Psoriasis
Conditions
Keywords
Raptiva, Moderate plaque psoriasis, Severe plaque psoriasis, Scalp
Brief summary
This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.
Detailed description
* Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0. * Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84
Interventions
DRUGefalizumab
All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
DRUGplacebo
All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents * Be aged 18 years or older * Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp * Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis * Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI) * Have at least one of three clinical signs involving the scalp (erythema, induration, and desquamation) be rated as at least moderate (2) with the other two rated as at least slight (1) using PSSI * Be a candidate for systemic therapy in the opinion of the investigator * Be naive to efalizumab treatment * For women of childbearing potential, must be willing to use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
Exclusion criteria
* Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components * Are using any excluded therapy * Have a history of drug or alcohol abuse in the past five years * Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection * Have any history of opportunistic infections (e.g., systemic fungal infections, parasites) * Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) * Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis, including latent tuberculosis with isoniazid * Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders * Are pregnant or breastfeeding * Have a diagnosis of hepatic cirrhosis, regardless of cause or severity * Have a history in the last 5 years of thrombocytopenia * Have a history in the last 5 years of hemolytic anemia or any other clinically significant anemia * Have been exposed to any experimental and/or unapproved drugs or treatments within 30 days or 5 half-lives, whichever is longer, before the screening visit * Have been vaccinated with a live virus or live bacteria within the 14 days before the first dose of efalizumab * Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks | Week 12 | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks | Week 24 | Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. |
| Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks | Week 12 | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. |
| Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks | Week 24 | Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72. |
| Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks | Week 12 | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84) Physician's Global Assessment (PGA) scale: 0: Clear. No signs of plaque psoriasis. 1. Almost clear. Just perceptible erythema and just perceptible scaling. 2. Mild disease. Light pink erythema with minimal scaling. 3. Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening. 4. Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening. |
| Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks | Week 24 | Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks. |
| Mean Change in Scalpdex Score at 12 Weeks | The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84 | Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. |
| Mean Change in Scalpdex Score at 24 Weeks | Week 24 | Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'. |
| Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Week 12 | Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching. |
| Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Week 24 | Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching. |
| Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Week 12 | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). |
| Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Week 24 | Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24). | 27 |
| Efalizumab All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24). | 62 |
| Total | 89 |
Baseline characteristics
| Characteristic | Placebo | Efalizumab | Total |
|---|---|---|---|
| Age, Continuous | 42.78 years STANDARD_DEVIATION 16.53 | 43.16 years STANDARD_DEVIATION 13.46 | 43.04 years STANDARD_DEVIATION 14.37 |
| Sex: Female, Male Female | 9 Participants | 30 Participants | 39 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 27 | 32 / 55 | 11 / 22 | 22 / 55 | 3 / 18 | 15 / 48 |
| serious Total, serious adverse events | 1 / 27 | 1 / 62 | 0 / 22 | 1 / 55 | 0 / 18 | 2 / 48 |
Outcome results
Primary
Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Time frame: Week 12
Population: Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks | 0.111 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks | 0.274 Proportion of patients |
p-value: 0.105495% CI: [-0.063, 0.393]Fisher Exact
Secondary
Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks
Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching.
