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Observational Study
. 2019 May;34(5):855-863.
doi: 10.1007/s00467-018-4172-3. Epub 2018 Dec 18.

Low-dose rituximab is no less effective for nephrotic syndrome measured by 12-month outcome

Andrew P Maxted  1 , Rebecca A Dalrymple  2 , Denise Chisholm  3 , John McColl  4 , Yincent Tse  3 , Martin T Christian  1 , Ben C Reynolds  5
Affiliations
Observational Study

Low-dose rituximab is no less effective for nephrotic syndrome measured by 12-month outcome

Andrew P Maxted et al. Pediatr Nephrol. 2019 May.

Abstract

Objective: Rituximab is an effective treatment for children with steroid dependent or frequently relapsing nephrotic syndrome. The optimum dosing schedule for rituximab has not been established. We hypothesized that a single low dose of 375 mg/m2 would have comparable outcomes to higher doses in reducing the frequency of relapse and time to B cell reconstitution.

Methods: We conducted a multicenter retrospective observational cohort study of children with steroid-sensitive frequently relapsing nephrotic syndrome. Data were extracted from clinical records including the dates of diagnosis, treatment, relapses, the use of concomitant immunosuppression, and lymphocyte subset profiling. Patients treated earlier received variable doses of rituximab, although typically two doses of 750 mg/m2. Later, patients received the current regimen of a single dose of 375 mg/m2. The primary outcome was an absence of clinically confirmed relapse 12 months following rituximab administration. Secondary outcomes were median time to relapse, probability of being relapse-free at 6 and 24 months and time to reconstitution of CD19+ B cells.

Results: Sixty patients received 143 courses of rituximab. Seven different dosing regimen strategies were used, ranging between 375 and 750 mg/m2 per dose, with administration of 1-4 doses. There was no significant difference in event-free survival at 12 months between dosing strategies. The median time to reconstitution of B cells was not significantly different between groups.

Conclusions: Use of a single low-dose regimen of rituximab in the management of frequently relapsing nephrotic syndrome does not affect the probability of relapse at 12 months or time to B cell reconstitution compared to a conventional higher dose.

Keywords: Dosing; Nephrotic syndrome; Rituximab.

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Conflict of interest statement

Ben Reynolds has previously had speaking fees from Alexion Pharmaceuticals. The remaining authors have no financial relationships relevant to this article to disclose.

Figures

Fig. 1
Fig. 1
Kaplan-Meier estimates of relapse-free survival curves by dosing schedule, p = 0.32
Fig. 2
Fig. 2
Kaplan-Meier survival curves of time relapse-free survival by dose schedule for first dose of rituximab (RTX) only (p = 0.05)
Fig. 3
Fig. 3
Kaplan-Meier estimates of survivor curves by course of treatment, p = 0.02
Fig. 4
Fig. 4
Kaplan-Meier survival (by interval censored analysis) of the time to B cell reconstitution, > 0.2 × 109/L between high, intermediate, and low groups
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References

    1. Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003;362(9384):629–639. doi: 10.1016/S0140-6736(03)14184-0. - DOI - PubMed
    1. Özlü SG, Demircin G, Tökmeci N, Çaltık Yılmaz A, Aydoğ Ö, Bülbül M, Öner A. Long-term prognosis of idiopathic nephrotic syndrome in children. Ren Fail. 2015;37(4):672–677. doi: 10.3109/0886022X.2015.1010940. - DOI - PubMed
    1. Kemper MJ, Valentin L, van Husen M. Difficult-to-treat idiopathic nephrotic syndrome: established drugs, open questions and future options. Pediatr Nephrol. 2017;33(10):1641–1649. doi: 10.1007/s00467-017-3780-7. - DOI - PubMed
    1. Karp AM, Gbadegesin RA. Genetics of childhood steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 2016;32(9):1481–1488. doi: 10.1007/s00467-016-3456-8. - DOI - PMC - PubMed
    1. Kang HG, Cheong HI. Nephrotic syndrome: what’s new, what’s hot? Korean J Pediatr. 2015;58(8):275–282. doi: 10.3345/kjp.2015.58.8.275. - DOI - PMC - PubMed

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