Annie Xiao, Lu Chen, Stacy Pak, Brian Lee, Matthew Mei, Elizabeth Budde, Tanya Siddiqi, James Godfrey, Alex Herrera, Avyakta Kallam, Tycel Phillips, John H Baird, Azra Borogovac, Larry Kwak, Steven T Rosen, Alexey Danilov, Sanjeet Dadwal, Geoffrey Shouse, Swetha K Thiruvengadam
{"title":"CD3/CD20双特异性抗体在复发/难治性非霍奇金淋巴瘤中的真实世界感染并发症","authors":"Annie Xiao, Lu Chen, Stacy Pak, Brian Lee, Matthew Mei, Elizabeth Budde, Tanya Siddiqi, James Godfrey, Alex Herrera, Avyakta Kallam, Tycel Phillips, John H Baird, Azra Borogovac, Larry Kwak, Steven T Rosen, Alexey Danilov, Sanjeet Dadwal, Geoffrey Shouse, Swetha K Thiruvengadam","doi":"10.1080/10428194.2025.2540442","DOIUrl":null,"url":null,"abstract":"<p><p>Infections occur in up to 44% of trial participants treated with CD3/CD20 bispecific antibodies (BsAb), but real-world data are limited. In this study of 48 real-world R/R-NHL patients receiving commercial BsAbs, 50% and 23% experienced any-grade and grade ≥3 infections, respectively. The cumulative number of infections per patient at 12 months was 1.3 (95% CI: 0.81-2.1). Severe infections were mostly bacterial. Only 1 grade 5 event occurred, and no COVID-19-related deaths were observed. Severe neutropenia, lymphopenia, and hypogammaglobulinemia occurred in 39.6, 83.3, and 64.1% of patients, respectively. In exploratory univariate analyses, recent infection, aggressive histology, number of prior lines of therapy, CAR T exposure, and severe treatment-emergent lymphopenia and hypogammaglobulinemia were linked to increased infection risk. Moreover, infection was associated with decreased overall survival (HR 3.4, <i>p</i> = 0.0066) in the Cox proportional hazards model. These real-world findings reinforce the need for monitoring of infectious complications following BsAb therapy.</p>","PeriodicalId":18047,"journal":{"name":"Leukemia & Lymphoma","volume":" ","pages":"1-9"},"PeriodicalIF":2.2000,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world infectious complications of CD3/CD20 bispecific antibodies in relapsed/refractory non-Hodgkin lymphoma.\",\"authors\":\"Annie Xiao, Lu Chen, Stacy Pak, Brian Lee, Matthew Mei, Elizabeth Budde, Tanya Siddiqi, James Godfrey, Alex Herrera, Avyakta Kallam, Tycel Phillips, John H Baird, Azra Borogovac, Larry Kwak, Steven T Rosen, Alexey Danilov, Sanjeet Dadwal, Geoffrey Shouse, Swetha K Thiruvengadam\",\"doi\":\"10.1080/10428194.2025.2540442\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Infections occur in up to 44% of trial participants treated with CD3/CD20 bispecific antibodies (BsAb), but real-world data are limited. In this study of 48 real-world R/R-NHL patients receiving commercial BsAbs, 50% and 23% experienced any-grade and grade ≥3 infections, respectively. The cumulative number of infections per patient at 12 months was 1.3 (95% CI: 0.81-2.1). Severe infections were mostly bacterial. Only 1 grade 5 event occurred, and no COVID-19-related deaths were observed. Severe neutropenia, lymphopenia, and hypogammaglobulinemia occurred in 39.6, 83.3, and 64.1% of patients, respectively. In exploratory univariate analyses, recent infection, aggressive histology, number of prior lines of therapy, CAR T exposure, and severe treatment-emergent lymphopenia and hypogammaglobulinemia were linked to increased infection risk. Moreover, infection was associated with decreased overall survival (HR 3.4, <i>p</i> = 0.0066) in the Cox proportional hazards model. These real-world findings reinforce the need for monitoring of infectious complications following BsAb therapy.</p>\",\"PeriodicalId\":18047,\"journal\":{\"name\":\"Leukemia & Lymphoma\",\"volume\":\" \",\"pages\":\"1-9\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Leukemia & Lymphoma\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/10428194.2025.2540442\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Leukemia & Lymphoma","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10428194.2025.2540442","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Real-world infectious complications of CD3/CD20 bispecific antibodies in relapsed/refractory non-Hodgkin lymphoma.
Infections occur in up to 44% of trial participants treated with CD3/CD20 bispecific antibodies (BsAb), but real-world data are limited. In this study of 48 real-world R/R-NHL patients receiving commercial BsAbs, 50% and 23% experienced any-grade and grade ≥3 infections, respectively. The cumulative number of infections per patient at 12 months was 1.3 (95% CI: 0.81-2.1). Severe infections were mostly bacterial. Only 1 grade 5 event occurred, and no COVID-19-related deaths were observed. Severe neutropenia, lymphopenia, and hypogammaglobulinemia occurred in 39.6, 83.3, and 64.1% of patients, respectively. In exploratory univariate analyses, recent infection, aggressive histology, number of prior lines of therapy, CAR T exposure, and severe treatment-emergent lymphopenia and hypogammaglobulinemia were linked to increased infection risk. Moreover, infection was associated with decreased overall survival (HR 3.4, p = 0.0066) in the Cox proportional hazards model. These real-world findings reinforce the need for monitoring of infectious complications following BsAb therapy.
期刊介绍:
Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor