Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug: * unknown adverse drug reactions, especially clinically significant adverse reactions * incidence and conditions of occurrence of adverse reactions in the clinical setting * factors that may affect the safety and effectiveness of Humira.
Detailed description
This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice. When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period. Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.
Interventions
None listed
Sponsors
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
All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be * those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or * patients with intractable eruptions of joint signs/symptoms.
Exclusion criteria
Contraindications according to the Package Insert include patients who have any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of Humira * demyelinating disease or a history of demyelinating disease * congestive cardiac failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24 | Week 24 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | From study registration through Week 24 | This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than not related (ie, probable, possible, or unclear). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events. |
| Physician's Global Assessment at Week 4 | Week 4 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
| Physician's Global Assessment At Week 8 | Week 8 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
| Physician's Global Assessment at Week 16 | Week 16 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
| Physician's Global Assessment at Week 24 | Week 24 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
| Psoriasis Area and Severity Index (PASI) at Week 16 | Week 16 | PASI 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). |
| Psoriasis Area and Severity Index (PASI) at Week 24 | Week 24 | PASI 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). |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | Baseline and Week 16 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 | Baseline and Week 24 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. |
| Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | Baseline and Week 16 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. |
| Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 | Baseline and Week 24 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. |
| Dermatology Life Quality Index at Week 16 | Week 16 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. |
| Dermatology Life Quality Index at Week 24 | Week 24 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. |
| Pain Visual Analog Scale (VAS) at Week 4 | Week 4 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). |
| Pain Visual Analog Scale (VAS) at Week 16 | Week 16 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). |
| Pain Visual Analog Scale (VAS) at Week 24 | Week 24 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4 | Week 4 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16 | Week 16 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24 | Week 24 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4 | Week 4 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16 | Week 16 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Overall Response Rating At Week 24 | Baseline and Week 24 | Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as markedly improved, improved, not changed, or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions. |
Countries
Japan
Participant flow
Recruitment details
Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.
Pre-assignment details
Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).
Participants by arm
| Arm | Count |
|---|---|
| Humira Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. | 734 |
| Total | 734 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 39 |
| Overall Study | Adverse Event + Lack of Efficacy | 2 |
| Overall Study | Adverse Event + Other Reasons | 7 |
| Overall Study | Lack of Efficacy | 46 |
| Overall Study | No Hospital Visits | 7 |
| Overall Study | Other Reasons | 23 |
| Overall Study | Participant's Economic Reasons | 17 |
| Overall Study | Participant's Economic Reasons + Other | 1 |
Baseline characteristics
| Characteristic | Humira |
|---|---|
| Age Continuous | 50.7 years STANDARD_DEVIATION 13.4 |
| Dermatology Life Quality Index (DLQI) | 8.43 units on a scale STANDARD_DEVIATION 6.77 |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) | 3.5 units on a scale STANDARD_DEVIATION 1.3 |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) | 4.4 units on a scale STANDARD_DEVIATION 1.7 |
| Pain Visual Analog Scale (VAS) | 49.5 units on a scale STANDARD_DEVIATION 30.7 |
| Physician's Global Assessment (PGA) | 2.7 units on a scale STANDARD_DEVIATION 5.7 |
| Psoriasis Area and Severity Index (PASI) | 15.7 units on a scale STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 176 Participants |
| Sex: Female, Male Male | 558 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 734 |
| serious Total, serious adverse events | 35 / 734 |
Outcome results
Primary
Dermatology Life Quality Index at Week 16
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time frame: Week 16
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Dermatology Life Quality Index at Week 16 | 3.01 units on a scale | Standard Deviation 4.51 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Dermatology Life Quality Index at Week 24
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time frame: Week 24
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Dermatology Life Quality Index at Week 24 | 2.30 units on a scale | Standard Deviation 3.89 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16
DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 16
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16 | 2.0 units on a scale | Standard Deviation 0.9 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24
DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 24
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24 | 1.8 units on a scale | Standard Deviation 0.9 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4
DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 4
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4 | 2.3 units on a scale | Standard Deviation 1.2 |
Comparison: comparison versus Baseline at Week 4p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16
DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 16
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16 | 2.4 units on a scale | Standard Deviation 1.3 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24
DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 24
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24 | 2.3 units on a scale | Standard Deviation 1.3 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Primary
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4
DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time frame: Week 4
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4 | 3.0 units on a scale | Standard Deviation 1.6 |
Comparison: comparison versus Baseline at Week 4p-value: <0.0001t-test, 2 sided
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs
This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than not related (ie, probable, possible, or unclear). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.
