Trial Outcomes & Findings for Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP) (NCT NCT01952015)
NCT ID: NCT01952015
Last Updated: 2019-03-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-03-15
Participant Flow
A total of 15 patients were screened, and 12 patients entered the induction period. The reason for all screen failures was patient/guardian decisions
Participant milestones
| Measure |
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.
|
|---|---|
|
Induction
STARTED
|
12
|
|
Induction
COMPLETED
|
11
|
|
Induction
NOT COMPLETED
|
1
|
|
Maintenance
STARTED
|
11
|
|
Maintenance
COMPLETED
|
9
|
|
Maintenance
NOT COMPLETED
|
2
|
|
Treatment Period 3
STARTED
|
9
|
|
Treatment Period 3
COMPLETED
|
0
|
|
Treatment Period 3
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Induction
Protocol Violation
|
1
|
|
Maintenance
Adverse Event
|
2
|
|
Treatment Period 3
Physician Decision
|
9
|
Baseline Characteristics
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Baseline characteristics by cohort
| Measure |
AIN457
n=12 Participants
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.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 15.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
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.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Treatment success - Yes
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Treatment success - No
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Very much improved
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Much improved
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Minimally improved
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
No change
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Worse
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Missing
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
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".
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Treatment success - Yes
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Treatment success - No
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
CGI - very much improved
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
CGI - much improved
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
CGI - minimally improved
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
CGI - No change
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
CGI - worse
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: week 148Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Very much improved
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Much improved
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Minimally improved
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
No change
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Worse
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Missing
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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".
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
Much Improved
n=12 Participants
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.
|
Minimally Improved
n=12 Participants
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.
|
No Change
n=12 Participants
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.
|
Worse
n=12 Participants
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.
|
Missing
n=12 Participants
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.
|
|---|---|---|---|---|---|---|
|
Summary of Clinical Global Impression up to End of Trial
Week 1
|
4 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 2
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 3
|
10 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 4
|
10 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 8
|
9 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 16
|
9 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 24
|
8 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 36
|
7 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 52
|
7 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 64
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 80
|
7 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 96
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 112
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 128
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Clinical Global Impression up to End of Trial
Week 140
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
Much Improved
n=12 Participants
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.
|
Minimally Improved
n=12 Participants
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.
|
No Change
n=12 Participants
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.
|
Worse
n=12 Participants
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 16
|
0 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 96
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 24
|
1 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 36
|
1 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 52
|
1 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 64
|
1 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 80
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 112
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 128
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 144
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Baseline
|
0 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 1
|
0 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 2
|
0 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 3
|
0 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 4
|
1 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Week 8
|
0 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
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 0.00
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.00
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.00
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.50
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Fever - Baseline
|
0.2 mean scores on a scale
Standard Deviation 0.39
|
—
|
—
|
—
|
—
|
—
|
|
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Fever - Week 24
|
0.2 mean scores on a scale
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.30
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.00
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.40
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.50
|
—
|
—
|
—
|
—
|
—
|
|
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Serum albumin - Baseline
|
0.0 mean scores on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Serum albumin - Week 24
|
0.0 mean scores on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.00
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
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 0.000
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
WBC (Week 24)
|
-15.16 Percent change
Standard Deviation 23.120
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
CRP (Week 24)
|
18.12 Percent change
Standard Deviation 197.270
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 0.000
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 107.200
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 2.520
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
CRP (Week 148)
|
30.60 Percent change
Standard Deviation 146.990
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
|
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 4.670
|
—
|
—
|
—
|
—
|
—
|
|
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 outcome
Timeframe: up to week 52Population: Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.
Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Outcome measures
| Measure |
AIN457
n=12 Participants
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.
|
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.
|
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.
|
No Change
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.
|
Worse
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.
|
Missing
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Topical co-medication related to GPP
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Systemic co-medication related to GPP
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
AIN457
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457
n=12 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
CELLULITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
ERYSIPELAS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
Other adverse events
| Measure |
AIN457
n=12 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Eye disorders
CATARACT
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
DUODENITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
General disorders
PYREXIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
CELLULITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
ECZEMA IMPETIGINOUS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
ERYTHRASMA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
FOLLICULITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
GENITAL CANDIDIASIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
HELICOBACTER INFECTION
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
IMPETIGO
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
NASOPHARYNGITIS
|
58.3%
7/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
OTITIS EXTERNA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
PARONYCHIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
PHARYNGITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
SINUSITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
STREPTOCOCCAL INFECTION
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Injury, poisoning and procedural complications
FALL
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Investigations
WEIGHT DECREASED
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
16.7%
2/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
2/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Nervous system disorders
BURNING SENSATION
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Nervous system disorders
DIZZINESS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Nervous system disorders
SOMNOLENCE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Reproductive system and breast disorders
BREAST CYST
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
ECZEMA ASTEATOTIC
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
PEMPHIGOID
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
PURPURA SENILE
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
SOLAR DERMATITIS
|
8.3%
1/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
16.7%
2/12 • Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.
AE additional description
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the pooled data (o.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER