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Appendix Table 3. Questions for the literature search and results from the systematic review of the literature Q1. What are the indications and optimal timing for first renal biopsy in SLE patients and are they different compared to non-SLE patients? Item Example(s) of outcome or effect size No. studie s Desig n 1 Referen ces Abnormal SCr (≥130 μmol/L [1.4 mg/dL]) and/or GFR levels (<80 ml/min/1.73m 2 ) correlate with adverse histological forms of LN SCr ≥130 μmol/L associated with OR 2.1 for class IV LN 24 III 1-24 Abnormal urinalysis (proteinuria >0.5 g/24- hr and/or haematuria and/or cellular casts) with normal SCr is associated with class III-IV LN Proteinuria >0.5 g/24-hr or haematuria or cellular casts: 70% class III-IV LN at biopsy; isolated haematuria (>5 RBC/hpf) with proteinuria <0.5 g/24-hr: 22% active class III- IV LN at biopsy 26 III 1,3,6,7,9,11, 13-20,23,25- 35 Clinically ‘silent’ LN (proteinuria <0.3-0.5 g/24-hr, inactive urinary sediment, normal GFR) is associated with class I-II LN and a favorable outcome Prevalence of histologic class III-V LN: 86% in ‘overt’ versus 36% in ‘silent’ cases (defined as proteinuria <0.3 g/24-hr with inactive urinary sediment and GFR >70 ml/min//1.73m 2 ) 10 III 36-45 Delay in kidney biopsy and diagnosis of LN is associated with progression of renal disease and histological lesions, reduced rates of renal remission after treatment, and increased risk for ESRD Delay >6 months is associated with adjusted HR 4.2–9.3 for ESRD 9 II 3,13,28,46-51 Q2. Evaluation of the ISN/RPS 2003 classification system. What is the prognostic significance of renal biopsy findings? Item Example(s) of outcome or effect size No. Desig References 1

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Appendix Table 3. Questions for the literature search and results from the systematic review of the literature

Q1. What are the indications and optimal timing for first renal biopsy in SLE patients and are they different compared to non-SLE patients?

Item Example(s) of outcome or effect size No. studies

Design 1 References

Abnormal SCr (≥130 μmol/L [1.4 mg/dL]) and/or GFR levels (<80 ml/min/1.73m2) correlate with adverse histological forms of LN

SCr ≥130 μmol/L associated with OR 2.1 for class IV LN 24 III 1-24

Abnormal urinalysis (proteinuria >0.5 g/24-hr and/or haematuria and/or cellular casts) with normal SCr is associated with class III-IV LN

Proteinuria >0.5 g/24-hr or haematuria or cellular casts: 70% class III-IV LN at biopsy; isolated haematuria (>5 RBC/hpf) with proteinuria <0.5 g/24-hr: 22% active class III-IV LN at biopsy

26 III 1,3,6,7,9,11,13-

20,23,25-35

Clinically ‘silent’ LN (proteinuria <0.3-0.5 g/24-hr, inactive urinary sediment, normal GFR) is associated with class I-II LN and a favorable outcome

Prevalence of histologic class III-V LN: 86% in ‘overt’ versus 36% in ‘silent’ cases (defined as proteinuria <0.3 g/24-hr with inactive urinary sediment and GFR >70 ml/min//1.73m2)

10 III 36-45

Delay in kidney biopsy and diagnosis of LN is associated with progression of renal disease and histological lesions, reduced rates of renal remission after treatment, and increased risk for ESRD

Delay >6 months is associated with adjusted HR 4.2–9.3 for ESRD 9 II 3,13,28,46-51

Q2. Evaluation of the ISN/RPS 2003 classification system. What is the prognostic significance of renal biopsy findings?

Item Example(s) of outcome or effect size No. studies Design References

Improved inter-observer reproducibility with the ISN/RPS 2003 classification

Kappa coefficient for inter-observer reproducibility is 0.53 versus 0.44 with the WHO classification; cases re-classified from WHO class III into ISN/RPS class IV had lower rates of response to therapy and increased risk for progression to ESRD

6 III 5,16,52-55

The histological class of nephritis (defined by the WHO or the ISN/RPS classification) correlates with patient and renal outcome (death, ESRD, doubling SCr, development of chronic renal insufficiency)

Proliferative (class III-IV) versus non-proliferative LN is associated with RR 3.0 for death; class IV versus class III LN is associated with HR 4.3 for ESRD; class V LN has worse outcome than class I-II (abnormal renal function in 15% and ESRD in 5% during long-term follow-up); class V with superimposed proliferative lesions (class V+III-IV) has worse outcome than pure class V (ESRD rate 36% versus 12%)

52 II 1,3-6,11,14,16,28,47,48,56-96

ISN/RPS class IV-G versus IV-S is associated with more severe clinical disease and/or worse histological

Increased endo-capillary hyper-cellularity, interstitial inflammation, 11 III 5,12,17,18,33,55,97-101

1

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lesions activity lesions; no definitive difference in renal outcome

Prognostic significance of kidney deposits detected by immunofluorescence or electron microscopy

Intensity/extension of deposits correlates with clinical & histological severity of renal disease, and renal outcome; intra-membranous electron-dense deposits are associated (RR 4.8) with death

19 II 1,7,46,47,61,94,102-114

Prognostic significance of activity lesions on kidney biopsy (hypercellularity, leukocyte exudation, karyorrhexis/fibrinoid necrosis, cellular crescents, hyaline deposits, interstitial inflammation)

The composite AI correlates with poor renal outcome (increased relapse rates, doubling SCr, ESRD, death; HR 1.4 per 1-unit); cellular crescents >30% of glomeruli is associated with RR 7.2 for doubling SCr; ≥25% interstitial infiltration is associated with HR 1.9 for doubling SCr or ESRD

44 II 1,7-9,11,13,15,25,46-48,56-

58,65,79,101-103,106,113,115-125 16,28,91,92,100,126-128,

50,94,110,111

Prognostic significance of chronicity lesions on kidney biopsy (glomerular sclerosis, fibrous crescents, tubular atrophy, interstitial fibrosis)

The composite CI correlates with poor response to immunosuppressive therapy, and poor long-term renal outcome (increased relapse rates, doubling SCr, ESRD, death; HR 1.18 per 1-unit for doubling Scr or death); glomerular sclerosis ≥25% glomeruli is associated (RR 3.3) with ESRD; interstitial fibrosis is associated (HR 2.0) with doubling SCr or ESRD; tubular atrophy ≥25% is associated (HR 2.4) with doubling SCr or ESRD

60 II1,3,8,10,11,13,17,23,25,28,47,48,56,57

,61,63,65,73,75,76,79,81,84,87,90,92,1

00-103,110,111,113,115,119-127,129-

145

Prognostic significance of tubulointerstitial lesions on kidney biopsy

The composite tubulo-interstitial index (interstitial infiltrates + tubulorrhexis + interstitial sclerosis) is associated with higher proteinuria and SCr levels, and increased risk for ESRD (HR 72 in patients with class V LN)

15 II 7-9,15,46,47,58,79,101,102,106,115-

118

Prognostic significance of renal vascular lesions (lupus vasculopathy, HUS/TTP/malignant hypertension-like lesions, vasculitis, arteriosclerosis)

Association with higher SCr levels, increased rates of hypertension, lower 5- and 10-yr kidney survival rates (74% and 58% vs. 90% and 86% in patients without vascular lesions)

3 III 67,146,147

Additional prognostic value of renal histology to renal clinical disease severity

The proportion of sclerosed glomeruli combined with SCr levels at 2 years post initiation of therapy may predict 59% of the variation in SCr levels at last follow-up in proliferative LN

4 II 23,46,47,70

Q3. How well do biochemistry tests, serological tests, urinalysis, biomarkers correlate with renal biopsy findings in lupus nephritis?

