Psoriasis
Conditions
Keywords
Psoriatic arthritis, PsA, Psoriasis, PsO, Early arthritis for psoriatic patients, EARP, Classification criteria for psoriatic arthritis, CASPAR
Brief summary
This was a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional study to evaluate the detection rate of Psoriatic arthritis (PsA) in Korean moderate to severe Psoriasis (PsO) patients with or without the Early arthritis for psoriatic patients (EARP) screening.
Detailed description
All procedures for each patient were performed for one day. If an additional time was required depending on the circumstances of the institution and so on, the data specified in this study protocol were recommended to be collected as soon as possible. After the participants enrolled in this study, they were assessed whether they met the inclusion/exclusion criteria. In terms of the severity of PsO, it was assessed with the Psoriasis Area and Severity Index (PASI) and if the score of 10 or higher was defined as moderate to severe PsO. A total 368 eligible participants were randomized 1:1 ratio into the EARP group and the Routine practice group. For the EARP group, the investigator asked the participants about the EARP questionnaire consisting of 10 questions. When the EARP score \>= 3, the participants were suspected for having potential PsA. For Routine practice group, the investigator selected the participants suspected of PsA in consideration of the various clinical characteristics of the participants. 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.
Interventions
DIAGNOSTIC_TESTRoutine practice group
Routine practice group
DIAGNOSTIC_TESTEARP group
EARP group
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient who is \>= 19 years of age at the time of study enrollment * Patient who had an established diagnosis of PsO based upon clinical evidence and documented medical history * Patient who is moderate to severe PsO (Psoriasis Area and Severity Index (PASI) score \>= 10) * Patient who is willing and able to comply with study procedures * Patient who is able to provide the informed consent form (ICF)
Exclusion criteria
* Patients who have formal pre-existing diagnosis of PsA * Patients who have ever received treatment with biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) * Patients who currently receive systemic glucocorticoids * Patients who currently receive opioid analgesics * Patients who has other known pre-existing dermatological or rheumatological diseases: * Non-plaque psoriasis * Rheumatoid arthritis * Osteoarthritis * Gout * Reactive arthritis * Ankylosing spondylitis * Axial spondyloarthritis * Enteropathic arthritis * Plantar fasciitis * Systemic lupus erythematosus (SLE) * Female patients who are pregnant * Patients who are participating in other interventional clinical trials * Patients who have already had PsA screening via screening questionnaires or imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Psoriatic Arthritis (PsA) | Visit 1 (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Age characteristics between patients with PsA and without PsA were analyzed and compared. |
| Gender Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Gender characteristics between patients with PsA and without PsA were analyzed and compared. |
| Body Mass Index (BMI) Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared. |
| Drinking and Smoking History Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared. |
| Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared. |
| Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared. |
| Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group) | Visit 1 (Day 1) | 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). |
| The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | 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. |
| Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | 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). |
| SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | 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. |
| Solicited Medical History by Participants With or Without PsA | Visit 1 (Day 1) | 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. |
| Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Visit 1 (Day 1) | 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. |
| Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA | Visit 1 (Day 1) | 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). |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at 15 centers in the Republic of Korea.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 181 |
| 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. | 187 |
| Total | 368 |
Baseline characteristics
| Characteristic | Routine Practice Group | Total | EARP Group |
|---|---|---|---|
| Age, Continuous | 43.48 Years STANDARD_DEVIATION 14.11 | 44.33 Years STANDARD_DEVIATION 14.56 | 45.22 Years STANDARD_DEVIATION 15 |
