Trial Outcomes & Findings for A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME) (NCT NCT02394561)

Last Updated: 2019-04-23

Results Overview

PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

434 participants

Primary outcome timeframe

Baseline up to 16 weeks

Results posted on

2019-04-23

Participant Flow

Five hundred thirty participants were screened and 434 entered the CORE Phase. However, there were 3 patients without Cw6 assessment which was necessary for stratification to the two arms, therefore 431 were considered enrolled.

Participant milestones

Participant milestones
Measure	Cw6-positive AIN457 300 mg Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
CORE Phase STARTED	185	246
CORE Phase Full Analysis Set	185	246
CORE Phase Safety Set	185	246
CORE Phase ITT Set	184	246
CORE Phase COMPLETED	172	227
CORE Phase NOT COMPLETED	13	19
Extension Phase STARTED	162	219
Extension Phase COMPLETED	151	207
Extension Phase NOT COMPLETED	11	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cw6-positive AIN457 300 mg Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
CORE Phase Adverse Event	7	9
CORE Phase Death	0	1
CORE Phase Pregnancy	1	0
CORE Phase Lost to Follow-up	1	0
CORE Phase Physician Decision	1	1
CORE Phase Withdrawal by Subject	2	2
CORE Phase Lack of Efficacy	1	6
Extension Phase Adverse Event	6	1
Extension Phase Death	0	1
Extension Phase Protocol Violation	1	0
Extension Phase Lost to Follow-up	1	0
Extension Phase Physician Decision	0	2
Extension Phase Withdrawal by Subject	0	5
Extension Phase Lack of Efficacy	3	3

Baseline Characteristics

A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cw6-positive AIN457 300 mg n=185 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Total n=431 Participants Total of all reporting groups
Age, Continuous	42.71 years STANDARD_DEVIATION 13.148 • n=5 Participants	47.18 years STANDARD_DEVIATION 12.919 • n=7 Participants	45.26 years STANDARD_DEVIATION 13.189 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	184 Participants n=7 Participants	309 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	184 Participants n=5 Participants	241 Participants n=7 Participants	425 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Time since first diagnosis of psoriasis	19.63 years STANDARD_DEVIATION 12.489 • n=5 Participants	17.46 years STANDARD_DEVIATION 11.343 • n=7 Participants	18.39 years STANDARD_DEVIATION 11.883 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 16 weeks

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=184 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)	80.4 percentage of participants Interval 74.0 to 85.9	81.7 percentage of participants Interval 76.3 to 86.3	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: Number of patients varied across visits

IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=184 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) n=430 Participants Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W1 IGA 0/1	2.2 percentage of participants Interval 0.62 to 5.65	2.1 percentage of participants Interval 0.68 to 4.79	0.16 percentage of participants Interval -2.86 to 3.75
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W1 PASI 50	13.4 percentage of participants Interval 8.78 to 19.29	12.1 percentage of participants Interval 8.24 to 16.89	1.32 percentage of participants Interval -5.02 to 8.09
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W1 PASI 75	2.2 percentage of participants Interval 0.61 to 5.62	0.4 percentage of participants Interval 0.01 to 2.3	1.82 percentage of participants Interval -0.52 to 5.2
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W2 IGA 0/1	8.7 percentage of participants Interval 5.05 to 13.74	6.9 percentage of participants Interval 4.08 to 10.83	1.79 percentage of participants Interval -3.29 to 7.36
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W2 PASI 50	44.0 percentage of participants Interval 36.73 to 51.51	44.5 percentage of participants Interval 38.16 to 50.95	-0.47 percentage of participants Interval -9.84 to 8.98
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W2 PASI 75	15.8 percentage of participants Interval 10.82 to 21.84	10.2 percentage of participants Interval 6.71 to 14.69	5.56 percentage of participants Interval -0.8 to 12.32
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W2 PASI 90	3.3 percentage of participants Interval 1.21 to 6.96	2.4 percentage of participants Interval 0.9 to 5.25	0.81 percentage of participants Interval -2.49 to 4.71
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W2 PASI 100	0.5 percentage of participants Interval 0.01 to 2.99	0.4 percentage of participants Interval 0.01 to 2.25	0.14 percentage of participants Interval -1.78 to 2.63
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W3 IGA 0/1	24.5 percentage of participants Interval 18.43 to 31.32	21.1 percentage of participants Interval 16.21 to 26.78	3.32 percentage of participants Interval -4.58 to 11.46
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W3 PASI 50	76.1 percentage of participants Interval 69.26 to 82.06	71.8 percentage of participants Interval 65.76 to 77.38	4.25 percentage of participants Interval -4.23 to 12.4
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W3 PASI 75	38.6 percentage of participants Interval 31.52 to 46.03	34.3 percentage of participants Interval 28.36 to 40.6	4.30 percentage of participants Interval -4.81 to 13.46
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W3 PASI 90	13.0 percentage of participants Interval 8.54 to 18.78	11.4 percentage of participants Interval 7.73 to 16.09	1.61 percentage of participants Interval -4.55 to 8.19
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W3 PASI 100	2.7 percentage of participants Interval 0.89 to 6.23	2.4 percentage of participants Interval 0.9 to 5.25	0.27 percentage of participants Interval -2.92 to 4.0
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W4 IGA 0/1	42.4 percentage of participants Interval 35.15 to 49.88	39.8 percentage of participants Interval 33.67 to 46.25	2.55 percentage of participants Interval -6.75 to 11.89
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W4 PASI 50	87.5 percentage of participants Interval 81.84 to 91.91	87.4 percentage of participants Interval 82.59 to 91.27	0.10 percentage of participants Interval -6.51 to 6.31
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W4 PASI 75	61.4 percentage of participants Interval 53.97 to 68.48	57.3 percentage of participants Interval 50.88 to 63.58	4.10 percentage of participants Interval -5.29 to 13.28
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W4 PASI 90	27.7 percentage of participants Interval 21.39 to 34.78	22.0 percentage of participants Interval 16.94 to 27.65	5.77 percentage of participants Interval -2.4 to 14.1
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W4 PASI 100	10.3 percentage of participants Interval 6.33 to 15.66	9.8 percentage of participants Interval 6.35 to 14.17	0.57 percentage of participants Interval -5.09 to 6.66
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W8 IGA 0/1	72.3 percentage of participants Interval 65.22 to 78.61	73.2 percentage of participants Interval 67.17 to 78.6	-0.89 percentage of participants Interval -9.48 to 7.47
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W8 PASI 50	95.7 percentage of participants Interval 91.61 to 98.1	95.1 percentage of participants Interval 91.63 to 97.45	0.53 percentage of participants Interval -3.97 to 4.59
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W8 PASI 75	84.8 percentage of participants Interval 78.76 to 89.64	85.0 percentage of participants Interval 79.87 to 89.18	-0.18 percentage of participants Interval -7.26 to 6.53
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W8 PASI 90	61.4 percentage of participants Interval 53.97 to 68.48	60.6 percentage of participants Interval 54.16 to 66.72	0.84 percentage of participants Interval -8.46 to 10.01
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) W8 PASI 100	34.8 percentage of participants Interval 27.93 to 42.14	34.6 percentage of participants Interval 28.63 to 40.86	0.23 percentage of participants Interval -8.72 to 9.34
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK12 IGA 0/1	81.0 percentage of participants Interval 74.55 to 86.38	81.7 percentage of participants Interval 76.3 to 86.33	-0.73 percentage of participants Interval -8.36 to 6.57
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK12 PASI 50	97.3 percentage of participants Interval 93.77 to 99.11	97.2 percentage of participants Interval 94.23 to 98.85	0.13 percentage of participants Interval -3.65 to 3.43
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK12 PASI 75	92.9 percentage of participants Interval 88.22 to 96.18	90.7 percentage of participants Interval 86.3 to 93.98	2.28 percentage of participants Interval -3.27 to 7.46
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK12 PASI 90	72.8 percentage of participants Interval 65.79 to 79.11	73.6 percentage of participants Interval 67.6 to 78.98	-0.75 percentage of participants Interval -9.3 to 7.56
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK12 PASI 100	49.5 percentage of participants Interval 42.02 to 56.91	43.9 percentage of participants Interval 37.6 to 50.35	5.55 percentage of participants Interval -3.93 to 14.94
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK16 IGA 0/1	85.3 percentage of participants Interval 79.37 to 90.1	86.2 percentage of participants Interval 81.23 to 90.23	-0.85 percentage of participants Interval -7.79 to 5.7
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK16 PASI 50	97.8 percentage of participants Interval 94.53 to 99.4	98.8 percentage of participants Interval 96.48 to 99.75	-0.95 percentage of participants Interval -4.33 to 1.7
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK16 PASI 75	94.0 percentage of participants Interval 89.56 to 96.98	93.1 percentage of participants Interval 89.17 to 95.92	0.93 percentage of participants Interval -4.16 to 5.6
