Psoriasis
Conditions
Brief summary
This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.
Interventions
DRUG80 mg ixekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men must agree to use a reliable method of birth control during the study * Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment * Candidates for phototherapy and/or systemic therapy * Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment * At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis * Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis
Exclusion criteria
* History of drug-induced psoriasis * Concurrent or recent use of any biologic agent * Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis * Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study * Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab * Serious disorder or illness other than psoriasis * Serious infection within the last 3 months * Breastfeeding or nursing (lactating) women * Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) | Week (Wk) 12 | The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab | Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168) | PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24. |
| Number of Participants With Anti-Ixekizumab Antibodies | Baseline through Wk 52 | Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10. |
| Percent of Participants Achieving PASI 90% and 100% Improvement | Wks 12, 24 and 52 | The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). |
| Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wks 12, 24 and 52 | The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal). |
| Change From Baseline in Percent of Body Surface Area (BSA) Involvement | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). |
| Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis. |
| Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. |
| Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. |
| Change From Baseline in Itch Numeric Rating Scale (NRS) Score | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52 | DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant. |
| Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] | Wks 12, 24 and 52 | ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR). |
| Percentage of Participants Achieving ≥75% Improvement in PASI | Wks 24 and 52 | The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). |
| Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 100 and Retreatment Wk 192 | The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). |
| Percentage of Participants With sPGA (0 or 1) and sPGA (0) | Wk 100 and Retreatment Wk 192 | The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal). |
| Change From Baseline in Percent of BSA Involvement | Baseline, Wk 100; Baseline, Retreatment Wk 192 | BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). |
| Change From Baseline in NAPSI | Baseline, Wk 100; Baseline, Retreatment Wk 192 | The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis. |
| Change From Baseline in PSSI | Baseline, Wk 100; Baseline, Retreatment Wk 192 | The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. |
| Change From Baseline in QIDS-SR16 Score | Baseline, Wk 100; Baseline, Retreatment Wk 192 | QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. |
| Change From Baseline in Itch NRS Score | Baseline, Wk 100; Baseline, Retreatment Wk 192 | The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. |
| Change From Baseline in DLQI Score | Baseline, Wk 100; Baseline, Retreatment Wk 192 | DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant. |
| Change From Baseline in Participants Assessment of Joint Pain VAS | Baseline, Wk 100; Baseline, Retreatment Wk 192 | The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). |
| Number of Participants Achieving ACR20 | Wk 100 and Wk Retreatment Wk 192 | ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR. Analysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline. |
| Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) | Baseline, Wk 12; Baseline, Wk 52 | The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine). |
Countries
Japan
Participant flow
Recruitment details
Period 2-Induction Dosing Period (Weeks 0 up to 12), Period 3-Maintenance Dosing Period (Weeks 12 up to 52), Period 4-Drug Free Period (Weeks 52 up to 100), Period 5-Retreatment Period (up to 192 additional weeks) and Period 6-Post-Treatment Follow-Up Period up to 12 weeks after the last visit.
Participants by arm
| Arm | Count |
|---|---|
| 80 mg Ixekizumab (LY2439821) Ixekizumab:
Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks. | 91 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period 2 - Induction | Adverse Event | 1 |
| Period 3 - Maintenance | Adverse Event | 2 |
| Period 3 - Maintenance | Lack of Efficacy | 1 |
| Period 3 - Maintenance | Physician Decision | 2 |
| Period 3 - Maintenance | Withdrawal by Subject | 2 |
| Period 4 - Drug Free Period | Relapsed | 61 |
| Period 5 - Retreatment Period | Adverse Event | 5 |
| Period 5 - Retreatment Period | Lack of Efficacy | 1 |
| Period 5 - Retreatment Period | Physician Decision | 1 |
| Period 5 - Retreatment Period | Withdrawal by Subject | 3 |
| Period 6: Follow-up | Adverse Event | 3 |
| Period 6: Follow-up | Lack of Efficacy | 2 |
| Period 6: Follow-up | Physician Decision | 1 |
| Period 6: Follow-up | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | 80 mg Ixekizumab (LY2439821) |
|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 11.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Itch Numeric Rating Scale (NRS) Score | 6.1 units on a scale STANDARD_DEVIATION 2.53 |
| Joint Pain Visual Analog Scale (VAS) | 62.4 units on a scale STANDARD_DEVIATION 23.79 |
| Nail Psoriasis Severity Index (NAPSI) Total Score | 31.1 units on a scale STANDARD_DEVIATION 22.16 |
| Percentage (%) of Body Surface Area (BSA) | 45.5 units on a scale STANDARD_DEVIATION 23.22 |
| Psoriasis Area and Severity Index (PASI) Total Score | 27.24 units on a scale STANDARD_DEVIATION 10.545 |
| Psoriasis Scalp Severity Index (PSSI) Total Score | 27.0 units on a scale STANDARD_DEVIATION 15.99 |
| Quick Inventory of Depressive Symptomatology-Self Reported 16 Items(QIDS-SR16) Total Score | 4.6 units on a scale STANDARD_DEVIATION 4.14 |
| Quick Inventory of Depressive Symptomatology-Self Reported (DLQI) Total Score | 10.8 units on a scale STANDARD_DEVIATION 6.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 91 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 91 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 70 Participants |
| Static Physician Global Assessment (sPGA) Score 0: Clear | 0 participants |
| Static Physician Global Assessment (sPGA) Score 1: Minimal | 0 participants |
| Static Physician Global Assessment (sPGA) Score 2: Mild | 1 participants |
