injection

injection

injection

The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)

100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)

100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)

100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)

100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).

100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).

eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).

The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability

eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).

The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability

C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.

CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation

C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.

CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.

Change from Baseline in C-Reactive Protein.

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.

The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).

DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health

A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:

1. tender joint count ≤1;

2. swollen joint count ≤1;

3. PASI score ≤1 or BSA ≤3%;

4. patient Arthritis Pain (VAS)

   ≤15 mm;

5. patient's global arthritis assessment (VAS) ≤20 mm;

6. HAQ-DI score ≤0.5;

7. tender entheseal points (using LEI) ≤1.

tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)

Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score

Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45

The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.

Lower Leeds Dactylitis Index score represent better outcome.

tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)

Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score

Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45

The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.

Lower Leeds Dactylitis Index score represent better outcome.

The LEI examines tenderness at 6 sites:

2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.

Lower the score better is the outcome

The LEI examines tenderness at 6 sites:

2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.

Lower the score better is the outcome

Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks

Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48

Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48

Total of all reporting groups

Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks

Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks

Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks

Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks

The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Full Analysis Set

The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set.

ACR50 Response Rates up to Week 52 Full Analysis Set.

The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set ACR70 Response Rates up to Week 52 Full Analysis Set.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Full Analysis Set

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

Full Analysis Set

100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)

100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)

Full Analysis Set

100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)

100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)

Full Analysis Set

100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).

Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Patient's Pain Assessment up to Week 24 - (No Imputation) Full Analysis Set

100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).

Full Analysis Set

eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).

The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability

eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).

The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability

Full Analysis Set

C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.

CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation

Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set

C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.

CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.

Change from Baseline in C-Reactive Protein.

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.

Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.

Full Analysis Set

Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set

The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).

DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health

Cochran-Mantel-Haenszel Analysis of DAS28-CRP Response Rates up to Week 24 Full Analysis Set.

DAS28-CRP Response Rates up to Week 52-Full Analysis Set

A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:

1. tender joint count ≤1;

2. swollen joint count ≤1;

3. PASI score ≤1 or BSA ≤3%;

4. patient Arthritis Pain (VAS)

   ≤15 mm;

5. patient's global arthritis assessment (VAS) ≤20 mm;

6. HAQ-DI score ≤0.5;

7. tender entheseal points (using LEI) ≤1.

Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set.

MDA Response Rates up to Week 52- Full Analysis Set