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The Paediatric Rheumatology International Trials Organization (PRINTO)

N Ruperto1, A Bazso, A Ravelli

  • 1IRCCS G Gaslini, Pediatria , Reumatologia, PRINTO, Genova, Italy. nicolaruperto@ospedale-gaslini.ge.it

Lupus
|August 23, 2007
PubMed

Insights

Researchers developed core measures and a definition of improvement to evaluate treatment response in juvenile systemic lupus erythematosus (JSLE). This aims to standardize assessment in clinical trials and practice for better patient outcomes.

Area of Science:

  • Pediatric Rheumatology
  • Clinical Trial Methodology
  • Systemic Lupus Erythematosus Research

Background:

  • Juvenile Systemic Lupus Erythematosus (JSLE) requires standardized methods for evaluating treatment efficacy.
  • Existing assessment tools may lack consistency for clinical trials and daily practice.
  • The Paediatric Rheumatology International Trials Organization (PRINTO) initiated a project to address this gap.

Purpose of the Study:

  • To identify, validate, and promote core outcome measures for assessing treatment response in JSLE.
  • To establish a clear definition of improvement for patients with JSLE.
  • To facilitate consistent evaluation of therapy effectiveness in both clinical trials and routine care.

Main Methods:

  • An international project by PRINTO focused on selecting and validating key clinical measures.
  • Core measures included physician and patient global assessments, proteinuria, and quality of life.
  • A composite endpoint definition was developed requiring at least 50% improvement in two measures and no more than 30% worsening in one.

Main Results:

  • The PRINTO core set of outcome measures was found to be feasible, non-redundant, and possess good validity and reliability.
  • The measures demonstrated fair responsiveness to changes in disease activity and correlated with treatment outcomes.
  • The 'PRINTO/ACR provisional criteria for JSLE' were established, defining treatment response.

Conclusions:

  • The proposed core set and definition of improvement provide a composite endpoint for evaluating JSLE therapy response.
  • These criteria are recommended for use in JSLE clinical trials.
  • The new definition can assist clinicians in determining adequate treatment response in pediatric lupus patients.

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