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Table 2 Summary of the randomised-controlled trials of rituximab therapy in systemic lupuserythematosus

From: B-cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumaband implications for study design

Study Rituximab regimen Concomitant therapy Endpoints Results
LUNAR Randomised 1:1 to receive either rituximab or placebo on days 1, 15, 168,and 182 MMF and corticosteroids Primary: (i) % patients with complete or partial renal responses at week 52.Secondary: (ii) patients with BL UPCR >3 to UPCR <1; (iii) % changefrom BL in anti-dsDNA; and (iv) mean change from BL in C3 (mg/dl) (i) and (ii) no significant difference; (iii) placebo (50%) and rituximab(69%) (P <0.01); and (iv) placebo (25.9%) and rituximab (37.5%)(P <0.03). % patients requiring a new immunosuppressive agentplacebo (11.1%) and rituximab (1.4%)
EXPLORER Randomised 1:2 to receive placebo or rituximab, methyl prednisolone 100 mgand acetaminophen and diphenhydramine or placebo on days 1, 15, 168, and182 Usual dose prednisolone and either azathioprine 100 to 250 mg/day, MMF 1 to4 g/day or MTX 7.5 to 27.5 mg/week, and additional prednisolone (0.5 mg/kg,0.75 mg/kg, or 1.0 mg/kg), tapered beginning on day 16 to a dosage of 10mg/day over 10 weeks and 5 mg/day by week 52 Primary: effect of placebo or rituximab in achieving and maintaining amajor, partial or no response at week 52 in each of the eight BILAG indexorgan system scores. Secondary: described earlier Primary EP: major clinical response 15.9% vs. 12.4% and PCR 12.5% vs. 17.2%for placebo and rituximab, respectively. In the African American/Hispanicgroup: major clinical response 9.4% vs. 13.8% and PCR 6.3% vs. 20.0% forplacebo and rituximab, respectively
Li and colleagues [68] Randomised to receive either rituximab or a combination of rituximab andcyclophosphamide 750 mg on day 1 and day 15, followed by intravenousmethylprednisolone 250 mg and oral prednisolone 30 mg from day 2 to day 5,then 0.5 mg/kg for 4 weeks and then reducing the dose by 5 mg every 2 weeksto 5 mg/day Other medications were stopped except for hydroxychloroquine, oralprednisolone and statins. All patients also received angiotensin-convertingenzymes inhibitors Primary: in each of the groups, % patients with complete response at week48. Secondary: % patients with partial response; and duration of completeCD19+ B-lymphocyte depletion, histological assessment, adverseeffects or death at week 48 Primary EP: no significant difference between the two groups. Overall, atweek 48, 21% had a complete response, 58% achieved partial response, 11%remained the same and 11% worsened. Secondary EP: 42% patients achieved acomplete response; 95% achieved effective depletion; no significantdifference in the proportion of patients achieving a complete depletion atweeks 4, 8, 24 and 48 between the two groups except at week 2; a significantimprovement in mean serum albumin levels (28.1 to 39.4), changes in theconcentration of serum C3 (0.55 to 0.85), dsDNA antibody (693 to 8) andimmunoglobulins. At week 48, the urinary protein excretion improved andthere was an improvement in the ESR (62.1 to 30) and SLEDAI (9.2 to 2.5)
  1. BL, baseline; EP, endpoint; ESR, erythrocyte sedimentation rate; MMF,mycophenolate mofetil; MTX, methotrexate; PCR, partial clinical response; SLEDAI,Systemic Lupus Erythematosus Disease Activity Index; UPCR, urine proteincreatinine ratio.