Trial Outcomes & Findings for A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study) (NCT NCT05758402)
NCT ID: NCT05758402
Last Updated: 2025-05-16
Results Overview
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared. The detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group. The true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score \>= 3 among EARP \>= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.
COMPLETED
NA
368 participants
Visit 1 (Day 1)
2025-05-16
Participant Flow
This study was conducted at 15 centers in the Republic of Korea.
Participants who met all inclusion criteria and none of the exclusion criteria were centrally, randomly allocated with a 1:1 ratio to either the EARP group or the Routine practice group using an Interactive Web Response System (IWRS).
Participant milestones
| Measure |
EARP Group
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
187
|
|
Overall Study
COMPLETED
|
181
|
187
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)
Baseline characteristics by cohort
| Measure |
EARP Group
n=181 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=187 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
Total
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.22 Years
STANDARD_DEVIATION 15.00 • n=5 Participants
|
43.48 Years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
44.33 Years
STANDARD_DEVIATION 14.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
181 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Height
|
169.07 cm
STANDARD_DEVIATION 8.87 • n=5 Participants
|
171.48 cm
STANDARD_DEVIATION 8.58 • n=7 Participants
|
170.29 cm
STANDARD_DEVIATION 8.80 • n=5 Participants
|
|
Weight
|
74.41 kg
STANDARD_DEVIATION 16.54 • n=5 Participants
|
75.53 kg
STANDARD_DEVIATION 15.66 • n=7 Participants
|
74.98 kg
STANDARD_DEVIATION 16.09 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.87 kg/m^2
STANDARD_DEVIATION 4.65 • n=5 Participants
|
25.54 kg/m^2
STANDARD_DEVIATION 4.38 • n=7 Participants
|
25.70 kg/m^2
STANDARD_DEVIATION 4.51 • n=5 Participants
|
|
Drinking history
Current
|
99 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Drinking history
Past
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Drinking history
Never
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Smoking history
Current
|
80 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Smoking history
Past
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Smoking history
Never
|
71 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Duration of Psoriasis (PsO)
|
124.33 months
STANDARD_DEVIATION 129.16 • n=5 Participants
|
114.20 months
STANDARD_DEVIATION 126.14 • n=7 Participants
|
119.19 months
STANDARD_DEVIATION 127.56 • n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) score
|
13.55 Unit on a scale
STANDARD_DEVIATION 4.78 • n=5 Participants
|
13.70 Unit on a scale
STANDARD_DEVIATION 4.98 • n=7 Participants
|
13.63 Unit on a scale
STANDARD_DEVIATION 4.88 • n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
10 to <12
|
93 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
12 to <14
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
14 to <16
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
16 to <18
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
18 to <20
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) category
>= 20
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Psoriasis (PsO) family history
Yes
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Psoriasis (PsO) family history
No
|
155 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Psoriatic Arthritis (PsA) family history
Yes
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Psoriatic Arthritis (PsA) family history
No
|
177 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails)
Yes
|
117 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails)
No
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Presence or absence of musculoskeletal symptoms
Yes
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Presence or absence of musculoskeletal symptoms
No
|
139 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Total Nail Psoriasis Severity Index (NAPSI) score
NAPSI score of left hand
|
4.71 Unit on a scale
STANDARD_DEVIATION 7.91 • n=5 Participants
|
5.56 Unit on a scale
STANDARD_DEVIATION 9.14 • n=7 Participants
|
5.14 Unit on a scale
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Total Nail Psoriasis Severity Index (NAPSI) score
NAPSI score of right hand
|
4.61 Unit on a scale
STANDARD_DEVIATION 7.94 • n=5 Participants
|
5.85 Unit on a scale
STANDARD_DEVIATION 9.68 • n=7 Participants
|
5.24 Unit on a scale
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Total Nail Psoriasis Severity Index (NAPSI) score
NAPSI score of left foot
|
3.71 Unit on a scale
STANDARD_DEVIATION 8.30 • n=5 Participants
|
5.71 Unit on a scale
STANDARD_DEVIATION 10.35 • n=7 Participants
|
4.73 Unit on a scale
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Total Nail Psoriasis Severity Index (NAPSI) score
NAPSI score of right foot
|
4.01 Unit on a scale
STANDARD_DEVIATION 8.10 • n=5 Participants
|
5.95 Unit on a scale