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK16 PASI 90	80.4 percentage of participants Interval 73.96 to 85.9	81.7 percentage of participants Interval 76.3 to 86.33	-1.27 percentage of participants Interval -8.94 to 6.08
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK16 PASI 100	59.2 percentage of participants Interval 51.77 to 66.41	53.3 percentage of participants Interval 46.81 to 59.62	5.99 percentage of participants Interval -3.49 to 15.24
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK20 IGA0/1	87.0 percentage of participants Interval 81.22 to 91.46	87.4 percentage of participants Interval 82.59 to 91.27	-0.44 percentage of participants Interval -7.11 to 5.83
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK20 PASI 50	97.8 percentage of participants Interval 94.53 to 99.4	97.6 percentage of participants Interval 94.77 to 99.1	0.27 percentage of participants Interval -3.27 to 3.34
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK20 PASI 75	94.6 percentage of participants Interval 90.23 to 97.36	92.7 percentage of participants Interval 88.68 to 95.61	1.88 percentage of participants Interval -3.14 to 6.53
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK20 PASI 90	81.0 percentage of participants Interval 74.55 to 86.38	81.7 percentage of participants Interval 76.3 to 86.33	-0.73 percentage of participants Interval -8.36 to 6.57
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK20 PASI 100	59.8 percentage of participants Interval 52.32 to 66.93	57.3 percentage of participants Interval 50.88 to 63.58	2.47 percentage of participants Interval -6.93 to 11.71
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK24 IGA 0/1	89.7 percentage of participants Interval 84.34 to 93.67	85.4 percentage of participants Interval 80.32 to 89.54	4.31 percentage of participants Interval -2.21 to 10.45
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK24 PASI 50	97.3 percentage of participants Interval 93.77 to 99.11	97.2 percentage of participants Interval 94.23 to 98.85	0.13 percentage of participants Interval -3.65 to 3.43
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK24 PASI 75	94.6 percentage of participants Interval 90.23 to 97.36	93.1 percentage of participants Interval 89.17 to 95.92	1.48 percentage of participants Interval -3.51 to 6.07
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK24 PASI 90	84.2 percentage of participants Interval 78.16 to 89.18	83.3 percentage of participants Interval 78.08 to 87.77	0.91 percentage of participants Interval -6.35 to 7.79
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK24 PASI 100	62.0 percentage of participants Interval 54.52 to 69.0	61.4 percentage of participants Interval 54.99 to 67.5	0.57 percentage of participants Interval -8.71 to 9.71
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK36 IGA 0/1	91.9 percentage of participants Interval 86.59 to 95.63	90.9 percentage of participants Interval 86.25 to 94.33	1.06 percentage of participants Interval -5.06 to 6.68
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK36 PASI 50	98.8 percentage of participants Interval 95.58 to 99.85	99.1 percentage of participants Interval 96.74 to 99.89	-0.33 percentage of participants Interval -3.57 to 2.19
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK36 PASI 75	94.4 percentage of participants Interval 89.65 to 97.41	95.0 percentage of participants Interval 91.19 to 97.47	-0.57 percentage of participants Interval -5.75 to 4.0
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK36 PASI 90	88.8 percentage of participants Interval 82.91 to 93.24	84.0 percentage of participants Interval 78.48 to 88.61	4.80 percentage of participants Interval -2.39 to 11.54
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK36 PASI 100	65.8 percentage of participants Interval 57.96 to 73.12	64.4 percentage of participants Interval 57.65 to 70.72	1.45 percentage of participants Interval -8.27 to 10.95
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK48 IGA 0/1	87.8 percentage of participants Interval 80.42 to 93.18	86.8 percentage of participants Interval 80.52 to 91.63	1.03 percentage of participants Interval -7.43 to 8.82
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK48 PASI 50	98.3 percentage of participants Interval 93.86 to 99.79	98.1 percentage of participants Interval 94.59 to 99.61	0.15 percentage of participants Interval -4.41 to 3.88
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK48 PASI 75	93.9 percentage of participants Interval 87.86 to 97.52	91.2 percentage of participants Interval 85.67 to 95.1	2.72 percentage of participants Interval -4.18 to 8.98
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK48 PASI 90	84.3 percentage of participants Interval 76.4 to 90.45	80.5 percentage of participants Interval 73.48 to 86.35	3.84 percentage of participants Interval -5.59 to 12.64
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK48 PASI 100	68.7 percentage of participants Interval 59.38 to 77.02	61.6 percentage of participants Interval 53.6 to 69.23	7.06 percentage of participants Interval -4.44 to 18.02
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK60 IGA 0/1	87.5 percentage of participants Interval 78.21 to 93.84	83.9 percentage of participants Interval 76.0 to 90.02	3.60 percentage of participants Interval -6.97 to 13.09
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK60 PASI 50	96.3 percentage of participants Interval 89.43 to 99.22	95.0 percentage of participants Interval 89.35 to 98.13	1.29 percentage of participants Interval -5.94 to 7.34
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK60 PASI 75	90.0 percentage of participants Interval 81.24 to 95.58	89.9 percentage of participants Interval 83.05 to 94.68	0.08 percentage of participants Interval -9.42 to 8.37
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK60 PASI 90	82.5 percentage of participants Interval 72.38 to 90.09	74.8 percentage of participants Interval 66.01 to 82.3	7.71 percentage of participants Interval -4.27 to 18.58
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK60 PASI 100	65.0 percentage of participants Interval 53.52 to 75.33	56.3 percentage of participants Interval 46.91 to 65.37	8.70 percentage of participants Interval -5.19 to 21.8
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK72 IGA 0/1	85.4 percentage of participants Interval 70.83 to 94.43	80.0 percentage of participants Interval 67.67 to 89.22	5.37 percentage of participants Interval -10.7 to 19.47
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK72 PASI 50	92.7 percentage of participants Interval 80.08 to 98.46	93.4 percentage of participants Interval 84.05 to 98.18	-0.76 percentage of participants Interval -13.5 to 9.55
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK72 PASI 75	85.4 percentage of participants Interval 70.83 to 94.43	88.5 percentage of participants Interval 77.78 to 95.26	-3.16 percentage of participants Interval -18.1 to 9.79
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK72 PASI 90	75.6 percentage of participants Interval 59.7 to 87.64	73.8 percentage of participants Interval 60.93 to 84.2	1.84 percentage of participants Interval -15.8 to 17.98
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set) WK72 PASI 100	58.5 percentage of participants Interval 42.11 to 73.68	50.8 percentage of participants Interval 37.7 to 63.86	7.72 percentage of participants Interval -11.7 to 26.08

