No. | Studies | Induction/Maintenance | Country | Setting | Study Design | n | Treatment Group: M vs F, or % F, or Total n |
---|---|---|---|---|---|---|---|
1 | Austin, et al35 | Induction | USA | NIH | RCT | 42 | CS: M/F: 3/12, IV CYC: M/F: 3/12, CSA: M/F: 1/11 |
2 | Carette, et al36 | Induction and maintenance | USA | NIH | RCT | 53 | CS: M/F: 3/12, AZA: M/F: 2/18, CYC: M/F: 5/13 |
3 | Steinberg and Steinberg37 | Followup | USA | NIH | RCT | 111 | CS: n = 30, AZA: n = 20, PO CYC: n = 18, IV CYC: n = 20, AZA + CYC: n = 23 |
4 | Donadio, et al38 | Induction | USA | Single center | RCT | 39 | CS: n = 20, CYC + CS: n = 19 |
5 | Pohl, et al39 | Induction, followup | USA | Multicenter | RCT | 86 | Standard group: 84.8% F, PLASMA group: 82.5% F |
6 | Mok, et al40 | Induction and maintenance | Hong Kong | 2 hospital sites | RCT | 43 | IV pulse CYC: M/F: 1/21, pulse CYC followed by AZA: M/F: 1/20 |
7 | Hu, et al41 | Induction | China | Single center | RCT | 46 | MMF group: 19 F, CYC group: 19 F |
8 | Wang, et al42 | Induction | China | Single center | RCT | 20 | MMF group: n = 9, CYC group: n = 11 |
9 | Isenberg, et al43 | Induction | Multinational | Multicenter | RCT | 370 | Induction therapy: M/F: 57/313, maintenance therapy: M/F: 32/195 |
10 | Radhakrishnan, et al44 | Induction pooled data | USA/multinational | Multicenter, 2 RCT | Pooled analysis of 2 large RCT | 84 | US study: M/F: 4/20, ALMS study subgroup: M/F: 17/43 |
11 | Wang, et al45 | Induction | China | Multicenter | RCT | 110 | LEF: M/F: 10/60, CYC: M/F: 3/37 |
12 | Appel, et al46 | Induction and maintenance | Multinational | NIH trial, multicenter | RCT, open-label, parallel-group | 370 | Induction therapy: M/F: 57/313, maintenance therapy: M/F: 32/195 |
13 | Austin, et al47 | Induction | USA | NIH trials, multicenter | RCT, open-label | 107 | M/F: 15/92 |
14 | Balletta, et al48 | Induction | Italy | NS | RCT | 10 | CS: M/F: 1/4, CS + CSA: M/F: 0/5 |
15 | Bao, et al49 | Induction | China | Single center | RCT, open-label | 40 | MMF + TAC + CS: M/F: 4/16, IV CYC: M/F: 2/18 |
16 | Barron, et al50 | Induction | USA | Single center | Quasi-RCT | 22 | Oral HD CS: M/F: 2/13, IV pulse CS, then PO CS: M/F: 1/6 |
17 | Boumpas, et al51 | Induction | USA | NS | RCT | 65 | Pulse CS: M/F: 1/24, pulse CYC: M/F: 3/17, pulse CYC, then quarterly: M/F: 1/19 |
18 | Cade, et al52 | Induction | USA | Teaching hospital | Quasi-RCT | 54 | HD CS: M/F: 3/12, AZA: M/F: 1/12, AZA + CS: M/F: 3/10, AZA + heparin: M/F: 6/7 |
19 | Chan, et al53 | Induction and maintenance | Hong Kong | Multicenter | RCT | 42 | CS + MMF: M/F: 6/26, CS + CYC, then CS + AZA: M/F: 4/26 |
20 | Chen, et al54 | Induction | China | Multicenter | RCT | 81 | CS + TAC: M/F: 5/37, CS + CYC: M/F: 7/32 |
21 | Clark, et al55 | Induction | Canada | Outpatient | RCT | 12 | Conventional therapy: n = 6, conventional therapy + PLASMA: n = 6 |