Time frame: From study registration through Week 24
Population: Safety Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | AEs | 237 participants |
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | SAEs | 35 participants |
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | ADRs | 191 participants |
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | Deaths | 4 participants |
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 48 participants |
| Humira | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | SADRs | 24 participants |
Primary
Pain Visual Analog Scale (VAS) at Week 16
Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time frame: Week 16
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Pain Visual Analog Scale (VAS) at Week 16 | 21.3 units on a scale | Standard Deviation 23.7 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Pain Visual Analog Scale (VAS) at Week 24
Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time frame: Week 24
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Pain Visual Analog Scale (VAS) at Week 24 | 16.3 units on a scale | Standard Deviation 21.3 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Primary
Pain Visual Analog Scale (VAS) at Week 4
Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time frame: Week 4
Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Pain Visual Analog Scale (VAS) at Week 4 | 26.7 units on a scale | Standard Deviation 26.3 |
Comparison: comparison versus Baseline at Week 4p-value: <0.0001t-test, 2 sided
Primary
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.
Time frame: Baseline and Week 16
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | 49.2 percentage of participants |
| Humira (Adalimumab-naive Participants) | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | 52.9 percentage of participants |
Primary
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.
Time frame: Baseline and Week 24
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 | 58.2 percentage of participants |
| Humira (Adalimumab-naive Participants) | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 | 62.1 percentage of participants |
Primary
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.
Time frame: Baseline and Week 16
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | 27.0 percentage of participants |
| Humira (Adalimumab-naive Participants) | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | 28.7 percentage of participants |
Primary
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24
PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.
Time frame: Baseline and Week 24
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 | 39.3 percentage of participants |
| Humira (Adalimumab-naive Participants) | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 | 41.7 percentage of participants |
Primary
Physician's Global Assessment at Week 16
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time frame: Week 16
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Physician's Global Assessment at Week 16 | 1.5 units on a scale | Standard Deviation 1.1 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Physician's Global Assessment at Week 24
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time frame: Week 24
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Physician's Global Assessment at Week 24 | 1.2 units on a scale | Standard Deviation 1.1 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Primary
Physician's Global Assessment at Week 4
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time frame: Week 4
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Physician's Global Assessment at Week 4 | 2.2 units on a scale | Standard Deviation 1.1 |
Comparison: comparison versus Baseline at Week 4p-value: <0.0001t-test, 2 sided
Primary
Physician's Global Assessment At Week 8
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: * 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); * 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); * 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); * 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); * 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); * 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time frame: Week 8
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Physician's Global Assessment At Week 8 | 1.8 units on a scale | Standard Deviation 1.1 |
Comparison: comparison versus Baseline at Week 8p-value: <0.0001t-test, 2 sided
Primary
Psoriasis Area and Severity Index (PASI) at Week 16
PASI 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).
Time frame: Week 16
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Psoriasis Area and Severity Index (PASI) at Week 16 | 5.0 units on a scale | Standard Deviation 7.3 |
Comparison: comparison versus Baseline at Week 16p-value: <0.0001t-test, 2 sided
Primary
Psoriasis Area and Severity Index (PASI) at Week 24
PASI 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).
Time frame: Week 24
Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humira | Psoriasis Area and Severity Index (PASI) at Week 24 | 4.0 units on a scale | Standard Deviation 7.4 |
Comparison: comparison versus Baseline at Week 24p-value: <0.0001t-test, 2 sided
Secondary
Physician's Overall Response Rating At Week 24
Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as markedly improved, improved, not changed, or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions.
Time frame: Baseline and Week 24
Population: Participants in the Efficacy Analysis Population with assessment at Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira | Physician's Overall Response Rating At Week 24 | Not changed | 65 participants |
| Humira | Physician's Overall Response Rating At Week 24 | Improved | 255 participants |
| Humira | Physician's Overall Response Rating At Week 24 | Not assessable | 10 participants |
| Humira | Physician's Overall Response Rating At Week 24 | Markedly improved | 354 participants |
| Humira | Physician's Overall Response Rating At Week 24 | Aggravated | 16 participants |