Psoriasis
Conditions
Brief summary
The objective of this study was to evaluate the safety and efficacy profile of Humira (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This open-label study was conducted in a patient population of moderate to severe chronic plaque psoriasis patients, which is an approved patient population for adalimumab.
Detailed description
This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB). Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB. Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0). Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC. This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B. Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP). Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).
Interventions
BIOLOGICALadalimumab
Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months * Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy
Exclusion criteria
* Prior treatment with adalimumab * Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies) * Prior treatment with natalizumab * Concurrent active skin diseases/infections * Poorly controlled medical conditions * History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease * History of certain cancers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 | Week 16 | The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe \[extreme red coloration, dusky to deep red coloration\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening | From Screening to Week 16 | — |
| Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Weeks 2, 4, and 8 | The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease. |
| Dermatology Life Quality Index (DLQI) Total Score | From Screening to Week 4 and Week 16 | The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0. |
| Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 4 and Week 16 | DLQI total score of 0 indicates psoriasis had no effect at all on participant's life. |
| Psoriasis-related Pruritus Assessment | From Screening to Week 16 | The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus. |
| Number of Participants Achieving a PGA of Clear (0) at Week 16 | Week 16 | — |
| Percent Work Time Missed Due to Psoriasis | From Screening to Week 16 | Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%. |
| Percent Overall Work Impairment Due to Psoriasis | From Screening to Week 16 | Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement. |
| Percent Impairment While Working Due to Psoriasis | From Screening to Week 16 | Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement. |
| Percent Activity Impairment Due to Psoriasis | From Screening to Week 16 | Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%. |
| Sleep Problems Index II | From Screening to Week 16 | Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement. |
| Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis | From Screening to Week 16 | The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement. |
Countries
Canada, United States
Participant flow
Recruitment details
Patients who were previously treated with etanercept, methotrexate (MTX), or narrow-band ultraviolet-B (NB-UVB) and had a sub-optimal response were recruited for participation in the study.
Pre-assignment details
Participants who were receiving more than 1 of the treatments (etanercept, MTX, NB-UVB) at the time of screening must have discontinued 1 therapy (e.g., MTX) at least 30 days before first dose of adalimumab and must have discontinued the other therapy (e.g., NB-UVB) during a specified time before first dose of adalimumab. See Detailed Description.
Participants by arm
| Arm | Count |
|---|---|
| Sub-optimal Response to MTX MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse. | 41 |
| Sub-optimal Response to Narrow-band Ultraviolet-B NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse. | 29 |
| Sub-optimal Response to Etanercept Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse. | 82 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Did not meet exclusion criteria | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Noncompliant with drug administration | 0 | 0 | 1 |
| Overall Study | Serious adverse event | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Sub-optimal Response to MTX | Sub-optimal Response to Narrow-band Ultraviolet-B | Sub-optimal Response to Etanercept | Total |
|---|---|---|---|---|
| Age Continuous | 47.4 years STANDARD_DEVIATION 13.11 | 45.7 years STANDARD_DEVIATION 14.6 | 48.3 years STANDARD_DEVIATION 13.7 | 47.6 years STANDARD_DEVIATION 13.67 |
| Region of Enrollment Canada | 15 participants | 19 participants | 12 participants | 46 participants |
| Region of Enrollment United States | 26 participants | 10 participants | 70 participants | 106 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 35 Participants | 61 Participants |
| Sex: Female, Male Male | 28 Participants | 16 Participants | 47 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 41 | 12 / 29 | 20 / 82 |
| serious Total, serious adverse events | 0 / 41 | 1 / 29 | 4 / 82 |
Outcome results
Primary
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe \[extreme red coloration, dusky to deep red coloration\]).
Time frame: Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sub-optimal Response to MTX | Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 | 25 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 | 14 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 | 40 Participants |
Secondary
Dermatology Life Quality Index (DLQI) Total Score
The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.
Time frame: From Screening to Week 4 and Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-optimal Response to MTX | Dermatology Life Quality Index (DLQI) Total Score | Week 4 | -4.8 Change in scores on a scale | Standard Deviation 5.89 |
| Sub-optimal Response to MTX | Dermatology Life Quality Index (DLQI) Total Score | Week 16 | -7.0 Change in scores on a scale | Standard Deviation 7.45 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Dermatology Life Quality Index (DLQI) Total Score | Week 4 | -5.2 Change in scores on a scale | Standard Deviation 5.45 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Dermatology Life Quality Index (DLQI) Total Score | Week 16 | -6.5 Change in scores on a scale | Standard Deviation 6.44 |
| Sub-optimal Response to Etanercept | Dermatology Life Quality Index (DLQI) Total Score | Week 4 | -3.3 Change in scores on a scale | Standard Deviation 4.93 |
| Sub-optimal Response to Etanercept | Dermatology Life Quality Index (DLQI) Total Score | Week 16 | -3.8 Change in scores on a scale | Standard Deviation 5.66 |
Secondary
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.
