Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo (NCT NCT02798211)

Last Updated: 2021-10-07

Results Overview

A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in two of the following measures:Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

258 participants

Primary outcome timeframe

16 Weeks

Results posted on

2021-10-07

Participant Flow

Of 349 patients screened for the study, 271 passed screening and 258 were randomized (103 to secukinumab 300 mg, 103 to secukinumab 150 mg, and 52 to placebo). A higher percentage of patients in the secukinumab 300 mg group completed Period 1 (94.2%) than in the secukinumab 150 mg (90.3%) or placebo (88.5%) groups.

This was a 2-Period study in which participants were randomized to one of three treatment groups (i.e., "secukinumab 300mg s.c. injection", "secukinumab 1500mg s.c. injection" and "placebo s.c. injection") in Period 1 and then some participants switched to Arms/Groups "Group 4", "Group 5", and "Group 6", in Period 2.

Participant milestones

Participant milestones
Measure	Group 1 secukinumab 300mg s.c. injection	Group 2 secukinumab 150 mg s.c. injection	Group 3 Placebo s.c. injection	Group 4 Secukinumab 150 mg - 150 mg (R)	Group 5 Secukinumab 150 mg - 300 mg (NR)	Group 6 Placebo - Secukinumab 300 mg
Period 1 STARTED	103	103	52	0	0	0
Period 1 COMPLETED	97	93	46	0	0	0
Period 1 NOT COMPLETED	6	10	6	0	0	0
Period 2 STARTED	97	0	0	50	42	46
Period 2 COMPLETED	83	0	0	43	34	40
Period 2 NOT COMPLETED	14	0	0	7	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 secukinumab 300mg s.c. injection	Group 2 secukinumab 150 mg s.c. injection	Group 3 Placebo s.c. injection	Group 4 Secukinumab 150 mg - 150 mg (R)	Group 5 Secukinumab 150 mg - 300 mg (NR)	Group 6 Placebo - Secukinumab 300 mg
Period 1 Adverse Event	1	1	0	0	0	0
Period 1 Lost to Follow-up	2	1	0	0	0	0
Period 1 Protocol Violation	0	0	2	0	0	0
Period 1 Withdrawal by Subject	1	1	0	0	0	0
Period 1 Death	0	0	1	0	0	0
Period 1 Withdrawal of Informed Consent	2	7	3	0	0	0
Period 2 Withdrawal by Subject	2	0	0	0	2	2
Period 2 Adverse Event	5	0	0	0	1	0
Period 2 Lack of Efficacy	1	0	0	1	0	1
Period 2 Lost to Follow-up	3	0	0	0	2	0
Period 2 Physician Decision	1	0	0	1	1	0
Period 2 Pregnancy	0	0	0	2	0	0
Period 2 Technical problems	1	0	0	1	0	0
Period 2 Withdrawal of Informed Consent	1	0	0	2	2	3

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=103 Participants secukinumab 150 mg s.c. injection	Group 3 n=52 Participants Placebo s.c. injection	Total n=258 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 12.56 • n=5 Participants	51.3 years STANDARD_DEVIATION 14.58 • n=7 Participants	53.1 years STANDARD_DEVIATION 12.67 • n=5 Participants	52.2 years STANDARD_DEVIATION 80.86 • n=4 Participants
Age, Customized ≥18-<40	20 Participants n=5 Participants	20 Participants n=7 Participants	8 Participants n=5 Participants	48 Participants n=4 Participants
Age, Customized ≥40-<65	65 Participants n=5 Participants	61 Participants n=7 Participants	35 Participants n=5 Participants	161 Participants n=4 Participants
Age, Customized ≥65-<75	14 Participants n=5 Participants	18 Participants n=7 Participants	9 Participants n=5 Participants	41 Participants n=4 Participants
Age, Customized ≥75	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	47 Participants n=7 Participants	29 Participants n=5 Participants	126 Participants n=4 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	56 Participants n=7 Participants	23 Participants n=5 Participants	132 Participants n=4 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	88 Participants n=5 Participants	88 Participants n=7 Participants	45 Participants n=5 Participants	221 Participants n=4 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=103 Participants secukinumab 150 mg s.c. injection	Group 3 n=52 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16	51.46 percentage of participants	36.89 percentage of participants	23.08 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Dactylitis Subset: The Dactylitis Subset comprises patients who have LDI \>= 1 at baseline

The percent of patients in the Dactylitis Subset with dactylitis in the secukinumab 300 mg group at Week 16. Dactylitis is severe inflammation of the finger and toe joints. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=49 Participants secukinumab 300mg s.c. injection	Group 2 n=52 Participants secukinumab 150 mg s.c. injection	Group 3 n=23 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16	53.06 percent of participants	44.23 percent of participants	65.22 percent of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC) subset. The SPARCC Subset is comprised of patients who have SPARCC \>= 1 at baseline. Score range is 0-16 sites where a higher indicates more enthesitis.

Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=72 Participants secukinumab 300mg s.c. injection	Group 2 n=76 Participants secukinumab 150 mg s.c. injection	Group 3 n=39 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16	63.89 percentage of participants	57.89 percentage of participants	76.92 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: LEI subset: The LEI Subset comprises patients who have LEI \>= 1 at baseline. LEI uses 6 sites for evaluation of enthesitis, so the range is 0-6 withy a higher number indicating more arthritis.

Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. LEI=Leeds Enthesitis Index

Outcome measures

Outcome measures
Measure	Group 1 n=66 Participants secukinumab 300mg s.c. injection	Group 2 n=67 Participants secukinumab 150 mg s.c. injection	Group 3 n=34 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI)	56.06 percentage of participants	52.24 percentage of participants	82.35 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: Combined SPARCC and LEI Subset: The LEI and SPARCC Subset comprises patients who have an enthesitis score \>= 1 when sites from LEI and SPARCC are assessed together at baseline.

Statistical analysis (logistic regression) of presence of enthesitis (Combined SPARCC and LEI) by visit - in treatment period 1 (non-responder imputation) (Combined SPARCC and LEI Subset) Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=74 Participants secukinumab 300mg s.c. injection	Group 2 n=76 Participants secukinumab 150 mg s.c. injection	Group 3 n=39 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI)	62.16 percentage of participants	59.21 percentage of participants	82.05 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

A patient was considered as improved according the ACR50 criteria if she/he had at least 50% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR50 response by visit - in treatment period 1 (non-responder imputation) (Full Analysis Set) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=103 Participants secukinumab 150 mg s.c. injection	Group 3 n=3 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16	28.16 percentage of participants	24.27 percentage of participants	5.77 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

A patient was considered as improved according the ACR70 criteria if she/he had at least 70% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR70 response by visit - in treatment period 1 (non-responder imputation) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=103 Participants secukinumab 150 mg s.c. injection	Group 3 n=52 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16	17.48 percentage of participants	10.68 percentage of participants	1.92 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis.

Outcome measures

Outcome measures
Measure	Group 1 n=79 Participants secukinumab 300mg s.c. injection	Group 2 n=83 Participants secukinumab 150 mg s.c. injection	Group 3 n=43 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16	64.56 percentage of participants	54.22 percentage of participants	16.28 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline

A 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis.

Outcome measures

Outcome measures
Measure	Group 1 n=79 Participants secukinumab 300mg s.c. injection	Group 2 n=83 Participants secukinumab 150 mg s.c. injection	Group 3 n=43 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16	49.37 percentage of participants	36.14 percentage of participants	9.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 Weeks

Population: Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline

A 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=79 Participants secukinumab 300mg s.c. injection	Group 2 n=83 Participants secukinumab 150 mg s.c. injection	Group 3 n=43 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16	25.32 percentage of participants	18.07 percentage of participants	2.33 percentage of participants	—	—

SECONDARY outcome

Timeframe: baseline, 16 weeks

DAS-CRP uses the C-Reactive Protein (CRP) value. Disease Activity Score (DAS28-CRP) values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission. DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters. Least squares mean (LSM), Least squares mean (LSM) treatment difference, 95% confidence interval (CI) for treatment difference, and p-values are from an analysis of covariance (ANCOVA) model with treatment (3 treatment groups), baseline DAS28-CRP score, methotrexate usage at baseline (yes, no), and body weight(kg) as explanatory variables.

