Evidence map›Paper›PMID 40657029›Full record

ArticleEJHaem2025

Real-World Use of Rituximab in the Treatment of Cold Agglutinin Disease in the United States: A Retrospective Study.

Caroline Piatek, Irina Murakhovskaya, Alia Karaouni, Gandarvaka Miles, Sylvie Bozzi, Carrie Heller, Jacqueline Lucia, Reena Patel, Brad Ward, Ronnie Yoo and 1 more

Abstract read
In one paragraph

Article in EJHaem, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Caroline PiatekJane Anne Nohl Division of Hematology and Center for the Study of Blood Diseases USC Norris Comprehensive Cancer Center Los Angeles California USA.ORCID https://orcid.org/0000-0001-8628-8348
Irina MurakhovskayaDepartment of Hematology and Oncology Division of Hematology Montefiore Medical Center/Albert Einstein College of Medicine Bronx New York USA.
Alia KaraouniBMAPS SARL Geneva Switzerland.
Gandarvaka MilesSanofi Bridgewater New Jersey USA.
Sylvie BozziSanofi Gentilly France.
Carrie HellerSanofi Cambridge Massachusetts USA.
Jacqueline LuciaAetion New York New York USA.
Reena PatelSanofi Cambridge Massachusetts USA.
Brad WardSanofi Cambridge Massachusetts USA.
Ronnie YooSanofi Cambridge Massachusetts USA.
Morie GertzDepartment of Medicine Division of Hematology Mayo Clinic Rochester Minnesota USA.ORCID https://orcid.org/0000-0002-3853-5196

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Rituximab is used off-label for treating cold agglutinin disease (CAD) in the United States; however, real-world data on its use are limited. Methods: This study examined (1) treatment patterns, (2) prespecified safety outcomes, and (3) changes in hemolytic markers post rituximab infusion (threshold change from baseline: hemoglobin [Hb]: ≥2 g/dL increase; bilirubin or lactate dehydrogenase [LDH]: ≥50% decrease). Of 611 patients with CAD (Cohort 1) identified using Optum's de-identified Market Clarity database (2007-2021), 94 who received rituximab (Cohort 2) were included. Results: Rituximab was predominantly used as monotherapy; the median (interquartile range; IQR) number of rituximab courses per patient was 1.0 (1.0-2.0); 24 (25.5%) patients had ≥1 incomplete course and 37 (39.4%) required blood transfusion. The incidence rate (IR) of serious infections per 1000 patient-years (95% CI) post rituximab initiation was three times higher than before rituximab initiation (637.1 [242.2-1032.0] vs. 245.4 [125.1-365.6]). Cohort 2 had a similar IR of thromboembolic events and slightly higher hospitalization rates and deaths than Cohort 1. After the first course of rituximab, 69.5% (41/59), 59.6% (28/47), and 31.3% (10/32) of patients reached thresholds for Hb, bilirubin, and LDH, respectively. The median (IQR) duration of improvement was 44 (13.3-90.8), 98 (29.0-257.0), and 93 (21.3-161.8) days for Hb, bilirubin, and LDH, respectively. Reversal from threshold occurred in 68.3% (28/41), 53.6% (15/28), and 80.0% (8/10) of patients for Hb, bilirubin, and LDH, respectively. Conclusion: Rituximab showed a limited durability of response and an increased risk of infection, suggesting the need for more effective and safer treatment options.

Indexed as

cold agglutinin diseasecombination therapymonotherapyreal‐worldrituximabtreatment patternsUnited States

Identifiers

PMID40657029
PMCPMC12255320

What OpenQuestion holds

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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.