Item Example(s) of outcome or effect size No. studies Design References

Diagnostic value of SCr and/or GFR (estimated or measured) levels

Higher SCr and/or lower GFR levels correlate with more advanced histological class (class IV>III>other; IV-G>IV-S), higher biopsy AI and CI (r = 0.27-0.46), tubulo-interstitial lesions, kidney deposits, and presence of cellular crescents; in patients with SCr ≤1.4 mg/dL, those with MDRD-GFR below 60 ml/min/1.73m2 had more

26 III 1-24,30,103

2

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chronic lesions in renal biopsy

Diagnostic value of hemoglobin levels Lower hemoglobin levels correlate with more advanced histological class (Hb <9 g/dL is associated with OR 3.2 for class IV LN)

6 III 6,7,14,17,18,33

Diagnostic value of serum complement levels

Lower levels at the time of diagnosis correlate modestly with more advanced histology (proliferative < non-proliferative LN; class IV < III; IV-G < IV-S); correlation with karryorrhexis, endocapillary proliferation, and CI (r = -0.32 to -0.39); there is a single study reporting better predictive ability of serum C3 versus C4

13 III 2,4,14,18,23,30,148-154

Diagnostic value of serum anti-dsDNA antibodies

Increased titers (ELISA, Crithidia, or Farr assay) at the time of diagnosis is associated with proliferative versus non-proliferative LN (OR 6.0), class IV > other; correlation with active / severe renal histology (biopsy AI, extra-capillary proliferation, karryorhexis, hyaline deposits, fibrinoid necrosis, electron-dense deposits; r coefficient ranging 0.35 to 0.81)

18 III 1,2,7,23,103,148-150,152-161

Diagnostic value of serum anti-C1q antibodies

Increased titers (ELISA) are associated with active proliferative (class III-IV) LN (PPV 68%, NPV 98%); higher titers in class IV > other classes); correlation with biopsy AI and CI, glomerular infiltration, endo-capillary proliferation, fibrinoid necrosis, crescents (r coefficient ranging 0.32 to 0.56)

10 III 18,63,149,155,159,162-166

Diagnostic value of other serological tests (anti-chromatin, anti-histone, anti-nucleosome, anti-ribosomal P, anti-RNP, anti-Sm, ANCA, anti-endothelial cell antibodies)

Limited diagnostic value; higher titers of anti-endothelial cell IgG in class IV vs. other classes of LN

19 III 17,18,149,151,156,159,160,167-178

Diagnostic value of proteinuria (24-hr urine collection or random spot urine protein to creatinine ratio)

Higher proteinuria levels correlate with more advanced histological lesions (class IV-V > III > II; IV-G > IV-S), higher biopsy AI and CI, increased glomerular and tubulo-interstitial lesions; proteinuria >0.2 g/24-hr is associated (OR 4.4) with class IV LN; nephrotic-range proteinuria is common in class IV or V (± III-IV) LN

14 III 1,3,6,9,11,13-16,18,19,32-34

Diagnostic value of active urine sediment (haematuria >5 RBC/hpf and/or pyuria >5 WBC/hpf and/or cellular casts); see also Q1

More common in active class III-IV LN (OR 6.0), class IV-G versus IV-S, crescentic versus non-crescentic forms of LN; correlation with proteinuria levels and higher biopsy AI and CI; isolated abnormalities (in absence of proteinuria >0.5 g/24-hr) are less predictive for active class III-IV LN

11 III 1,7,9,11,15,17,19,23,29,33,35

Diagnostic value of serum biomarkers (ICAM-1, VCAM-1, fribrinolytic split products, IL-18, nitrate, IL-12p70, IFN-γ, IL-2-receptor, IFN-γ+/ΙL-4+ PBMCs [flow cytometry])

Limited diagnostic value 9 III 149,179-186

Diagnostic value of urine biomarkers MCP-1 levels correlate with active class III-IV LN, biopsy AI and CI (n=4 studies); 12 III 30,182,185,187-195

3

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(cytokines [IL-6, IL-12, IL-10, IL-2], TGFβ, ICAM-1, VCAM-1, T-bet, GATA-3, RANTES, MCP-1, proteomics)

proteomic analysis demonstrates sensitivity 86-100% and specificity 50-100% for different histological classes of LN, and correlates with biopsy AI (r = 0.77) and CI (r = 0.87)

Q4. What are the indications for initiating immunosuppressive therapy in lupus nephritis?

Item Outcome and example(s) of effect size No. studies Design References

Class II LN Treatment with low-to-moderate doses of GC (0.25-0.5 mg/kg/day) if proteinuria exceeds 1 g/24-hr especially in presence of glomerular haematuria; immunosuppressive therapy (usually AZA; MPA and CY have also been used) is added in cases of inadequate response to GC (± HCQ), or when unable to taper their dose

6 V 59,196-200

Class III-IV LN

Combination of immunosuppressive agents with GC are more effective than GC alone in prevention of ESRD or death; effect more pronounced in class IV versus III LN

4 I 201-204

13 II 57,139,205-215

9 III/IV 63,82,83,123,134,143,216,217

Class V LN Combination of immunosuppressive agents with GC are indicated in cases with persistent proteinuria >1 g/24-hr despite optimal use of renin-angiotensin-aldosterone blockade; the use of adjunctive immunosuppression is independent predictor for remission of proteinuria in cases with nephrotic-range proteinuria

1 II 218

2 III 219,220

8 V 221-228

Q5. What is the comparative evidence for the benefits and harms of therapeutic agents or interventions in patients with lupus nephritis and according to different histologic classes of kidney disease?

Item Outcome and example(s) of effect size No. studies Design ReferencesClass II LN Low-to-moderate doses of GC (0.25-0.5 mg/kg/day); immunosuppressive therapy can be added (usually

AZA; also MPA, CY) if proteinuria exceeds 1 g/24-hr, especially in presence of glomerular haematuria6 V 59,196-200

Class III-IV LN: initial treatment

Glucocorticoids

GC-only regimens are less efficacious than the combination of GC and immunosuppressive agents in prevention of ESRD and/or death

4 I 201-204

14 II 57,139,205-215,229

4

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9 III/IV63,82,83,123,134,1

43,216,217

Regimens used: high-dose GC (1 mg/kg/day ×4-6 wks, then tapered); or, pulses IV-MP (0.5-1 g ×3 days), followed by oral prednisone (0.5-0.7 mg/kg/day); both regimens have been used in RCTs

─ ─ ─

Benefit from the use of IV-MP pulses: may expedite the reduction of abnormal SCr and/or proteinuria levels; has been associated with improved renal outcome (increased remission rates, reduced relapse rates; extrapolation from two RCTs); has been used in severe crescentic LN

2 II 208,212

1 III 230

3 IV 16,138,231

8 V 17,232-238

Cyclophosphamide Combination of CY (IV or oral) with GC is efficacious in stabilizing renal function (RR 0.63 for ESRD;

RR 0.59 for doubling SCr); superiority over GC-only regimen becomes evident after 5 years of follow-up; long-term (≥10 years) follow-up data available

4 I 201-204

14 II 57,139,206-

212,214,215,229

9 III/IV63,82,83,123,134,1

43,216,217

11 V87,119,140,198,199

,239-244

Benefit demonstrated in patients with high-risk features (high biopsy CI, impaired renal function, nephrotic syndrome, class V+IV LN, crescentic LN, rapidly progressive glomerulonephritis)

3 II 209,210,245

3 III 237,246,247

10 V17,134,237,238,248

-253

Comparable efficacy of IV-CY versus oral CY; in the long-term (7 years) follow-up of a RCT comparing immunosuppressive agents versus GC alone, only the IV-CY regimen was statistically superior in individual group comparisons; in the meta-analyses of early RCTs, results were more robust for the IV-CY regimen; a single RCT comparing intermittent IV-CY versus oral CY followed by AZA found no difference in efficacy or adverse events (trial prematurely terminated); trend for more adverse reactions (herpes zoster infections, leukopenia) with oral CY; oral CY has demonstrated efficacy in class IV LN with rapidly progressive renal failure

1 I 204

5 II 57,209-211,254

2 III 246,247

2 IV 134,255

Low-dose versus high-dose IV-CY. In White patients with moderate-risk features (class IV 70%; mean proteinuria 2.9-3.2 g/24-hr; mean biopsy CI 0.8-0.9), initial treatment with low-dose IV-CY (3g) has similar efficacy (prevention of ESRD; follow-up 10 years) and better toxicity profile (reduced

1 I 256

6 II 245,257-261

2 IV 134,216

5

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infections) than high-dose IV-CY (NIH regimen; both regimens followed by AZA); in patients with high-risk features (class IV 85-90%; 35-50% Black; nephritic with GFR <80 ml/min or GFR >80 ml/min with crescents >25%; mean proteinuria 5.0 g/24-hr; mean biopsy CI 3.7-4.4), extended course (30 months) of IV-CY was associated with lower rates of doubling SCr and of renal relapse compared to short course (6 months) IV-CY