Time frame: Week 12
Population: ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Baseline Scale | 6.81 Points on VAS | Standard Deviation 2.34 |
| Placebo | Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Week 12 Change from Baseline | 1.00 Points on VAS | Standard Deviation 1.95 |
| Efalizumab | Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Baseline Scale | 7.47 Points on VAS | Standard Deviation 2.24 |
| Efalizumab | Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks | Week 12 Change from Baseline | 2.19 Points on VAS | Standard Deviation 2.91 |
p-value: 0.043595% CI: [-0.161, 2.532]Student T-test
Secondary
Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
Time frame: Week 12
Population: ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Week 12 Change from Baseline | 2.00 Pecentage of BSA | Standard Deviation 5.65 |
| Placebo | Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Baseline BSA | 14.74 Pecentage of BSA | Standard Deviation 15.48 |
| Efalizumab | Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Week 12 Change from Baseline | 6.43 Pecentage of BSA | Standard Deviation 10.3 |
| Efalizumab | Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks | Baseline BSA | 19.61 Pecentage of BSA | Standard Deviation 18.51 |
p-value: 0.0224Wilcoxon rank sum
Secondary
Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
Time frame: Week 24
Population: ITT population. N's reflect patients who received at least one dose of study drug in the open-label period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Baseline BSA | 14.74 Percentage of BSA | Standard Deviation 15.48 |
| Placebo | Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Week 24 Change from Baseline | 4.53 Percentage of BSA | Standard Deviation 6.53 |
| Efalizumab | Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Baseline BSA | 19.61 Percentage of BSA | Standard Deviation 18.51 |
| Efalizumab | Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks | Week 24 Change from Baseline | 7.53 Percentage of BSA | Standard Deviation 12.59 |
Secondary
Mean Change in Scalpdex Score at 12 Weeks
Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Time frame: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84
Population: ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Scalpdex Score at 12 Weeks | Baseline Score | 63.91 Points on Scalpdex | Standard Deviation 15.4 |
| Placebo | Mean Change in Scalpdex Score at 12 Weeks | Week 12 Change from Baseline | 6.82 Points on Scalpdex | Standard Deviation 7.76 |
| Efalizumab | Mean Change in Scalpdex Score at 12 Weeks | Baseline Score | 67.83 Points on Scalpdex | Standard Deviation 13.88 |
| Efalizumab | Mean Change in Scalpdex Score at 12 Weeks | Week 12 Change from Baseline | 10.15 Points on Scalpdex | Standard Deviation 13.56 |
p-value: 0.181695% CI: [-2.811, 9.471]Student T-test
Secondary
Mean Change in Scalpdex Score at 24 Weeks
Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Time frame: Week 24
Population: ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Scalpdex Score at 24 Weeks | Baseline Score | 63.91 Points on Scalpdex | Standard Deviation 15.4 |
| Placebo | Mean Change in Scalpdex Score at 24 Weeks | Week 24 Change from Baseline | 7.81 Points on Scalpdex | Standard Deviation 9.8 |
| Efalizumab | Mean Change in Scalpdex Score at 24 Weeks | Baseline Score | 67.83 Points on Scalpdex | Standard Deviation 13.88 |
| Efalizumab | Mean Change in Scalpdex Score at 24 Weeks | Week 24 Change from Baseline | 13.26 Points on Scalpdex | Standard Deviation 14.02 |
Secondary
Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks
Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching.
Time frame: Week 24
Population: ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Baseline Points | 6.81 Points on VAS | Standard Deviation 2.34 |
| Placebo | Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Week 24 Change from Baseline | 2.06 Points on VAS | Standard Deviation 3.61 |
| Efalizumab | Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Baseline Points | 7.47 Points on VAS | Standard Deviation 2.24 |
| Efalizumab | Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks | Week 24 Change from Baseline | 3.07 Points on VAS | Standard Deviation 3.09 |
Secondary
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Time frame: Week 12
Population: ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks | 0.296 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks | 0.452 Proportion of patients |
p-value: 0.240495% CI: [-0.072, 0.388]Fisher Exact
Secondary
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Time frame: Week 24
Population: ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks | 0.455 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks | 0.500 Proportion of patients |
Secondary
Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Time frame: Week 24
Population: ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks | 0.273 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks | 0.323 Proportion of patients |
Secondary
Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.
Time frame: Week 24
Population: ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks | 0.545 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks | 0.387 Proportion of patients |
Secondary
Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84) Physician's Global Assessment (PGA) scale: 0: Clear. No signs of plaque psoriasis. 1. Almost clear. Just perceptible erythema and just perceptible scaling. 2. Mild disease. Light pink erythema with minimal scaling. 3. Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening. 4. Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening.
Time frame: Week 12
Population: ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks | 0.111 Proportion of patients |
| Efalizumab | Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks | 0.339 Proportion of patients |
p-value: 0.036695% CI: [0.003, 0.452]Fisher Exact