| Static Physician Global Assessment (sPGA) Score 3: Moderate | 26 participants |
| Static Physician Global Assessment (sPGA) Score 4: Severe | 53 participants |
| Static Physician Global Assessment (sPGA) Score 5: Very Severe | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 61 / 91 | 18 / 70 | 52 / 80 | 2 / 88 |
| serious Total, serious adverse events | 4 / 91 | 3 / 70 | 9 / 80 | 0 / 88 |
Outcome results
Primary
Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time frame: Week (Wk) 12
Population: All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) | 98.7 percentage of participants |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Wk 12 (80 mg Q2W) | -9.2 units on a scale | Standard Deviation 5.75 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Wk 24 (80 mg Q4W) | -9.2 units on a scale | Standard Deviation 6.57 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Wk 52 (80 mg Q4W) | -9.6 units on a scale | Standard Deviation 6.24 |
Secondary
Change From Baseline in DLQI Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing DLQI at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in DLQI Score | Baseline, Wk 100 | -2.3 units on a scale | Standard Deviation 4.83 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in DLQI Score | Baseline, Wk 192 | -8.9 units on a scale | Standard Deviation 5.7 |
Secondary
Change From Baseline in Itch NRS Score
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Itch NRS at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Itch NRS Score | Baseline, Wk 100 | -1.1 units on a scale | Standard Deviation 2.62 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Itch NRS Score | Baseline, Wk 192 | -4.9 units on a scale | Standard Deviation 2.59 |
Secondary
Change From Baseline in Itch Numeric Rating Scale (NRS) Score
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Itch Numeric Rating Scale (NRS) Score | Wk 12 (80 mg Q2W) | -4.7 units on a scale | Standard Deviation 2.68 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Itch Numeric Rating Scale (NRS) Score | Wk 24 (80 mg Q4W) | -4.8 units on a scale | Standard Deviation 2.9 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Itch Numeric Rating Scale (NRS) Score | Wk 52 (80 mg Q4W) | -4.8 units on a scale | Standard Deviation 2.83 |
Secondary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Wk 12 (80 mg Q2W) | -7.7 units on a scale | Standard Deviation 14.65 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Wk 24 (80 mg Q4W) | -20.5 units on a scale | Standard Deviation 19.42 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Wk 52 (80 mg Q4W) | -23.4 units on a scale | Standard Deviation 23.67 |
Secondary
Change From Baseline in NAPSI
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing NAPSI at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in NAPSI | Baseline, Wk 100 | -16.8 units on a scale | Standard Deviation 19.87 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in NAPSI | Baseline, Wk 192 | -21.4 units on a scale | Standard Deviation 26.31 |
Secondary
Change From Baseline in Participants Assessment of Joint Pain VAS
The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Joint Pain VAS at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Participants Assessment of Joint Pain VAS | Baseline, Wk 100 | -12.8 mm | Standard Deviation 39.59 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Participants Assessment of Joint Pain VAS | Baseline, Wk 192 | -43.8 mm | Standard Deviation 25.66 |
Secondary
Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)
The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).
Time frame: Baseline, Wk 12; Baseline, Wk 52
Population: Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) | Wk 12 (80 mg Q2W) | -47.3 mm | Standard Deviation 22.05 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) | Wk 52 (80 mg Q4W) | -51.0 mm | Standard Deviation 19.05 |
Secondary
Change From Baseline in Percent of Body Surface Area (BSA) Involvement
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Percent of Body Surface Area (BSA) Involvement | Wk 12 (80 mg Q2W) | -38.3 percentage of BSA | Standard Deviation 19.26 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Percent of Body Surface Area (BSA) Involvement | Wk 24 (80 mg Q4W) | -41.2 percentage of BSA | Standard Deviation 20.23 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Percent of Body Surface Area (BSA) Involvement | Wk 52 (80 mg Q4W) | -40.8 percentage of BSA | Standard Deviation 19.73 |
Secondary
Change From Baseline in Percent of BSA Involvement
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing BSA at Wks 100 and 192 were imputed by last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Percent of BSA Involvement | Baseline, Wk 100 | -24.7 percentage of BSA | Standard Deviation 17.32 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Percent of BSA Involvement | Baseline, Wk 192 | -40.2 percentage of BSA | Standard Deviation 21.18 |
Secondary
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Wk 12 (80 mg Q2W) | -24.8 units on a scale | Standard Deviation 15.12 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Wk 24 (80 mg Q4W) | -24.9 units on a scale | Standard Deviation 15.11 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Wk 52 (80 mg Q4W) | -23.3 units on a scale | Standard Deviation 16.48 |
Secondary
Change From Baseline in PSSI
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing PSSI at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in PSSI | Baseline, Wk 100 | -8.5 units on a scale | Standard Deviation 16.16 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in PSSI | Baseline, Wk 192 | -23.2 units on a scale | Standard Deviation 15.17 |
Secondary
Change From Baseline in QIDS-SR16 Score
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Time frame: Baseline, Wk 100; Baseline, Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing QIDS-SR16 at Wks 100 and 192 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in QIDS-SR16 Score | Baseline, Wk 100 | -0.5 units on a scale | Standard Deviation 4.02 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in QIDS-SR16 Score | Baseline, Wk 192 | -1.8 units on a scale | Standard Deviation 3.87 |
Secondary
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Time frame: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Population: Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Wk 12 (80 mg Q2W) | -1.1 units on a scale | Standard Deviation 3.65 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Wk 24 (80 mg Q4W) | -1.6 units on a scale | Standard Deviation 3.8 |
| 80 mg Ixekizumab (LY2439821) | Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Wk 52 (80 mg Q4W) | -1.4 units on a scale | Standard Deviation 3.57 |
Secondary
Number of Participants Achieving ACR20
ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR. Analysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.
