Abstract: FR-PO1056
IV Cyclophosphamide vs Tacrolimus and Azathioprine as Induction in Proliferative Lupus Nephritis: A Randomized Controlled Trial
Session Information
- Late-Breaking Clinical Trial Posters
November 03, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Glomerular
- 1005 Clinical Glomerular Disorders
Authors
- Roychowdhury, Arpita, IPGMER, Kolkata, West Bengal, India
- Sircar, Dipankar, IPGMER,SSKM HOSPITAL, KOLKATA, India
Background
Therapy for proliferative lupus nephritis is limited to cyclophosphamide or mycophenolate as induction regimens. We present a randomized controlled trial of a regimen comprising of tacrolimus, azathioprine and steroids compared to IV cyclophosphamide and steroids for induction of lupus nephritis.
Methods
Patients of lupus nephritis ( classes III, IV, V+III or V+IV), age 15-60 years were included. Exclusion criteria included patients with biopsy proven class IIIC/IV C lupus nephritis, an estimated glomerular filtration rate (eGFR) of <30ml/min/1.73m2, severe infections or contraindications to any drugs.
All patients received 3 pulses of methylprednisolone (500 mg). Subsequently, prednisolone was given at doses of 0.5 mg/kg/day and tapered. The Triple Drug regimen group received tacrolimus (0.075 mg/kg; trough 5-10 ng/ml ) and azathioprine (2mg/kg). The control group received IV cyclophosphamide, 500 mg/m2 monthly. All patients received hydroxychloroquine.
The primary end point was achievement of complete renal remission. Secondary end points included decrease of proteinuria, decrease in disease activity scoring(SLEDAI Score) and incidence of severe adverse events.
Results
137 patients were screened and 92 patients were randomly assigned to both arms and of them 65 completed the study for first 6 months induction phase. There were 33 patients in group 1and 32 patients in group 2.
Complete remission occurred in 22/33 patients in the triple drug group and 22/32 patients in the IV Cyc group (p=0.857). Secondary end points were also similar between treatment groups- Group1 & Group2 . Major infective complications requiring hospital admission in the Group1 (2/33) were less in number than in group 2( 5/32 ) had significant adverse effect but it did not reach significance (p= 0.183)
Conclusion
The novel triple therapy comprising of TAC-AZA-PRED as induction therapy in proliferative lupus nephritis is comparable to IV cyclophosphamide with respect to efficacy and safety.
Triple drug regimen vs IV Cyc
| Tac-Aza:baseline | Cyc Baseline | P value | Tac aza 6 months | Cyc 6months | p value | |
| SLEDAI | 16.60±6.09 | 19.78±7.80 | 0.066 | 3.20±3.77 | 1.96±2.66 | 0.144 |
| 24 Hr urine protein (g/day) | 2.658±1.623 | 3.249±2.212 | 0.214 | 0.388±0.441 | 0.530±0.631 | 0.417 |
| Serum creatinine (mg/dl) | 1.003±0.436 | 1.062±0.408 | 0.571 | 0.886±0.415 | 0.829±0.366 | 0.559 |
| C3 (mg/dl) | 63.53±32.06 | 57.99±32.38 | 0.488 | 96.29±26.52 | 116.65±28.18 | 0.007 |
| Response (present) | 22/33 | 22/32 | 0.857 |
All figures are mean ± standard deviation
Funding
- Government Support - Non-U.S.