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.

The Journal of Rheumatology
|September 3, 2014
PubMed

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.
Abstract

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
8.5K
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents01:29

Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents

Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
744
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
240
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids01:21

Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids

Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
686
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.6K