Evidence map›Paper›PMID 32817288›Full record

ArticleHaematologica2021

Efficacy, safety and immunological profile of combining rituximab with belimumab for adults with persistent or chronic immune thrombocytopenia: results from a prospective phase 2b trial.

Matthieu Mahévas, Imane Azzaoui, Etienne Crickx, Florence Canoui-Poitrine, Delphine Gobert, Laetitia Languille, Nicolas Limal, Constance Guillaud, Laure Croisille, Mohamed Jeljeli and 8 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Haematologica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
4.4field-weighted citation impact, top 4% of its field
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.

NCT03154385 nacompletednot on this map

RITUX-PLUS. A Prospective Open Trial to Assess the Efficacy and Safety of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia.

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2017 to 2019Enrolled15ConditionsImmune ThrombocytopeniaArmsRituximab (Mabthera ®) Belimumab (Benlysta ®)
NCT06093529 unknown statusnot on this mapstarted 2024, after this paper: background citation

Marker Expression in Pediatric Patients With Immune Thrombocytopenic Purpura Receiving Second Line Therapy

TypeobservationalSponsorAssiut UniversityRan2024 to 2025Enrolled42ConditionsITP - Immune ThrombocytopeniaArmscomplete blood count, CD3+ , CD4+ , CD8+, CD16+, CD56+, IFN-γ.
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 56 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. On the horizon: upcoming new agents for the management of ITP.Hematology. American Society of Hematology. Education Program · 2024
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Rituximab resistance in ITP and beyond.Frontiers in immunology · 2023
    Review
  20. Article
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

18 authors at 6 institutions in 1 country.

Matthieu MahévasCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Imane AzzaouiIMRB - U955,Hopital Henri-Mondor, Creteil, France.
Etienne CrickxCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Florence Canoui-PoitrineUniversity Paris-Est, Paris Est Creteil University, CEpiA, Henri-Mondor Hospital, Creteil, France.
Delphine GobertHopital Saint-Antoine, Sorbonne Université, Creteil, France.
Laetitia LanguilleCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Nicolas LimalCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Constance GuillaudCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Laure CroisilleService d'immunologie plaquettaire, Hopital Henri Mondor, Creteil, France.
Mohamed JeljeliService d'Immunologie biologique, Hopital Cochin, Institut Cochin, Paris, France.
Fréderic BatteuxService d'Immunologie biologique, Hopital Cochin, Institut Cochin, Paris, France.
Samia BaloulUniversity Paris-Est, Paris Est Creteil University, CEpiA, Henri-Mondor Hospital, Creteil, France.
Olivier FainSorbonne Université, Service de Medecine Interne, Hopital Saint-Antoine, Paris, France.
France PirenneIMRB - U955, Hopital Henri-Mondor, Creteil, France.
Jean-Claude WeillInstitut Necker Enfants Malades, Université Paris Descartes, Paris, France.
Claude-Agnès ReynaudInstitut Necker Enfants Malades, Université Paris Descartes, Paris, France.
Bertrand GodeauCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Marc MichelCentre Hospitalier Universitaire Henri-Mondor, Université Paris Est Creteil, Creteil, France.
Institut Mondor de Recherche Biomédicale · FRCentre Hospitalier Universitaire Henri-Mondor · FRHôpital Cochin · FRHôpital Saint-Antoine · FRHôpital Necker-Enfants Malades · FRInstitut Necker Enfants Malades · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

B-cell activating factor may be involved in the failure of B-cell depleting therapy with rituximab in immune thrombocytopenia (ITP) by promoting the emergence of splenic long-lived plasma cells. From results obtained in mouse models, we hypothesized that combining rituximab with sequential injections of belimumab could increase the rate of response at one year in patients with persistent or chronic ITP by preventing the emergence of these long-lived plasma cells. The study was a single-center, single arm, prospective phase 2b trial (RITUX-PLUS, NCT03154385) investigating the safety and efficacy of rituximab given at a fixed dose of 1,000 mg, two weeks apart, combined with five infusions of belimumab, 10 mg/kg at week 0 (W0)+2 days, W2+2 days, W4, W8 and W12 for adults with primary persistent or chronic ITP. The primary endpoint was the total number of patients achieving an overall response (complete response + response) at W52 according to a standard definition. In total, 15 non-splenectomized adults, nine (60%) with persistent IPT and six (40%) with chronic ITP, were included. No severe adverse event, infection, or severe hypogammaglobulinemia was observed. Thirteen patients achieved an initial overall response. At W52, 12 (80%) patients achieved an overall response, including ten (66.7%) with complete response. When compared with a cohort of patients receiving rituximab alone, the kinetics of B-cell repopulation appeared similar, but the number of circulating T follicular helper cells was significantly decreased with belimumab combination therapy. Combining rituximab and belimumab seems a promising strategy in ITP, with high efficacy and acceptable safety.

Indexed as

Purpura, Thrombocytopenic, IdiopathicAdultAnimalsAntibodies, Monoclonal, HumanizedHumansMiceProspective StudiesRituximabTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabRituximab

Identifiers

PMID32817288
PMCPMC8409028
OpenAlexW3049771190

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.