22 | Clark, et al56 | Induction | Canada and West Indies | Multicenter | RCT | 39 | Conventional therapy: M/F: 1/19, conventional therapy + PLASMA: M/F: 5/15 |
23 | Contreras, et al57 | Maintenance | USA | Single center | RCT, open-label | 59 | IV CYC: M/F: 1/19, AZA: M/F: 2/18, MMF: M/F: 1/19 |
24 | Zavada, et al58 | Induction and maintenance | European countries | Multicenter | RCT, open-label | 40 | CYC: M/F: 6/15, CSA: M/F: 5/14 |
25 | Derksen, et al59 | Induction | the Netherlands | Multicenter | RCT | 20 | AZA or CYC: M/F 3/8, PLASMA: M/F: 2/7 |
26 | Donadio, et al60 | Induction | USA | NS | RCT | 16 | M/F: 2/14, CS vs CS + AZA |
27 | Donadio, et al61 | Induction | USA | Single center | RCT, open-label | 26 | CS: M/F: 4/22, CS + CYC: M/F: 5/19 |
28 | Doria, et al62 | Induction | Italy | Single center | RCT | 18 | M/F: 2/16, std therapy vs std therapy + PLASMA vs std therapy + CS |
29 | Dyadyk, et al63 | Induction | Ukraine | NS | RCT | 59 | M/F: 9/50, PO CYC: M/F: 4/17, PO AZA: M/F: 5/33 |
30 | El-Shafey, et al64 | Induction | Egypt | Single center | RCT, open-label | 47 | MMF: M/F: 1/23, IV pulse CYC: M/F: 1/22 |
31 | Fu, et al65 | Maintenance | Taiwan | Single center | RCT | 40 | CYC: n = 20, CS + CSA: n = 20 |
32 | Ginzler, et al66 | Induction | USA | Single center | RCT, open-label, noninferiority | 140 | MMF: M/F: 10/61, CYC: M/F: 4/65 |
33 | Gourley, et al67 | Induction | USA | Single center | RCT | 82 | CS: M/F: 5/22, CYC: M/F: 6/21, CYC + CS: M/F: 3/25 |
34 | Grootscholten, et al68 | Induction and maintenance | the Netherlands | Multicenter | RCT | 87 | CYC + CS: M/F: 6/44, AZA + CS: M/F: 9/28 |
35 | Hahn, et al69 | Induction | USA | Single center | RCT | 20 | CS: M/F: 2/11, AZA: M/F: 2/9 |
36 | Hong, et al70 | Induction | China | NS | RCT | 25 | Not available |
37 | Houssiau, et al71 | Induction and maintenance | European | Multicenter | RCT | 90 | HD IV CYC followed by AZA: M/F: 3/43, LD IV CYC followed by AZA: M/F: 3/41 |
38 | Lewis, et al72 | Induction | USA | Multicenter | RCT | 86 | CYC + CS: M/F: 7/33, CYC + CS + PLASMA: M/F: 7/39 |
39 | Li, et al73 | Induction | Hong Kong | Single center | RCT | 19 | RTX: M/F: 9/9, RTX + IV CYC : M/F: 1/9 |
40 | Li, et al74 | Induction | China | NS | RCT, open-label | 60 | MMF: M/F: 3/17 TAC: M/F: 3/17 CYC: M/F: 2/18 |
41 | Lui, et al75 | Induction | Hong Kong | NS | RCT | 34 | Not available CSA + CS + AZA vs PO CYC + CS + AZA |
42 | Rovin, et al76 | Induction | Multinational | NIH trials, multicenter | RCT | 144 | Std therapy + Placebo: M/F: 5/67 std therapy + RTX: M/F: 9/63 |
43 | Houssiau, et al12 | Maintenance | European | Multicenter | RCT | 105 | AZA: M/F: 4/48 MMF: M/F: 5/48 |
44 | Mitwalli, et al77 | Induction and maintenance | Saudi Arabia | Single center | RCT | 117 | HD CYC: M/F: 12/6 1LD CYC: M/F: 5/39 |
45 | Mok, et al78 | Induction | Hong Kong, China | NS | RCT | 109 | M/F: 11/98 MMF vs TAC |
