Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis

Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab

The ACR Pedi 30/50/70/90 is defined as a minimum of 30/50/70/90 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30/50/70/90 percent.

The ACR Pedi consists of 6 core criteria:

• physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity
• assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
• functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]);
• number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
• number of joints with limited range of motion
• laboratory marker of inflammation (C-reactive protein [CRP]).

To state the absence of disease activity (inactive phase of the disease), the patient must meet all of the listed criteria.

• absence of joints with active arthritis,
• absence of fever, rash, serositis, splenomegaly or generalized lymphadenopathy typical of juvenile arthritis;
• absence of active uveitis,
• normal ESR and (or) CRP,
• absence of disease activity according to the doctor's general assessment (VAS),
• morning stiffness less than 15 minutes.

Describes the child's usual activities in eight domains over the past week. It include dressing, getting up, eating, walking, hygiene, reaching overhead objects, grip and activities. Each question is scored from 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do). The score for each of the eight functional areas will be averaged to calculate the disability index.

Physician global assessment of disease activity assessed on a VAS scale of 0 [no activity] to 10 [extreme activity]

Patient/legal representative global assessment of disease activity assessed on a VAS scale of 0 [no activity] to 10 [extreme activity]

Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response.

The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 percent.

The ACR Pedi consists of 6 core criteria:

• physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity
• assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
• functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]);
• number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
• number of joints with limited range of motion
• laboratory marker of inflammation (C-reactive protein [CRP]).

Score to evaluate the number of joints inflamed. A joint is considered to be inflamed when at leats two of the following criteria are present:

• pain
• Swelling
• limited motion. The score range (total) is from 0-101, where higher scores indicate worse outcome.

The JSpADA score is a comprehensive

clinical assessment tool designed to measure the impact of juvenile spondyloarthritis on the patient. The JSpADA scale includes 8 indicators that assess the signs and symptoms of spondyloarthritis. Patients receive an overall score based on scores on each of 8 indicators. There are two options for assessing morning stiffness, clinical sacroiliitis, uveitis and back mobility: presence or absence. Number of joints with active arthritis: 0 joints = 0; 1-2 joints = 0.5; > 2 joints = 1; Number of active enthesites: 0 = 0; 1-2 = 0.5; > 2 = 1; Patient-Reported Pain Score (VAS 0-10): 0 = 0; 1-4 = 0.5; 5-10 = 1; Assessment of ESR or CRP level: normal = 0; 1-2x = 0.5; > 2x = 1.

As a result, we add up the scores for the obtained indicators and get an overall score, and the higher it is, the higher the disease activity.

Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA) to be provided. Score can range from 0 (no disease) to 72 (maximal disease).

Reasons for discontinuation:

• lack of efficacy,
• adverse events
• administrative reasons (no medication available in the hospital, etc.)
• lack of patient's adherence
• patient's or legal representative's wish
• other.