| Body Mass Index (BMI) | 25.54 kg/m^2 STANDARD_DEVIATION 4.38 | 25.70 kg/m^2 STANDARD_DEVIATION 4.51 | 25.87 kg/m^2 STANDARD_DEVIATION 4.65 |
| Drinking history Current | 107 Participants | 206 Participants | 99 Participants |
| Drinking history Never | 34 Participants | 69 Participants | 35 Participants |
| Drinking history Past | 46 Participants | 93 Participants | 47 Participants |
| Duration of Psoriasis (PsO) | 114.20 months STANDARD_DEVIATION 126.14 | 119.19 months STANDARD_DEVIATION 127.56 | 124.33 months STANDARD_DEVIATION 129.16 |
| Height | 171.48 cm STANDARD_DEVIATION 8.58 | 170.29 cm STANDARD_DEVIATION 8.8 | 169.07 cm STANDARD_DEVIATION 8.87 |
| Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) No | 66 Participants | 130 Participants | 64 Participants |
| Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) Yes | 121 Participants | 238 Participants | 117 Participants |
| Presence or absence of musculoskeletal symptoms No | 143 Participants | 282 Participants | 139 Participants |
| Presence or absence of musculoskeletal symptoms Yes | 44 Participants | 86 Participants | 42 Participants |
| Psoriasis Area and Severity Index (PASI) category 10 to <12 | 98 Participants | 191 Participants | 93 Participants |
| Psoriasis Area and Severity Index (PASI) category 12 to <14 | 33 Participants | 72 Participants | 39 Participants |
| Psoriasis Area and Severity Index (PASI) category 14 to <16 | 21 Participants | 34 Participants | 13 Participants |
| Psoriasis Area and Severity Index (PASI) category 16 to <18 | 15 Participants | 29 Participants | 14 Participants |
| Psoriasis Area and Severity Index (PASI) category 18 to <20 | 2 Participants | 7 Participants | 5 Participants |
| Psoriasis Area and Severity Index (PASI) category >= 20 | 18 Participants | 35 Participants | 17 Participants |
| Psoriasis Area and Severity Index (PASI) score | 13.70 Unit on a scale STANDARD_DEVIATION 4.98 | 13.63 Unit on a scale STANDARD_DEVIATION 4.88 | 13.55 Unit on a scale STANDARD_DEVIATION 4.78 |
| Psoriasis (PsO) family history No | 159 Participants | 314 Participants | 155 Participants |
| Psoriasis (PsO) family history Yes | 28 Participants | 54 Participants | 26 Participants |
| Psoriatic Arthritis (PsA) family history No | 187 Participants | 364 Participants | 177 Participants |
| Psoriatic Arthritis (PsA) family history Yes | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 187 Participants | 368 Participants | 181 Participants |
| Sex: Female, Male Female | 35 Participants | 99 Participants | 64 Participants |
| Sex: Female, Male Male | 152 Participants | 269 Participants | 117 Participants |
| SJC66/TJC68 total joint count SJC66 joint count | 0.77 Joint count STANDARD_DEVIATION 4.45 | 0.88 Joint count STANDARD_DEVIATION 4.67 | 1.00 Joint count STANDARD_DEVIATION 4.89 |
| SJC66/TJC68 total joint count SJC66/TJC68 total joint count | 1.89 Joint count STANDARD_DEVIATION 8.53 | 2.10 Joint count STANDARD_DEVIATION 8.74 | 2.32 Joint count STANDARD_DEVIATION 8.97 |
| SJC66/TJC68 total joint count TJC68 joint count | 1.12 Joint count STANDARD_DEVIATION 4.55 | 1.22 Joint count STANDARD_DEVIATION 4.54 | 1.32 Joint count STANDARD_DEVIATION 4.53 |
| Smoking history Current | 91 Participants | 171 Participants | 80 Participants |
| Smoking history Never | 67 Participants | 138 Participants | 71 Participants |
| Smoking history Past | 29 Participants | 59 Participants | 30 Participants |
| Total Nail Psoriasis Severity Index (NAPSI) score NAPSI score of left foot | 5.71 Unit on a scale STANDARD_DEVIATION 10.35 | 4.73 Unit on a scale STANDARD_DEVIATION 9.44 | 3.71 Unit on a scale STANDARD_DEVIATION 8.3 |
| Total Nail Psoriasis Severity Index (NAPSI) score NAPSI score of left hand | 5.56 Unit on a scale STANDARD_DEVIATION 9.14 | 5.14 Unit on a scale STANDARD_DEVIATION 8.55 | 4.71 Unit on a scale STANDARD_DEVIATION 7.91 |
| Total Nail Psoriasis Severity Index (NAPSI) score NAPSI score of right foot | 5.95 Unit on a scale STANDARD_DEVIATION 10.46 | 4.99 Unit on a scale STANDARD_DEVIATION 9.41 | 4.01 Unit on a scale STANDARD_DEVIATION 8.1 |
| Total Nail Psoriasis Severity Index (NAPSI) score NAPSI score of right hand | 5.85 Unit on a scale STANDARD_DEVIATION 9.68 | 5.24 Unit on a scale STANDARD_DEVIATION 8.88 | 4.61 Unit on a scale STANDARD_DEVIATION 7.94 |
| Total Nail Psoriasis Severity Index (NAPSI) score Total NAPSI score | 23.06 Unit on a scale STANDARD_DEVIATION 36.7 | 20.10 Unit on a scale STANDARD_DEVIATION 33.29 | 17.04 Unit on a scale STANDARD_DEVIATION 29.14 |
| Weight | 75.53 kg STANDARD_DEVIATION 15.66 | 74.98 kg STANDARD_DEVIATION 16.09 | 74.41 kg STANDARD_DEVIATION 16.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Detection Rate of Psoriatic Arthritis (PsA)
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.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EARP Group | Detection Rate of Psoriatic Arthritis (PsA) | 8 Participants |
| Routine Practice Group | Detection Rate of Psoriatic Arthritis (PsA) | 6 Participants |
p-value: 0.54495% CI: [-2.71, 5.13]Chi-squared
Secondary
Age Characteristics by Participants With or Without PsA
Age characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EARP Group | Age Characteristics by Participants With or Without PsA | 48.14 Years | Standard Deviation 12.13 |
| Routine Practice Group | Age Characteristics by Participants With or Without PsA | 44.02 Years | Standard Deviation 14.71 |
Comparison: Age characteristicsp-value: 0.101Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index (BMI) Characteristics by Participants With or Without PsA
Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EARP Group | Body Mass Index (BMI) Characteristics by Participants With or Without PsA | 25.02 kg/m^2 | Standard Deviation 3.38 |
| Routine Practice Group | Body Mass Index (BMI) Characteristics by Participants With or Without PsA | 25.76 kg/m^2 | Standard Deviation 4.59 |
Comparison: Body Mass Index (BMI) characteristicsp-value: 0.52Wilcoxon (Mann-Whitney)
Secondary
Drinking and Smoking History Characteristics by Participants With or Without PsA
Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Past | 4 Participants |
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Current | 20 Participants |
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Never | 4 Participants |
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Current | 12 Participants |
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Past | 6 Participants |
| EARP Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Never | 10 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Past | 53 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Past | 89 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Current | 159 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Current | 186 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Smoking history | Never | 128 Participants |
| Routine Practice Group | Drinking and Smoking History Characteristics by Participants With or Without PsA | Drinking history | Never | 65 Participants |
Comparison: Drinking history characteristicsp-value: 0.216Chi-squared
Comparison: Smoking history characteristicsp-value: 0.719Chi-squared
Secondary
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA
Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EARP Group | Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA | 132.08 months | Standard Deviation 147.33 |
| Routine Practice Group | Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA | 118.12 months | Standard Deviation 125.99 |
Comparison: Duration of Psoriasis (PsO) characteristicsp-value: 0.831Wilcoxon (Mann-Whitney)
Secondary
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EARP Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriasis (PsO) family history | Yes | 6 Participants |
| EARP Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriasis (PsO) family history | No | 22 Participants |
| EARP Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriatic Arthritis (PsA) family history | Yes | 1 Participants |
| EARP Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriatic Arthritis (PsA) family history | No | 27 Participants |
| Routine Practice Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriatic Arthritis (PsA) family history | No | 337 Participants |
| Routine Practice Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriasis (PsO) family history | Yes | 48 Participants |
| Routine Practice Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriatic Arthritis (PsA) family history | Yes | 3 Participants |
| Routine Practice Group | Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA | Psoriasis (PsO) family history | No | 292 Participants |
Comparison: Family history of psoriasis (PsO) characteristicsp-value: 0.274Fisher Exact
Comparison: Family history of psoriatic arthritis (PsA) characteristicsp-value: 0.272Fisher Exact
Secondary
Gender Characteristics by Participants With or Without PsA
Gender characteristics between patients with PsA and without PsA were analyzed and compared.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EARP Group | Gender Characteristics by Participants With or Without PsA | Male | 20 Participants |
| EARP Group | Gender Characteristics by Participants With or Without PsA | Female | 8 Participants |
| Routine Practice Group | Gender Characteristics by Participants With or Without PsA | Male | 249 Participants |
| Routine Practice Group | Gender Characteristics by Participants With or Without PsA | Female | 91 Participants |
Comparison: Gender characteristicsp-value: 0.836Chi-squared
Secondary
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
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).
