| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| Treatment success - Yes | | | | Treatment success - No | | | | Very much improved | | |
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| 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". | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | 52 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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". | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | week 148 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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". | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | up to week 148 (End of Trial) | | | | ID | Title | Description |
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| OG000 | Very Much Improved | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing. | | OG001 | Much Improved | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing. | | OG002 | Minimally Improved | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. Clinical global impression (CGI) was evaluated as very much improved, much improved, minimally improved, no change, worse, and missing. |
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| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | up to week 148 (End of Trial) | | | | ID | Title | Description |
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| OG000 | None | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe. | | OG001 | Mild | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe. | | OG002 | Moderate | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. The category of JDA severity index was defined by 3 categories: mild, moderate, and severe. | | OG003 | Severe |
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| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Mean | Standard Deviation | mean scores on a scale | | up to week 148 (end of trial) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Mean | Standard Deviation | Percent change | | up to week 148 (end of trial) | | | | ID | Title | Description |
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| OG000 | AIN457 | All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. |
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| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Mean | Standard Deviation | scores on a scale | | Up to week 148 (end of treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Posted | | Number | | Participants | | up to week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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