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=103 Participants secukinumab 150 mg s.c. injection	Group 3 n=52 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Change From Baseline to Week 16 in DAS28-CRP	-1.39 scores on a scale Standard Deviation 0.120	-1.18 scores on a scale Standard Deviation 0.125	-0.35 scores on a scale Standard Deviation 0.170	—	—

SECONDARY outcome

Timeframe: 16 Weeks

The Health assessment questionnaire disability index (HAQ-DI) is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).

Outcome measures

Outcome measures
Measure	Group 1 n=101 Participants secukinumab 300mg s.c. injection	Group 2 n=101 Participants secukinumab 150 mg s.c. injection	Group 3 n=50 Participants Placebo s.c. injection	Group 4 Any Secukinumab 150mg	Group 5 Placebo s.c. injection 300mg
Change From Baseline to Week 16 in HAQ-DI	-0.32 scores on a scale Interval -0.37 to -0.05	-0.24 scores on a scale Interval -0.3 to 0.03	-0.11 scores on a scale Placebo not compared to itself. It is below the level of detection	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Full Analysis Set

Exploratory The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=50 Participants secukinumab 150 mg s.c. injection	Group 3 n=42 Participants Placebo s.c. injection	Group 4 n=103 Participants Any Secukinumab 150mg	Group 5 n=52 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 1	17.48 percentage of participants	8.00 percentage of participants	4.76 percentage of participants	5.83 percentage of participants	1.92 percentage of participants
Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 16	51.46 percentage of participants	72.00 percentage of participants	4.76 percentage of participants	36.89 percentage of participants	23.08 percentage of participants
Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 52	47.57 percentage of participants	68.00 percentage of participants	28.57 percentage of participants	44.66 percentage of participants	42.31 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Full Analysis Set

Exploratory

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=50 Participants secukinumab 150 mg s.c. injection	Group 3 n=42 Participants Placebo s.c. injection	Group 4 n=103 Participants Any Secukinumab 150mg	Group 5 n=52 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) ACR50 - week 1	2.91 percentage of participants	—	2.38 percentage of participants	.97 percentage of participants	—
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) ACR50 - week 16	28.16 percentage of participants	46.00 percentage of participants	4.76 percentage of participants	24.27 percentage of participants	5.77 percentage of participants
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) ACR70 - week 16	17.48 percentage of participants	22.00 percentage of participants	—	10.68 percentage of participants	1.92 percentage of participants
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) ACR50 - week 52	32.04 percentage of participants	48.00 percentage of participants	14.29 percentage of participants	29.13 percentage of participants	17.31 percentage of participants
Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) ACR70 - week 52	21.36 percentage of participants	28.00 percentage of participants	4.76 percentage of participants	15.53 percentage of participants	5.77 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Dactylitis Subset The Dactylitis Subset comprised patients who had LDI ≥1 at baseline.

Exploratory

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=50 Participants secukinumab 150 mg s.c. injection	Group 3 n=42 Participants Placebo s.c. injection	Group 4 n=103 Participants Any Secukinumab 150mg	Group 5 n=52 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 1	42.72 percentage of participants	42.00 percentage of participants	35.71 percentage of participants	40.78 percentage of participants	32.69 percentage of participants
Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 16	25.24 percentage of participants	24.00 percentage of participants	26.19 percentage of participants	22.33 percentage of participants	28.85 percentage of participants
Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 52	10.68 percentage of participants	6.00 percentage of participants	11.90 percentage of participants	7.77 percentage of participants	9.62 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Leeds Enthesitis Index (LEI) Subset: The LEI Subset comprised patients who had LEI ≥1 at baseline.

