Table 2

Clinical and biomarker outcomes

120 Q2W
n=372
120 Q4W
n=376
Placebo
n=376
SRI-5143 (38.4)
p=0.002
131 (34.8)
p=0.051
104 (27.7)
Components of SRI
 ≥5 point reduction in SELENA-SLEDAI score145 (39.0)
p=0.001
133 (35.4)
p=0.043
105 (27.9)
 No worsening in BILAG*252 (67.7)
p=0.091
242 (64.4)
p=0.609
234 (62.2)
 No worsening in PGA†250 (67.2)
p=0.003
234 (62.2)
p=0.199
215 (57.2)
Other clinical outcomes
 Severe flares on the SFI
  Median time-to-first severe flare, days169141123
  HR for severe flares (95% CI)0.88 (0.61,1.26)
p=0.480
0.98 (0.69,1.40)
p=0.911
 Corticosteroid sparing‡41 (22.5)
p=0.051
31 (17.5)
p=0.342
24 (13.9)
 BFI, LSM change−0.78
p=0.957
−0.70
p=0.779
−0.76
 SELENA-SLEDAI, LSM change−5.5
p=0.002
−5.1
p=0.039
−4.5
 PGA score, LSM change−23.5
p=0.001
−21.6
p=0.052
−18.6
 SLEDAI-2K, LSM change−5.0
p<0.001
−4.8
p=0.013
−4.1
 SLICC, LSM change0.1
p=0.997
0.2
p=0.113
0.1
Biomarkers
 Anti-dsDNA, IU, LSM change−28.3
p<0.001
−27.7
p<0.001
−6.7
 Anti-dsDNA-positive at baselinen=225n=224n=220
 Normalisation at week 52, n (%)28 (12)26 (12)16 (7)
 Complement C3, g/L, mean change0.052
p<0.001
0.037
p<0.053
0.006
 Complement C4, g/L, mean change0.036
p<0.001
0.028
p<0.001
0.003
 Low complement (C3 and/or C4) at baselinen=166n=171n=153
  Normalised at week 52, n (%)62 (37)53 (31)33 (22)
  • All data are n (%) unless otherwise indicated.

  • *No new BILAG A and no more than one new BILAG B.

  • †Worsening defined as an increase of ≥0.3 points from baseline.

  • ‡Percentage of patients able to decrease corticosteroid dose by at least 25% to ≤7.5 mg/day prednisone for at least three consecutive months from weeks 24 to week 52 without an increase in dose of either antimalarials or immunosuppressants at any time during the treatment period.

  • Anti-dsDNA, anti-double-stranded DNA; BFI, Brief Fatigue Inventory; BILAG, British Isles Lupus Assessment Group index; LSM, least square mean change from baseline; PGA, Physician's Global Assessment; Q2W, every 2 weeks; Q4W, every 4 weeks; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment—Systemic Lupus Erythematosus Disease Activity Index; SFI, SELENA-SLEDAI Flare Index; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SLICC, Systemic Lupus International Collaborating Clinics; SRI-5, Systemic Lupus Erythematosus Responder Index 5.