6 V 240,250,255,262-

264

Toxicity of CY-based regimens: amenorrhea (dose- and age-dependent risk: in women aged ≥32 years D50 has been calculated to 8 g/m2), infections (particularly herpes zoster), leukopenia

3 IV 265-267

Azathioprine Early trials showed that the combination of AZA with GC is more efficacious than GC alone in

preventing death (RR 0.6) but not ESRD In patients with class III-IV (±V) LN and moderate-risk features (70% Whites; mean SCr 109 μmol/L,

mean proteinuria 3.2 g/24-hr, mean biopsy CI 2.3), the AZA/IV-MP/GC regimen had comparable rates of renal response with the IV-CY/GC regimen during the first 2 years (after a median follow-up of 6.3 years more than 80% of AZA-treated patients remained free of CY; after a median follow-up of 9.6 years there were no significant differences between the two regimens in terms of doubling SCr, ESRD, or mortality, although AZA-treated patients had HR 4.5 for renal relapse)

Weak evidence-base for efficacy of AZA (prevention of ESRD) in severe forms of class III-IV LN

3 I 201-204

14 II23,139,205,206,209

,210,213,230,268-

273

3 III 274-276

9 V 50,119,197,277-282

Mycophenolic acid (mycophenolate mofetil, mycophenolate sodium) Comparable efficacy with CY regimens in terms of induction of renal remission (rates 56-81% in MPA,

52-76% in CY), prevention of ESRD and death; characteristics of patients included in the RCTs: most (53-67%) had class IV LN, relatively preserved renal function (mean SCr 1.1-1.3 mg/dL), average proteinuria 4.1-6.2 g/24-hr (except for two trials: 1.8-2.0 g/24-hr), chronic lesions in kidney biopsies (mean biopsy CI 2.8-3.9), heterogeneous ethnic background; MMF dose: 2-3 g/day

A single RCT demonstrating superiority of MPA over CY included more Black patients, more patients with pure class V LN, and only 62% of patients in the CY arm received all 6 pulses of IV-CY

Significant variation in renal response rates according to race (lower response rates of IV-CY in Black/Hispanics) and region (better efficacy of MPA in regions outside Asia)

More favorable toxicity profile of MPA versus CY (reduced amenorrhea, leukopenia, alopecia rates; trend for lower rates of infections; increased gastrointestinal events [diarrhea] with MPA versus CY)

Open-label studies have also demonstrated efficacy and histological improvement with MPA in class III-IV LN

8 I 256,283-289

7 II 290-296

1 III 297

8 V 49,88,199,298-302

Efficacy of enteric-coated mycophenolate sodium (1440-2160 mg/day) in class III-IV LN 1 II 303

1 III 304

2 V 305,306

Crescentic LN with impaired renal function: comparable efficacy of MPA versus CY (higher response 1 II 307

6

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rates but also more relapses with MPA) 1 III 308

1 V 237

Ciclosporin A A single RCT comparing oral CsA versus IV-CY (both in combination with GC) in patients with

moderate-risk features (class IV 53-67%; SCr <140 μmol/L; mean proteinuria 2.5-3.8 g/24-hr; mean biopsy CI 3.5-4.0) found comparable rates of renal response (at 9 months) and improvements in renal disease parameters (reduction in proteinuria)

Toxicity: hypertension (very common); hirsuitism, dose adjustments may be needed due to SCr elevations

1 II 309

3 V 310-312

Tacrolimus Comparable short-term efficacy of tacrolimus versus pulses IV-CY (both in combination with GC) in

class III-IV LN with moderate-risk features (class IV 72%; normal SCr levels; mean proteinuria 2.2-3.0 g/24-hr; mean biopsy CI 1.0-1.2).

In patients with mixed class V+IV LN (normal SCr levels; mean proteinuria 4.1-4.4 g/24-hr, mean biopsy CI 1.3-1.4; 65% had been previously treated with MPA or CY), combination therapy with tacrolimus/MMF/prednisone was associated with higher rates of complete response at 6 months compared to pulse IV-CY therapy (50% versus 5%)

3 II 129,313,314

6 V 315-320

Plasma exchange No benefit of adding plasma exchange cycles to immunosuppressive therapy (AZA, IV-CY) in terms of

renal remission or death rates (evidence from RCTs that included patients with class IV 40-100%; mean proteinuria 5.5-8.6 g/24-hr, impaired renal function)

Plasma exchange / immunoadsorption cycles in combination with GC and/or cytotoxic therapy have been used in cases with rapidly progressive glomerulonephritis or crescentic class IV LN

1 I 202,203

3 II 321-324

1 III 325

2 IV 326,327

2 V 328,329

Leflunomide Single non-randomized study in mild class III-IV LN has shown comparable efficacy with low-dose

pulse IV-CY; increased biopsy CI at follow-up renal biopsy1 II 330

1 III 331

1 V 332

Chlorambucil Oral chlorambucil in combination with GC has shown comparable efficacy with the combination of oral

CY with GC in prevention of renal or patient death (active class III-IV ± V cases; histological improvements at follow-up renal biopsy)

1 III 274

1 V 333

Rituximab Combination therapy with rituximab/MMF/GC was no superior than MMF/GC in terms of renal

response rates (57% versus 46% at 1 year); n=8 placebo patients versus no rituximab-treated patients 2 II 334,335

7

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required CY rescue therapy (cases with moderate-risk features: White 31%; class IV 66%; mean SCr 1.0 mg/dL; mean proteinuria 4.0 g/24-hr)

Efficacious in small case-series of active class III-IV LN (used as first-line treatment) 3 V 336-338

Belimumab Post-hoc analysis of RCT: reduced rates of renal flares in the high-dose drug arm versus placebo 1 III 339

Class III-IV LN: subsequent treatment

In class III-IV LN patients responding to initial immunosuppressive therapy (‘induction therapy’), absence or shorter duration of subsequent immunosuppressive therapy (‘maintenance therapy’) is associated with increased risk for renal relapse

4 IV 134,199,340,341

Cyclophosphamide Lower dose and/or less frequently administered intermittent IV-CY (quarterly pulses) or oral CY,

sequentially administered after remission induction for another 12-24 months is associated with lower rates of renal relapse, doubling SCr or ESRD; experience in patients with high-risk features (nephrotic syndrome and/or impaired renal function) with remission rates up to 72%

15 II 57,139,206,208-

21

2,229,245,260,272,

309,342,343

2 III 246,297

2 IV 134,216

10 V87,136,198,239,240

,243,252,263,264,3

41

Azathioprine Used for maintenance of renal remission following successful initial treatment with CY (evidence from

RCTs and uncontrolled case series); also, sequentially after initial treatment with AZA (in milder LN cases)

A single retrospective controlled study in class IV LN (mean proteinuria 5.9-6.8 g/24-hr, mean SCr 122-135 μmol/L) comparing pulse IV-CY versus oral CY followed by AZA found no difference in renal relapse or doubling SCr rates

11 II23,140,209,210,257

-

25

9,261,272,273,290,

343

2 III 247,274

3 IV 133,134,217

13 V50,140,197,242,244

,249,250,263,264,2

78,280,281,305

Mycophenolic acid Used after initial treatment with CY or MPA (sequential therapy) 2 I 256,288

8

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RCT comparing quarterly pulses IV-CY (0.5-1 g/m2) versus MMF (0.5-3 g/day) versus AZA (1-3 mg/kg/day) after initial treatment with pulse IV-CY in patients with high-risk features (Hispanics 50%; class IV 68-85%; mean SCr 1.5-1.7 mg/dL; mean proteinuria 4.7-5.7 g/24-hr; mean biopsy CI 1.9-3.8): during follow-up (mean 5.5 years) there were reduced renal and patient survival rates and more relapses in the IV-CY group (40% versus 32% in AZA, 15% in MMF)

ALMS trial (42% Whites, class IV ± V 72%, composite endpoint, responders after initial treatment with either IV-CY or MMF were re-randomized to study arms): reduced renal flares with MMF versus AZA (13% versus 23% during 3-year period); MAINTAIN trial (79% Whites, class IV 59%, time to flare used as endpoint, randomization upon enrollment regardless of response to initial low-dose IV-CY regimen): comparable rates of renal flares with MMF versus AZA (19% versus 25% during 3-year period)