STANDARD_DEVIATION 10.46 • n=7 Participants
|
4.99 Unit on a scale
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Total Nail Psoriasis Severity Index (NAPSI) score
Total NAPSI score
|
17.04 Unit on a scale
STANDARD_DEVIATION 29.14 • n=5 Participants
|
23.06 Unit on a scale
STANDARD_DEVIATION 36.70 • n=7 Participants
|
20.10 Unit on a scale
STANDARD_DEVIATION 33.29 • n=5 Participants
|
|
SJC66/TJC68 total joint count
SJC66 joint count
|
1.00 Joint count
STANDARD_DEVIATION 4.89 • n=5 Participants
|
0.77 Joint count
STANDARD_DEVIATION 4.45 • n=7 Participants
|
0.88 Joint count
STANDARD_DEVIATION 4.67 • n=5 Participants
|
|
SJC66/TJC68 total joint count
TJC68 joint count
|
1.32 Joint count
STANDARD_DEVIATION 4.53 • n=5 Participants
|
1.12 Joint count
STANDARD_DEVIATION 4.55 • n=7 Participants
|
1.22 Joint count
STANDARD_DEVIATION 4.54 • n=5 Participants
|
|
SJC66/TJC68 total joint count
SJC66/TJC68 total joint count
|
2.32 Joint count
STANDARD_DEVIATION 8.97 • n=5 Participants
|
1.89 Joint count
STANDARD_DEVIATION 8.53 • n=7 Participants
|
2.10 Joint count
STANDARD_DEVIATION 8.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared. The detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group. The true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score \>= 3 among EARP \>= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.
Outcome measures
| Measure |
EARP Group
n=181 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=187 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Detection Rate of Psoriatic Arthritis (PsA)
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Sensitivity was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false negative (FN). Specificity was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false positive (FP). Positive predictive value (PPV) was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false positive (FP). Negative predictive value (NPV) was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false negative (FN).
Outcome measures
| Measure |
EARP Group
n=181 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=187 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Specificity
|
129 Participants
|
157 Participants
|
|
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Positive Predictive Value (PPV)
|
8 Participants
|
6 Participants
|
|
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Negative Predictive Value (NPV)
|
129 Participants
|
157 Participants
|
|
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Sensitivity
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Age characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Age Characteristics by Participants With or Without PsA
|
48.14 Years
Standard Deviation 12.13
|
44.02 Years
Standard Deviation 14.71
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Gender characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Gender Characteristics by Participants With or Without PsA
Male
|
20 Participants
|
249 Participants
|
|
Gender Characteristics by Participants With or Without PsA
Female
|
8 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=339 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Body Mass Index (BMI) Characteristics by Participants With or Without PsA
|
25.02 kg/m^2
Standard Deviation 3.38
|
25.76 kg/m^2
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Drinking history · Current
|
20 Participants
|
186 Participants
|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Drinking history · Past
|
4 Participants
|
89 Participants
|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Drinking history · Never
|
4 Participants
|
65 Participants
|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Smoking history · Current
|
12 Participants
|
159 Participants
|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Smoking history · Past
|
6 Participants
|
53 Participants
|
|
Drinking and Smoking History Characteristics by Participants With or Without PsA
Smoking history · Never
|
10 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA
|
132.08 months
Standard Deviation 147.33
|
118.12 months
Standard Deviation 125.99
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Psoriasis (PsO) family history · Yes
|
6 Participants
|
48 Participants
|
|
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Psoriasis (PsO) family history · No
|
22 Participants
|
292 Participants
|
|
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Psoriatic Arthritis (PsA) family history · Yes
|
1 Participants
|
3 Participants
|
|
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Psoriatic Arthritis (PsA) family history · No
|
27 Participants
|
337 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 (0% of involved area) to 6 (90-100% of involved area). Within each area, the severity is estimated by three clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 (none) to 4 (maximum). The sum of all three severity parameters is then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA
|
13.76 Unit on a scale
Standard Deviation 4.68
|
13.62 Unit on a scale
Standard Deviation 4.90
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
The presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) and presence or absence of musculoskeletal symptoms between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) · Yes
|
27 Participants
|
211 Participants
|
|
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) · No
|
1 Participants
|
129 Participants
|
|
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
Presence or absence of musculoskeletal symptoms · Yes
|
16 Participants
|
70 Participants
|
|
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
Presence or absence of musculoskeletal symptoms · No
|
12 Participants
|
270 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
NAPSI score of left hand
|
10.43 Unit on a scale
Standard Deviation 11.21
|
4.71 Unit on a scale
Standard Deviation 8.17
|
|
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
NAPSI score of right hand
|
9.18 Unit on a scale
Standard Deviation 11.10
|
4.91 Unit on a scale
Standard Deviation 8.61
|
|
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
NAPSI score of left foot
|
9.29 Unit on a scale
Standard Deviation 13.06
|
4.35 Unit on a scale
Standard Deviation 9.00
|
|
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
NAPSI score of right foot
|
9.54 Unit on a scale
Standard Deviation 11.57
|
4.62 Unit on a scale
Standard Deviation 9.13
|
|
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
Total NAPSI score
|
38.43 Unit on a scale
Standard Deviation 43.45
|
18.59 Unit on a scale
Standard Deviation 31.93
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=54 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
SJC66 joint count
|
5.36 Joint count
Standard Deviation 11.18
|
0.51 Joint count
Standard Deviation 3.44
|
|
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
TJC68 joint count
|
6.00 Joint count
Standard Deviation 9.88
|
0.83 Joint count
Standard Deviation 3.53
|
|
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
SJC66/TJC68 total joint count
|
11.36 Joint count
Standard Deviation 20.01
|
1.34 Joint count
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS)
The presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver)) between patients with PsA and without PsA were analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=28 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=340 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Solicited Medical History by Participants With or Without PsA
Heart diseases · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Heart diseases · Current
|
3 Participants
|
8 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Heart diseases · Never
|
25 Participants
|
332 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Stroke · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Stroke · Current
|
0 Participants
|
3 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Stroke · Never
|
28 Participants
|
337 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Diabetes · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Diabetes · Current
|
2 Participants
|
27 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Diabetes · Never
|
26 Participants
|
313 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hyperlipidemia · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hyperlipidemia · Current
|
8 Participants
|
40 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hyperlipidemia · Never
|
20 Participants
|
300 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hypertension · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hypertension · Current
|
9 Participants
|
62 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Hypertension · Never
|
19 Participants
|
278 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Fatty liver · Past
|
0 Participants
|
0 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Fatty liver · Current
|
2 Participants
|
15 Participants
|
|
Solicited Medical History by Participants With or Without PsA
Fatty liver · Never
|
26 Participants
|
325 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)Population: Full Analysis Set (FAS). Only participants with PsO related treatment other than medications included.
The presence or absence of PsO related treatment other than medications (UV light therapy, Psoralen with ultraviolet A (PUVA), Phototherapy and Laser therapy and Naturopathy) between patients with PsA and without PsA was analyzed and compared.
Outcome measures
| Measure |
EARP Group
n=3 Participants
For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.
|
Routine Practice Group
n=40 Participants
In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.
|
|---|---|---|
|
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
UV light therapy
|
2 Participants
|
20 Participants
|
|
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
Psoralen with ultraviolet A (PUVA)
|
1 Participants
|
11 Participants
|
|
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
Phototherapy
|
0 Participants
|
7 Participants
|
|
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
Laser therapy
|
0 Participants
|
2 Participants
|
Adverse Events
EARP Group
Routine Practice Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER