Psoriasis
Conditions
Keywords
generalized pustular psoriasis, skin condition, skin disease,
Brief summary
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
Interventions
BIOLOGICALSecukinumab
Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA) * At baseline, erythema area with pustule ≥ 10%
Exclusion criteria
* Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening. * At baseline, : total score of JDA severity index for GPP ≥ 14 * Drug-induced psoriasis * Ongoing use of prohibited psoriasis treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | 16 weeks | Treatment success was defined as Minimally improved, Much improved or Very much improved in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | week 148 | Clinical global impression (CGI) evaluated as very much improved, much improved, Minimally improved. |
| Summary of Clinical Global Impression up to End of Trial | up to week 148 (End of Trial) | Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success. |
| Summary of JDA Total Score Category for GPP by Visit up to End of Trial | up to week 148 (End of Trial) | Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index. |
| Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | 52 weeks | Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as very much improved, much improved, minimally improved. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success. |
| Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | up to week 148 (end of trial) | The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL). Percent change=100 x Absolute change/post baseline. |
| Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | Up to week 148 (end of treatment) | DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay & Khan 94). The measure is self-admin. & includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute & chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life. |
| Number of Patients With GPP-related Systemic and Topical Co-medication Over Time | up to week 52 | Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline. |
| The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | up to week 148 (end of trial) | The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin. The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2. The higher the JDA severity index for GPP score the worse the outcome. |
Countries
Japan
Participant flow
Pre-assignment details
A total of 15 patients were screened, and 12 patients entered the induction period. The reason for all screen failures was patient/guardian decisions
Participants by arm
| Arm | Count |
|---|---|
| AIN457 All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.
* No up-titration group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.
* Up-titration group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48.
Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Induction | Protocol Violation | 1 |
| Maintenance | Adverse Event | 2 |
| Treatment Period 3 | Physician Decision | 9 |
Baseline characteristics
| Characteristic | AIN457 |
|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 15.33 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 3 / 12 |
Outcome results
Primary
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Treatment success was defined as Minimally improved, Much improved or Very much improved in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
Time frame: 16 weeks
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Minimally improved | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | No change | 1 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Treatment success - Yes | 10 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Treatment success - No | 2 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Very much improved | 9 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Much improved | 1 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Worse | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | Missing | 1 Participants |
Secondary
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL). Percent change=100 x Absolute change/post baseline.
Time frame: up to week 148 (end of trial)
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Erythema (Week 148) | -87.01 Percent change | Standard Deviation 15.826 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | WBC (Week 52) | -22.16 Percent change | Standard Deviation 28.009 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | WBC (Week 148) | -25.63 Percent change | Standard Deviation 18.838 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of erythema with pustules (Week 24) | -89.09 Percent change | Standard Deviation 33.001 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of erythema with pustules (Week 52) | -100.00 Percent change | Standard Deviation 0 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of erythema with pustules (Week 148) | -100.00 Percent change | Standard Deviation 0 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Erythema (Week 24) | -63.56 Percent change | Standard Deviation 46.693 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Erythema (Week 52) | -83.60 Percent change | Standard Deviation 24.442 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Edema (Week 24) | -47.92 Percent change | Standard Deviation 107.2 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Edema (Week 52) | -69.17 Percent change | Standard Deviation 69.733 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Area of Edema (Week 148) | -99.05 Percent change | Standard Deviation 2.52 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Body temperature (Week 24) | -0.27 Percent change | Standard Deviation 1.071 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Body temperature (Week 52) | 0.08 Percent change | Standard Deviation 1.076 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Body temperature (Week 148) | -0.87 Percent change | Standard Deviation 1.473 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | WBC (Week 24) | -15.16 Percent change | Standard Deviation 23.12 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | CRP (Week 24) | 18.12 Percent change | Standard Deviation 197.27 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | CRP (Week 52) | 34.21 Percent change | Standard Deviation 245.564 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | CRP (Week 148) | 30.60 Percent change | Standard Deviation 146.99 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Serum Albumin (Week 24) | 0.73 Percent change | Standard Deviation 7.952 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Serum Albumin (Week 52) | 0.63 Percent change | Standard Deviation 12.952 |
| AIN457 | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | Serum Albumin (Week 148) | 1.64 Percent change | Standard Deviation 3.688 |
Secondary
Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay & Khan 94). The measure is self-admin. & includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute & chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.