4 II 140,343-345

2 IV 242,346

12 V49,88,199,241,251,

264,299-

301,305,347

Ciclosporin A Used after initial treatment with CY or CsA (sequential therapy); efficacious in class III-IV LN with

preserved renal function and moderate-risk features2 II 309,348

1 V 312

Tacrolimus Limited experience with prolonged (sequential) treatment of class III-IV LN 2 V 315,318

Intravenous Ig (IVIG) Has been used after good response to initial treatment with IV-CY, with comparable efficacy with

extended pulse IV-CY treatment (LN cases with moderate-risk features: White patients, class IV 20-23%; single study)

1 II 349

Plasma exchange / immunoadsorption Weak evidence-base; benefit has been demonstrated for prolonged versus short duration treatment

cycles1 II 350

1 III 327

Duration of subsequent immunosuppressive therapy: at least three years (by extrapolating from RCTs and retrospective cohort data); in class II-IV LN cases treated with MMF, tapering of MMF dose <2 g/day before 18 months after renal remission has been associated with increased risk (HR 6.3-6.8) for relapse

5 II 126,212,343-345

4 IV 134,199,340,341

Class III-IV LN: relapsing or refractory disease

Heterogeneity in the clinical characteristics of the studied patients, the number, type, dosages and duration of prior therapies; most studies have included patients who either flared or did not respond (refractory) to immunosuppressive treatment

Re-introduction or extended treatment with immunosuppressive agent CY. Evidence extrapolated from the long-term follow-up of RCTs; in patients who failed or relapsed 2 II 212,245

9

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after initial treatment with 6 monthly pulses IV-CY, extended treatment with IV-CY (0.5-1 g/m2 ×6 monthly pulses) had comparable efficacy with enteric coated MPS in terms of renal remission (34% versus 57%), prevention of ESRD, improvement in renal parameters (less adverse effects in the MPS group)

2 III 126,304

6 V87,130,140,198,249

,263

Switch to or add another immunosuppressive agent CY. Non-responders to MPA may respond to CY (but not to AZA) 2 V 298

MPA has demonstrated efficacy in class III-IV LN patients who relapsed or were refractory to CY or AZA (mean proteinuria ranging 3.3 to 5.5 g/24-hr; complete and partial renal response rates 50-60%)

5 V 351-355

CsA in combination with moderate doses of GC (prednisone 0.5 mg/kg/day) is efficacious in class III-IV LN cases with incomplete response or proteinuric relapse while on immunosuppressive treatment with CY or AZA (response rates 50-60%; stabilization of SCr levels); maintenance CsA therapy is needed to prevent relapses; histological improvements have been shown in follow-up renal biopsies (class down-transformation, reduced biopsy AI)

5 V 310,312,356-358

Tacrolimus in combination with GC is efficacious in refractory class III-IV LN or in cases with persistent proteinuria despite immunosuppressive treatment with MMF or CY: reduction in proteinuria, stabilization of SCr levels, steroid-sparring effect; has been used as add-on therapy to MMF in cases with incomplete or no response or flare (renal response rates up to 70% after an average 11 months therapy; increased risk for infections and neurotoxicity)

6 V 315,317,318,359-

361

IVIG. Rapid (within 1 month) anti-proteinuric effect in severe LN cases (nephrotic syndrome, impaired renal function) refractory to immunosuppressive treatment (CY); paucity of long-term data

2 V 362,363

Plasma exchange – Immunoadsorption Plasma exchange or immunoadsorption sessions added to standard immunosuppressive therapy in

refractory cases with nephrotic syndrome and impaired renal function: anti-proteinuric effect and stable or improved renal function

3 V 364-366

Rituximab (anti-CD20 mAb) Regimen: IV RTX (375 mg/m2 on days 1,9,16,23 or 1000 mg ×2 times 3 weeks apart) + IV-MP 250 mg

+ IV-CY 0.5 g/m2 (on days 1, 23); concomitant immunosuppressive treatment can be continued Efficacious in refractory or relapsing class III-IV cases (majority previously treated with CY; mean

proteinuria 4.3 g/24-hr; mean serum albumin 2.4 g/dL; mean GFR 80 ml/min; mean biopsy AI 8, CI 3) with renal response rates 60% (class III), 39% (class IV), 26% (mixed V+III-IV); steroid-sparring effect; mostly used in White patients but also efficacious in case series with Black/Asian patients

Predictors for poor response: baseline GFR <30 ml/min; rapidly progressive glomerulonephritis; nephrotic syndrome; Black race; no B-cell depletion after 1 month

18 V 336-338,349,367-

380

10

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Relapses are common (27% after mean 12 months); 80% are successfully re-treated with RTX Well tolerated; mild infections

Other options Stem cell transplantation 7 V 381-387

Immunoablative IV-CY 1 V 388

Leflunomide 1 V 389

Total lymphoid irradiation 4 V 390-393

Pentoxifylline 1 V 394

Infliximab 1 V 395

Class V LN: initial treatment

(evidence-base for adjunctive therapy is presented in Q7)

Glucocorticoids GC-alone is less efficacious than the combination of GC with immunosuppressive agents in class V LN

with high-risk features (non-White race 80%; mean proteinuria 5.7 g/24-hr) Comparable efficacy of GC versus GC in combination with immunosuppressive agents administered for

6 months in class V LN with moderate-risk features (Whites 72%; mean eGFR 77 ml/min; mean UP 3.1 g/24-hr)

1 II 218

1 III 220

Chlorambucil Oral chlorambucil (0.2 mg/kg) alternating monthly with IV-MP is more efficacious (higher renal

response rate; fewer relapses) than GC alone (WHO class Va/b/c; preserved renal function at baseline; mean SCr 1.6 mg/dL at last follow-up)

1 III 219

Azathioprine Prolonged (for at least 1 year) treatment with AZA in combination with GC is efficacious in class V LN

with moderate-risk features (mean proteinuria 3.9 g/24-hr; mean GFR 80 ml/min)1 III 220

2 V 221,223

Cyclophosphamide The combination of GC with IV-CY (0.5-1 g/m2 bimonthly ×6 pulses) is more efficacious than GC

alone (complete response rates at 1 year 40% versus 13%), and is associated with fewer relapses than the combination of GC with CsA (baseline clinical characteristics: 71% non-White; GFR 80-89 ml/min; proteinuria 5.0-5.8 g/24-hr); oral CY regimen also efficacious

2 II 218,396

2 III 220,297

2 V 198,222

Mycophenolic acid In a pooled analysis of two RCTs comparing MMF (2-3 g/day) versus IV-CY (pulses 0.5-1 g/m2), both

in combination with GC, the two groups had comparable improvements in proteinuria at 24 wks; there 1 II 396

1 III 297

11

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was no difference within the subset of nephrotic patients (clinical characteristics of patients: 30% Blacks; mean proteinuria 5.0-5.8 g/24-hr; mean SCr 61-72 μmol/L); leukopenia and alopecia were more common with IV-CY

6 V224,225,298,347,39

7,398

Ciclosporin A The combination of GC with IV-CY (0.5-1 g/m2 bimonthly ×6 pulses) is more efficacious than GC

alone (complete response rates at 1 year 40% versus 13%), and is associated with fewer relapses than the combination of GC with CsA (baseline clinical characteristics: 71% non-White; GFR 80-89 ml/min; proteinuria 5.0-5.8 g/24-hr)

1 II 218

Efficacious in nephrotic patients with preserved renal function; dose adjustments may be needed based on SCr levels; toxicity: hypertension, metabolic adverse effects

3 V 226-228

Tacrolimus Efficacious in nephrotic patients with preserved renal function 1 III 399

1 V 319

Rituximab Efficacious in small case series in class V LN (used as first-line treatment) 3 V 336-338

Class V LN: subsequent treatment

Low-dose GC 1 III 219

Pulses IV-CY (quarterly) in combination with low-dose GC 1 III 297

MPA (sequential therapy) in combination with low-dose GC 1 III 297

7 V224,225,242,298,34

7,397,398

AZA in combination with low-dose GC (after initial treatment with CY) 3 V 222,223,242

CsA (sequential therapy) in combination with low-dose GC 2 V 226,227

Class V LN: relapsing or refractory disease

Pulses IV-CY (after failure/relapse to glucocorticoids or CsA, AZA, MPA) 2 V 221,298

MPA (after failure or relapse to AZA, CY) 3 V 221,397,400

12

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CsA 7 V 221,353-358

Tacrolimus 1 V 221

RTX (± other concomitant immunosuppressive agent) 13 V 336-

33

8,367,368,372,374-

380

IVIG (severe nephrotic cases with impaired renal function) 2 V 362,363

Plasma exchange / immunoadsorption (severe nephrotic cases with impaired renal function) 3 V 364-366

Leflunomide 1 V 389

Other options (immunoablative dose of IV-CY; mesenchymal stem cell transplantation) 3 V 383,386,388

Q6. What are the best validated definitions of therapeutic goals in lupus nephritis?

