Background/Purpose: We present the long-term follow-up of patients with lupus nephritis who completed the randomized controlled trial on comparison of low-dose intravenous cyclophosphamide (IV CYC) with oral mycophenolate mofetil (MMF) as the induction therapy.

Methods: Prospective data on kidney function and survival in 83 out of 100 patients, who completed the initial trial, were collected over at least 36 months. Response, number of relapses, and time to first relapse were compared between the low dose IV CYC and oral MMF group on follow-up. Response, complete remission (CR) and partial remission (PR) and relapse (mild, moderate and severe) were defined according to Kidney Disease Initiative Global Outcomes (KDIGO) criteria.

Results: Of the initial 100 patients randomized to two groups, 83 patients (42 in IV CYC arm and 41 in oral MMF arm) completed 24 weeks study period. Of these, 67 patients had achieved treatment response, while 16 patients did not achieve response. All the 67 responders were started on azathioprine as the maintenance agent. On follow-up, 15 relapses occurred in the MMF group (13 patients had 1 relapse each and 2 had more than 1 relapse) and 12 relapses were seen in the IV CYC group (12 patients had 1 relapse each) on a follow-up of 36 months (p>0.05). Of the 15 relapses in the MMF group, 9 were mild, 5 were moderate and 1 was severe relapse, respectively. The patient with severe relapse died due to disease activity at 36^th month of follow-up. Of the 12 relapses in the IV CYC group, 8 were mild and 4 were moderate relapses, respectively.

Of the 16 non-responders, 11 were started on azathioprine, 4 were started on alternate induction agent and one patient was continued on the same induction agent. Of the 11 patients on azathioprine, the mean time to achieve response was 9.38 months in all, except in 3 lost to follow-up and 3 had mild relapse on follow-up. Of the 4 patients on alternate induction therapy, 2 required further change in therapy, 1 responded at 18 months and 1 died at 12 months due to disease activity. The patient on the same induction agent achieved response at 30 months. Overall, the mean time to first relapse was 23.95 months in the IV CYC group and 23.22 months in the oral MMF group (p=0.807).

Conclusion: Long term follow-up data shows that both low dose IV CYC and oral MMF induction therapy followed by azathioprine maintenance are equally effective in maintaining response in patients with lupus nephritis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-low-dose-intravenous-cyclophosphamide-with-oral-mycophenolate-mofetil-in-the-treatment-of-lupus-nephritis-long-term-follow-up-data/