Table 2

Response rates at 48–52 weeks for placebo-treated patients

OutcomePatients (responders/all)

Response rate

(%)

Range of response

(%)

Primary end pointa1154/318436.217.5–48.6
SRI-4984/250339.332.3–48.4
SRI-5400/142428.120.4–39.3
SRI-6389/142427.318.9–37.4
BICLA344/108831.625.7–36.1
Patients reducing prednisone to ≤7.5 mg/day141/91915.312–26.6
Normalization of anti-dsDNA antibodies83/10557.95.7–11.9
Normalization of C3126/61620.514–22.4
Normalization of C459/347177.7–21.9
OutcomePatients (responders/all)

Response rate

(%)

Range of response

(%)

Primary end pointa1154/318436.217.5–48.6
SRI-4984/250339.332.3–48.4
SRI-5400/142428.120.4–39.3
SRI-6389/142427.318.9–37.4
BICLA344/108831.625.7–36.1
Patients reducing prednisone to ≤7.5 mg/day141/91915.312–26.6
Normalization of anti-dsDNA antibodies83/10557.95.7–11.9
Normalization of C3126/61620.514–22.4
Normalization of C459/347177.7–21.9

aAs defined by each study

SRI-4: SLE Responder Index 4 (reduction of ≥4 in SELENA-SLEDAI or SLEDAI-2K, no worsening in PGA, no new A or two new B scores in the British Isles Lupus Assessment Group, BILAG)

SRI-5: as above with ≥5 reduction in SELENA-SLEDAI or SLEDAI-2K

SRI-6: as above with ≥6 reduction in SELENA-SLEDAI or SLEDAI-2K

BICLA: (BILAG-based Combined Lupus Assessment) improvement from baseline in the BILAG-2004 score, no worsening in SLEDAI-2K and PGA, no unpermitted changes in concomitant medications.

Table 2

Response rates at 48–52 weeks for placebo-treated patients

OutcomePatients (responders/all)

Response rate

(%)

Range of response

(%)

Primary end pointa1154/318436.217.5–48.6
SRI-4984/250339.332.3–48.4
SRI-5400/142428.120.4–39.3
SRI-6389/142427.318.9–37.4
BICLA344/108831.625.7–36.1
Patients reducing prednisone to ≤7.5 mg/day141/91915.312–26.6
Normalization of anti-dsDNA antibodies83/10557.95.7–11.9
Normalization of C3126/61620.514–22.4
Normalization of C459/347177.7–21.9
OutcomePatients (responders/all)

Response rate

(%)

Range of response

(%)

Primary end pointa1154/318436.217.5–48.6
SRI-4984/250339.332.3–48.4
SRI-5400/142428.120.4–39.3
SRI-6389/142427.318.9–37.4
BICLA344/108831.625.7–36.1
Patients reducing prednisone to ≤7.5 mg/day141/91915.312–26.6
Normalization of anti-dsDNA antibodies83/10557.95.7–11.9
Normalization of C3126/61620.514–22.4
Normalization of C459/347177.7–21.9

aAs defined by each study

SRI-4: SLE Responder Index 4 (reduction of ≥4 in SELENA-SLEDAI or SLEDAI-2K, no worsening in PGA, no new A or two new B scores in the British Isles Lupus Assessment Group, BILAG)

SRI-5: as above with ≥5 reduction in SELENA-SLEDAI or SLEDAI-2K

SRI-6: as above with ≥6 reduction in SELENA-SLEDAI or SLEDAI-2K

BICLA: (BILAG-based Combined Lupus Assessment) improvement from baseline in the BILAG-2004 score, no worsening in SLEDAI-2K and PGA, no unpermitted changes in concomitant medications.

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