Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 이승주 | - |
dc.contributor.author | 이정원 | - |
dc.date.accessioned | 2019-01-02T16:30:06Z | - |
dc.date.available | 2019-01-02T16:30:06Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0025-7974 | - |
dc.identifier.issn | 1536-5964 | - |
dc.identifier.other | OAK-24079 | - |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/248027 | - |
dc.description.abstract | Background: The anti-CD20 monoclonal antibody rituximab (RTX) has been proposed as a rescue therapy for difficult-to-treat nephrotic syndrome (NS). We conducted a clinical trial to evaluate the efficacy and safety of RTX in children with difficult-to-treat NS dependent on or resistant to steroids and calcineurin inhibitors (CNIs). Methods: A multicenter open-label trial was performed at 8 major pediatric nephrology centers in Korea. The investigation consisted of a randomized controlled trial for steroid-and CNI-dependent NS (DDNS; randomization into the RTX group and the control group, at a ratio of 2:1) and a single-arm study of steroid and CNI-resistant NS (DRNS). DDNS patients in the RTX group and DRNS patients received a single dose of intravenous RTX (375mg/m(2) of body surface area) for B-cell depletion. A second RTX dose was administered at week 2 if the first dose failed to achieve depletion of CD19(+) cells. The primary endpoint was rate of maintaining remission at 6 months after treatment for DDNS and rate of remission achievement for DRNS. Results: Sixty-one children with DDNS were enrolled while in remission and randomized to the control group (21 patients) or the RTX group (40 patients). At 6 months after treatment, the remission rates were 74.3% in the RTX group and 31.3% in the control group (P=.003). The mean duration of remission maintenance was significantly higher in the RTX group than in the control group (9.0 vs 2.9 months, P=.004). Of the 23 patients with DRNS enrolled in the single-arm study and treated with RTX, 9 (39.1%) achieved partial or complete remission within 6 months. Depletion of B cells occurred in all patients with RTX therapy. Thirty patients (50.8% of 59 patients analyzed) experienced mild and transient infusion reaction during RTX administration, and most adverse events were mild. Conclusions: RTX administration was safe and effective in patients with difficult-to-treat NS. One or 2 doses of RTX may be sufficient to deplete B cells and achieve better control of pediatric NS. | - |
dc.language | English | - |
dc.publisher | LIPPINCOTT WILLIAMS & | - |
dc.publisher | WILKINS | - |
dc.subject | nephrotic syndrome | - |
dc.subject | rituximab | - |
dc.subject | children | - |
dc.title | Efficacy and safety of rituximab in childhood-onset, difficult-to-treat nephrotic syndrome A multicenter open-label trial in Korea | - |
dc.type | Article | - |
dc.relation.issue | 46 | - |
dc.relation.volume | 97 | - |
dc.relation.index | SCIE | - |
dc.relation.index | SCOPUS | - |
dc.relation.journaltitle | MEDICINE | - |
dc.identifier.doi | 10.1097/MD.0000000000013157 | - |
dc.identifier.wosid | WOS:000452462400030 | - |
dc.author.google | Ahn, Yo Han | - |
dc.author.google | Kim, Seong Heon | - |
dc.author.google | Han, Kyoung Hee | - |
dc.author.google | Choi, Hyun Jin | - |
dc.author.google | Cho, Heeyeon | - |
dc.author.google | Lee, Jung Won | - |
dc.author.google | Shin, Jae Il | - |
dc.author.google | Cho, Min Hyun | - |
dc.author.google | Lee, Joo Hoon | - |
dc.author.google | Park, Young Seo | - |
dc.author.google | Ha, Il-Soo | - |
dc.author.google | Cheong, Hae Il | - |
dc.author.google | Kim, Su Young | - |
dc.author.google | Lee, Seung Joo | - |
dc.author.google | Kang, Hee Gyung | - |
dc.contributor.scopusid | 이승주(54583939900;57219300715) | - |
dc.contributor.scopusid | 이정원(26028875500;57314335300) | - |
dc.date.modifydate | 20220428161240 | - |