Item Outcome and example(s) of effect size No. studies

Design References

Renal response Failure to achieve complete renal response/remission is associated with poor long-term renal outcome (most patients with class IV LN)

Heterogeneity in definitions of renal response; usually it includes normal (or improved) SCr / GFR, proteinuria below 0.3 to 1 g/24-hr, and inactive urinary sediment; lack of complete response after immunosuppressive treatment is associated with increased risk (HR 4.5 – 9.9) for ESRD

16 III73,77,123,126,129,133

,134,140,141,258,401-

403

10 IV17,58,59,78,135,136,1

96,404-406

Complete response of the nephrotic syndrome (class V LN; usually defined as proteinuria below 0.25-0.4 g/24-hr with normal GFR, inactive urinary sediment, and normal serum albumin) is associated with favourable long-term outcome (lack of complete response is associated with HR 9.3 for ESRD)

1 III 56

1 IV 117

Patients who achieve partial renal response (usually defined as reduction in proteinuria by ≥50% but not reaching the complete response thresholds plus no deterioration in renal function) have worse prognosis than those who achieve complete complete response (RR 5.2 for doubling SCr or ESRD)

5 III 126,129,140,141,401

1 IV 405

Renal flare Flares ( ‘proteinuric’ or ‘nephritic’) are associated with adverse renal outcome (both in class III-IV and class V LN)

8 III73,126,133,221,403,40

13

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Severe nephritic flares accompanied by deterioration of renal function demonstrate the strongest association with adverse renal outcome (LR 11.8 for ESRD)

Proteinuric flares also associated with worse renal outcome (increase in proteinuria by ≥2 g/24-hr or doubling if initial proteinuria was >3.5 g/24-hr is associated with OR 9.3 for doubling SCr)

7-409

7 IV 17,117,124,135,136

Q7. What is the evidence for the benefits and harms of adjunct therapies in lupus nephritis?

Item Outcome and example(s) of effect size No. studies Design References

ACE-inhibitors (ACEi) / angiotensin receptor blockers (ARBs)

Class II LN: use of ACEi (in addition to steroids) is associated with increased rates of renal response 1 IV 196

Class III–V LN: in stable renal disease with persistent proteinuria >1 g/24-hr despite steroids and immunosuppressive therapy, addition of ACEi/ARB results in reduction of proteinuria and blood pressure levels

5 II 88,218,410-412

In SLE patients with no renal involvement, use of ACEi has been associated with reduced risk (HR 0.31) for renal disease

1 III 413

Hydroxychloroquine Use of HCQ is associated with higher rates of renal remission, fewer renal relapses during maintenance therapy, lower risk for major renal flare (HR 0.26), and lower accrual of renal damage (HR 0.19)

8 II 49,80,298,406,414-

417

Omega-3 fatty acid Lipid-lowering effect; no significant impact on renal function 4 II 418-421

Lipid-lowering therapies [See Q10]

Q8. How do blood tests, serological tests, urinalysis/proteinuria, biomarkers, kidney histology (repeat biopsy) compare with regard to their ability to monitor lupus nephritis?

Item Outcome and example(s) of effect size No. studies

Design References

Reproducible increases in SCr levels (≥20-30% above baseline value) and/or reduction in GFR (≥10% from baseline)

Included in the definitions of active or flare of LN; specificity >80% but low sensitivity for proteinuric renal activity; 24-hr creatinine clearance is considered the ‘gold standard’ in assessing renal function (not validated in LN; single study showing unpredictable variability in serial measurements); The Cockcroft-Gault equation tends to overestimate, the MDRD equation tends to underestimate GFR; in Caucasians the accuracy for classifying patients with GFR 60-89 ml/min/1.73m2 was 82% with the Cockcroft-Gault

6 II 422-427

14

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vs. 59% with the MDRD equation

Monitoring ability of other blood tests (hemoglobin, serum albumin)

Improvements during inactive versus active LN 3 II 163,212,428; data also from RCTs

Monitoring ability of serum anti-dsDNA antibodies

Increased titers during active/flare state versus lower titers during inactive/remission of LN; most useful in class III-V LN (lower predictive value for proteinuric flares of class V LN); have been evaluated in the context of RCTs (reductions correlating with response to therapy); sensitivity 46-89% (typically ~70%), specificity 52-98%, PPV 11-52%, high NPV (typically 86-90%); the Farr method has been most extensively studied, yielding higher sensitivity/specificity rates than ELISA

48 II 69,129,130,149,150,152,158-

160,162,164,212,359,422,429-462

Rise in titers ≥25% (within 6 months prior to flare) are 65-91% sensitive for impending renal flare (poor specificity as it may also antedate non-renal SLE flare)

6 II 130,162,434,449,455,459

Monitoring ability of serum complement (C3, C4)

Reduced levels during active/flare state versus normal titers during inactive/remission of LN; serial measurements are useful to identify active proliferative renal disease (insensitive for proteinuric flares of class V LN); studied in the context of RCTs (normalization correlating with response to therapy); low C3 (e.g. ≤ 81) has sensitivity 72-85%, specificity 51-93% (typically 70%), PPV 22-28%, and NPV 93-97% for active renal disease; low C4 (e.g. ≤ 11) has sensitivity 28-74%, specificity 50-71%, PPV 17-31%, NPV 92-95%; two studies have reported superior performance of C3 versus C4, whereas data from a single RCT show that increases in C4 (not in C3) correlate with induction of LN remission

25 II129,130,149,150,163,212,409,422,440,442,4

43,450,452,458,459,463-472

Persistently low levels (within 3-6 months prior to flare) are 75-90% sensitive for future renal flare

4 II 130,459,463,467

Monitoring ability of serum anti-C1q antibodies

Increased titres are found at active versus inactive stage of proliferative LN; sensitivity 74-88%, specificity 70-92%, PPV 37-68%, NPV 91-100%; outperforms serum anti-dsDNA and C3/C4 (including in detecting class V proteinuric flares); combination with anti-dsDNA (Farr) further enhances sensitivity (91%) and specificity (100%) for active nephritis; have been validated against biopsy-proven active proliferative LN (PPV 68%, NPV 98%); less well studied than other serological markers in prospective controlled trials

26 II 130,149,152,159,162-164,166,431,435,439-

441,453,455,457,473-482

Appearance or increase in titres ≥50% (within 6 months prior to flare) have sensitivity 71-76%, specificity 84-92%, PPV 50-56%, NPV 70-97% for future renal flare

3 II 162,164,455

Monitoring ability of serum anti-nucleosome antibodies

Increased titres are found at active stage of proliferative LN; sensitivity (32-89%), specificity (22-67%), PPV (16-40%), NPV (77-88%)

9 II 158,431,432,436,439,449,454,483,484

Monitoring ability of other serological tests (anti-chromatin, anti-histone, anti-ribosomal P, anti-

Changes in titres correlate with LN activity; less extensively studied or validated 19 II 130,149,151,159,160,176-

178,436,437,448,451,456,460,484-488

15

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CRP, anti-heparan sulfate, anti-α-actinin, anti-endothelial cell antibodies)

Monitoring ability of urine sediment

‘Active sediment’ ([re-]appearance of haematuria, pyuria, casts) included in definition of active LN; also in the context of therapeutic (controlled) trials to define remission and flare of LN; cellular casts have sensitivity 81% for flares (defined according to increases in SCr and/or proteinuria; 96% for flares with proteinuria >1 g/24-hr), and may precede other flare signs by 10-13 weeks; haematuria (>5 RBC/hpf) has sensitivity 42% and specificity 84% for active versus inactive LN; urine cytology (lymphoblasts, plasma cells, monocytes) abnormal during renal flare

