Table 1.
Studies of Rituximab in SLE by author; same colour text denotes same patient cohort
| Author | Study population | Dose | Other immunosuppression | Subjects | Median F/U months | SLEDAI change | % change | BILAG change | % change | Auto-antibodies | Proportion achieving BCD | Median BCD (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Albert [35] | Mild-moderate | 375 mg/m2/week × 4 weeks | 100 mg MP with infusion only | 18 | 12 | 4 | 50 | 17/18 | 7 | |||
| Anolik [17] | Active SLE; 15 pts included in Looney 2004 data, but different outcome measures | Low dose (100 mg/m2), med (375 mg/m2), high (375 mg/m2) for 4 weeks | Current medications continued | 15 | 41 | Correlate with repopulation | 11/15 | 10.5 | ||||
| Looney [13] | Active SLE | As above | Excluded CYC patients | 17 | 12 | No change ds-DNA | ||||||
| Boletis [54] | Lupus nephritis | 375 mg/m2/week × 4 weeks | MMF and prednisolone | 10 | 38 | dsDNS decreased | ||||||
| Catapano [55] | Refractory SLE | 375 mg/m2/week × 4 weeks or 1 g days 1 and 15 | 31 | 30 | Remission in 27/31 | |||||||
| Galarza [39] | SLEDAI >8, nephritis/cytopenia/NPSLE | 375 mg/m2/week ×4 weeks or 1 g days 1 and 15 | MP with infusion; CYC stopped in all; MMF continued in 6 patients | 43 | 12 | 8 | 64 | |||||
| Gottenberg[53] | SLE and other autoimmune diseases | 375 mg/m2/week × 4 weeks | 2 patients AZA, 1 HCQ, 2 MP, 1 CIC, 1 CYC | 11 | 8.3 | 5.9 | 53 | Variable | 6/6 | 4–8 | ||
| Gillis [18] | Refractory SLE | Varied | Steroids and existing Rx | 6 | 12 | 7.7 | 57 | No change | ||||
| Gunnarsson [37] | Lupus nephritis; 7 pts included in Jonsdottir paper, but some different outcome measures | 375 mg/m2/week × 4 weeks | 7 | 12 | 80 | dsDNA decreased (174 to 56) | ||||||
| Jonsdottir [20] | Refractory SLE | 375 mg/m2/week × 4 weeks | CYC with 1st and last RTX; prednisolone (tapered) | 16 | 27 | 7.4 | 61 | 11 | 81 | dsDNA decreased | 16/16 | 7 (2-12) |
| Hernandez [56] | Refractory SLE | 375 mg/m2/week × 4 weeks | CYC, steroids + others “as necessary” | 7 | 12.8 |
18/ 19 |
5.5 | |||||
| Karpouzas [57] | Refractory SLE; 10 nephritis | 375 mg/m2/week × 4 weeks | 30 | 9 | 7.1 | 82 | 223 to 34 at 6/12 | 30/30 | ||||
| Li [46] | Lupus nephritis | 375 mg/m2/week × 2 weeks | 9 RTX alone, 10 RTX+CYC | 19 | 4 | 26/26 | Repopulation: 17% by 3/12, 80% by 12/12 | |||||
| Lindholm [25] | Refractory nephritis (17) or cytopenia (14) | 375 mg/m2/week × 4 weeks | RTX added to regimen (CYC/MMF), maintained until remission | 29 | 22 | ds-DNA: 34.5 to 27.3 after 6/12, to 16.3 after 12/12 | 11/17 | Variable ( 65% of baseline levels at 1 year) | ||||
| Lu [24] | Refractory SLE | 1 g IVI 2 weeks apart | CYC 750 mg, MP 250 mg | 45 | 39.6 | 7 | 58 | ds-DNA 106 to 42 | 45/46 | 6 (15pts >1 year) | ||
| LUNAR [29] | Placebo-controlled RCT, double blind, class III/IV lupus nephritis | 375 mg/m2 days 1 and 15 | MMF and corticosteroids; retreated at 6/12 with same | 144 | 12+ | Failed to meet outcomes | ||||||
| Melander [58] | Lupus nephritis | 375 mg/m2/week × 4 weeks | 3 also got CYC | 20 | 22 | Remission in 12/20 | ||||||
| Merrill [30] | Placebo-controlled (88 vs 169) RCT, moderate-severe active extrarenal SLE | 1 g days 1, 15, 168 and 182 | RTX added to existing regimen; steroids tapered down | 257 | 12 | Failed to meet outcomes | ||||||
| Pepper [59] | Lupus nephritis | 1 g days 1 and 15 | MP during infusion; maintenance MMF (500 mg-1 g) | 20 | 12 | 14/18 achieved remission | ||||||
| Reynolds [21] | Refractory SLE, only 9/11 met ACR criteria | 8 pts:750 mg or 1 g days 1 and 15; 2 pts: 375 mg/m2 × 2 | 7 had CYC 500-750 mg; 6 had MP | 11 | 10 | 7.3 | 85 | ds-DNA: no change | 10/11 | 6, recovery predicts flare | ||
| Sangle [36] | Refractory; 12 with lupus nephritis | 1 g days 1 and 15 | 500 mg CYC and 500 mg MP with RTX infusions | 16 | 4–6 | 5 | 18 | |||||
| Shahrir [40] | 7 refractory, 1 emergency (4 nephritis, 3 AIHA, 2 thrombocytopenia, 1 hepatitis) | Mean total 2,812.5 ml | RTX and MP added to existing regimen | 8 | 2–8 | 11.6 | 65 | |||||
| Sfikakis [42] | Lupus nephritis | 375 mg/m2/week × 4 weeks | Prednisolone | 10 | 12 | 10/10 | 1–7 months | |||||
| Smith [31] | Active or refractory SLE | 375 mg/m2/week × 4 weeks | 500 mg CYC with 1st RTX, added to existing regimen | 11 | 24 | 11 | 79 | ds-DNA 91 to 86 to 51.5 at 6 and 12 months (8/11pts) | 11/11 | 9 | ||
| Tamimoto [19] | 3 NPSLE, 4 nephritis, 3 cytopenia; refractory to at least one treatment | 4 × weekly 100/250/375 mg/m2 | All on prednisolone; 2 CIC; 1 CYC | 8 | 10.3 | 59 | dsDNA: 3/4 became -ve | 8/9 | >6 | |||
| Tanaka [34] | Active (1+ A or 2+ B), renal and NPSLE | 1 g×2 2 weeks apart (10pts) or 500 mg/week ×4 | Prednisolone only; others not allowed | 14 | 7 | 5.4 | 43 | 15/15 | >6 | |||
| Tokunaga [49] | Refractory renal and NPSLE. Analysed 4 wks, F/U >1 year | 375 mg/m2/week × 2 weeks | Prednisolone | 5 | 12+ | 14.2 | 58 | dsDNA reduced 4/5 | ||||
| Tokunaga [38] | Active NPSLE | Variable | Low-dose steroid only | 10 | 7–45 | 13.7 | 69 | Good BCD | ||||
| Vigna-Perez [15] | Active rIenal (WHO III/IV) | 0.5–1 g day 1 and 15 | RTX added to regimen | 22 | 3.85 | 36 | Variable | 0 | 0 |