Dataset Information

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20⁺ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

ABSTRACT: Rituximab combined with chemotherapy is the first-line induction therapy of CD20 positive B-cell non-Hodgkin lymphomas (CD20⁺ B-NHL). Recently new anti-CD20 monoclonal antibodies (mAbs) have been developed, but their efficacy and safety compared with rituximab are still controversial. We searched MEDLINE, Embase, and Cochrane Library for eligible randomized controlled trials (RCTs) that compared new anti-CD20 mAbs with rituximab in induction therapy of B-NHL. The primary outcomes are progression-free survival (PFS) and overall survival (OS), additional outcomes include event-free survival (EFS), disease-free survival (DFS), overall response rate (ORR), complete response rate (CRR) and incidences of adverse events (AEs). Time-to-event data were pooled as hazard ratios (HRs) using the generic inverse-variance method and dichotomous outcomes were pooled as odds ratios (ORs) using the Mantel-Haenszel method with their respective 95% confidence interval (CI). Eleven RCTs comprising 5261 patients with CD20⁺ B-NHL were included. Compared with rituximab, obinutuzumab significantly prolonged PFS (HR 0.84, 95% CI 0.73-0.96, P?=?0.01), had no improvement on OS, ORR, and CRR, but increased the incidences of serious AEs (OR 1.29, 95% CI 1.13-1.48, P?131I-tositumomab yielded similar PFS, OS, ORR and CRR with rituximab. ⁹⁰Y-ibritumomab tiuxetan increased ORR (OR 3.07, 95% CI 1.47-6.43, P?=?0.003), but did not improve PFS, DFS, OS and CRR compared with rituximab. In conclusion, compared with rituximab in induction therapy of CD20⁺ B-NHL, obinutuzumab significantly improves PFS but with higher incidence of AEs, ofatumumab decreases ORR, ⁹⁰Y-ibritumomab tiuxetan increases ORR.

SUBMITTER: Luo C

PROVIDER: S-EPMC7864901 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20<sup>+</sup> B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

Luo Chengxin C Wu Guixian G Huang Xiangtao X Ma Yanni Y Zhang Yali Y Song Qiuyue Q Xie Mingling M Sun Yanni Y Huang Yarui Y Huang Zhen Z Hou Yu Y Xu Shuangnian S Chen Jieping J Li Xi X

Scientific reports 20210205 1

Rituximab combined with chemotherapy is the first-line induction therapy of CD20 positive B-cell non-Hodgkin lymphomas (CD20<sup>+</sup> B-NHL). Recently new anti-CD20 monoclonal antibodies (mAbs) have been developed, but their efficacy and safety compared with rituximab are still controversial. We searched MEDLINE, Embase, and Cochrane Library for eligible randomized controlled trials (RCTs) that compared new anti-CD20 mAbs with rituximab in induction therapy of B-NHL. The primary outcomes are ...[more]

PMID: 33547368

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Project description:ObjectiveThis multi-center, open-label, randomized, parallel-controlled phase II study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety profile of ripertamab (SCT400), a recombinant anti-CD20 monoclonal antibody, to rituximab (MabThera®) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL).MethodsPatients with CD20-positive B-cell NHL who achieved complete remission or unconfirmed complete remission after standard treatment were randomly assigned at a 1:1 ratio to receive a single dose of ripertamab (375 mg/m2) or rituximab (MabThera®, 375 mg/m2). PK was evaluated using area under the concentration-time curve (AUC) from time 0 to d 85 (AUC0-85 d), AUC from time 0 to week 1 (AUC0-1 w), AUC from time 0 to week 2 (AUC0-2 w), AUC from time 0 to week 3 (AUC0-3 w), AUC from time 0 to week 8 (AUC0-8 w), maximum serum concentration (Cmax), terminal half-life (T1/2), time to maximum serum concentration (Tmax) and clearance (CL). Bioequivalence was confirmed if the 90% confidence interval (90% CI) of the geometric mean ratio of ripertamab/rituximab was within the pre-defined bioequivalence range of 80.0%-125.0%. PD, immunogenicity, and safety were also evaluated.ResultsFrom December 30, 2014 to November 24, 2015, a total of 84 patients were randomized (ripertamab, n=42; rituximab, n=42) and the PK analysis was performed on 76 patients (ripertamab, n=38; rituximab, n=38). The geometric mean ratios of ripertamab/rituximab for AUC0-85 d, AUC0-inf, and Cmax were 96.1% (90% CI: 87.6%-105.5%), 95.9% (90% CI: 86.5%-106.4%) and 97.4% (90% CI: 91.6%-103.6%), respectively. All PK parameters met the pre-defined bioequivalence range of 80.0%-125.0%. For PD and safety evaluation, there was no statistical difference in peripheral CD19-positive B-cell counts and CD20-positive B-cell counts at each visit, and no difference in the incidence of anti-drug antibodies was observed between the two groups. The incidences of treatment-emergent adverse events and treatment-related adverse events were also comparable between the two groups.ConclusionsIn this study, the PK, PD, immunogenicity, and safety profile of ripertamab (SCT400) were similar to rituximab (MabThera®) in Chinese patients with CD20-positive B-cell NHL.

Dataset Information

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20⁺ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

Publications

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20<sup>+</sup> B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

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Dataset Information

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20+ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

Publications

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20<sup>+</sup> B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20⁺ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.