Survival analysis of time to flare in treatment period 2 (TP2) FAS2

Subjects are either ERA or JPsA

Full Analysis Set for TP2: The FAS TP2 (FAS 2) consisted of all randomized subjects who received at least one dose of study drug in TP2. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization in TP2.

Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1)

The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components

• Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.
• Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.
• Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)
• Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)
• Number of joints with limitation of motion
• Laboratory measure of inflammation: CRP (mg/L)

Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.

Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1)

The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components

• Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.
• Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.
• Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)
• Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)
• Number of joints with limitation of motion
• Laboratory measure of inflammation: CRP (mg/L)

Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.

Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1

Negative percent change indicates improvement

Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.

FAS TP1 including patients with valid measurements at week 12

Median Percent Change from baseline for C-reactive protein standardized value (mg/L)

FAS TP1

JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).

FAS treatment period 1

Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best

A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis.

This is the mean (SD) enthesitis count (range 0-16) for FAS subjects

A zero score means no enthesitis, so a zero score is better for the patient

FAS TP1 including patients with valid measurements at week 12

Summary of total dactylitis count for all subjects - TP1 (FAS1)

Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient

FAS TP1 including patients with valid measurements at week 12

Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.

FAS

Summary of pharmacokinetic concentrations - Treatment period 1

Safety Set

Summary of inactive disease status for all subjects - TP1 (FAS1)

Clinical inactive disease definition was adapted from the JIA ACR criteria.

All were required to be met:

• No joints with active arthritis
• No uveitis
• CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA
• Physician's global assessment of disease activity score ≤ 10mm
• Duration of morning stiffness attributable to JIA ≤15 min

FAS1