Table 1

Phase III studies conducted in non-renal patients with SLE targeting Blys

Phase IIIBLISS 52BLISS 76ILLUMINATE 1ILLUMINATE 2
N86581911381124
Type of SLEAAN+SLEDAI≥6AAN+SLEDAI≥6AAN+SLEDAI≥6AAN+SLEDAI≥6
DrugBelimumabBelimumabTabalumabTabalumab
SOC (%)
 Corticoids96767873
 Antimalarials67636370
 Immunosuppressant42564340
Dosages1 or 10 mg/kg
Q4W*
1 or 10 mg/kg
Q4W*
120 mg Q4W or Q2W†120 mg Q4W or Q2W†
Anti-dsDNA+ (%)75646059
AdministrationIntravenousIntravenousScutScut
Black/Asian (%)4/3814/310/1712/10
Countries (%)
 North America533538
 South America50112316
 Europe11252022
 Asia381611
EndpointSRI-4 W52SRI-4 W52SRI-5 W52SRI-5 W52
Response rate,‡ placebo/dose 1/dose 2 (%)44/51/5834/41/4329.3/35.2§/31.827.7/34.8/38.4
Delta max (%)1495.910.7
Long-term response rate, placebo/dose 1/dose 2 (%)W76
32/39/39
Corticoid–sparing effectNo¶NoNoNo**
Qol
 IndicesSF36 PCSSF36BFIBFI
 EffectYes but NCSNo††No§No
Biological effect
 Anti-dsDNAYesYesYesYes
 ComplementYesYesYesYes
Sensitivity analyses‡‡
 EthnicityYes (negative)Yes (negative)NoNo
 DNA+ Comp−Yes (positive)Yes (positive)NoNo
  • *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.