Time frame: Weeks 2, 4, and 8
Population: All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-optimal Response to MTX | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 4 | 13 Participants |
| Sub-optimal Response to MTX | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 2 | 5 Participants |
| Sub-optimal Response to MTX | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 8 | 22 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 4 | 7 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 2 | 0 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 8 | 13 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 2 | 9 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 8 | 29 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 | Week 4 | 20 Participants |
Secondary
Number of Participants Achieving a PGA of Clear (0) at Week 16
Time frame: Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear \[0\] not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sub-optimal Response to MTX | Number of Participants Achieving a PGA of Clear (0) at Week 16 | 15 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving a PGA of Clear (0) at Week 16 | 6 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving a PGA of Clear (0) at Week 16 | 10 Participants |
Secondary
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Time frame: From Screening to Week 16
Population: All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sub-optimal Response to MTX | Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening | 32 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening | 23 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening | 59 Participants |
Secondary
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.
Time frame: Week 4 and Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-optimal Response to MTX | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 4 | 6 Participants |
| Sub-optimal Response to MTX | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 16 | 12 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 4 | 2 Participants |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 16 | 6 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 4 | 2 Participants |
| Sub-optimal Response to Etanercept | Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 | Week 16 | 17 Participants |
Secondary
Percent Activity Impairment Due to Psoriasis
Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Percent Activity Impairment Due to Psoriasis | -13.3 Change in percent activity impairment | Standard Deviation 33.08 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Percent Activity Impairment Due to Psoriasis | -12.2 Change in percent activity impairment | Standard Deviation 25.62 |
| Sub-optimal Response to Etanercept | Percent Activity Impairment Due to Psoriasis | -4.7 Change in percent activity impairment | Standard Deviation 23.03 |
Secondary
Percent Impairment While Working Due to Psoriasis
Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Percent Impairment While Working Due to Psoriasis | -5.5 Change in % impairment while working | Standard Deviation 30.31 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Percent Impairment While Working Due to Psoriasis | -8.0 Change in % impairment while working | Standard Deviation 19.35 |
| Sub-optimal Response to Etanercept | Percent Impairment While Working Due to Psoriasis | -1.5 Change in % impairment while working | Standard Deviation 18.46 |
Secondary
Percent Overall Work Impairment Due to Psoriasis
Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Percent Overall Work Impairment Due to Psoriasis | -4.0 Change in % overall work impairment | Standard Deviation 28.06 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Percent Overall Work Impairment Due to Psoriasis | -6.4 Change in % overall work impairment | Standard Deviation 19.75 |
| Sub-optimal Response to Etanercept | Percent Overall Work Impairment Due to Psoriasis | -2.8 Change in % overall work impairment | Standard Deviation 16.92 |
Secondary
Percent Work Time Missed Due to Psoriasis
Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Percent Work Time Missed Due to Psoriasis | 0.7 Change in percent time missed | Standard Deviation 3.43 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Percent Work Time Missed Due to Psoriasis | 1.3 Change in percent time missed | Standard Deviation 4.75 |
| Sub-optimal Response to Etanercept | Percent Work Time Missed Due to Psoriasis | -0.1 Change in percent time missed | Standard Deviation 1.85 |
Secondary
Psoriasis-related Pruritus Assessment
The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Psoriasis-related Pruritus Assessment | -2.9 Change in scores on a scale | Standard Deviation 3.9 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Psoriasis-related Pruritus Assessment | -3.0 Change in scores on a scale | Standard Deviation 2.96 |
| Sub-optimal Response to Etanercept | Psoriasis-related Pruritus Assessment | -1.7 Change in scores on a scale | Standard Deviation 3.24 |
Secondary
Sleep Problems Index II
Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants for all items; as a result, not all participants were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Sleep Problems Index II | -9.7 Change in scores on a scale | Standard Deviation 18.01 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Sleep Problems Index II | -7.7 Change in scores on a scale | Standard Deviation 15.82 |
| Sub-optimal Response to Etanercept | Sleep Problems Index II | -2.0 Change in scores on a scale | Standard Deviation 14.57 |
Secondary
Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis
The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.
Time frame: From Screening to Week 16
Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-optimal Response to MTX | Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis | -14.7 Change in scores on a scale | Standard Deviation 24.41 |
| Sub-optimal Response to Narrow-band Ultraviolet-B | Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis | -21.4 Change in scores on a scale | Standard Deviation 30.01 |
| Sub-optimal Response to Etanercept | Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis | -12.7 Change in scores on a scale | Standard Deviation 29.9 |