Time frame: Up to week 148 (end of treatment)
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - MCS at Baseline | 43.69 scores on a scale | Standard Deviation 17.472 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - MCS at end of trial | 47.70 scores on a scale | Standard Deviation 13.457 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - PCS at Week 24 | 52.39 scores on a scale | Standard Deviation 4.438 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | DLQI total score at Baseline | 8.4 scores on a scale | Standard Deviation 6.88 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | DLQI total score at Week 24 | 4.5 scores on a scale | Standard Deviation 5.16 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | DLQI total score at Week 52 | 2.7 scores on a scale | Standard Deviation 2.41 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | DLQI total score at end of treatment | 4.7 scores on a scale | Standard Deviation 8.25 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - MCS at Week 24 | 46.70 scores on a scale | Standard Deviation 9.9696 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - MCS at Week 52 | 46.27 scores on a scale | Standard Deviation 11.768 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - PCS at Baseline | 50.61 scores on a scale | Standard Deviation 3.258 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - PCS at Week 52 | 50.20 scores on a scale | Standard Deviation 4.67 |
| AIN457 | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | SF-36 - PCS at end of treatment | 49.82 scores on a scale | Standard Deviation 6.528 |
Secondary
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Time frame: up to week 52
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Number of Patients With GPP-related Systemic and Topical Co-medication Over Time | Topical co-medication related to GPP | 12 Participants |
| AIN457 | Number of Patients With GPP-related Systemic and Topical Co-medication Over Time | Systemic co-medication related to GPP | 8 Participants |
Secondary
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Clinical global impression (CGI) evaluated as very much improved, much improved, Minimally improved.
Time frame: week 148
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | Very much improved | 8 Participants |
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | Much improved | 1 Participants |
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | Minimally improved | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | No change | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | Worse | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | Missing | 0 Participants |
Secondary
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as very much improved, much improved, minimally improved. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success.
Time frame: 52 weeks
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | CGI - No change | 0 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | CGI - worse | 2 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | Treatment success - Yes | 10 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | Treatment success - No | 2 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | CGI - very much improved | 7 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | CGI - much improved | 2 Participants |
| AIN457 | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | CGI - minimally improved | 1 Participants |
Secondary
Summary of Clinical Global Impression up to End of Trial
Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success.
Time frame: up to week 148 (End of Trial)
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 1 | 4 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 3 | 10 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 16 | 9 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 2 | 7 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 80 | 7 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 128 | 2 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 4 | 10 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 36 | 7 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 112 | 4 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 24 | 8 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 64 | 8 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 96 | 8 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 52 | 7 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 8 | 9 Participants |
| AIN457 | Summary of Clinical Global Impression up to End of Trial | Week 140 | 8 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 8 | 2 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 36 | 3 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 24 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 16 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 128 | 0 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 112 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 1 | 5 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 2 | 4 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 96 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 80 | 2 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 3 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 64 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 4 | 2 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 140 | 1 Participants |
| Much Improved | Summary of Clinical Global Impression up to End of Trial | Week 52 | 2 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 64 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 2 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 1 | 1 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 3 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 4 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 8 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 16 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 24 | 1 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 36 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 52 | 1 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 80 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 96 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 112 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 128 | 0 Participants |
| Minimally Improved | Summary of Clinical Global Impression up to End of Trial | Week 140 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 36 | 1 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 140 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 2 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 80 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 52 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 1 | 1 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 96 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 16 | 1 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 128 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 4 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 24 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 3 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 64 | 0 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 8 | 1 Participants |
| No Change | Summary of Clinical Global Impression up to End of Trial | Week 112 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 2 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 36 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 4 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 52 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 64 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 3 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 80 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 1 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 96 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 112 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 24 | 1 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 140 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 16 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 8 | 0 Participants |
| Worse | Summary of Clinical Global Impression up to End of Trial | Week 128 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 64 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 16 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 112 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 8 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 3 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 36 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 52 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 4 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 140 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 1 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 128 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 96 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 80 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 24 | 0 Participants |
