Table 2

Comparison of the SRI-4 and BICLA composite response indices

ComponentsSRI-4BICLA
SLEDAIMain driver of improvement in SRI-4

  • Improvement of 4 points or more

  • No worsening of the total SLEDAI-2K score from baseline

BILAG

  • No worsening with no new A score and/or ≤2 new B scores

Main driver of improvement in BICLA

  • BILAG scores improve from A to B/C/D for all items with A scores or from B to C/D for all items with B scores


AND

  • No worsening with no new A score and/or ≥2 new B scores

PGA

  • PGA does not worsen by 0.3 points or more (10% or more)

  • PGA does not worsen by 0.3 points or more (10% or more)

Treatment failure criteria

  • N/A

  • No treatment failure (defined as non-protocol treatment or premature discontinuation of study treatment)

  • BICLA, BILAG-based Combined Lupus Assessment; BILAG, British Isles Lupus Assessment Group; N/A, not available; PGA, Physician Global Assessment; SLEDAI-2K, SLE Disease Activity Index 2000; SRI-4, SLE Responder Index-4.