 0.81
|
-1.2 score on a scale
Standard Deviation 0.83
|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 8
|
-1.17 score on a scale
Standard Deviation 0.88
|
-1.8 score on a scale
Standard Deviation 0.94
|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 12
|
-2.1 score on a scale
Standard Deviation 0.97
|
-2.1 score on a scale
Standard Deviation 1.05
|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 24
|
-2.2 score on a scale
Standard Deviation 1.07
|
-2.2 score on a scale
Standard Deviation 1.5
|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 36
|
-2.1 score on a scale
Standard Deviation 1.10
|
-2.2 score on a scale
Standard Deviation 1.17
|
|
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Week 48
|
-2.1 score on a scale
Standard Deviation 1.15
|
-2.1 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 24, 36, and 48The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48; Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders.
Outcome measures
| Measure |
CHS-0214
n=261 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=260 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 4
|
17.2 percentage of participants
|
17.1 percentage of participants
|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 8
|
43.7 percentage of participants
|
39.3 percentage of participants
|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 12
|
60.7 percentage of participants
|
59.1 percentage of participants
|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 24
|
64.7 percentage of participants
|
62.4 percentage of participants
|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 36
|
60.8 percentage of participants
|
64.6 percentage of participants
|
|
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Week 48
|
65.5 percentage of participants
|
62.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 24, 36, and 48Population: Part 2 of the study(weeks 13-48) did not include the full analysis population from part 1 of the study.
Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 8
|
-35.0 units on a scale
Standard Deviation 25.15
|
-37.1 units on a scale
Standard Deviation 25.97
|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 12
|
-45.1 units on a scale
Standard Deviation 27.81
|
-45.7 units on a scale
Standard Deviation 25.62
|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 24
|
-47.2 units on a scale
Standard Deviation 28.98
|
-50.1 units on a scale
Standard Deviation 28.50
|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 36
|
-47.4 units on a scale
Standard Deviation 29.95
|
-46.9 units on a scale
Standard Deviation 29.23
|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 48
|
-48.7 units on a scale
Standard Deviation 30.12
|
-50.0 units on a scale
Standard Deviation 28.29
|
|
Change in Subject's Global Assessment (SGA) of PsO
Week 4
|
-24.0 units on a scale
Standard Deviation 22.59
|
-23.0 units on a scale
Standard Deviation 25.11
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1
Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48 The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It 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
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in DLQI (Dermatology Life Quality Index)
Baseline
|
18.6 score on a scale
Standard Deviation 5.86
|
17.9 score on a scale
Standard Deviation 5.7
|
|
Change in DLQI (Dermatology Life Quality Index)
Week 12
|
-13.4 score on a scale
Standard Deviation 7.18
|
-12.7 score on a scale
Standard Deviation 6.2
|
|
Change in DLQI (Dermatology Life Quality Index)
Week 24
|
-14.4 score on a scale
Standard Deviation 6.85
|
-14.3 score on a scale
Standard Deviation 6.24
|
|
Change in DLQI (Dermatology Life Quality Index)
Week 48
|
-14.3 score on a scale
Standard Deviation 6.81
|
-13.9 score on a scale
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48 The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 24 - Anxiety/Depression
|
-0.7 units on a scale
Standard Deviation 1.06
|
-0.7 units on a scale
Standard Deviation 1.10
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 48 - Mobility
|
-0.3 units on a scale
Standard Deviation 0.90
|
-0.4 units on a scale
Standard Deviation 0.84
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 12 - Mobility
|
-0.3 units on a scale
Standard Deviation 0.83
|
-0.3 units on a scale
Standard Deviation 0.81
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 12 - Self Care
|
-0.3 units on a scale
Standard Deviation 0.73
|
-0.2 units on a scale
Standard Deviation 0.70
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 12 - Usual Activities
|
-0.4 units on a scale
Standard Deviation 0.91
|
-0.6 units on a scale
Standard Deviation 0.94
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 12 - Pain/Discomfort
|
-0.9 units on a scale
Standard Deviation 1.1
|
-0.9 units on a scale
Standard Deviation 1.12
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 12 - Anxiety/Depression
|
-0.7 units on a scale
Standard Deviation 1.01
|
-0.6 units on a scale
Standard Deviation 1.01
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 24 - Mobility
|
-0.3 units on a scale
Standard Deviation 0.80
|
-0.3 units on a scale
Standard Deviation 0.93
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 24 - Self Care
|
-0.3 units on a scale
Standard Deviation 0.75
|
-0.2 units on a scale
Standard Deviation 0.70
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 24 - Usual Activities
|
-0.5 units on a scale
Standard Deviation 0.93
|
-0.6 units on a scale
Standard Deviation 0.96
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 48 - Self Care
|
-0.3 units on a scale
Standard Deviation 0.76
|
-0.3 units on a scale
Standard Deviation 0.70
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 48 - Usual Activities
|
-0.4 units on a scale
Standard Deviation 0.98
|
-0.7 units on a scale
Standard Deviation 0.95
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 48 - Pain/Discomfort
|
-0.8 units on a scale
Standard Deviation 1.13
|
-1.0 units on a scale
Standard Deviation 1.18
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 48 - Anxiety/Depression
|
-0.6 units on a scale
Standard Deviation 1.16
|
-0.7 units on a scale
Standard Deviation 1.08
|
|
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Week 24 - Pain/Discomfort
|
-0.9 units on a scale
Standard Deviation 1.08
|
-1.0 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Part 2 of the study(weeks-13-48) did not include the full analysis population from part 1.
HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Week 12
|
-0.4 units on a scale
Standard Deviation 0.39
|
-0.4 units on a scale
Standard Deviation 0.59
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Week 24
|
-0.5 units on a scale
Standard Deviation 0.42
|
-0.4 units on a scale
Standard Deviation 0.75
|
|
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Week 48
|
-0.4 units on a scale
Standard Deviation 0.59
|
-0.6 units on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: The population from part 2(weeks 13-48) did not include the full analysis population from part 1.
Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only. Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed.
Outcome measures
| Measure |
CHS-0214
n=228 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=228 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Baseline
|
6.2 mg/L
Standard Deviation 8.39
|
11.8 mg/L
Standard Deviation 29.80
|
|
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Week 12
|
-3.3 mg/L
Standard Deviation 6.63
|
-8.9 mg/L
Standard Deviation 32.10
|
|
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Week 24
|
-1.3 mg/L
Standard Deviation 9.69
|
-9.1 mg/L
Standard Deviation 31.98
|
|
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Week 48
|
-2.8 mg/L
Standard Deviation 6.01
|
-11.2 mg/L
Standard Deviation 33.69
|
SECONDARY outcome
Timeframe: Weeks 24, 36, and 48 when compared to baseline (Week 0).The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).
Outcome measures
| Measure |
CHS-0214
n=225 Participants
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
Enbrel (Etanercept)
n=213 Participants
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
|---|---|---|
|
The Proportion of Subjects With a Durability of Response at Week 48
Durability of Response - Yes
|
77.8 percentage of participants
|
77 percentage of participants
|
|
The Proportion of Subjects With a Durability of Response at Week 48
Durability of Response - No
|
22.2 percentage of participants
|
23 percentage of participants
|
Adverse Events
Enbrel (Etanercept)
CHS-0214
Serious adverse events
| Measure |
Enbrel (Etanercept)
n=260 participants at risk
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
CHS-0214
n=261 participants at risk
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
|---|---|---|
|
Gastrointestinal disorders
Fecaloma
|
0.00%
0/260
|
0.38%
1/261
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.38%
1/260
|
0.00%
0/261
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/260
|
0.38%
1/261
|
|
Gastrointestinal disorders
Esophageal Varices Hemorrhage
|
0.38%
1/260
|
0.00%
0/261
|
|
Cardiac disorders
Angina Pectoris
|
0.38%
1/260
|
0.00%
0/261
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/260
|
0.77%
2/261
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/260
|
0.38%
1/261
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.38%
1/260
|
0.00%
0/261
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.38%
1/260
|
0.00%
0/261
|
|
Infections and infestations
Bartholin's Abscess
|
0.00%
0/260
|
0.38%
1/261
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/260
|
0.38%
1/261
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/260
|
0.38%
1/261
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.38%
1/260
|
0.00%
0/261
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian Syndrome
|
0.00%
0/260
|
0.38%
1/261
|
|
General disorders
Chest Pain
|
0.38%
1/260
|
0.00%
0/261
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.38%
1/260
|
0.00%
0/261
|
|
Investigations
Transaminases Increased
|
0.38%
1/260
|
0.00%
0/261
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.38%
1/260
|
0.00%
0/261
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.38%
1/260
|
0.00%
0/261
|
Other adverse events
| Measure |
Enbrel (Etanercept)
n=260 participants at risk
Enbrel 50mg twice weekly times 12 weeks
Etanercept: Head-to-head comparison
|
CHS-0214
n=261 participants at risk
CHS-0214 50mg twice weekly times 12 weeks
CHS-0214
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.2%
42/260
|
15.3%
40/261
|
|
Infections and infestations
Upper Respiratory Infection
|
10.4%
27/260
|
9.2%
24/261
|
|
Vascular disorders
Hypertension
|
5.4%
14/260
|
5.0%
13/261
|
|
Injury, poisoning and procedural complications
Injection Site Reaction
|
17.7%
46/260
|
4.2%
11/261
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.4%
14/260
|
3.8%
10/261
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
13/260
|
3.1%
8/261
|
Additional Information
Barbara K. Finck, MD Chief Medical Officer
Coherus BioSciences, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place