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: The number of patients across visits varied

IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=184 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W36	-88.6 percent change Standard Deviation 22.34	-87.6 percent change Standard Deviation 23.82	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W1	-8.5 percent change Standard Deviation 16.08	-7.3 percent change Standard Deviation 17.04	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W2	-22.4 percent change Standard Deviation 22.73	-21.6 percent change Standard Deviation 22.72	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W3	-38.0 percent change Standard Deviation 25.45	-36.5 percent change Standard Deviation 27.20	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W4	-49.6 percent change Standard Deviation 29.36	-49.5 percent change Standard Deviation 29.24	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W8	-71.2 percent change Standard Deviation 28.60	-71.2 percent change Standard Deviation 28.91	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W12	-78.7 percent change Standard Deviation 27.31	-79.0 percent change Standard Deviation 25.37	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W16	-84.1 percent change Standard Deviation 24.52	-83.3 percent change Standard Deviation 22.97	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W20	-85.3 percent change Standard Deviation 24.26	-84.5 percent change Standard Deviation 23.80	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W24	-86.2 percent change Standard Deviation 25.17	-84.1 percent change Standard Deviation 26.34	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W48	-86.2 percent change Standard Deviation 25.75	-84.9 percent change Standard Deviation 26.06	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W60	-83.3 percent change Standard Deviation 28.44	-81.0 percent change Standard Deviation 26.97	—
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT) W72	-79.1 percent change Standard Deviation 32.92	-75.8 percent change Standard Deviation 29.58	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Time in days to reach PASI scores of 90 and 75.

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=184 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Median Time to Reach PASI 90 and 75 (ITT) PASI 90	57 days Interval 30.0 to 89.0	58 days Interval 55.0 to 92.0	—
Median Time to Reach PASI 90 and 75 (ITT) PASI 75	29 days Interval 22.0 to 57.0	29 days Interval 22.0 to 57.0	—

SECONDARY outcome

Timeframe: Baseline up to approximatly 72 weeks

Population: Number of patients varied across visits. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on Quality of Life.

The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=431 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) Week 16	-8.5 numbers in a score Standard Deviation 6.79	—	—
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) Week 24	-8.8 numbers in a score Standard Deviation 7.05	—	—
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) Week 48	-8.9 numbers in a score Standard Deviation 7.13	—	—
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS) Week 72	-8.3 numbers in a score Standard Deviation 6.70	—	—

SECONDARY outcome

Timeframe: Baseline up approximately 72 weeks

Population: Number of patients varies by visit. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.

