Table 5.
Study | Type | Intervention/aim | Number of participants | RTX regimen | Concomitant immunosuppression | B-cell depletion reported | Study duration | Primary findings | Adverse events |
---|---|---|---|---|---|---|---|---|---|
Minimal change disease | |||||||||
Takei et al51
Japan |
PCS | Assess the therapeutic effects of RTX in adult patients with GC dependent MCD | 25 | 375 mg/m2 (maximum, 500 mg) ×2, 6 months apart | Tapering cyclosporine | Yes | 12 months | A significant reduction in the number of relapses and
the total/maintenance dose of GC when compared with the
findings during the prior 12-month period (25 [100%] vs
4 [16%], P < .001; 8.2 vs 3.3 g,
P < .001; 26.4 mg/day at
baseline vs 1.1 mg/day at 12-month, P
< .0001) CR achieved/maintained in 17/25 and 4/17 developed relapse |
AE: 5 SAE: 0 |
Papakrivopoulou et al52
UK |
PCS | Evaluate the efficacy and safety of RTX in maintaining remission, reducing relapse frequency and enabling withdrawal of immunosuppression, in frequently relapsing and steroid-dependent MCD | 15 | 1000 mg ×2, 6 months apart | GC tapered by 3 month and CNI tapered after 12 months by 25% every 6 months | Yes | 36 months | Median GC-free survival after RTX was 25 months (range,
4-34) Mean relapse frequency decreased from 2.60 ± 0.28 to 0.4 ± 0.19 (P < .001) after RTX Seven relapses occurred, 5 of which (71%) when CD19 counts were greater than 100 per μl. |
AE: 9 SAE: 0 |
Minimal change disease and focal segmental glomerulosclerosis | |||||||||
Ruggenenti et al53
Italy |
PCS | Evaluate the efficacy of RTX in reducing relapse and steroid exposure in children and adults with steroid-dependent or frequently relapsing NS due to MCD, MesGN, or FSGS | 30 (adults: 20) | 1-2 doses of rituximab (375 mg/m2/wk) | GC, CNI, MMF, CYC | Yes | 1 year | At 1 year, all patients were in remission 18/30 (60%) were treatment-free 15/30 (50%) never relapsed Compared with the year pre-rituximab, total relapses decreased from 88 to 22 and per-patient median number of relapses decreased from 2.5 (IQR, 2–4) to 0.5 (IQR, 0–1; P = .001) per year |
AE: 8 SAE: 8 |
Ren et al54
China |
PCS | Investigate the therapeutic effects of RTX in patients with refractory MCD or FSGS | 15 | 4 doses of rituximab (375 mg/m2/wk) | GC and other immunosuppressive medications allowed. All were tapered during the study | Yes | Median: 8 months (range, 3-36 months) | At 3 months: CR: 13/15 (87%) PR: 2/15 (13%) Relapses approximately 30-fold less compared with the year pre-RTX |
AE: 0 SAE: 0 |
Ramachandran et al55
India |
PCS | Describe the clinical outcome of adults with SD/SR NS treated with RTX | 53 | 375 mg/m2 followed by 100 mg based on CD19 level after 2-3 days | GC and CNI | Yes | Median: 36 months (IQR 19-48) | CR: 44/53 (83%) PR: 6/53 (11%) 33/53 (62%) did not require steroid or CNI during the follow-up period |
AE: 27 SAE: 0 |
Post-kidney transplant focal segmental glomerulosclerosis | |||||||||
Alasfar et al56
USA |
PCS | Evaluate risk factors for posttransplant FSGS recurrence, describes its course, and determine the efficacy of RTX and TPE in its prevention and treatment | 66 | 1 or 2 doses (375 mg/m2 per dose) | Perioperative TPE sessions were started anytime between day 7 before transplant to postoperative day 2 (3–10 sessions) | No | Median 29.5 months | 23 /37 (62%) who received preventative therapy developed
recurrence compared with 14/27 (51%) who did not receive
any therapy (P = .21) There was a trend for less relapse when rituximab was used as a therapy for recurrent FSGS, (6/22 vs 9/18, P = .066) |
Not mentioned |
Note. RTX = rituximab; PCS = prospective cohort study; GC = glucocorticoids; wk = week; MCD = minimal change disease; CR = complete remission; AE = adverse events; SAE = severe adverse events; CNI = calcineurin inhibitor; NS = nephrotic syndrome; FSGS = focal segmental glomerulosclerosis; MMF = mycophenolate mofetil; CYC = cyclophosphamide; IQR = interquartile range; PR = partial remission; SD = steroid dependent; SR = steroid resistant; TPE = plasma exchange.