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Table 5 Renal outcomes

From: Safety and efficacy of biological agents in the treatment of Systemic Lupus Erythematosus (SLE)

Study

Complete renal remission

Partial renal remission

Abatacept

 ACCESS 2014 [4]

UPCR < 0.5 based on a 24-h urine collection,

Serum creatinine ≤ 1.2 mg/dl or ≤ 125% of baseline

Adherence to the prednisone taper to 10 mg/day by week12

UPCR 50% improvement from baseline

Serum creatinine ≤ 1.2 mg/dl or ≤ 125% of baseline

Adherence to the prednisone taper to 10 mg/day by week12

 Furie 2014 [3]

EGFR 90% of screening level if normal at screening visit

or eGFR 90% of 6-month, pre-flare value if abnormal at screening,

UPCR 0.26 gm/gm (30 mg/mmole)

Inactive urinary sediment (RBCs and WBCs per hpf within normal limits, no RBC or WBC casts

All complete response criteria had to be met once again, 4 weeks after they were initially achieved

Inactive urinary sediment regardless of the screening value

UPCR 50% improvement from screening value

eGFR ≥ 90% of screening value if eGFR 60–89

 ≥ 50% improvement in eGFR if screening eGFR was between 15–59, or eGFR ≥ 90% of the screening or 6 month pre-flare value

 Furie 2018 [5]

Maintenance of GFR

UPCR ≤ 0.5

Absence of urinary cellular casts

Pednisone ≤ 10 mg/day

None

Belimumab

 Furie 2020 [16]

UPCR of < 0.5

eGFR that was no worse than 10% below the preflare value or ≥ 90

No rescue therapy

 ≥ 50% decrease in the uPCR and either uPCR < 1.0, if the baseline ratio was ≤ 3.0 or < 3.0, if the baseline ratio was > 3.0

 Atisha-Fregoso 2021 [17]

UPCR of < 0.5 based on a 24-h urine sample collection

eGFR of ≥ 120

or if the value was < 120, then > 80% of the eGFR recorded at the time of study entry

Adherence to the prednisone dosing provisions. (prednisone 40 mg/day with taper to 10 mg/day by week 12, and ≤ 10 mg/day through week 96.)

eGFR no more than 10% below the baseline value or within normal range

Ocrelizumab

 Mysler 2013 [26]

Serum creatinine ≤ 25% increase from baseline

UPCR < 0.5

Serum creatinine ≤ 25% above baseline

50% improvement in UPCR, if baseline ratio > 3.0, then UPCR < 3.0

Obinutuzumab

 Furie 2019 [7]

Maintenance of eGFR,

UPCR) ≤ 0.5

Absence of urinary cellular casts

Prednisone ≤ 10 mg/day

Serum creatinine ≤ 15% above baseline value

No urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF

50% improvement in UPCR, with one of following conditions met: If baseline UPCR is ≤ 3.0, then a UPCR of < 1.0

If baseline UPCR > 3.0, then a UPCR of < 3.0

Rituximab

 Rovin 2012 [28]

Normal creatinine level if it was abnormal at baseline

or a creatinine level of ≤ 115% of baseline if it was normal at baseline

Inactive urinary sediment (< 5 RBCs/hpf and absence of RBC casts); and UPCR ratio < 0.5

Creatinine level ≤ 115% of baseline

RBCs/hpf ≤ 50% above baseline and no RBC casts

At least a 50% decrease in the UPC ratio to < 1.0 (if the baseline UPC ratio was ≤ 3.0) or to ≤ 3.0 (if the baseline UPC ratio was > 3.0)