Exploratory

Outcome measures

Outcome measures
Measure	Group 1 n=66 Participants secukinumab 300mg s.c. injection	Group 2 n=33 Participants secukinumab 150 mg s.c. injection	Group 3 n=27 Participants Placebo s.c. injection	Group 4 n=67 Participants Any Secukinumab 150mg	Group 5 n=34 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 1	84.85 percentage of participants	66.67 percentage of participants	88.89 percentage of participants	77.61 percentage of participants	79.41 percentage of participants
Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 16	56.06 percentage of participants	24.24 percentage of participants	77.78 percentage of participants	52.24 percentage of participants	82.35 percentage of participants
Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 52	53.03 percentage of participants	36.36 percentage of participants	66.67 percentage of participants	53.73 percentage of participants	61.76 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Full Analysis Set

Exploratory

Outcome measures

Outcome measures
Measure	Group 1 n=103 Participants secukinumab 300mg s.c. injection	Group 2 n=50 Participants secukinumab 150 mg s.c. injection	Group 3 n=42 Participants Placebo s.c. injection	Group 4 n=103 Participants Any Secukinumab 150mg	Group 5 n=52 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 1	0.97 percentage of participants	—	—	—	—
Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 16	36.36 percentage of participants	69.70 percentage of participants	25.93 percentage of participants	44.78 percentage of participants	26.47 percentage of participants
Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) week 52	26.21 percentage of participants	42.00 percentage of participants	14.29 percentage of participants	26.21 percentage of participants	3.85 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 52 weeks

Population: Psoriasis subset The psoriasis subset comprises patients having Body Surface Area (BSA) \>= 3% at baseline

Exploratory

Outcome measures

Outcome measures
Measure	Group 1 n=79 Participants secukinumab 300mg s.c. injection	Group 2 n=40 Participants secukinumab 150 mg s.c. injection	Group 3 n=34 Participants Placebo s.c. injection	Group 4 n=83 Participants Any Secukinumab 150mg	Group 5 n=43 Participants Placebo s.c. injection 300mg
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI90- week 52	48.10 percentage of participants	67.50 percentage of participants	35.29 percentage of participants	46.99 percentage of participants	44.19 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI75 - week 1	8.86 percentage of participants	7.5 percentage of participants	11.76 percentage of participants	8.43 percentage of participants	4.65 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI90 - week 1	1.27 percentage of participants	—	2.94 percentage of participants	1.2 percentage of participants	1 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI100 - week 1	—	—	—	—	2.33 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI75 - week 16	64.56 percentage of participants	80.00 percentage of participants	38.24 percentage of participants	54.22 percentage of participants	16.28 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI90 - week 16	49.37 percentage of participants	60.00 percentage of participants	17.65 percentage of participants	36.14 percentage of participants	9.30 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI100 - week 16	25.32 percentage of participants	37.50 percentage of participants	—	18.07 percentage of participants	2.33 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI75 - week 52	67.09 percentage of participants	77.50 percentage of participants	52.94 percentage of participants	59.04 percentage of participants	53.49 percentage of participants
Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) PASI100 - week 52	31.65 percentage of participants	55.00 percentage of participants	26.47 percentage of participants	37.35 percentage of participants	32.56 percentage of participants

Adverse Events

Secukinumab 300mg

Serious events: 15 serious events

Other events: 66 other events

Deaths: 0 deaths

Secukinumab 150mg

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Secukinumab 300mg n=191 participants at risk Secukinumab 300mg	Secukinumab 150mg n=103 participants at risk Secukinumab 150mg	Placebo n=52 participants at risk Placebo
Gastrointestinal disorders Diarrhoea	5.8% 11/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	6.8% 7/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	3.8% 2/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Infections and infestations Bronchitis	5.2% 10/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	0.97% 1/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	1.9% 1/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Infections and infestations Nasopharyngitis	3.1% 6/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 6/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	1.9% 1/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Infections and infestations Sinusitis	4.2% 8/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	2.9% 3/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	7.7% 4/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Infections and infestations Upper respiratory tract infection	13.6% 26/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 6/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	1.9% 1/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Infections and infestations Urinary tract infection	5.2% 10/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	4.9% 5/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	0.00% 0/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 9/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	2.9% 3/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	7.7% 4/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Musculoskeletal and connective tissue disorders Back pain	5.2% 10/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	7.8% 8/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	15.4% 8/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.1% 6/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	0.97% 1/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 3/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 3/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	4.9% 5/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 3/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	1.6% 3/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 6/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	0.00% 0/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
Vascular disorders Hypertension	4.2% 8/191 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	5.8% 6/103 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2	0.00% 0/52 • Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up An AE is any untoward sign or symptom that occurs in \>=5% of participants during study treatment. AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (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