Table 1

Application of the proposed matrix for non-renal disease activity and organ damage disease modification criteria

ProductDisease modification potentialDisease modification confirmed (beyond 5 years)
Outcomes: year 1Outcomes: years 2–5Outcomes: year 5 or later
❶ Significant reduction in disease activity measured using a validated tool (ie, SELENA-SLEDAI, BILAG, SRI-4)
❷ Significant reduction in severe flare measured using a validated tool (ie, SFI or BILAG)
❸ Reduction in use of steroids* and/or immunosuppressants

❶ Sustained improvement in multiple
organ domains/no worsening in multiple organ domains
❷ Prevention of severe flares
❸ Continued reduction in use of steroids* and/or immunosuppressants
No change in SDI or delayed progression
GlucocorticoidsEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
HydroxychloroquineEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
Immunosuppressants
 AzathioprineEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 CyclophosphamideEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 LeflunomideEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 MethotrexateEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 MizoribineEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 Mycophenolate mofetilEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
Calcineurin inhibitors
 CiclosporinEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 TacrolimusEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
Biologics
 AbataceptEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 AnifrolumabEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 BelimumabEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
 RituximabEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded ImageEmbedded Image
  • Embedded Image, criterion met;Embedded Image, insufficient evidence in the literature to meet the specific criterion, but strong general indications of met criterion;Embedded Image, inconclusive;Embedded Image, data not available in the literature to support criterion met;Embedded Image, negative impact on criterion.

  • *≤7.5 mg/day prednisone-equivalent as per 2019 EULAR SLE treatment guidelines and LLDAS; ≤5 mg/day as per DORIS remission definition.

  • BILAG, British Isles Lupus Assessment Group; DORIS, Definition of Remission in SLE; EULAR, European Alliance of Associations for Rheumatology; LLDAS, Lupus Low Disease Activity State; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Index; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index; SFI, SELENA-SLEDAI Flare Index; SRI-4, SLE Responder Index-4.