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Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA):
Pamela F Weiss1,2, Cora E Sears3, Timothy G Brandon3
1Division of Rheumatology and Center for Pediatric Clinical Effectiveness, Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 11121, Philadelphia, PA, 19104, USA. weisspa@chop.edu.
Insights
This study investigates stopping or reducing biologic medication for children with juvenile spondyloarthritis (JSpA) who have achieved inactive disease. It aims to provide evidence for shared decision-making regarding treatment de-escalation.
Area of Science:
- Pediatric rheumatology
- Immunology
- Clinical trial methodology
Background:
- Biologic therapies, particularly tumor necrosis factor inhibitors (TNFi), are effective for juvenile spondyloarthritis (JSpA), enabling inactive disease as an outcome.
- High costs, administration routes, and side effects of biologics prompt questions about discontinuing them once inactive disease is achieved.
- Uncertainty exists regarding whether to maintain, taper, or stop TNFi in children with JSpA in remission.
Purpose of the Study:
- To assess the efficacy of different tumor necrosis factor inhibitor (TNFi) de-escalation strategies in children with juvenile spondyloarthritis (JSpA) who have achieved sustained inactive disease.
- To compare the risk of flare and evaluate emotional health outcomes among children randomized to continue standard TNFi dosing, reduce TNFi dosing intervals, or stop TNFi.
- To inform shared decision-making between patients, caregivers, and rheumatologists regarding the continuation or de-escalation of TNFi therapy.
Main Methods:
- The Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile SpA (BACK-OFF JSpA) trial is a multicenter pragmatic randomized controlled trial.
- 198 participants aged 8-21 years with JSpA and sustained inactive disease on standard TNFi dosing were randomized into three groups: standard dosing, longer dosing intervals, or cessation of TNFi.
- The study will compare the hazard rate of protocol-defined flare and participants' emotional health over 12 months, utilizing an electronic health record-based recruitment strategy and involving patient/parent stakeholders.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This is the first randomized pragmatic trial to evaluate TNFi de-escalation in children with JSpA and sustained inactive disease.
- The findings will enhance the evidence base for treatment decisions concerning TNFi continuation versus de-escalation in pediatric patients.
- This research supports shared decision-making processes for managing JSpA treatment.
Background:
The effectiveness of biologic therapies, primarily tumor necrosis factor inhibitors (TNFi), for children with spondyloarthritis (SpA) has made inactive disease a realistic patient outcome. However, biologic therapies are costly, primarily delivered by subcutaneous or intravenous route, and have non-trivial side effects. Many patients and families want to know if biologic medications can be discontinued after inactive disease is achieved. It remains unclear whether medication dose should remain unchanged, tapered (increase the time between doses), or discontinued once when inactive disease is attained.
Methods:
The Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile SpA (BACK-OFF JSpA) trial is a multicenter pragmatic trial that will randomize 198 participants ages 8-21 years old with SpA and sustained inactive disease on standard TNFi dosing to (1) continue standard TNFi dosing, (2) fixed longer dosing intervals of TNFi, or (3) stop TNFi. The trial will compare the hazard rate of protocol-defined flare and participants' emotional health among the 3 groups over 12 months. Innovative aspects of this trial are the involvement of patient and parent stakeholders in the design and conduct of the study as well as an electronic health record-based enhanced recruitment strategy.
Discussion:
This is the first randomized pragmatic trial to assess the efficacy of TNFi de-escalation strategies in children with JSpA with sustained inactive disease. This research will improve the evidence base that patients, caregivers, and rheumatologists use to make shared decisions about continued treatment versus de-escalation of TNFi therapy in this population.
Trial Registration:
ClinicalTrials.gov NCT04891640. Registered on 18 May 2021.
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