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EARP Group | 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 11.1 |
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| Routine Practice Group | Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | Total NAPSI score | 18.59 Unit on a scale | Standard Deviation 31.93 |
| Routine Practice Group | Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | NAPSI score of left hand | 4.71 Unit on a scale | Standard Deviation 8.17 |
| Routine Practice Group | Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | NAPSI score of right hand | 4.91 Unit on a scale | Standard Deviation 8.61 |
| Routine Practice Group | Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | NAPSI score of left foot | 4.35 Unit on a scale | Standard Deviation 9 |
| Routine Practice Group | Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA | NAPSI score of right foot | 4.62 Unit on a scale | Standard Deviation 9.13 |
Comparison: NAPSI score of right foot characteristicsp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: NAPSI score of left hand characteristicsp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: NAPSI score of right hand characteristicsp-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: NAPSI score of left foot characteristicsp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Total NAPSI score characteristicsp-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
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.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS). Only participants with PsO related treatment other than medications included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EARP Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | UV light therapy | 2 Participants |
| EARP Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Psoralen with ultraviolet A (PUVA) | 1 Participants |
| EARP Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Phototherapy | 0 Participants |
| EARP Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Laser therapy | 0 Participants |
| Routine Practice Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Laser therapy | 2 Participants |
| Routine Practice Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | UV light therapy | 20 Participants |
| Routine Practice Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Phototherapy | 7 Participants |
| Routine Practice Group | Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA | Psoralen with ultraviolet A (PUVA) | 11 Participants |
Secondary
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA
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).
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EARP Group | Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA | 13.76 Unit on a scale | Standard Deviation 4.68 |
| Routine Practice Group | Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA | 13.62 Unit on a scale | Standard Deviation 4.9 |
Comparison: Psoriasis Area and Severity Index (PASI) score characteristicsp-value: 0.622Wilcoxon (Mann-Whitney)
Secondary
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 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).
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| Routine Practice Group | 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) | 157 Participants |
| Routine Practice Group | 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 | 6 Participants |
| Routine Practice Group | 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) | 6 Participants |
| Routine Practice Group | 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 | 157 Participants |
Comparison: Sensitivityp-value: 0.256Chi-squared
Comparison: Specificityp-value: <0.001Chi-squared
Comparison: Positive Predictive Value (PPV)p-value: 0.336Fisher Exact
Comparison: Negative Predictive Value (NPV)p-value: 0.49Chi-squared
Secondary
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
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.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EARP Group | SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | SJC66 joint count | 5.36 Joint count | Standard Deviation 11.18 |
| EARP Group | SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | TJC68 joint count | 6.00 Joint count | Standard Deviation 9.88 |
| EARP Group | 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 |
| Routine Practice Group | SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | SJC66 joint count | 0.51 Joint count | Standard Deviation 3.44 |
| Routine Practice Group | SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | TJC68 joint count | 0.83 Joint count | Standard Deviation 3.53 |
| Routine Practice Group | SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA | SJC66/TJC68 total joint count | 1.34 Joint count | Standard Deviation 6.57 |
Comparison: SJC66 total joint count characteristicsp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: TJC68 total joint count characteristicsp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: SJC66/TJC68 total joint count characteristicsp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Solicited Medical History by Participants With or Without PsA
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.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EARP Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Never | 25 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Current | 3 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Stroke | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Stroke | Current | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Stroke | Never | 28 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Current | 2 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Never | 26 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Current | 8 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Never | 20 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Current | 9 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Never | 19 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Past | 0 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Current | 2 Participants |
| EARP Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Never | 26 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Current | 62 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Never | 325 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Current | 8 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Heart diseases | Never | 332 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Current | 40 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Stroke | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Never | 278 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Stroke | Current | 3 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hyperlipidemia | Never | 300 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Stroke | Never | 337 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Current | 15 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Hypertension | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Current | 27 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Fatty liver | Past | 0 Participants |
| Routine Practice Group | Solicited Medical History by Participants With or Without PsA | Diabetes | Never | 313 Participants |
Comparison: Heart diseasesp-value: 0.043Fisher Exact
Comparison: Strokep-value: 1Fisher Exact
Comparison: Diabetesp-value: 1Fisher Exact
Comparison: Hyperlipidemiap-value: 0.019Chi-squared
Comparison: Hypertensionp-value: 0.073Chi-squared
Comparison: Fatty liverp-value: 0.377Fisher Exact
Secondary
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
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.
Time frame: Visit 1 (Day 1)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| EARP Group | 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 |
| Routine Practice Group | 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 | 270 Participants |
| Routine Practice Group | 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 | 211 Participants |
| Routine Practice Group | 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 | 70 Participants |
| Routine Practice Group | 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 | 129 Participants |
Comparison: Status of hard-to-treat area involvement characteristicsp-value: <0.001Chi-squared
Comparison: Status of musculoskeletal symptoms characteristicsp-value: <0.001Chi-squared