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

N/ANot Yet RecruitingNCT07190053

Novartis Pharmaceuticals100 enrolled

Overview

The goal of this study is to understand the long-term treatment strategies in children and adolescents diagnosed with ERA or JPsA who received secukinumab and achieved inactive disease and to evaluate the long-term treatment effectiveness of secukinumab in the ERA or JPsA patients in the postauthorization setting.

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."

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Interventions

SecukinumabOTHER

This is an observational study, there is no treatment allocation

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In the BIKER registry, males and females ≥ 6 years old and ≤ 17 years old diagnosed with ERA according to the ILAR-criteria or JPsA according to the ILAR or the Vancouver criteria, who initiated at least one dose of secukinumab after it was approved in Germany and according to the label. * Written informed consent from parent/legal guardian and assent from minor patient (11-17 years of age) for participating in the BIKER registry and for this study enrolment. Exclusion Criteria: * Patients taking other biologic immunomodulating agent(s) or Janus kinase (JAK) inhibitors concomitantly with secukinumab at index date. * Patients participating in any interventional trials at index date.

Outcomes

Primary Outcomes

Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab

Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab * Secukinumab treatment remained unchanged or dose was increased. * Dose tapering of secukinumab (by dose reduction or prolongation of treatment interval). * Increase of secukinumab dose after a tapering period. * Initiation of other biologics after a tapering period. * Entering a secukinumab-free period due to achieving inactive disease or clinical remission (stratified by those who discontinue secukinumab due to achieving inactive disease without achieving clinical remission and those who achieve clinical remission) * Re-initiation of secukinumab after a secukinumab-free period * Initiation of other biologics after a secukinumab-free period

Time frame: Up to 5 years

Number of patients experiencing at least one episode of flare

Number of patients experiencing at least one episode of flare: * Following inactive disease for patients whose secukinumab treatment remained unchanged or increased dose. * Following the start of tapering or discontinuation of secukinumab treatment after achieving inactive disease

Time frame: Up to 5 years

Secondary Outcomes

Number of patients with following secukinumab treatment patterns

Number of patients with following secukinumab treatment patterns: * Secukinumab treatment remained unchanged or dose was increased * Dose tapering of secukinumab (by dose reduction or prolongation of dosing interval) * Increase of secukinumab dose after a tapering period. * Initiation of other biologics after a tapering period. * Discontinuation of secukinumab: * Switching directly from secukinumab to other therapies. * Entering a secukinumab-free period. * Re-initiation of secukinumab after a secukinumab-free period. * Initiation of other biologics after a secukinumab-free period.

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

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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The reason for changes to treatment strategy: * Achieving inactive disease * Achieving clinical remission * Lack of effectiveness * Occurrence of adverse events * Patient's /Parent's decision * Other

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

The adapted ACR Pediatric 30/50/70/90 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90% 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)

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

Patients who achieved minimal disease activity and inactive disease can be defined based on JADAS-10 score. JADAS-10 is a composite disease activity score for JIA including four measures: * physician's global assessment of disease activity (NRS) * parent/guardian's or patient's global assessment of overall wellbeing (NRS) * number of joints (up to 10) with active arthritis * CRP/ESR, whichever is available

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

Inactive disease is achieved if either of the following two criteria is fulfilled: * Wallace et al (2011) ACR criteria for inactive disease: * no joints with active arthritis * no active uveitis * normal CRP/ESR, or if elevated, not attributable to JIA * physician's global assessment of disease activity ≤ 1 (NRS) * duration of morning stiffness attributable to JIA ≤ 15 minutes * JADAS-10 score-based definition for inactive disease: * physician's global assessment of disease activity (NRS) * parent/guardian's or patient's global assessment of overall wellbeing (NRS) * number of joints (up to 10) with active arthritis * CRP/ESR, whichever is available

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

Patients with 6 consecutive months of inactive disease are defined as entering 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

Change from baseline in pain score through numeric rating scale (NRS). Numeric rating scale spans from 0 (no pain) to 10 (strongest pain).

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

Summary of JIA ACR core components for all subjects and each JIA category. Negative percent change indicates improvement. JIA ACR criteria individual components: * Number of joints with active arthritis * Number of joints with limited range of motion * C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), whichever is available. * Functional status using the Childhood Health Assessment Questionnaire (CHAQ) disability index and Health Assessment Questionnaire for adults. * Physician global assessment of overall well-being through NRS. * Parent/guardian's or patient's global assessment of overall well-being through NRS.

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:

JADAS-10 stands for Juvenile Arthritis Disease Activity Score, with up to 10 joints assessed for active arthritis as part of the score. JADAS-10 individual criteria are: * Physician's global assessment: NRS scale - 0 (inactive disease ) to 10 (active disease) * Parent/guardian's or patient's global assessment: NRS scale - 0 (inactive disease ) to 10 (active disease) * Number of joints with active arthritis: from 0 active joints to 10 active joints. * CRP/ESR, whichever is available: Westergren erythrocyte sedimentation rate (ESR), normalized to a 0-10 scale. The CRP was truncated to a 0-10 scale accord¬ing to the following formula: (CRP (mg/l)-10)/10, similar to the normalized ESR used in the original JADAS. Before calculation, CRP values \<10 mg/l were converted to 10 and CRP values \>110 mg/l were converted to 110.

Time frame: Baseline, up to 5 years

JADAS-10 score

JADAS-10 stands for Juvenile Arthritis Disease Activity Score, with up to 10 joints assessed for active arthritis as part of the score. The score spans from 0 to 40. Lower values mean lower activity and higher values mean higher activity.