Table 1.
Reported efficacy of rituximab in nonrandomised trials of systemic lupus erythematosus
| Study | Rituximab regimen | Organ-specific disease | Number of patients/follow-up (months) | Method of assessment (mean disease activity score before/after B-cell depletion) |
|---|---|---|---|---|
| Anolik and colleagues [64]; Looney and colleagues [26] | Variable | No (7 LN) | 17/12 | SLAM improved in patients achieving effective B-cell depletion (6.8/5.2) |
| Leandro and colleagues [15]b | 2-dose | No (17/19 LN) | 19/6 | BILAG (13.9/5) |
| Vigna-Perez and colleagues [65] | 2-dose | Yes, LN | 22/3 | Mexico-SLEDAI (10.8/6.8) |
| Cambridge and colleagues [21]b | 2-dose | No (12/15 LN) | 15/6 | BILAG |
| Tamimoto and colleagues [66] | Variable | No (4/8LN) | 8 | SLEDAI (17.6/7.3) |
| Tokunaga and colleagues [28] | Variable | Yes, NPSLE | 10/7 to 45 | Neurological parameters (GCS) |
| Tanaka and colleagues [67] | 2-dose | No (6LN) | 14/7 | BILAG (12.5/7.1) |
| Ng and colleagues [17]b | 2-dose | No (21 LN) | 32/39 | BILAG (13/5) |
| Reynolds and colleagues [45] | Variable | No | 11/10 | BILAG (median reduction of 7.5) |
| Li and colleagues [68], | 2-dose | Yes, LN | 19/12 | SLEDAI (9.2/2.5) |
| Lu and colleagues [69]b | 2-dose | No (33/45 LN) | 45/39.6 | BILAG (12/5) |
| Pepper and colleagues [56] | 2-dose + MMF maintenance | Yes, LN | 20/12 | Renal parameters improved in 14/18 at 12 months |
| Catapano and colleagues [19] | 4-dose (15) or2-dose + CYC (16) | No (11 LN) | 31/30 | BILAG (14.5/3.5 at 24 months) |
| Sfikakis and colleagues [70] | 4-dose | Yes, LN | 10/12 | Renal parameters |
| Gottenberg and colleagues [71] | 4-dose | No (4 LN) | 13/8.3 | SLEDAI (8/2) |
| Smith and colleagues [18] | 4-dose, retreated with 2-dose | No | 11/24 | BILAG (14/2) |
| Gunnarsson and colleagues [72] | 4-dose | Yes, LN | 7/6 | SLEDAI (15/3) |
| Galarza and colleagues [73] | 4-dose | No | 43/12 | SLEDAI (12.5/4.5) |
| Jonsdottir and colleagues [74] | 4-dose | No (10 LN) | 16/27 | SLEDAI (12.1/4.7) |
| Lindholm and colleagues [75] | 4-dose | No (17 LN) | 29/22 | Renal parameters |
| Sutter and colleagues [76] | 4-dose | No | 12 | SLEDAI (9/5) |
| Boletis and colleagues [77] | 4-dose | Yes, LN | 10/38 | Renal parameters |
| Melander and colleagues [78] | 4-dose regimen (10 retreated) | Yes, LN | 20/22 | 12/20 improved |
BILAG, British Isles Lupus Assessment Group; CYC, cyclophosphamide; GCS, Glasgow Coma Scale; MMF, mycophenolate mofetil; SLAM, systemic lupus activity measure; LN, lupus nephritis; NPSLE, neuropsychiatric systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index. aRandomised controlled trial. bSame cohort in these studies.