This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
Age ≥6 to <18 years old.
Peripheral arthritis and enthesitis, or
Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
Chronic recurrent infections.
Clinically significant infection exacerbation, including active tuberculosis.
Age <6 years or ≥18 years.
Pediatric patients with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment
Cohort
Prospective
Secukinumab
Other interventionThis is an observational study, there is no treatment allocation.
Drug survival rate
Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab
American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates
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: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. 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) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]).
Clinical remission/inactive disease rates by Wallace criteria
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.
Childhood Health Assessment Questionnaire (CHAQ) score
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
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
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
Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response.
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