7 II 129,422,444,448,473,489,490

Monitoring ability of proteinuria Should be quantified as part of monitoring lupus renal disease; urine dipstick has suboptimal performance in detecting/excluding significant proteinuria (62-86% specificity to correctly exclude proteinuria ≥0.5 g/24-hr); spot urine measurements of urine protein to creatinine ratio show very good correlation with ratios determined by 24-hr urine collection over the entire range of proteinuria (r = 0.81-0.91) but poor concordance over the range of 0.5-3.0 (r = 0.48); first morning void urine sample performs better than random spot urine sample

22 II 23,129,422,443,444,448,464,465,473,491-

502

Monitoring ability of serum biomarkers (ICAM-1, VCAM-1, MCP-1, IL-2-receptor, IL-17, CXCL13, β2-microglobulin, nitrate, MMP-3, flow cytometry for various subsets of peripheral blood mononuclear cells)

Limited diagnostic value 17 III 149,160,179,183,186,461,503-513

Monitoring ability of urine biomarkers (cytokines, lipocalin-2, slit diaphragm proteins, FoxP3, ICAM-1, VCAM-1, TGFβ, OPG, MCP-1, TWEAK, NGAL, proteomics)

MCP-1 mRNA correlates with proteinuria, haematuria, renal SLEDAI (levels >7.5 has PPV 98% and NPV 100% for renal SLEDAI >3); TWEAK mRNA shows modest correlation with renal SLEDAI (r = 0.39-0.41; values >9.1 has PPV 93% and NPV 67% for active nephritis); NGAL (ELISA) >13.6 ng/mL has 89% sensitivity and 72% specificity for biopsy-proven active LN; Proteomics: hepcidin-20/25 (changes in levels 4 months before and at the time of renal flare)

22 III30,187,188,190,192,193,422,438,443,444,46

5,490,500,514-522

Monitoring ability of repeat kidney biopsy

In patients with proliferative LN who have responded to immunosuppressive treatment repeat biopsy shows histological class down-transformation (from III-IV to II / V), reduced AI (stable / mildly increased CI), improved immunofluorescence findings, reduced deposits; in treatment failure or severe flare there is often transformation from class II-III to class IV and from class V to mixed V+III-IV (no change in histological class in patients with class IV at initial biopsy), increased CI, scarring, glomerular sclerosis, and deposits; repeat biopsy can assist therapeutic decisions in patients with persistent non-nephrotic proteinuria (despite improved renal function) or with worsening

27 II7,10,23,59,61,66,72,88,90,107,115,117,118,1

29,196,211,255,312,403,523-530

16

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of renal function

Q9. What is the prognostic performance of biochemistry tests, serological tests, urinalysis, and biomarkers in lupus nephritis?

Item Example(s) of outcome or effect size No. studies

Design References

Prognostic value of SCr and/or GFR levels

Higher baseline (and follow-up) SCr correlates with higher follow-up SCr values, higher rates of doubling of SCr or ESRD (HR 1.26 per 1-mg/dL), lower odds for response to immunosuppressive treatment, and increased risk for death (HR 5.9); reduction of initially abnormal SCr at 6 months after treatment has OR 14.9 for good long-term renal outcome; in the ALMS trial patients with baseline GFR <30 ml/min/1.73m2 had OR 0.2 for response to therapy at 24 wks

65 II 3,4,13,19,22-24,46-48,57,58,60,65,68,71-

73,76-79,83,84,86,88,91,101,105,115-

117,120-124,126,127,134-

13

6,140,141,143,145,255,258,401,402,404,4

05,464,500,531-541

Prognostic value of haemoglobin (haematocrit) levels

Haematocrit <26-36% or haemoglobin <11 g/dL at LN onset is associated with increased rates of chronic renal failure, doubling SCr or ESRD (OR 0.6 for renal survival per 1-g/dL decrement); persistent anaemia (haematocrit <33%) at the time of response is associated with LR 4.6 for ESRD

14 II65,68,115,120,121,126,135,136,452,531,5

32,542,543

Prognostic value of platelet count

Lower numbers correlate with increased rates of deterioration of renal function (thrombocytopenia <20,000/μL is associated with HR 14.2 for ESRD)

3 II 47,91,531

Prognostic value of serum albumin levels

Lower values associated with adverse renal outcome in class III-V LN (HR 0.9 per 1-g/dL increment for doubling SCr/ESRD; persistently levels <3.5 g/dL after immunosuppressive therapy is associated with RR 3.3 for doubling SCr)

10 II 47,115,133,134,144,258,290,359,539,542

Prognostic value of serum lipids

High serum total cholesterol levels correlates with ESRD (HR 1.02) and death (HR 1.20); persistent dyslipidaemia after treatment of class III-IV LN is associated with future decline in GFR

4 II 69,401,538,539

Prognostic value of serum anti-dsDNA antibodies

Persistently high titres despite treatment is associated with increased risk for renal flare (RR 2.3 in class IV LN; LR 4.9 in complete responders); most associations are with anti-dsDNA measured by the Farr method

15 II 1,46,126,133,261,525,544-551

Prognostic value of serum C3 levels

Low C3 (<76 mg/dL) levels is associated with lower rates of complete remission, persistent proteinuria (>1 g/24-hr), increased rates of chronic renal failure and ESRD; persistently low C3 after immunosuppressive treatment is associated with renal flares (RR 2.2) and adverse outcome (HR 2.3 for doubling SCr or ESRD or death)

15 II19,46,103,120,121,130,133,134,464,468,5

25,547,548,552,553

Prognostic value of serum C4 levels

Low C4 (<10-11 mg/dL) levels at baseline is associated with increased risk for future relapses, deterioration of renal function; low C4 at the time of response to treatment has LR 14.2 for

8 II 19,73,126,255,409,464,548,554

17

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future renal flare (follow-up of RCTs)

Prognostic value of other serological tests (anti-ribosomal P, anti-nucleosome, anti-Sm, anti-C1q, ANCA, anti-endothelial cell antibodies)

Limited prognostic value 15 II63,73,78,151,168,173,534,544,546,549,55

1,555-557

Prognostic value of urine sediment (haematuria , pyuria, cellular casts)

Active urine sediment at the time of diagnosis is associated with worse renal outcome (HR 2.6 for SCr >130 μmol/L at last follow-up visit; RR 4.0 for patient death); disappearance of sediment abnormalities following therapy is associated with favourable long-term patient prognosis

5 III 1,28,69,76,539

Prognostic value of proteinuria level

Nephrotic-range proteinuria at LN onset is associated with increased risk for ESRD (OR 6.5) or death (HR 4.0); associations confirmed in both proliferative and membranous LN; there is a dose effect (in LN cases with normal GFR and proteinuria in the range of 0.25-3.5 g/24-hr, baseline proteinuria >0.5 g/24-hr [vs. <0.5 g/24-hr] is associated with HR 2.3 for future decline in GFR); persistent proteinuria >0.5 g/24-hr despite immunosuppressive treatment is associated with future deterioration of renal function (HR 2.4 for doubling SCr; LR 5.9 for ESRD); reduction in proteinuria to less than 1 g/24-hr at 6 months after treatment has PPV 87% for good long-term renal outcome

37 II16,23,46,47,56,60,68,73,77,82,87,115,117

,126,127,130,133,134,218,221,257,258,35

9,401,404,405,464,537-542,554,558-560

Hypertension Hypertension (at baseline and/or persistent following treatment) is associated with doubling SCr (RR 6.7) and development of ESRD (HR 5.0)

27 II19,47,48,58,60,65,68,69,72,77,79,83,86,1

23,130,133-136,532,539,561-566

Q10. Are effective management options for chronic kidney disease and end-stage renal disease (including renal replacement therapies) different in SLE compared to non-SLE patients?

