Psoriasis, Psoriatic Arthritis
Conditions
Keywords
Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence
Brief summary
Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of participants with moderate or severe psoriasis. The purpose of this study was to describe the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate adalimumab efficacy and safety profile.
Detailed description
Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator * Participant has indication of psoriasis systemic therapy * If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: * Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) * Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration * A vasectomized partner * Total abstinence from sexual intercourse * Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion criteria
* Participants who have active infections * Participants enrolled in another study or clinical trial * Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk * History of active tuberculosis (TB), histoplasmosis or listeriosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | A participant is said to have PsA if they meet the following criteria: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions. |
| Percentage of Participants Who Developed Signs or Symptoms of PsA | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA | Baseline up to Visit 4 (month 12) | Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed. |
| Mean Change in Quality of Life (QoL) | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL. |
| Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA. |
| Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). |
| Mean Time to First Occurrence of PsA Signs or Symptoms | Baseline up to Visit 4 (month 12) | The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms. |
| Percentage of Participants With Joint Symptoms | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms. |
| Incidence Rate of PsA Since Psoriasis Diagnosis | Baseline up to Visit 4 (month 12) | The number of new PsA cases were determined by: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA). |
| Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50% | At Baseline, Week 24, and Week 48 | This outcome measure was not calculated. |
| Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) | Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions. |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12) | The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease). |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate or Severe Psoriasis Participants with moderate or severe psoriasis in treatment with adalimumab | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Adverse Event With Treatment Failure | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Other | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Moderate or Severe Psoriasis |
|---|---|
| Age, Continuous | 48.85 Years STANDARD_DEVIATION 14.66 |
| Body Mass Index (BMI) | 28.83 kg/m^2 STANDARD_DEVIATION 5.06 |
| C-Reactive Protein (CRP) (N=10) | 1.39 mg/dl STANDARD_DEVIATION 1.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 34 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment Colombia | 52 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 31 Participants |
| Study Specific Characteristic Current Methotrexate Use | 11 Participants |
| Study Specific Characteristic Participants Who Smoke | 21 Participants |
| Study Specific Characteristic Positive History of Comorbidities | 28 Participants |
| Study Specific Characteristic Presence of Family History of PsA (N=49) | 11 Participants |
| Study Specific Characteristic Presence of Hypertension | 15 Participants |
| Study Specific Characteristic Presence of Metabolic Syndrome | 8 Participants |
| Study Specific Characteristic Prior Biologic Therapy | 14 Participants |
| Study Specific Characteristic Prior Methotrexate Use | 36 Participants |
| Weight | 78.70 kg STANDARD_DEVIATION 14.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 52 |
| serious Total, serious adverse events | 16 / 52 |
Outcome results
Primary
Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
A participant is said to have PsA if they meet the following criteria: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 3 - Visit 3 (N=39) | 46.2 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 3 - Visit 4 (N=28) | 35.7 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 1 - Visit 3 (N=38) | 47.4 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 1 - Visit 4 (N=28) | 35.7 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 2 - Baseline | 17.3 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 2 - Visit 3 (N=39) | 10.3 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | Definition 2 - Visit 4 (N=28) | 3.6 Percentage of participants |
Primary
Percentage of Participants Who Developed Signs or Symptoms of PsA
Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Signs or Symptoms of PsA | Baseline | 61.2 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Signs or Symptoms of PsA | Visit 3 (N=39) | 33.3 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants Who Developed Signs or Symptoms of PsA | Visit 4 (N=28) | 25.0 Percentage of participants |
Secondary
Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%
This outcome measure was not calculated.
Time frame: At Baseline, Week 24, and Week 48
Secondary
Incidence Rate of PsA Since Psoriasis Diagnosis
The number of new PsA cases were determined by: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA).
Time frame: Baseline up to Visit 4 (month 12)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moderate or Severe Psoriasis | Incidence Rate of PsA Since Psoriasis Diagnosis | 2.66 new PsA cases per 100 person years |
Secondary
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).
