IMPORTANCE Calcineurin inhibitors are an established first-line corticosteroid-sparing therapy for patients with corticosteroid-dependent nephrotic syndrome (CDNS), whereas B-lymphocyte-depleting therapy is mostly used as a rescue for calcineurin inhibitor-resistant cases. The positive efficacy and safety profile of rituximab raises the question of whether it could be used as a first-line alternative to calcineurin inhibitor therapy. OBJECTIVE To compare the efficacy of rituximab and tacrolimus in maintaining relapse-free survival among children with CDNS. DESIGN, SETTING, AND PARTICIPANTS A parallel-arm, open-label, randomized clinical trial was performed from May 8, 2015, to September 20, 2016, with 1-year follow-up in a single-center, tertiary care unit. A total of 176 consecutive children aged 3 to 16 years with CDNS not previously treated with corticosteroid-sparing agents were screened for eligibility. INTERVENTIONS The children received either tacrolimus (along with tapering alternate-day prednisolone) for 12 months or a single course of rituximab (2 infusions of 375 mg/m 2). MAIN OUTCOMES AND MEASURES Twelve-month relapse-free survival in the intention-to-treat population. RESULTS Of the 176 children screened for eligibility, 120 were randomized and all but 3 patients completed 1 year of follow-up. The groups were comparable, with mean (SD) age of 7.2 (2.8) years, 32 boys (53.3%) in each group, mean (SD) disease duration of 2.5 (1.5) years and 2.3 (1.7) in the tacrolimus and rituximab groups, respectively, disease duration less than 1 year among 15 children (25.0%) in each group, median (interquartile range) of 4 (3-5) relapses in each group, and mean (SD) cumulative prednisolone dose of 246 (48) mg/kg and 239 (52) mg/kg in the prestudy year in the tacrolimus and rituximab groups, respectively. Rituximab therapy was associated with a higher 12-month relapse-free survival rate than tacrolimus (54 [90.0%] vs 38 [63.3%] children; P < .001; odds ratio, 5.21; 95% CI, 1.93-14.07). Among the patients who experienced relapse, median time to first relapse was 40 weeks in the rituximab group and 29 weeks in the tacrolimus group. Only 2 patients in the rituximab group had more than 1 relapse during the study period compared with 10 patients in the tacrolimus group. The cumulative corticosteroid dose during the 12-month study period was lower with rituximab compared with tacrolimus (mean [SD], 25.8 [27.8] vs 86.3 [58.0] mg/kg). Although both treatments were well tolerated, mild to moderate infections were twice as common in the tacrolimus group (26 [43.3%] vs 13 [21.7%] events). CONCLUSIONS AND RELEVANCE In children with CDNS, rituximab appears to be more effective than tacrolimus in maintaining disease remission and minimizing corticosteroid exposure and, given its good tolerability and lack of nephrotoxic effects, may be considered as first-line corticosteroid-sparing therapy.

BackgroundDespite large numbers of asylum seekers, there is a lack of evidence on pregnancy outcomes and obstetric care of asylum seeking women in Germany.MethodsCross-sectional study (2010–2016) using administrative data of the main referral hospital for pregnant asylum seekers of the reception center of a large federal state in South Germany. Inclusion criteria: women aged 12–50 years, admitted in relation to pregnancy, childbirth or post-partum complications. Outcomes: differences between asylum seekers and residents in the prevalence of high-risk pregnancy conditions, abortive outcomes/stillbirths, peri- and postnatal maternal complications, neonatal complications, and caesarean sections. Analysis: odds ratios (OR) and 95% confidence intervals (CI) obtained by single and multiple logistic regression analysis. Attributable fractions among the exposed (Afe) and among the total population (Afp) were calculated for selected outcomes.ResultsOf 19,864 women admitted in relation to pregnancy, childbirth or post-partum complications, 2.9% (n = 569) were asylum seekers. Adjusted odds for high-risk pregnancy conditions (OR = 0.76, 95%CI: 0.63–0.91, p < 0.0001), caesarean sections (OR = 0.84, 95%CI 0.66–1.07, p = 0.17) and perinatal complications (OR = 0.65, 95%CI: 0.55–0.78, p < 0.0001) were lower; those for abortive outcomes/stillbirths (OR = 1.58, 95%CI: 1.11–2.20, p = 0.01) and postnatal complications (OR = 1.80, 95%CI: 0.93–3.19, p = 0.06) higher among asylum seeking women relative to residents in models adjusted for age, length of admission, and high-risk pregnancy conditions. The Afe for abortive outcomes and stillbirths among asylum seekers was 40.3% (95% CI, 16.3–56.5) and the Afp was 1.8%. The Afe for postnatal complications was 53.1% (95% CI, 7.1–74.0) and the Afp was 3.1%.ConclusionAsylum seeking women are at higher risk of abortive outcomes/stillbirths and show a tendency towards higher postnatal complications. This excess risk calls for adequate responses by health care providers and policy makers to improve outpatient postnatal care in reception centers and mitigate adverse birth outcomes among asylum seeking women. Although further research is needed, scaling-up midwivery care, improving outreach by maternity care teams, and routinely identifying and addressing mental illness by psychosocial services could be ways forward to improve outcomes in this population.Electronic supplementary materialThe online version of this article (10.1186/s12884-018-2053-1) contains supplementary material, which is available to authorized users.

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