Evidence map›Paper›PMID 38965145›Full record

Observational studyAnnals of hematology2024

A retrospective observational study of ibrutinib in chronic lymphocytic leukaemia in a real-life setting in France using the national claims database (OSIRIS).

Sylvain Choquet, Clarisse Marchal, Floriane Deygas, Marine Deslandes, Nahid Macher, Gérard de Pouvourville, Vincent Levy

Abstract readObservational Study
In one paragraph

Observational study in Annals of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

7 authors.

Sylvain ChoquetHôpital Pitié salpêtrière AP-HP, Paris, France.
Clarisse MarchalPELYON, Lyon, France. clarisse.marchal@pelyon.fr.
Floriane DeygasPELYON, Lyon, France.
Marine DeslandesJanssen-Cilag France, Issy-les-Moulineaux, France.
Nahid MacherJanssen-Cilag France, Issy-les-Moulineaux, France.
Gérard de PouvourvilleESSEC, Cergy-Pontoise, France.
Vincent LevyHôpital Avicenne AP-HP, Bobigny, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIbrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life.

methodsAll patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves.

resultsDuring this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached.

conclusionThis is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data.

Indexed as

AdenineDatabases, FactualLeukemia, Lymphocytic, Chronic, B-CellPiperidinesAgedAged, 80 and overFemaleFranceHumansMaleMiddle AgedProtein Kinase InhibitorsPyrimidinesRetrospective StudiesAdenineibrutinibPiperidinesProtein Kinase InhibitorsPyrimidinesChronic lymphocytic leukaemiaClaims databaseIbrutinibTreatment pattern

Identifiers

PMID38965145
PMCPMC11283383

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Registered trials

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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.