Evidence map›Paper›PMID 39719418›Full record

ArticleJournal of the American Heart Association2025

Myocarditis in Patients Starting Combination Checkpoint Inhibitor Therapy: Analysis of a Commercial Claims Database.

Alistair C Lindsay, Alexander M Walker, Sebastian Schneeweiss

Abstract read
In one paragraph

Article in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

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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

3 authors.

Alistair C LindsayDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital, Harvard Medical School Boston MA.
Alexander M WalkerDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital, Harvard Medical School Boston MA.ORCID 0000-0001-9738-5127
Sebastian SchneeweissDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital, Harvard Medical School Boston MA.ORCID 0000-0003-2575-467X

Funding

Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE)R01HL141505 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SCHNEEWEISS, SEBASTIAN G., WANG, SHIRLEY · 2019 to 2023
$3.6M
New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populationsR01AR080194 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Sebastian G. Schneeweiss · 2022 to 2026
$3.3M
NHLBI NIH HHS R01 HL141505NIAMS NIH HHS R01 AR080194
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors have improved the clinical outcomes of several cancers but have also been associated with a greater risk of immune-related adverse effects, especially when combined. The objective of this study was to investigate the incidence of myocarditis in relation to the use of dual concurrent versus single immune checkpoint inhibitors therapies. METHODS AND

resultsA cohort study was conducted using medical and pharmacy claims data (2011-2022) from a large US commercial insurer. Cox regression quantified the comparative risks of myocarditis or heart failure in patients with cancer receiving treatment with combination therapy (nivolumab and ipilimumab) in comparison to taking a single immune checkpoint inhibitor only. Mean follow-up time in 53 018 patients was 226 days (interquartile range, 93-495 days). There were 148 cases of myocarditis (0.3%), 33 (0.7%) in patients on combination therapy, and 115 (0.2%) in patients on monotherapy. The risk of myocarditis per 1000 patients was 7.40 in the combination therapy group and 2.37 in the monotherapy group (risk ratio, 3.12 [95% CI, 2.12-4.60]). Using multivariable regression analysis, the hazard ratio for myocarditis in the combination therapy group was 2.38 (1.57-3.63). No difference in the risk of heart failure was found between combination and single therapy.

conclusionsTherapy with 2 immune checkpoint inhibitors was associated with an increased risk of myocarditis compared with monotherapy, with most cases occurring in the first 6 months of therapy.

Indexed as

Immune Checkpoint InhibitorsIpilimumabMyocarditisNeoplasmsNivolumabAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDatabases, FactualFemaleHeart FailureHumansIncidenceMaleMiddle AgedRetrospective StudiesImmune Checkpoint InhibitorsIpilimumabNivolumabcardio‐oncologycheckpoint inhibitorheart failuremyocarditisreal‐world evidence

Identifiers

PMID39719418
PMCPMC12054407

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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.