Moderate-to-severe Chronic Plaque Psoriasis
Conditions
Keywords
Moderate Psoriasis, Psoriasis, Severe Psoriasis, Adalimumab, Effectiveness, Safety, Clinical practice
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.
Detailed description
PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
Interventions
None listed
Sponsors
IMS Health
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient 18 years of age or older. * Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use. * Patient gives informed consent in writing.
Exclusion criteria
* Patients who cannot be treated in accordance with the local product label * Patient participating or going to participate in a clinical trial during the study follow-up * Patient with difficulties for adequately reading, understanding and completing a questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF. |
| Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. |
| Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. |
| Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. |
| Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF. |
| Mean Change From Baseline in Body Surface Area (BSA) Affected | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF. |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 | PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | Baseline and every 6 months up to month 24 | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF. |
| Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | Baseline and every 6 months up to month 24 | WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | From time of informed consent to the final visit after 2 years of observation | AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event. |
| Number of Participants With Serious Adverse Events (SAEs) | From time of informed consent to the final visit after 2 years of observation | SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion. See the Reported Adverse Events Section for more details. |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline and every 6 months up to month 24 | DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF. |
Participant flow
Pre-assignment details
A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
Participants by arm
| Arm | Count |
|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice | 532 |
| Total | 532 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 197 |
Baseline characteristics
| Characteristic | Moderate-to-severe Chronic Plaque Psoriasis |
|---|---|
| Age, Continuous | 46.48 years STANDARD_DEVIATION 13.26 |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 314 / 542 |
| serious Total, serious adverse events | 24 / 542 |
Outcome results
Primary
Mean Change From Baseline in Body Surface Area (BSA) Affected
Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 12 | 18.62 percentage of body surface area | Standard Deviation 19.63 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 18 | 18.04 percentage of body surface area | Standard Deviation 19.76 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 1 | 11.24 percentage of body surface area | Standard Deviation 15.51 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 3 | 17.86 percentage of body surface area | Standard Deviation 18.43 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 6 | 18.86 percentage of body surface area | Standard Deviation 19.58 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 9 | 18.75 percentage of body surface area | Standard Deviation 19.73 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Body Surface Area (BSA) Affected | Month 24 | 18.18 percentage of body surface area | Standard Deviation 20.08 |
Primary
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 18 | 10.93 units on a scale | Standard Deviation 9.77 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 1 | 8.39 units on a scale | Standard Deviation 7.43 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 3 | 11.30 units on a scale | Standard Deviation 8.84 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 6 | 11.52 units on a scale | Standard Deviation 9.41 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 9 | 11.32 units on a scale | Standard Deviation 9.53 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 12 | 11.21 units on a scale | Standard Deviation 9.67 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) | Month 24 | 10.91 units on a scale | Standard Deviation 9.78 |
Primary
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 1 | 6.1 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 3 | 29.3 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 6 | 33.1 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 9 | 33.5 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 12 | 33.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 18 | 32.7 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) | Month 24 | 32.7 percentage of participants |
Primary
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 18 | 76.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 1 | 58.4 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 3 | 80.6 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 6 | 80.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 9 | 80.6 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 12 | 79.5 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) | Month 24 | 77.4 percentage of participants |
Primary
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 9 | 65.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 1 | 29.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 3 | 64.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 6 | 66.9 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 12 | 64.6 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 18 | 63.7 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) | Month 24 | 64.4 percentage of participants |
Primary
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 1 | 11.4 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 3 | 43.3 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 6 | 49.8 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 9 | 47.5 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 12 | 48.3 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 18 | 46.4 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) | Month 24 | 47.1 percentage of participants |
Primary
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.
Time frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 3 | 85.3 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 6 | 82.6 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 1 | 71.9 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 9 | 83.0 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 12 | 81.3 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 18 | 79.4 percentage of participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) | Month 24 | 79.2 percentage of participants |
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.
Time frame: Baseline and every 6 months up to month 24
Population: Efficacy analyses included ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Month 24 | 5.99 units on a scale | Standard Deviation 7.43 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Month 6 | 5.83 units on a scale | Standard Deviation 6.95 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Month 12 | 6.17 units on a scale | Standard Deviation 7.12 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | Month 18 | 6.05 units on a scale | Standard Deviation 7.31 |
Secondary
Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.
Time frame: Baseline and every 6 months up to month 24
Population: Analysis included ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | Month 6 | -10.79 units on a scale | Standard Deviation 21.75 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | Month 12 | -12.27 units on a scale | Standard Deviation 22.92 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | Month 18 | -12.91 units on a scale | Standard Deviation 23.45 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) | Month 24 | -12.71 units on a scale | Standard Deviation 23.71 |
Secondary
Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.
Time frame: Baseline and every 6 months up to month 24
Population: Analysis included ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | Month 6 (n=180) | 10.61 units on a scale (a derived score) | Standard Deviation 24.97 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | Month 12 (n=145) | 9.86 units on a scale (a derived score) | Standard Deviation 24.55 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | Month 24 (n=121) | 12.89 units on a scale (a derived score) | Standard Deviation 21.93 |
| Moderate-to-severe Chronic Plaque Psoriasis | Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) | Month 18 (n=137) | 12.63 units on a scale (a derived score) | Standard Deviation 25.39 |
Secondary
Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.
Time frame: From time of informed consent to the final visit after 2 years of observation
Population: Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Cerebrovascular accident | 2 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Haematological event | 1 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Hepatic event | 1 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Congestive heart failure | 1 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Opportunistic infections | 30 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Lupus-like syndrome | 1 participants |
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Adverse Events of Special Interest (AESIs) | Neoplasm | 11 participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion. See the Reported Adverse Events Section for more details.
Time frame: From time of informed consent to the final visit after 2 years of observation
Population: Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moderate-to-severe Chronic Plaque Psoriasis | Number of Participants With Serious Adverse Events (SAEs) | 24 participants |