Evidence map›Paper›PMID 39021571›Full record

ArticleFrontiers in immunology2024

Vedolizumab plus basiliximab as second-line therapy for steroid-refractory lower gastrointestinal acute graft-versus-host disease.

Zicheng Gao, Zhiping Fan, Zhi Liu, Xu Ye, Yunxin Zeng, Li Xuan, Fen Huang, Ren Lin, Jing Sun, Qifa Liu and 1 more

Abstract read
In one paragraph

Article in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Zicheng Gao *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Zhiping Fan *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Zhi LiuDepartment of Hematology, Guangdong Second Provincial General Hospital, Guangzhou, China.
Xu YeDepartment of Hematology, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yunxin ZengDepartment of Hematology, The Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, China.
Li XuanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Fen HuangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Ren LinDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jing SunDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Qifa LiuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Na XuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Steroid-resistant (SR) lower gastrointestinal (LGI) tract graft-versus-host disease (GVHD) is the predominant cause of morbidity and mortality from GVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The role of vedolizumab in the treatment of SR-LGI acute GVHD (aGVHD) remains uncertain. We aimed to assess the efficacy and safety of vedolizumab combined with basiliximab as second-line therapy for SR-LGI-aGVHD. Methods: This study aimed to explore the efficacy of vedolizumab combined with basiliximab for SR-LGI-aGVHD. The primary endpoint was the overall response (OR) on day 28. Secondary and safety endpoints included durable OR at day 56, overall survival (OS), chronic GVHD (cGVHD), non-relapse mortality (NRM), failure-free survival (FFS), and adverse events. Results: Twenty-eight patients with SR-LGI-aGVHD were included. The median time to start of combination therapy after SR-LGI-aGVHD diagnosis was 7 (range, 4-16) days. The overall response rate (ORR) at 28 days was 75.0% (95% CI: 54.8%-88.6%), and 18 achieved a complete response (CR) (64.3%, 95% CI: 44.1%-80.7%). The durable OR at day 56 was 64.3% (95% CI: 44.1%-80.7%). The 100-day, 6-month, and 12-month OS rates for the entire cohort of patients were 60.7% (95% CI: 45.1%-81.8%), 60.7% (95% CI: 45.1%-81.8%), and 47.6% (95% CI: 31.4%-72.1%), respectively. The median failure-free survival was 276 days; (95% CI: 50-not evaluable) 12-month NRM was 42.9% (95% CI: 24.1%-60.3%). The 1-year cumulative incidence of cGVHD was 35.7%. Within 180 days after study treatments, the most common grade 3 and 4 adverse events were infections. Nine (32.1%) patients developed cytomegalovirus (CMV) reactivation complicated with bacterial infections (25.0%, CMV infection; 7.1%, CMV viremia). Epstein-Barr virus (EBV) reactivation occurred in five patients (17.9%, 95% CI: 6.8%-37.6%). Only three patients (10.7%, 95% CI: 2.8%-29.4%) in our study developed pseudomembranous colitis. Conclusions: Vedolizumab plus basiliximab demonstrated efficacy in severe SR-LGI-aGVHD and was well-tolerated. Vedolizumab plus basiliximab may be considered a potential treatment option for patients with LGI-aGVHD.

Indexed as

Antibodies, Monoclonal, HumanizedBasiliximabGraft vs Host DiseaseHematopoietic Stem Cell TransplantationAcute DiseaseAdolescentAdultAgedDrug ResistanceDrug Therapy, CombinationFemaleGastrointestinal DiseasesHumansImmunosuppressive AgentsMaleMiddle AgedAntibodies, Monoclonal, HumanizedBasiliximabImmunosuppressive AgentsSteroidsvedolizumabbasiliximabHSCTlower intestinal GVHDsteroid-refractory GVHDvedolizumabα4β7

Identifiers

PMID39021571
PMCPMC11252588

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.