Time frame: At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate or Severe Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Baseline | 17.42 PASI score | Standard Deviation 12.11 |
| Moderate or Severe Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Change from Baseline at Visit 2 (N=51) | -11.56 PASI score | Standard Deviation 11.96 |
| Moderate or Severe Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Change from Baseline at Visit 3 (N=47) | -13.12 PASI score | Standard Deviation 12.69 |
| Moderate or Severe Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | Change from Baseline at Visit 4 (N=41) | -15.17 PASI score | Standard Deviation 12.69 |
Secondary
Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score
The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate or Severe Psoriasis | Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | Baseline | 2.82 CASPAR score | Standard Deviation 0.73 |
| Moderate or Severe Psoriasis | Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | Change from Baseline at Visit 3 (N=38) | 0.05 CASPAR score | Standard Deviation 0.73 |
| Moderate or Severe Psoriasis | Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | Change from Baseline at Visit 4 (N=27) | -0.07 CASPAR score | Standard Deviation 0.83 |
Secondary
Mean Change in Quality of Life (QoL)
The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in RE at Visit 4 (N=42) | 15.67 Score on scale | Standard Deviation 34.05 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Physical Functioning (PF) at Baseline | 78.46 Score on scale | Standard Deviation 28.66 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in PF at Visit 3 (N=47) | -1.52 Score on scale | Standard Deviation 25.8 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in PF at Visit 4 (N=47) | -0.95 Score on scale | Standard Deviation 24.92 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Role-Physical (RP) at Baseline | 68.75 Score on scale | Standard Deviation 26.89 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in RP at Visit 3 (N=47) | 6.52 Score on scale | Standard Deviation 26.67 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in RP at Visit 4 (N=42) | 6.55 Score on scale | Standard Deviation 35.16 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Bodily Pain (BP) at Baseline (N=51) | 66.78 Score on scale | Standard Deviation 29.73 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in BP at Visit 3 (N=47) | -0.87 Score on scale | Standard Deviation 32.08 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in BP at Visit 4 (N=42) | 9.10 Score on scale | Standard Deviation 34.82 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | General Health (GH) at Baseline | 57.88 Score on scale | Standard Deviation 23.55 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in GH at Visit 3 (N=46) | 8.24 Score on scale | Standard Deviation 28.3 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in GH at Visit 4 (N=42) | 12.95 Score on scale | Standard Deviation 31.45 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Vitality at Baseline | 60.58 Score on scale | Standard Deviation 24.37 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in vitality at Visit 3 (N=47) | 2.13 Score on scale | Standard Deviation 24.18 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline vitality at Visit 4 (N=42) | 5.51 Score on scale | Standard Deviation 30.78 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Social Functioning (SF) at Baseline | 66.35 Score on scale | Standard Deviation 31.07 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in SF at Visit 3 (N=47) | 13.56 Score on scale | Standard Deviation 29.24 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in SF at Visit 4 (N=42) | 13.39 Score on scale | Standard Deviation 36.98 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Role-Emotional (RE) at Baseline | 68.11 Score on scale | Standard Deviation 28.47 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in RE at Visit 3 (N=47) | 6.03 Score on scale | Standard Deviation 29.47 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Mental Health (MH) at Baseline | 64.13 Score on scale | Standard Deviation 25.7 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in MH at Visit 3 (N=47) | 6.28 Score on scale | Standard Deviation 24.33 |
| Moderate or Severe Psoriasis | Mean Change in Quality of Life (QoL) | Change from Baseline in MH at Visit 4 (N=42) | 5.45 Score on scale | Standard Deviation 30.73 |
Secondary
Mean Time to First Occurrence of PsA Signs or Symptoms
The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.
Time frame: Baseline up to Visit 4 (month 12)
Population: Participants who completed at least one of the follow up visits to the rheumatologist.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Moderate or Severe Psoriasis | Mean Time to First Occurrence of PsA Signs or Symptoms | 23.17 Years |
Secondary
Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist
The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point).
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | Baseline | 67.30 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | Visit 3 (N=39) | 64.10 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | Visit 4 (N=28) | 71.40 Percentage of participants |
Secondary
Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA
Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.
Time frame: Baseline up to Visit 4 (month 12)
Population: Participants who completed at least one of the follow up visits to the rheumatologist.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA | Non-PsA participants (N=25) | 60.0 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA | PsA participants (N=19) | 52.6 Percentage of participants |
Secondary
Percentage of Participants With Joint Symptoms
Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants With Joint Symptoms | Baseline | 61.20 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Joint Symptoms | Visit 3 (N=39) | 30.80 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Joint Symptoms | Visit 4 (N=28) | 25.00 Percentage of participants |
Secondary
Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero
Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Population: Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | SJC at Baseline | 24.50 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | SJC at Visit 3 (N=39) | 12.80 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | SJC at Visit 4 (N=28) | 7.10 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | TJC at Baseline | 36.70 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | TJC at Visit 3 (N=39) | 20.50 Percentage of participants |
| Moderate or Severe Psoriasis | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | TJC at Visit 4 (N=28) | 14.30 Percentage of participants |