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Table 4 Safety and efficacy of ocrelizumab in lupus nephritis: design and results of theBELONG study

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

Patients and methods Concomitant therapy Endpoints Results
A total of 381 patients with class III or class IV (80%) LN were randomisedequally to receive either: placebo, OCR 400 mg or OCR 1,000 mg on days 1, 15and every 16 weeks thereafter, >74% received three infusions and >50%received four infusions In addition, either: MMF up to 3 g/day (63%); or EL (cyclophosphamide 500 mg×6/2 weeks) followed by azathioprine 2 mg/kg up to 200 mg/day; and asteroid taper regimen - intravenous steroids: allowed up to 3 g by day 15,given in divided pulses), oral steroids: 0.5 to 0.75 mg/kg (≤60mg/day) with taper to ≤10 mg over 10 weeks Complete renal response: normal serum creatinine and ≤25% higher thanbaseline; urinary protein to creatinine ratio <0.5; inactive urinarysediment In all modified intention-to-treat populations, there was a treatmentdifference of 12.2% with 54.7% vs. 66.9% for placebo (n = 75) andOCR (n = 148) groups, respectively
   Partial renal response: serum creatinine ≤25% above baseline value;and 50% improvement in the urine protein to creatinine ratio, and ifbaseline ratio >3.0 then a urine protein to creatinine ratio <3.0 ORR higher in OCR (400 mg) + EL (65.6%) and OCR (1,000 mg) + EL (74.2%)groups vs. placebo + EL (42.9%), ORR was similar in OCR+ MMF (67.9%) vs.placebo + MMF (61.7%)
   Nonresponse: not achieving either a complete or partial renal response.Patients who died or discontinued the study prior to week 48 (and had norenal data within 12 weeks of week 48) were considered nonresponders ≥50% reduction in urine protein-to-creatinine ratio occurred in 69.6%vs. 58.7 % for OCR and placebo groups, respectively
    Urine protein-to-creatinine ratio <0.5 was achieved in 39.9% vs. 37.3%for
OCR and placebo, respectively
    Serious adverse effects imbalance
appeared to be driven by the combination with MMF: OCR 400 mg (41.8%)compared with 1,000 mg OCR + MMF (24.1%) and placebo + MMF (21.3%). Seriousadverse event rates in EL groups were not reported as higher in the OCRarms
    Serious infection imbalance appeared to be driven by the OCR combinationwith MMF. MMF groups: OCR 400 mg (32.9%) compared with 1,000 mg OCR (19%)and placebo + MMF (16.3%). EL groups: OCR 400 mg (12.8%) compared with 1,000mg OCR (10.4%) and placebo + MMF (11.1%)
  1. EL, EUROLUPUS regimen (cyclophosphamide followed by azathioprine); LN, lupusnephritis; MMF, mycophenolate mofetil; OCR, ocrelizumab; ORR, overall renalresponse.