Start Time Optimization of Biologic Therapy in Polyarticular JIA (STOP-JIA) Study

Disease Area:
Juvenile Idiopathic Arthritis (JIA)

Biosample Status:
No Biosample

About the STOP-JIA Study

More than half of children with JIA have a form of the disease called polyarticular JIA (pJIA), which causes swelling in five or more joints. Having pJIA can make it hard to do daily activities such as getting dressed, brushing teeth, eating, and climbing stairs. Because of painful bone and joint problems, children with pJIA may be less involved than their peers in school and social activities.

There are a number of effective biologic therapies approved for the treatment of pJIA, but we don’t know if using these treatments first makes an important difference in how well patients do.

Researchers want to learn:

• If early use of biologics makes a difference in how quickly patients get better
• If early use of biologics is safer than starting a traditional non-biologic medicine, like methotrexate, first, and only starting a biologic if the traditional medicine doesn’t work
• How well pJIA patients do on different treatment plans over a long period of time

This is the largest study to compare early versus delayed biologic therapy in pJIA. This is also the first large-scale comparative effectiveness study of the CARRA pJIA consensus treatment plans (CTPs), which are standard sets of treatment options used in clinical care.

Study Updates and Findings

Two papers presenting results from the (STOP-JIA) Study were published in Arthritis and Rheumatology. CARRA researchers began this study in 2015, and it was the first study to determine which consensus treatment plan (CTP) developed for children with newly diagnosed pJIA would result in the best outcomes. The CTPs studied were:

• Step Up: starting treatment with a disease-modifying antirheumatic drug (DMARD) which is not a biologic. An example is methotrexate. A biologic would be added 3 or more months later, if the DMARD was not working well enough.
• Early Combination: starting treatment with both a DMARD and a biologic. Examples of biologics include etanercept (Enbrel®), adalimumab (Humira®), abatacept (Orencia®), and tocilizumab (Actemra®).
• Biologic First: starting treatment with a biologic only, adding a DMARD later if needed.

The main results of the study showed that of 400 patients enrolled in 56 CARRA Registry sites around the U.S. and Canada:

• Most patients began Step Up treatment, followed by Early Combination, then Biologics First.
• There was not a major difference across the different treatment plans in patients reaching the study’s main goal of having inactive disease and being off steroid medications at one year.
• All patients had improved pain and mobility on all three plans.
• Other secondary disease activity outcomes, such as inactive disease (measured with commonly used research tools, including the clinical Juvenile Arthritis Disease Activity Score in 10 joints and the ACR Pediatric 70 criteria), were better in patients who started on the Early Combination plan compared to the Step Up plan.

Further research supported these results and showed:

• Early use of biologic treatment within three months of pJIA diagnosis led to faster improvement in disease activity for some patients.

Because the CARRA Registry follows all participants for at least 10 years, researchers will be able to see if and how these early treatment plans make a difference in long-term outcomes. The STOP-JIA study will continue to uncover important information to help patients, families and clinicians make informed decisions about treating pJIA.

About the Participants

• Children with pJIA. Participants with physician-confirmed arthritis active in greater than 5 joints and seen at a CARRA Registry site.
• Children with new diagnoses of pJIA within six months.
• Age less than 19 at disease onset and enrollment in the CARRA Registry.

About the Study Team

STOP-JIA was made possible through support from the Patient-Centered Outcomes Research Institute (PCORI) and CARRA Registry supporters, including the Arthritis Foundation. Blood sample collection was also made possible in part by the Arthritis Foundation to support a study called Precision Decisions.

Lead researchers (*Principal Investigator):

• Yukiko Kimura, MD, Hackensack University Medical Center*
• Laura Schanberg, MD, Duke Clinical Research Institute and Duke University
• Pamela Weiss, MD, MSCE, Children’s Hospital of Philadelphia

Patient and parent partners:

• Vincent Del Gaizo
• Kate Murphy

To learn more about this project, please contact [email protected].