Phase III | BLISS 52 | BLISS 76 | ILLUMINATE 1 | ILLUMINATE 2 |
---|---|---|---|---|
N | 865 | 819 | 1138 | 1124 |
Type of SLE | AAN+SLEDAI≥6 | AAN+SLEDAI≥6 | AAN+SLEDAI≥6 | AAN+SLEDAI≥6 |
Drug | Belimumab | Belimumab | Tabalumab | Tabalumab |
SOC (%) | ||||
Corticoids | 96 | 76 | 78 | 73 |
Antimalarials | 67 | 63 | 63 | 70 |
Immunosuppressant | 42 | 56 | 43 | 40 |
Dosages | 1 or 10 mg/kg Q4W* | 1 or 10 mg/kg Q4W* | 120 mg Q4W or Q2W† | 120 mg Q4W or Q2W† |
Anti-dsDNA+ (%) | 75 | 64 | 60 | 59 |
Administration | Intravenous | Intravenous | Scut | Scut |
Black/Asian (%) | 4/38 | 14/3 | 10/17 | 12/10 |
Countries (%) | ||||
North America | – | 53 | 35 | 38 |
South America | 50 | 11 | 23 | 16 |
Europe | 11 | 25 | 20 | 22 |
Asia | 38 | – | 16 | 11 |
Endpoint | SRI-4 W52 | SRI-4 W52 | SRI-5 W52 | SRI-5 W52 |
Response rate,‡ placebo/dose 1/dose 2 (%) | 44/51/58 | 34/41/43 | 29.3/35.2§/31.8 | 27.7/34.8/38.4 |
Delta max (%) | 14 | 9 | 5.9 | 10.7 |
Long-term response rate, placebo/dose 1/dose 2 (%) | – | W76 32/39/39 | – | – |
Corticoid–sparing effect | No¶ | No | No | No** |
Qol | ||||
Indices | SF36 PCS | SF36 | BFI | BFI |
Effect | Yes but NCS | No†† | No§ | No |
Biological effect | ||||
Anti-dsDNA | Yes | Yes | Yes | Yes |
Complement | Yes | Yes | Yes | Yes |
Sensitivity analyses‡‡ | ||||
Ethnicity | Yes (negative) | Yes (negative) | No | No |
DNA+ Comp− | Yes (positive) | Yes (positive) | No | No |
*After two first injections 2 weeks apart.
†After a 240 mg initial dosage.
‡Significant results are shown in bold.
§Nearly significant for Q4W.
¶Prednisone dose reduced by ≥25% to ≤7.5 mg/day during weeks 40–52. **Nearly significant for Q2W. ††Not significant for 10 mg/kg.
‡‡Predefined only for ILLUMINATE studies.
AAN, antinuclear antibodies; BFI, Brief Fatigue Inventory; Blys, a B lymphocyte stimulator; Comp−, complement fractions consumption; DNA+, positive DNA antibodies; NCS, not clinically significant; PCS, physical component score; Qol, quality of life; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SOC, standard of care; SRI, SLE Responder Index.