Long Term Treatment Strategies and Effectiveness of Secukinumab in Patient With JIA Subtypes of JPsA and ERA: Study From German BIKER Registry.

This is a multicenter, non-interventional cohort study with a combined data collection principle based on secondary use of data and primary data collection from the existing BIKER registry among pediatric patients with a recorded diagnosis of ERA or JPsA who have been treated with secukinumab.

The primary objective of this study is to characterize potentially less demanding long-term treatment strategies (e.g., dose tapering, treatment withdrawal followed by treatment re-initiation as needed) and to characterize their effectiveness (evaluated by occurrence of disease flares) in children and adolescents with Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) categories documented in the German Biologics in pediatric rheumatology (BIKER) registry who received secukinumab and achieved inactive disease.

The date of first treatment/prescription of secukinumab will be considered as the index date. The baseline period to evaluate the demographic and clinical characteristics includes the index date and up to 1 year prior to the index date; if no record is available at the index date whichever record is closest to the index date will be used. For JIA-related variables, such as JIA-related manifestations, the evaluation will not have a specific time limit prior to the index date."

• Number of patients with following secukinumab treatment patterns [Time frame: every 3 months after index date until end of follow-up, up to 5 years]
• Number of participants by reason for changes to treatment strategy [Time frame: every 3 months after index date until end of follow-up, up to 5 years]
• Number of patients achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 criteria at follow-up [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Number of patients achieving at least minimal disease activity [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Number of patients achieving inactive disease [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Number of patients achieving clinical remission [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Number of patients achieving complete resolution of dactylitis and enthesitis. [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Change from baseline in pain score [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Change from baseline in JIA ACR criteria individual components [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Change from baseline in JADAS-10 individual criteria: [Time frame: Baseline, up to 5 years]
• JADAS-10 score [Time frame: At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]
• Change from baseline in swollen joint count [Time frame: Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years]