Cited 36 times in
Efficacy and safety of rituximab in childhood-onset, difficult-to-treat nephrotic syndrome: A multicenter open-label trial in Korea
DC Field | Value | Language |
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dc.contributor.author | 신재일 | - |
dc.date.accessioned | 2019-02-12T16:49:32Z | - |
dc.date.available | 2019-02-12T16:49:32Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0025-7974 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167164 | - |
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 (375 mg/m 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.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isPartOf | MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adolescent | - |
dc.subject.MESH | Calcineurin Inhibitors/therapeutic use | - |
dc.subject.MESH | Child | - |
dc.subject.MESH | Child, Preschool | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glucocorticoids/therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunologic Factors/adverse effects | - |
dc.subject.MESH | Immunologic Factors/therapeutic use* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Nephrotic Syndrome/drug therapy* | - |
dc.subject.MESH | Remission Induction | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Rituximab/adverse effects | - |
dc.subject.MESH | Rituximab/therapeutic use* | - |
dc.subject.MESH | Treatment Outcome | - |
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.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아청소년과학교실) | - |
dc.contributor.googleauthor | Yo Han Ahn | - |
dc.contributor.googleauthor | Seong Heon Kim | - |
dc.contributor.googleauthor | Kyoung Hee Han | - |
dc.contributor.googleauthor | Hyun Jin Choi | - |
dc.contributor.googleauthor | Heeyeon Cho | - |
dc.contributor.googleauthor | Jung Won Lee | - |
dc.contributor.googleauthor | Jae Il Shin | - |
dc.contributor.googleauthor | Min Hyun Cho | - |
dc.contributor.googleauthor | Joo Hoon Lee | - |
dc.contributor.googleauthor | Young Seo Park | - |
dc.contributor.googleauthor | Il-Soo Ha | - |
dc.contributor.googleauthor | Hae Il Cheong | - |
dc.contributor.googleauthor | Su Young Kim | - |
dc.contributor.googleauthor | Seung Joo Lee | - |
dc.contributor.googleauthor | Hee Gyung Kang | - |
dc.identifier.doi | 10.1097/MD.0000000000013157 | - |
dc.contributor.localId | A02142 | - |
dc.relation.journalcode | J02214 | - |
dc.identifier.eissn | 1536-5964 | - |
dc.identifier.pmid | 30431588 | - |
dc.contributor.alternativeName | Shin, Jae Il | - |
dc.contributor.affiliatedAuthor | 신재일 | - |
dc.citation.volume | 97 | - |
dc.citation.number | 46 | - |
dc.citation.startPage | e13157 | - |
dc.identifier.bibliographicCitation | MEDICINE, Vol.97(46) : e13157, 2018 | - |
dc.identifier.rimsid | 58142 | - |
dc.type.rims | ART | - |
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