46 | Moroni, et al79 | Maintenance | Italy | Multicenter | RCT | 69 | CSA: M/F: 3/33 AZA: M/F: 4/29 |
47 | Mulic-Basic, et al80 | Induction | Bosnia-Herzegovina | NS | RCT | 45 | MMF, N = 20 CYC, N = 25 |
48 | Jayne and Zeher81 | Induction | Multinational | Multicenter | RCT, open-label | 81 | Not available |
49 | Ong, et al82 | Induction | Malaysia | Multicenter | RCT, open-label | 54 | MMF: M/F: 3/23 IV CYC: M/F: 4/15 |
50 | Sabry, et al83 | Induction | Egypt | Single center | Quasi-RCT | 46 | HD CYC: M/F: 4/22 LD CYC: M/F: 2/18 |
51 | Sesso, et al84 | Induction | Brazil | Single center | RCT | 29 | IV CYC: M/F: 2/12 IV CS : M/F: 2/13 |
52 | Steinberg, et al85 | Induction | USA | Single center | RCT | 15 | IV CYC + CS: M/F: 0/7 Placebo + CS: M/F: 0/6 |
53 | Sundel and Lisk86 | Induction | Multinational | Multicenter | RCT | 24 | M/F: 5/19 MMF vs IV CYC |
54 | Wallace, et al87 | Induction | Multinational | Multicenter | RCT | 19 | Std therapy: M/F: 1/8 std therapy + PLASMA: M/F: 0/9 |
55 | Yee, et al88 | Induction and maintenance | European | Multicenter | RCT, open-label | 32 | Pulse CYC: M/F: 2/11 Continuous PO CYC followed by PO AZA: M/F: 2/14 |
56 | Li, et al89 | Induction | China | Single center | RCT | 60 | MMF: M/F: 3/17, TAC: M/F: 3/17, IV CYC: M/F: 2/18 |
57 | Yap, et al90 | Induction | Hong Kong, China | Multicenter | RCT | 16 | CS + MMF: M/F: 2/5, CS + TAC: M/F: 4/5 |
58 | Stoenoiu, et al91 | Maintenance | Europe | Multicenter | RCT | 30 | M:F: 1/29 |
59 | Chen, et al92 | Maintenance | China | Multicenter | RCT | 70 | TAC: M/F: 2/5, 5/29, AZA group: M/F: 2/5, 4/32 |
60 | Arends, et al93 | Induction | the Netherlands | Multicenter | RCT | 87 | CYC + CS: M/F: 6/44, AZA + CS: M/F: 9/28 |
61 | Sundel, et al94 | Induction | Multinational | Multicenter | RCT | 370 | Induction, adults: MMF: M/F: 25/150, AZA: M/F: 27/144, Maintenance, adults: MMF: M/F: 15/93, AZA: M/F: 14/89 |
62 | Walsh, et al95 | Induction | Multinational | Multicenter | RCT, posthoc analysis | 32 | CYC: M/F: 2/10, MMF: M/F: 2/18 |
63 | Petri, et al96 | Induction and maintenance | USA | 2 hospital sites | RCT | 51 | SD CYC: M/F: 3/23, HD CYC: M/F: 2/19 |
64 | Zeher, et al97 | Induction and maintenance | Multinational | Multicenter | RCT | 81 | SD CS: M/F: 37/42, LD CS: M/F: 29/39 |
65 | Dooley, et al98 | Maintenance | UK | Single center | RCT | 227 | MMF: M/F: 99/116, AZA: M/F: 96/111 |
M: male; F: female; NIH: US National Institutes of Health; RCT: randomized controlled trial; NS: not specified; CS: corticosteroids; IV: intravenous; CYC: cyclophosphamide; CSA: cyclosporine; AZA: azathioprine; PO: oral; PLASMA: plasmapheresis; MMF: mycophenolate mofetil; ALMS: the Aspreva Lupus Management Study; LEF: leflunomide; TAC: tacrolimus; HD: high dose; std: standard; LD: low dose; SD: std dose (when dose is not specified, SD should be inferred).