Time frame: Wk 100 and Wk Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Number of Participants Achieving ACR20 | Wk 100 | 0 Participants |
| 80 mg Ixekizumab (LY2439821) | Number of Participants Achieving ACR20 | Wk 192 | 0 Participants |
Secondary
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]
ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).
Time frame: Wks 12, 24 and 52
Population: Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] | Wk 12 (80 mg Q2W) | 4 participants |
| 80 mg Ixekizumab (LY2439821) | Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] | Wk 24 (80 mg Q4W) | 4 participants |
| 80 mg Ixekizumab (LY2439821) | Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] | Wk 52 (80 mg Q4W) | 5 participants |
Secondary
Number of Participants With Anti-Ixekizumab Antibodies
Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.
Time frame: Baseline through Wk 52
Population: All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Number of Participants With Anti-Ixekizumab Antibodies | Pustular Ps | 0 participants |
| 80 mg Ixekizumab (LY2439821) | Number of Participants With Anti-Ixekizumab Antibodies | Plaque Ps | 10 participants |
| 80 mg Ixekizumab (LY2439821) | Number of Participants With Anti-Ixekizumab Antibodies | Erythrodermic Ps | 0 participants |
Secondary
Percentage of Participants Achieving ≥75% Improvement in PASI
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time frame: Wks 24 and 52
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants Achieving ≥75% Improvement in PASI | Wk 24 | 95.9 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants Achieving ≥75% Improvement in PASI | Wk 52 | 92.3 percentage of participants |
Secondary
Percentage of Participants With sPGA (0 or 1) and sPGA (0)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).
Time frame: Wk 100 and Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With sPGA (0 or 1) and sPGA (0) | Wk 100, sPGA(0, 1) | 4.5 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With sPGA (0 or 1) and sPGA (0) | Wk 100, sPGA(0) | 0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With sPGA (0 or 1) and sPGA (0) | Wk 192, sPGA(0, 1) | 0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With sPGA (0 or 1) and sPGA (0) | Wk 192, sPGA(0) | 0 percentage of participants |
Secondary
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).
Time frame: Wks 12, 24 and 52
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 12 (80 mg Q2W) sPGA (0 or 1) | 89.7 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 24 (80 mg Q4W) sPGA (0 or 1) | 89.2 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 52 (80 mg Q4W) sPGA (0 or 1) | 83.3 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 12 (80 mg Q2W) sPGA (0) | 35.9 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 24 (80 mg Q4W) sPGA (0) | 51.4 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) | Wk 52 (80 mg Q4W) sPGA (0) | 52.6 percentage of participants |
Secondary
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time frame: Wk 100 and Retreatment Wk 192
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 100, PASI 75 | 7.5 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 100, PASI 90 | 3.0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 100, PASI 100 | 0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 192, PASI 75 | 0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 192, PASI 90 | 0 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement | Wk 192, PASI 100 | 0 percentage of participants |
Secondary
Percent of Participants Achieving PASI 90% and 100% Improvement
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time frame: Wks 12, 24 and 52
Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 12 (80 mg Q2W) PASI 90% | 83.3 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 12 (80 mg Q2W) PASI 100% | 32.1 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 24 (80 mg Q4W) PASI 90% | 90.5 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 24 (80 mg Q4W) PASI 100% | 48.6 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 52 (80 mg Q4W) PASI 90% | 80.8 percentage of participants |
| 80 mg Ixekizumab (LY2439821) | Percent of Participants Achieving PASI 90% and 100% Improvement | Wk 52 (80 mg Q4W) PASI 100% | 48.7 percentage of participants |
Secondary
Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab
PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.
Time frame: Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)
Population: All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab (LY2439821) | Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab | Wk 12 (80 mg Q2W) Cohort 2 | 9.63 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 43.6 |
| 80 mg Ixekizumab (LY2439821) | Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab | Wk 24 (80 mg Q4W) Cohort 1 | 3.48 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 65.4 |