Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study.

IF 5.4 2区医学 Q1 IMMUNOLOGY BioDrugs Pub Date : 2024-07-01 Epub Date: 2024-06-27 DOI:10.1007/s40259-024-00666-1

Helen W Wong, Vivian H Nguyen, Timothy Y Mok, Fang Niu, Merta Cushing, Michael Lam, Stephanie L Ho, Lisa Law, Ashraf R Aziz, Rita L Hui

{"title":"Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study.","authors":"Helen W Wong, Vivian H Nguyen, Timothy Y Mok, Fang Niu, Merta Cushing, Michael Lam, Stephanie L Ho, Lisa Law, Ashraf R Aziz, Rita L Hui","doi":"10.1007/s40259-024-00666-1","DOIUrl":null,"url":null,"abstract":"Background: Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for diffuse large B-cell lymphoma (DLBCL). Rituximab comprises most of the treatment cost for this regimen; therefore, biosimilars, such as rituximab-abbs are crucial to provide affordable care. Although rituximab-abbs was studied primarily in follicular lymphoma, the Food and Drug Administration (FDA) approved this drug for all indications of the reference product on the basis of extrapolation. Effectiveness and safety data surrounding the use of rituximab-abbs in DLBCL is lacking.Objective: To evaluate the effectiveness and safety of rituximab-abbs and reference product rituximab as R-CHOP treatment for patients with DLBCL.Patients and methods: This noninferiority (NI) study compared the 2-year overall survival (OS), overall response rate (ORR), and incidence of adverse events (AEs) between rituximab-abbs and its reference product (RP) in R-CHOP among adult patients with newly diagnosed DLBCL. The study inclusion period was from 1 January 2019 to 31 December 2020. Analyses were performed on the basis of a noninferiority lower limit of 10% for OS and ORR, and an upper limit of 10% for serious AEs.Results: There were 240 patients who received RP rituximab, while 295 patients received rituximab-abbs. The cohort had a mean age of 63.7±12.2 years and 43% were female. The 2-year OS was 81.0% and 79.6% (NI p < 0.01) while the ORR was 80.0% and 69.6% (NI p < 0.01), among the rituximab-abbs and rituximab groups, respectively. The incidence of infusion reaction AEs (NI p < 0.01) and noninfusion reaction AEs (NI p < 0.01) also met noninferiority.Conclusions: We demonstrated that rituximab-abbs was noninferior to rituximab in both effectiveness and safety among patients receiving R-CHOP for DLBCL in this study. Long-term follow-up would be needed to confirm these results.","PeriodicalId":9022,"journal":{"name":"BioDrugs","volume":" ","pages":"601-610"},"PeriodicalIF":5.4000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BioDrugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40259-024-00666-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/27 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for diffuse large B-cell lymphoma (DLBCL). Rituximab comprises most of the treatment cost for this regimen; therefore, biosimilars, such as rituximab-abbs are crucial to provide affordable care. Although rituximab-abbs was studied primarily in follicular lymphoma, the Food and Drug Administration (FDA) approved this drug for all indications of the reference product on the basis of extrapolation. Effectiveness and safety data surrounding the use of rituximab-abbs in DLBCL is lacking.

Objective: To evaluate the effectiveness and safety of rituximab-abbs and reference product rituximab as R-CHOP treatment for patients with DLBCL.

Patients and methods: This noninferiority (NI) study compared the 2-year overall survival (OS), overall response rate (ORR), and incidence of adverse events (AEs) between rituximab-abbs and its reference product (RP) in R-CHOP among adult patients with newly diagnosed DLBCL. The study inclusion period was from 1 January 2019 to 31 December 2020. Analyses were performed on the basis of a noninferiority lower limit of 10% for OS and ORR, and an upper limit of 10% for serious AEs.

Results: There were 240 patients who received RP rituximab, while 295 patients received rituximab-abbs. The cohort had a mean age of 63.7±12.2 years and 43% were female. The 2-year OS was 81.0% and 79.6% (NI p < 0.01) while the ORR was 80.0% and 69.6% (NI p < 0.01), among the rituximab-abbs and rituximab groups, respectively. The incidence of infusion reaction AEs (NI p < 0.01) and noninfusion reaction AEs (NI p < 0.01) also met noninferiority.

Conclusions: We demonstrated that rituximab-abbs was noninferior to rituximab in both effectiveness and safety among patients receiving R-CHOP for DLBCL in this study. Long-term follow-up would be needed to confirm these results.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

弥漫大 B 细胞淋巴瘤患者使用利妥昔单抗与利妥昔单抗的非劣效性研究结果。

背景：利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（R-CHOP）是弥漫大 B 细胞淋巴瘤（DLBCL）的一线治疗方案之一。利妥昔单抗占这一治疗方案的大部分治疗费用；因此，生物仿制药（如利妥昔单抗-单抗）对于提供可负担得起的治疗至关重要。虽然利妥昔单抗-abbs 主要针对滤泡性淋巴瘤进行研究，但美国食品药品管理局（FDA）根据外推法批准该药物用于参照产品的所有适应症。目前还缺乏有关利妥昔单抗抗体用于DLBCL的有效性和安全性数据：评估利妥昔单抗和参比产品利妥昔单抗作为 R-CHOP 治疗 DLBCL 患者的有效性和安全性：这项非劣效性（NI）研究比较了利妥昔单抗和其参比产品（RP）在新诊断DLBCL成人患者R-CHOP治疗中的2年总生存率（OS）、总反应率（ORR）和不良事件（AEs）发生率。研究纳入期为2019年1月1日至2020年12月31日。在OS和ORR的非劣效性下限为10%、严重AEs的非劣效性上限为10%的基础上进行分析：240名患者接受了利妥昔单抗RP治疗，295名患者接受了利妥昔单抗-抗体治疗。患者平均年龄为（63.7±12.2）岁，43%为女性。利妥昔单抗-单抗组和利妥昔单抗组的2年OS分别为81.0%和79.6%（NI p < 0.01），ORR分别为80.0%和69.6%（NI p < 0.01）。输液反应AEs（NI p < 0.01）和非输液反应AEs（NI p < 0.01）的发生率也达到了非劣效性：我们证明，在接受R-CHOP治疗的DLBCL患者中，利妥昔单抗-抗体在有效性和安全性方面均不劣于利妥昔单抗。要证实这些结果，还需要长期随访。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

BioDrugs 医学-免疫学

CiteScore

12.60

自引率

2.90%

发文量

审稿时长

>12 weeks

期刊介绍： An essential resource for R&D professionals and clinicians with an interest in biologic therapies. BioDrugs covers the development and therapeutic application of biotechnology-based pharmaceuticals and diagnostic products for the treatment of human disease. BioDrugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.