Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

Mean 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.

Time frame: 12 Weeks

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.

Time frame: 12-weeks

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.

Time frame: Weeks 12, 24, and 48

Population: 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).

Time frame: Weeks 12, 24, and 48

Population: Part 2 (weeks 13-48) of the study 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.

Time frame: Weeks 12, 24, and 48

Population: Part 2 of the study(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.

Time frame: Weeks 12, 24, and 48

Population: The population from part 2(weeks 13-48) did not include the full analysis population from part 1.

Change 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.

Time frame: 4, 8, 12, 24, 36, and 48

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.

Time frame: Weeks 4, 8, 12, 24, 36, and 48

Population: Part 2 of the study(weeks 13-48) did not include the full analysis population from part 1 of the study.

Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48

Time frame: Weeks 4, 8, 12, 24, 36, and 48

Population: Part 2 of the study took place from week 13-48 and not all subjects that started the study were included in analysis

The 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.

Time frame: Weeks 4, 8, 12, 24, 36, and 48

The 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

Time frame: Weeks 4, 8, 12, 24, 36, and 48

The 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.

Time frame: Weeks 4, 8, 12, 24, 36, and 48

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).

Time frame: Weeks 24, 36, and 48 when compared to baseline (Week 0).