Table 4

Recommendations for more efficient lupus trials

In order to achieveRecommendationsMethods
Smaller and shorter trialsDecrease or control background medications
Pharmacodynamic-based selection of background medications
Focus on strategical populations based on disease severity or biomarkers
Use more discriminatory endpoints (especially as primary endpoints)More stringent improvement
Low disease activity
Sustained improvement
Single organ assessments
Flexibility in development programmesAdaptive trials
Phase II trials could provide pivotal proof of efficacy
Single organ endpoints should justify approval for all affected patients
(not just people with SLE)
Progress on unmet needs requiring community actionIdentification and training of more trial sites
Outreach to more patients (especially minority patients)
More work on PROs to incorporate patient perspectives in endpoints
Advance precision medicine concepts for lupus
  • PRO,┬ápatient-reported endpoint.