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Extension study of participants from the trial of early aggressive therapy in juvenile idiopathic arthritis
Carol A Wallace1, Sarah Ringold2, John Bohnsack2
1From the Seattle Children's Hospital and Research Institute, Seattle, Washington; University of Utah, Pediatrics, Salt Lake City, Utah; Cleveland Clinic, Cleveland, Ohio; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; University of California at San Francisco, San Francisco, California; Duke University Medical Center, Pediatrics, Durham, North Carolina; Ohio State University and Nationwide Children's Hospital, Pediatrics, Columbus, Ohio; University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; Steven and Alexandra Cohen Children's Medical Center of New York, New York; Stanford University School of Medicine, Palo Alto, California; Texas Scottish Rite Hospital, Dallas, Texas; Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, New Jersey, USA.C.A. Wallace, MD; S. Ringold, MD, MS, Seattle Children's Hospital and Research Institute; J. Bohnsack, MD, University of Utah; S.J. Spalding, MD, Cleveland Clinic; H.I. Brunner, MD, MSc, Cincinnati Children's Hospital Medical Center; D. Milojevic, MD, University of California at San Francisco; L.E. Schanberg, MD, Duke University Medical Center; G.C. Higgins, PhD, MD, Ohio State University and Nationwide Children's Hospital; K.M. O'Neil, MD, Oklahoma University Health Science Center, now at Riley Hospital for Children, Indianapolis, Indiana; B.S. Gottlieb, MD, MS, Steven and Alexandra Cohen Children's Medical Center of New York; J. Hsu, MD, MS, Stanford University School of Medicine; M.G. Punaro, MD, Texas Scottish Rite Hospital; Y. Kimura, MD, Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center; A. Hendrickson, MPH, Seattle Children's Hospital and Research Institute. cwallace@u.washington.edu.
Insights
Early aggressive treatment for juvenile idiopathic arthritis (JIA) led to prolonged periods of clinical inactive disease (CID) in most children. Follow-up showed mild active disease and no severe adverse events, indicating treatment safety.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Clinical Trials
Background:
- Juvenile idiopathic arthritis (JIA) is a chronic autoimmune disease affecting children.
- Early aggressive treatment aims to control inflammation and prevent long-term joint damage.
- The TRial of Early Aggressive Therapy (TREAT) study investigated initial treatment strategies for JIA.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of early aggressive therapy in JIA patients.
- To assess disease activity, functional outcomes, and duration of clinical inactive disease (CID) during a 2-year follow-up.
- To analyze the impact of early aggressive treatment on sustained remission in JIA.
Main Methods:
- Prospective follow-up of 48 children with JIA post-TREAT study for up to 2 years.
- Provider-directed treatment with regular assessments of disease status and safety.
- Data collection included physician, patient/parent, and laboratory measures every 3 months.
Main Results:
- Majority of patients (88%) achieved CID at some point; 54% achieved clinical remission on medication.
- Half of patients spent over 50% of follow-up time in CID.
- No serious adverse events (grade 3 or higher) were reported, indicating a favorable safety profile.
Conclusions:
- Early aggressive therapy in polyarticular JIA is associated with extended CID periods in most patients.
- Patients not in CID exhibited only mild levels of active disease.
- The findings support the long-term safety and effectiveness of early aggressive treatment strategies for JIA.
Objective:
To follow children with juvenile idiopathic arthritis (JIA) who had completed at least 6 months of the TRial of Early Aggressive Therapy (TREAT) clinical study for an additional 2 years, describing safety of early aggressive treatment, disease activity, function, and duration of clinical inactive disease (CID) during followup.
Methods:
Children were treated as per provider's discretion. Physician, patient/parent, and laboratory measures of disease status as well as safety information were collected at clinic visits every 3 months for up to 2 years.
Results:
Forty-eight children were followed for a mean of 28 months (range 12-42) beyond the end of the TREAT study. Half of patients were in CID for > 50% of their followup time. Overall, 88% of patients achieved CID at > 1 study visit and 54% achieved clinical remission while taking medication. Six patients were in CID for the duration of the study, and, of those, 2 achieved a full year of clinical remission while not taking medication. Active disease was mild: mean physician's global assessment 2.4, active joint count 3.5, parent global evaluation 2.4, Childhood Health Assessment Questionnaire 0.32, erythrocyte sedimentation rate 19 mm/h, and morning stiffness 23 min. There were no serious adverse events or adverse events reported at grade 3 or higher of Common Terminology Criteria for Adverse Events.
Conclusion:
Early aggressive therapy in this cohort of patients with polyarticular JIA who had high initial disease activity was associated with prolonged periods of CID in the majority of patients during followup. Those not in CID had low levels of disease activity.
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