Outcomes defined and prespecified in the BLISS 52 and BLISS 76 trials and their accompanying designated status
| Outcome | Measure | Outcome specification |
|---|---|---|
| SLE Responder Index (SRI*) | Percentage responders at week 52 | Primary outcome |
| Reduction in SLEDAI score by ≥4 points | Percentage responders at week 52 | Major secondary outcome |
| Change in PGA score from baseline | Mean change at week 24 | Major secondary outcome |
| Steroid reduction weeks 40–52 | Percentage responders | Major secondary outcome |
| SF-36 physical component summary score | Mean change at week 24 | Major secondary outcome |
| SLE Responder Index | Percentage responders at week 76 | Major secondary outcome |
| SLICC/ACR damage index | Mean change at week 52 | Secondary outcome |
| FACIT-fatigue scale mean change from baseline | Mean change at clinic visits | Secondary outcome |
| EQ-5D score | Mean change at clinic visits | Secondary outcome |
| Change in PGA score from baseline | Mean change at week 52 | Secondary outcome |
| SF-36 physical component summary score | Mean change at week 52 | Secondary outcome |
| SLEDAI SLE flare index over 52 weeks | Time to first flare | Secondary outcome |
| SLE Responder Index (SRI) | Percentage responders at timed clinic visits | Other outcome reported |
| Modified SLE responder index | Percentage responders at week 52 | Other outcome reported |
| No worsening in PGA score by ≥0.3 | Percentage responders at week 52 | Other outcome reported |
| No new BILAG 1A/2B domain scores | Percentage responders at week 52 | Other outcome reported |
| Change in SLEDAI score from baseline | Mean change at week 52 | Other outcome reported |
| Death | Number during exposure | Safety outcome |
| Treatment emergent adverse events | Number during exposure | Safety outcome |
| Serious infections | Number during exposure | Safety outcome |
*Composite outcome measure consisting of ≥4 points improvement in SLEDAI score, no worsening in PGA by ≥0.3 points and no new BILAG 1A or 2B domain scores. Continuous outcomes are in italics.
ACR, American College of Rheumatology; BILAG, British Isles Lupus Assessment Group; EQ-5D, EuroQoL 5 dimensions; FACIT, Functional Assessment of Chronic Illness Therapy; SF-36, Short Form 36-Item Health Survey; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SLICC, Systemic Lupus International Collaborating Clinics.