Defining remission in childhood-onset lupus: PReS-endorsed consensus definitions by an international task force

Area of Science:

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

Background:

• Childhood-onset SLE (cSLE) requires specific remission criteria for effective management.
• Existing adult SLE definitions may not fully capture pediatric disease nuances.
• Standardized definitions are crucial for advancing treat-to-target (T2T) strategies in cSLE.

Purpose of the Study:

• To establish cSLE-specific remission definitions.
• To support future T2T clinical trials and observational studies in pediatric lupus.
• To guide clinical practice for managing cSLE.

Main Methods:

• Utilized Delphi surveys with pediatric experts to gather perspectives on adult SLE remission targets.
• Employed a modified nominal group technique for refining and agreeing upon cSLE remission criteria.
• Involved international collaboration through the cSLE International T2T Task Force.

Main Results:

• Proposed two distinct remission definitions: cSLE clinical remission on steroids (cCR) and cSLE clinical remission off steroids (cCR-0).
• Common criteria include a Clinical SLE Disease Activity Index (SLEDAI-2K) of 0 and a Physician Global Assessment (PGA) score < 0.5.
• Specific steroid dosage criteria differentiate cCR (≤0.1 mg/kg/day, max 5 mg/day) from cCR-0 (zero).

Conclusions:

• Developed novel cSLE remission definitions tailored for pediatric populations.
• Ensured alignment with adult SLE remission criteria to enable life-course research.
• These definitions provide a foundation for consistent evaluation and management of cSLE.