| Missing | Summary of Clinical Global Impression up to End of Trial | Week 2 | 0 Participants |
Secondary
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Time frame: up to week 148 (End of Trial)
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 112 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 8 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 16 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 1 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 128 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 4 | 1 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 3 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 2 | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 24 | 1 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 64 | 1 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 144 | 2 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 96 | 2 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 52 | 1 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 80 | 3 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Baseline | 0 Participants |
| AIN457 | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 36 | 1 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 128 | 2 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 52 | 9 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 64 | 8 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 80 | 6 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 16 | 11 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Baseline | 9 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 36 | 10 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 1 | 10 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 2 | 11 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 3 | 11 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 112 | 5 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 4 | 11 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 8 | 12 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 144 | 7 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 24 | 9 Participants |
| Much Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 96 | 7 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 1 | 1 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 36 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 4 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 16 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 24 | 1 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 8 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 52 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Baseline | 3 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 112 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 128 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 2 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 64 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 96 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 3 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 144 | 0 Participants |
| Minimally Improved | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 80 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 36 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 64 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 112 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 2 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Baseline | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 1 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 3 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 8 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 16 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 24 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 4 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 52 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 80 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 96 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 128 | 0 Participants |
| No Change | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 144 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 24 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 16 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 64 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 96 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 144 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 8 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 3 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 1 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Baseline | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 2 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 4 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 128 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 52 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 112 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 80 | 0 Participants |
| Worse | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | Week 36 | 0 Participants |
Secondary
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin. The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2. The higher the JDA severity index for GPP score the worse the outcome.
Time frame: up to week 148 (end of trial)
Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ erythema with pustules - Baseline | 2 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ total erythema - Week 24 | 1.1 mean scores on a scale | Standard Deviation 0.54 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ edema - Week 52 | 0.3 mean scores on a scale | Standard Deviation 0.48 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Fever - Week 52 | 0.4 mean scores on a scale | Standard Deviation 0.52 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Serum albumin - End of Treatment | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ erythema with pustules - Week 24 | 0.3 mean scores on a scale | Standard Deviation 0.65 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ erythema with pustules - Week 52 | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ erythema w/ pustules - End of Treatment | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ total erythema - Baseline | 1.6 mean scores on a scale | Standard Deviation 0.67 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ total erythema - Week 52 | 0.8 mean scores on a scale | Standard Deviation 0.42 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ total erythema - End of Treatment | 0.7 mean scores on a scale | Standard Deviation 0.5 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ edema - Baseline | 1.3 mean scores on a scale | Standard Deviation 0.89 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ edema - Week 24 | 0.4 mean scores on a scale | Standard Deviation 0.67 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Body SA w/ edema - End of Treatment | 0.1 mean scores on a scale | Standard Deviation 0.33 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Fever - Baseline | 0.2 mean scores on a scale | Standard Deviation 0.39 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Fever - Week 24 | 0.2 mean scores on a scale | Standard Deviation 0.4 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Fever - End of Treatment | 0.1 mean scores on a scale | Standard Deviation 0.33 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | White blood cell (WBC) count - Baseline | 0.3 mean scores on a scale | Standard Deviation 0.65 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | White blood cell (WBC) count - Week 24 | 0.1 mean scores on a scale | Standard Deviation 0.3 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | White blood cell (WBC) count - Week 52 | 0.1 mean scores on a scale | Standard Deviation 0.32 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | White blood cell (WBC) count - End of Treatment | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | C-reactive protein - Baseline | 0.5 mean scores on a scale | Standard Deviation 0.67 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | C-reactive protein - Week 24 | 0.2 mean scores on a scale | Standard Deviation 0.4 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | C-reactive protein - Week 52 | 0.2 mean scores on a scale | Standard Deviation 0.42 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | C-reactive protein - End of Treatment | 0.3 mean scores on a scale | Standard Deviation 0.5 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Serum albumin - Baseline | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Serum albumin - Week 24 | 0.0 mean scores on a scale | Standard Deviation 0 |
| AIN457 | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | Serum albumin - Week 52 | 0.1 mean scores on a scale | Standard Deviation 0.32 |