Item Outcome and example(s) of effect size No. studies

Design References

Dialysis in SLE patients: outcome and predictors

SLE patients on HD are at increased risk for death (HR 1.17) and thrombotic microangiopathy (OR 3.7); majority of deaths are due to infections and cardiovascular disease events; high disease activity and need for immunosuppressives are predictors of adverse outcome (OR 7.3 for death); PD: increased rates of infections / peritonitis / hospitalizations due to infections (OR 6.0 versus non-diabetic controls), need for higher doses of erythropoietin to maintain similar haemoglobin levels; HD: increased rates of vascular access thrombosis (OR 3.1; risk factors are female gender, Black race, arterio-venous graft versus fistula, aPL positivity)

21 III 86,567-586

Renal activity Often (>50%) there is clinical and to lesser extent, serological remission 16 III 570,571,577,579,580,583,587-596

18

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during dialysis in SLE

Renal transplantation in SLE: outcome

Overall comparable renal graft and patient outcomes with other disease controls (data from single centres); increased risk for allograft loss (HR 1.09) and death (HR 1.18 versus diabetes controls) (data from registries);

Renal transplantation in SLE: predictors of allograft loss

Stronger evidence for recipient age, recurrent LN (HR 4.1), graft rejection (HR 2.7), ethnicity of the recipient (Black ethnicity has HR 1.6-1.7), living vs. cadaveric donor (HR 0.64), HLA mismatch (HR 1.8), delayed graft function (HR 1.7), previous renal transplantation (HR 2.3), aPL positivity; less strong evidence for recipient gender, recipient body mass index, panel-reactive antibodies, smoking, donor ethnicity, donor age, pregnancy history, pre-transplantation dialysis mode

25 III 589,597-620

Post-renal transplantation immunosuppressive therapy

Similar regimens with those used in non-SLE patients; calcineurin inhibitor-based triple immunosuppression is associated with improved outcomes

13 III 589,598,602,603,608,611,615,621-626

Recurrent lupus nephritis after renal transplantation

Wide range of reported frequencies (from 1.9% to 30-39% in studies performing protocol kidney biopsies; typically 4.5%)

18 IV 589,590,605-609,612-615,624-630

Renal transplantation in SLE: adjunct therapy

Lipid-lowering therapy. Fluvastatin (40-80 mg/day) in patients with dyslipidaemia resulted in reductions in serum LDL-cholesterol by 29% and in major cardiac events by 73% (p=0.064; follow-up 7.3 years)

1 II 631

Q11. What are the prognostic and therapeutic implications of the presence of anti-phospholipid antibody serology / anti-phospholipid syndrome or histological lesions of anti-phospholipid syndrome-associated nephropathy (APSN) in patients with lupus nephritis?

Item Outcome and example(s) of effect size No. studies Design References

Prognostic significance of aPL antibodies in renal outcome in SLE

No significant association with renal outcome (single study reporting association with chronic renal insufficiency)

8 III 632-640

Prevalence of APSN in SLE Prevalence of thrombotic microangiopathy: 6-46%; full-spectrum (thrombotic microangiopathy and chronic vascular lesions) of APSN lesions: 11-43%

6 IV 641-646

Association of aPL with APSN

APSN lesions are more frequent in aPL positive (lupus anticoagulant is associated with OR 11.5, anti-cardiolipin antibodies are associated with OR 5.7) and in APS patients (ca. 66% versus 20-30% in

18 III 632-634,638,641,642,644-

655

19

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SLE/aPL/non-APS patients)

Impact of APSN on renal outcome in SLE

Association of APSN lesions with hypertension, higher SCr / lower GFR (OR 5.8) and proteinuria levels, and increased interstitial fibrosis at renal biopsy); no association with rates of renal remission, doubling SCr, or ESRD (follow-up 2-10 years)

9 III 633,641-648

Q12. What is the optimal management of lupus nephritis in stable pregnant patients and in case of flare during pregnancy?

Item Outcome and example(s) of effect size No. studies

Design References

Risk factors for adverse pregnancy outcomes in LN

Risk factors are: a) high renal disease activity or renal flare at the time of conception (risk for miscarriage, stillbirth, pre-term delivery, IUGR, hypertension; first trimester proteinuria >0.5 g/24-hr has OR 4.1 for miscarriage; LN at remission for at least 6 months prior to and at pregnancy onset is associated with increased live birth rate [88% versus 64%]); b) high extra-renal SLE activity; c) thrombocytopenia (miscarriage, stillbirth; first trimester platelet count below 150,000/μL is associated with RR 3.3); d) hypertension (miscarriage, stillbirth, preterm delivery, IUGR); e) low serum C3/C4 (miscarriage, stillbirth, IUGR, neonatal death); f) anti-dsDNA (fetal loss); g) anti-SSA/Ro (pre-term delivery; CHB); h) anti-SSB/La (OR 11.5 for IUGR); i) aPL antibodies (miscarriage, stillbirth, preterm delivery, maternal hypertension, pre-eclampsia); j) hypo-albuminaemia (foetal loss [OR 19.1], IUGR [OR 7.0]); k) GC ≥10 mg/d prednisone (preterm delivery)

36 I 656-691

Risk factors for exacerbation of renal disease during pregnancy

Renal flares occur in 16-24% of LN pregnancies (often proteinuric); predictors for flares are: a) active renal disease at pregnancy onset (partial renal remission [proteinuria >0.2 but <1 g/24-hr] is associated with RR 3.0 for renal flare during pregnancy and 12 moths post-partum), b) high extra-renal disease activity at pregnancy onset (OR 1.6), c) use of glucocorticoids (OR 1.6) and azathioprine (HR 9.1) at pregnancy onset, d) no use of HCQ (association with higher rates of renal relapse; discontinuation of HCQ is associated with constitutional or arthritis flares), e) aPL positivity (OR 12.4), f) uncontrolled hypertension (OR 6.3)

30 I 656,659,661,663,665-

667,670,671,676,678-

684,686,690,692-702

Management of stable renal disease during pregnancy

Therapeutic agents include HCQ, GC (non-fluorinated, avoid >7.5 mg/d prednisone for more than 2 weeks), AZA, calcineurin inhibitors, aspirin; control hypertension with calcium-channel blockers, methyldopa, labetalol

4 III 668,682,683,691

Management of renal flare during pregnancy

GC (up to 1 mg/kg/day and/or IV-MP pulses); AZA (≤2.5 mg/kg/day); IVIG 10 IV658,663,665,666,671,679,680,

699,703,704

Monitoring of renal disease activity during pregnancy

Similar to adult non-pregnant LN patients; serial measurement of serum C3 and C4 can help differentiate between SLE flare and pre-eclampsia

1 II 705

20

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Q13. Is the management of paediatric lupus nephritis different from that in adult patients? Diagnosis, monitoring, and prognosis

Item Outcome and example(s) of effect size No. studies

Design References

Prevalence of paediatric LN

Childhood/juvenile-onset SLE patients are at increased risk for renal involvement compared to adult-onset SLE (>60-70% prevalence; OR 1.5-2.4 for proteinuria and/or casts); nephritis is often presenting feature of paediatric SLE; accompanying manifestations at onset are fever (OR 2.6), lymphadenopathy (OR 12.3), malar rash (OR 6.1), and arthritis; paediatric- vs. adult-onset LN: more severe disease (increased renal damage, increased progression to chronic renal insufficiency or ESRD, increased use of immunosuppressive agents)

33 I 706-738

Kidney biopsy for the diagnosis of paediatric LN

ISN/RPS 2003 classification (no difference in distribution of histological classes compared to adult patients); histological class correlates with clinical severity of LN (proteinuria level, haematuria, serum albumin, hypertension and need for anti-hypertensive medication)

[as above]

Prognostic value of kidney biopsy findings in paediatric LN

Proliferative LN is associated with worse renal outcome than non-proliferative LN; class IV LN is associated with worse outcomes compared to other classes (lower rates of response to therapy, increased damage accrual, higher rates [HR 1.8] of progression to ESRD, reduced patient survival; classes IV-G and mixed V+IV have worse prognosis; fibrinoid necrosis is associated with progression to CRF; biopsy CI correlates with progression to ESRD; tubulo-interstitial lesions correlate with the level of proteinuria, GFR, blood pressure, and progression to CRF; vascular lesions (vasculitis) are associated with increased rates of progression to CRF

21 III 707,718,721,731,736,739-754

Monitoring LN: blood, serological tests, and urinalysis

Renal function tests (SCr, GFR), proteinuria, urine sediment, serum C3/C4, serum anti-dsDNA antibodies, serum anti-C1q antibodies, haemoglobin, platelet count, and serum albumin levels have monitoring ability comparable with that in adult SLE patients

14 III 732,748,750,754-764

Monitoring LN: biomarkers

Urine NGAL levels show good correlation with the level of proteinuria, renal disease activity indices, kidney biopsy AI and CI (r = 0.39-0.73); urinary proteomics identify biomarkers with very good correlation with renal disease activity; weak evidence for other serum or urine biomarkers

11 III 757,758,761,762,764-770

Monitoring LN: diagnostic and prognostic value of repeat kidney biopsy

Histological class transformation into milder forms (if response to therapy) or severe forms (class IV; if no response or severe flare); response to therapy correlates with improvement in pathology findings (particularly reduction in AI); persistent class IV after immunosuppressive treatment is associated with future renal flares

