Arthritis, Psoriatic, Psoriasis, Skin Diseases, Papulosquamous
Conditions
Keywords
Arthritis
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.
Detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Interventions
DRUGEtanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of psoriatic arthritis
Exclusion criteria
* Sepsis or risk for sepsis, * Acute infection, * Hypersensitivity against Etanercept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Week 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Baseline, Week 52 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate disease activity and \>5.1 = high disease activity. |
| Change From Baseline in Ritchie Index at Week 52 | Baseline, Week 52 | Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness. |
| Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Baseline, Week 52 | Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity. |
| Change From Baseline in C-reactive Protein (CRP) at Week 52 | Baseline, Week 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change From Baseline in Patient Assessment of Itching at Week 52 | Baseline, Week 52 | Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale. |
| Change From Baseline in Patient Assessment of Pain at Week 52 | Baseline, Week 52 | Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale. |
| Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Baseline, Week 52 | SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL. |
| Number of Participants With Nail Involvement | Baseline, Week 12, 52 | Number of participants with psoriatic arthritis affecting the nails are reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 | Baseline, Week 52 | Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Psoriatic Arthritis Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year. | 1,285 |
| Total | 1,285 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 427 |
Baseline characteristics
| Characteristic | Participants With Psoriatic Arthritis |
|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.4 |
| Sex/Gender, Customized Female | 708 participants |
| Sex/Gender, Customized Male | 571 participants |
| Sex/Gender, Customized Missing | 6 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 453 / 1,285 |
| serious Total, serious adverse events | 77 / 1,285 |
Outcome results
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time frame: Baseline up to Week 52
Population: Safety analysis set included all participants who were enrolled in this study and had safety data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Psoriatic Arthritis | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 38.1 percentage of participants |
| Participants With Psoriatic Arthritis | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 6.0 percentage of participants |
Secondary
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Baseline: Physical component (n=1162) | 30.7 units on a scale | Standard Deviation 8.5 |
| Participants With Psoriatic Arthritis | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Baseline: Mental component (n=1162) | 41.4 units on a scale | Standard Deviation 11.7 |
| Participants With Psoriatic Arthritis | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Change at Week 52: Physical component (n=717) | 11.4 units on a scale | Standard Deviation 10.8 |
| Participants With Psoriatic Arthritis | Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 | Change at Week 52: Mental component (n=717) | 7.7 units on a scale | Standard Deviation 12.3 |
Secondary
Change From Baseline in C-reactive Protein (CRP) at Week 52
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in C-reactive Protein (CRP) at Week 52 | Baseline (n=1124) | 1.8 milligram per deciliter (mg/dL) | Standard Deviation 3 |
| Participants With Psoriatic Arthritis | Change From Baseline in C-reactive Protein (CRP) at Week 52 | Change at Week 52 (n=654) | -1.0 milligram per deciliter (mg/dL) | Standard Deviation 3 |
Secondary
Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate disease activity and \>5.1 = high disease activity.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Change at Week 52 (n=629) | -2.2 units on a scale | Standard Deviation 1.5 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 | Baseline (n=1093) | 4.8 units on a scale | Standard Deviation 1.4 |
Secondary
Change From Baseline in Patient Assessment of Itching at Week 52
Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Assessment of Itching at Week 52 | Change at Week 52 (n=838) | -22.7 units on a scale | Standard Deviation 31.8 |
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Assessment of Itching at Week 52 | Baseline (n=1259) | 36.8 units on a scale | Standard Deviation 31.1 |
Secondary
Change From Baseline in Patient Assessment of Pain at Week 52
Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Assessment of Pain at Week 52 | Baseline (n=1276) | 65.7 units on a scale | Standard Deviation 21.6 |
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Assessment of Pain at Week 52 | Change at Week 52 (n=849) | -37.9 units on a scale | Standard Deviation 28.3 |
Secondary
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were greater than (\>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Baseline (n=1227) | 9.7 percentage of BSA | Standard Deviation 15.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 | Change at Week 52 (n=796) | -6.6 percentage of BSA | Standard Deviation 13.4 |
Secondary
Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Baseline (n=1278) | 60.8 millimeter | Standard Deviation 18.8 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 | Change at Week 52 (n=851) | -39.8 millimeter | Standard Deviation 24.2 |
Secondary
Change From Baseline in Ritchie Index at Week 52
Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Ritchie Index at Week 52 | Baseline (n=1267) | 9.9 units on a scale | Standard Deviation 9.8 |
| Participants With Psoriatic Arthritis | Change From Baseline in Ritchie Index at Week 52 | Change at Week 52 (n=851) | -4.1 units on a scale | Standard Deviation 11.9 |
Secondary
Number of Participants With Nail Involvement
Number of participants with psoriatic arthritis affecting the nails are reported.
Time frame: Baseline, Week 12, 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Psoriatic Arthritis | Number of Participants With Nail Involvement | Baseline (n=1271) | 597 participants |
| Participants With Psoriatic Arthritis | Number of Participants With Nail Involvement | Week 12 (n=1121) | 456 participants |
| Participants With Psoriatic Arthritis | Number of Participants With Nail Involvement | Week 52 (n=837) | 259 participants |
Other Pre-specified
Change From Baseline in Patient Global Assessment of Disease Activity at Week 52
Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.
Time frame: Baseline, Week 52
Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 | Baseline (n=1277) | 65.0 millimeter | Standard Deviation 20.6 |
| Participants With Psoriatic Arthritis | Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 | Change at Week 52 (n=852) | -38.1 millimeter | Standard Deviation 27.3 |