Phone: (414) 918-9822    Email: [email protected]

WHY FROST IS NEEDED

Systemic juvenile idiopathic arthritis (sJIA) is a rare and aggressive form of childhood arthritis that can cause high fevers, rash, and other symptoms in addition to arthritis. In sJIA, the body’s own immune system attacks the joints and other parts of the body, and causes symptoms such as high fevers and rash.  In the past, high dose steroids were the only effective treatment that could control the disease by quieting the entire immune system.  But there are many side effects associated with steroid treatment that is given for a long time. Methotrexate is also used, but is not effective for all patients. Newer biologic drugs have been approved for use in sJIA patients and seem effective.  Biologics work by quieting the parts of the immune system that are attacking the body.  Recent studies suggest that using certain biologics when sJIA first starts might get the disease under control faster, which may make it less likely that joints and bones will become permanently damaged.  Also, using biologics might reduce or eliminate the need for steroid treatment. However, there are also some concerns about the safety of the biologic treatments in sJIA as well. Directly comparing the early use of biologics to the standard treatments of steroid and methotrexate treatment in sJIA is therefore very important. FROST is a study that was designed to be able to compare these very different treatments.

WHAT IS THE FROST STUDY?

FROST stands for “First-line Options for SJIA Treatment”.  Patients and families worked together with CARRA researchers to design the FROST study. The goal of FROST is to determine the best treatment approach for newly diagnosed sJIA patients. Doctors and families together will choose a treatment plan they feel is best for each child.  The plans all use medications that are commonly used to treat sJIA by pediatric rheumatologists. FROST will compare how the children respond to each plan, which are called CTPs (Consensus Treatment Plans). All patients in FROST are treated with one of these commonly used medications and information about how they are doing will be recorded in the CARRA Registry database. The plans are:

  1. Steroids alone (or prednisone)
  2. Methotrexate (methotrexate is a common anti-arthritis medication that is not a biologic medicine)
  3. IL-1 blocking Biologic (anakinra [Kineret] or canakinumab [Ilaris])
  4. IL-6 blocking Biologic (tocilizumab [Actemra])

WHAT’S INVOLVED IN FROST?

After agreeing to be a part of the CARRA Registry, the patient/family will be asked to answer survey questions about how they are doing and feeling. Experienced sJIA patients and families chose which surveys should be used, and which ones would be important in helping families decide which medications to use in the future. Patients/families will also be asked to answer simple questions about how the patients are doing at home, in between doctor visits, on an app on their phone or other device. Doctors and research assistants will also enter information into this registry.  When the FROST study is finished, the results will be shared with patients, families and researchers. The goal of FROST is to compare the treatment plans to see which one(s):

  • Work fastest in getting the child better
  • Are safest
  • Cause the least side effects
  • Use the least steroid treatment possible
  • Make sJIA completely inactive at 9 months after starting the treatment

In addition, FROST will also collect blood samples if patients are willing.  The blood samples are important because they will help researchers find markers in the blood which may be able to predict how each child will respond to a treatment in the future.

PATIENT AND FAMILY INVOLVEMENT IN FROST

Only the patients and their families have the first-hand knowledge of what it is like to live with sJIA. Patients and their caregivers have partnered with doctors and researchers to plan the FROST study from the beginning.  They will continue to be a part of the FROST team and will help guide researchers to make sure results will have maximum impact on improving outcomes for sJIA children, and their families. They will make sure all newly diagnosed sJIA families understand the reasons for FROST and what it means to participate. We are excited that FROST will help all of us finally understand how best to treat newly diagnosed sJIA.