6 III 707,719,731,750,754,771

Prognosis of paediatric LN

Increased mortality (~2-fold) (n=2 studies), damage accrual, and comorbidities (infections, cataract, avascular necrosis) compared to adult-onset LN; recently (years 2000-2011) published cohorts: 5-yr patient survival 77-98%, 10-yr rates: 65-92%; renal survival rates: 5-yr 75-94% (median 85%); 10-yr 54-90% (median 80%)

36 III 707,710,713,717-

71

9,721,722,727,732,733,736,739,740

,742-745,747,751,771-786

Prognostic factors in Predictors of adverse outcome: younger onset of LN; male gender (HR 2.6 for patient death); non-White 27 III 707,718,721,727,736,739-

21

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paediatric LN ethnicity (OR 3.3 for ESRD in black patients); renal histological class (worse outcome in class IV; favourable outcome in class II LN); level of proteinuria (urine protein-to-creatinine ratio >1.0 at onset is associated with OR 3.6 for ESRD); low GFR (<80 ml/min/1.73m2); hypertension (at onset or persistent; HR 1.67 for ESRD); anaemia (haemoglobin <10 g/dL)

74

8,751,752,754,772,777,779,780,782

,785,787-789

Q13. Is the management of paediatric lupus nephritis different from that in adult patients? ESRD

Item Outcome and example(s) of effect size No. studies Design References

HD in paediatric LN

Increased risk for death in SLE vs. non-SLE paediatric patients on HD (HR 3.1; major causes of mortality are infections, cardiovascular events) (single study); increased risk for complications: less likely to reach target serum albumin levels (OR 0.18), and increased risk for permanent vascular catheter access (OR 2.5; instead of A-V fistulas or grafts)

4 II 582,790-792

Renal transplantation in paediatric LN

Comparable renal outcomes versus disease controls (5-yr allograft survival 71% versus 77%); increased mortality in SLE (HR 1.8; 5-yr recipient survival 91% versus 98%); predictors of allograft loss are recipient age (HR 1.05 per 1-yr), female gender (HR 1.2), Black ethnicity (HR 2.0), cadaveric versus living donor transplant (HR 1.3), HLA mismatch, previous rejection (HR 3.1); predictors of recipient mortality are Black ethnicity (HR 1.6) and cadaveric versus living donor transplant (HR 1.9)

2 III 793,794

Q13. Is the management of paediatric lupus nephritis different from that in adult patients? Treatment

Item Outcome and example(s) of effect size No. studies

Design References

Class II LN Oral prednisone (starting dose up to 1-2 mg/kg); addition of AZA (2-3 mg/kg/d) or MPA (MMF 300-600 mg/m2) if proteinuria exceeds 1 g/24-hr or SCr exceeds 1.0 mg/dL

1 III 795

2 IV 740,796

Combination of the immunosuppressive agent mizoribine and steroids is not superior than steroids alone in improvement of renal disease parameters or prevention of flares

1 II 797

2 IV 798,799

Class III-IV LN: initial treatment

High-dose GC are used as part of the initial therapeutic regimen: pulses of IV-MP (30 mg/kg, maximum 1g) for 3 consecutive days, followed by oral prednisone 0.5-1 mg/kg/day; alternatively, high-dose oral prednisone (2 mg/kg/day) can be used

3 III 795,800,801

22

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3 V 797,802,803

Combination of GC and CY (IV 0.5-1 g/m2 ×7 monthly pulses or oral 2 mg/kg/day) is the treatment of choice in most studies with complete response rates 50-70%; benefit over AZA in long-term (8 years) preservation of renal function and patient survival; the regimen is efficacious in steroid-refractory LN, in cases with nephrotic syndrome, abnormal GFR and/or adverse histology (crescents)

1 II 804

2 III 802,803

17 V710,718,740,743,752,754,7

85,796,805-813

Combination of GC and MPA (MMF 300-900 mg/m2) is efficacious in class III-IV LN cases with preserved renal function; comparable short-term (6 months) efficacy with pulses IV-CY in class III LN; results from epidemiological studies suggest survival benefit since its introduction in the management of paediatric class III-IV LN

1 II 802

3 V 755,814,815

Combination of GC and AZA (2-3 mg/kg/day) is efficacious in mild LN cases 2 III 795,803

2 V 740,743

Combination of GC and calcineurin inhibitors (CsA, tacrolimus). Comparable efficacy of CsA (5 mg/kg/day) with the combination of high-dose steroids (2 mg/kg) plus oral CY (2 mg/kg) in reducing proteinuria in steroid-refractory class III-IV LN; ‘triple regimen’ (GC/MMF/CsA) has been used in severe LN cases

1 II 804

3 V 740,755,816

Combination of GC and oral mizoribine shows trend for reduced flares during 1-yr follow-up (single RCT); improvements in serology and proteinuria

1 II 797

4 V 798,799,817,818

Class III-IV LN: subsequent treatment

Combination of low-dose GC with IV-CY (quarterly pulses) has been used in severe cases with low GFR, high-level proteinuria, or crescents

2 III 802,803

7 V 754,807-811,813

Combination of low-dose GC with AZA has been used after successful induction with pulse IV-CY; relapses are 1 III 803

23

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common 3 V 752,806,811

Combination of low-dose GC with MPA is efficacious in patients who relapsed on AZA; has been used after initial treatment with either MPA or pulse IV-CY (including cases with crescentic nephritis)

1 III 802

5 V 806,808,811,814,815

Other agents: calcineurin inhibitors, mizoribine 1 II 804

5 V 755,798,816-818

Class V LN Oral GC (0.5-2 mg/kg/day) alone or in combination with immunosuppressive agent (usually AZA; also IV-CY, calcineurin inhibitors, MPA)

4 V 787,796,818,819

Refractory or relapsing LN

MPA (if failure to CY, AZA, or CsA) 2 V 814,820

Calcineurin inhibitors (CsA, tacrolimus) 3 V 816,818,821

Methotrexate (oral; combination of IV methotrexate with IV-CY); associated with significant toxicity 2 V 822,823

IVIG (400 mg/kg/d for 5 days): induction of sustained renal response; improved histology 1 V 824

Mizoribine: improvements in proteinuria and serology 3 V 818,825,826

RTX (miscellaneous regimens; 750 mg/m2 on days 1 and 15) alone or with concurrent/subsequent immunosuppression (MPA, AZA, or IV-CY): improvements in proteinuria, serum albumin levels, serology, and general SLE activity; steroid-sparring effect; complete renal remission 25-50%; partial renal remission rates 50%

3 V 827-829

Plasma exchange: used in cases of refractory class III-IV LN, rapidly progressive glomerulonephritis, concomitant micrangiopathy

3 V 740,830,831

Abbreviations: ACEi, ACE-inhibitor; AI, activity index; aPL, antiphospholipid antibody; APS, antiphospholipid syndrome; APSN, APS-associated nephropathy; ARB, angiotensin receptor blocker; AZA, azathioprine; CI, chronicity index; CRF, chronic renal failure; CsA, ciclosporin A; CY, cyclophosphamide; ESRD, end-stage renal disease; GC, glucocorticoids; GFR, glomerular filtration rate; HCQ, hydroxychloroquine; HD, haemodialysis; HR, hazard ratio; HUS, haemolytic-uremic syndrome; ISN/RPS, International Society of Nephrology / Renal Pathology Society; IUGR, intra-uterine growth restriction; IV-CY, intravenous cyclophosphamide; IVIG, intravenous immunoglobulin; IV-MP, intravenous methyl-prednisolone; LN, lupus nephritis; LR, likelihood ratio; MDRD, Modification of Diet in Renal Disease; MPA, mycophenolic acid; NIH, National Institutes of Health; OR, odds ratio; PD, peritoneal dialysis; RBC, red blood cells; RCT, randomized controlled trial; RR, relative risk; RTX, rituximab; SCr, serum creatinine; TTP, thrombocytopenic thrombotic purpura; WBC, white blood cells; WHO, World Health Organization

24

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1 The study design is assigned as follows: I, meta-analysis of RCTs; II, RCT (including long-term follow-up of original RCT using the same randomisation allocation); III, prospective controlled (non-randomized) study or epidemiological studies with prospective collection of data; IV, retrospective controlled or cross-sectional study, V, uncontrolled study (case series)

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