The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=431 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W16 Anxiety	-1.7 numbers on a scale Standard Deviation 3.37	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W24 Anxiety	-2.0 numbers on a scale Standard Deviation 3.38	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W48 Anxiety	-2.5 numbers on a scale Standard Deviation 3.67	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W72 Anxiety	-2.3 numbers on a scale Standard Deviation 3.44	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W16 Depression	-1.3 numbers on a scale Standard Deviation 3.19	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W24 Depression	-1.4 numbers on a scale Standard Deviation 3.22	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W48 Depression	-1.5 numbers on a scale Standard Deviation 3.31	—	—
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS) W72 Depression	-1.7 numbers on a scale Standard Deviation 3.19	—	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.

PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=431 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) Baseline	0.02 numbers on scores	—	—
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) Week 16	0.19 numbers on scores	—	—
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) Week 24	0.18 numbers on scores	—	—
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) Week 48	0.21 numbers on scores	—	—
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS) Week 72	0.32 numbers on scores	—	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: Number of patients varied across visits

Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=185 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Changes From Baseline in Body Mass Index (Safety Set) Week 16	-0.064 kg/m2 Standard Deviation 0.7748	-0.047 kg/m2 Standard Deviation 0.9905	—
Changes From Baseline in Body Mass Index (Safety Set) Week 24	0.086 kg/m2 Standard Deviation 1.0213	-0.071 kg/m2 Standard Deviation 1.2260	—
Changes From Baseline in Body Mass Index (Safety Set) Week 48	0.302 kg/m2 Standard Deviation 1.3474	-0.052 kg/m2 Standard Deviation 1.4991	—
Changes From Baseline in Body Mass Index (Safety Set) Week 72	0.533 kg/m2 Standard Deviation 1.8101	-0.015 kg/m2 Standard Deviation 1.8982	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: Number of patients varied across visits

Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=185 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Changes From Baseline in Waist Circumference (Safety Set) Week 16	-0.86 cm Standard Deviation 3.147	-0.40 cm Standard Deviation 3.006	—
Changes From Baseline in Waist Circumference (Safety Set) Week 24	-0.81 cm Standard Deviation 3.689	-0.73 cm Standard Deviation 4.119	—
Changes From Baseline in Waist Circumference (Safety Set) Week 48	-0.76 cm Standard Deviation 4.596	-0.72 cm Standard Deviation 5.547	—
Changes From Baseline in Waist Circumference (Safety Set) Week 72	-1.81 cm Standard Deviation 4.583	-0.47 cm Standard Deviation 4.501	—

SECONDARY outcome

Timeframe: Baseline up to approximately 72 weeks

Population: Number of patients varied across visits

Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit

Outcome measures

Outcome measures
Measure	Cw6-positive AIN457 300 mg n=185 Participants Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Cw6-negative AIN457 300 mg n=246 Participants Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks	Difference in % (Cw6-pos vs Cw6-neg) Difference in percentages of the two cohorts in IGA 0/1 and PASI 50, 75, 90,100 at all time points.
Changes From Baseline in Weight (Safety Set) Week 72	1.40 kg Standard Deviation 4.678	-0.05 kg Standard Deviation 5.538	—
Changes From Baseline in Weight (Safety Set) Week 16	-0.20 kg Standard Deviation 2.242	-0.13 kg Standard Deviation 2.809	—
Changes From Baseline in Weight (Safety Set) Week 24	0.24 kg Standard Deviation 3.008	-0.21 kg Standard Deviation 3.572	—
Changes From Baseline in Weight (Safety Set) Week 48	0.87 kg Standard Deviation 3.909	-0.15 kg Standard Deviation 4.329	—

Adverse Events

Cw6-Negative AIN457 300 mg

Serious events: 21 serious events

Other events: 14 other events

Deaths: 2 deaths

Cw6-Positive AIN457 300 mg

Serious events: 10 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cw6-Negative AIN457 300 mg n=246 participants at risk Cw6-Negative AIN457 300 mg	Cw6-Positive AIN457 300 mg n=185 participants at risk Cw6-Positive AIN457 300 mg
Skin and subcutaneous tissue disorders Pruritus	1.6% 4/246 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	6.5% 12/185 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Vascular disorders Hypertension	4.1% 10/246 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.9% 11/185 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER