Evidence map›Paper›PMID 40820417›Full record

ArticleDigestive diseases (Basel, Switzerland)2025

Real-World Dose Escalation and Associated Direct Costs of Biologics in Management of Ulcerative Colitis: A Retrospective Database Study.

Miguel Regueiro, Tania Gulati, Ashmita Bandyopadhyay, Deborah A Fisher, Richard Moses, Thomas Creveling, Payal Jha, Navneet Upadhyay

Abstract read
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Article in Digestive diseases (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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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

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Miguel RegueiroCleveland Clinic, Cleveland, Ohio, USA.
Tania GulatiEli Lilly and Company, Indianapolis, Indiana, USA.
Ashmita BandyopadhyayEli Lilly and Company, Indianapolis, Indiana, USA.
Deborah A FisherEli Lilly and Company, Indianapolis, Indiana, USA.
Richard MosesEli Lilly and Company, Indianapolis, Indiana, USA.
Thomas CrevelingEli Lilly and Company, Indianapolis, Indiana, USA.
Payal JhaEli Lilly and Company, Indianapolis, Indiana, USA.
Navneet UpadhyayEli Lilly and Company, Indianapolis, Indiana, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

<p>Introduction: Dose escalation with biologics is common among patients with ulcerative colitis (UC). We investigated the dose escalation and associated incremental costs among patients treated with biologics for UC.

methodsThis study utilized the Merative™ MarketScan® database in the USA to identify adults with at least two claims for UC and at least two refill/infusion claims for maintenance doses of biologics (including adalimumab, infliximab, ustekinumab, and vedolizumab) from January 1, 2015, to December 31, 2022. Patients were stratified by the presence (bio-experienced) or absence (bio-naïve) of other advanced therapy claims during the baseline period (12 months before index date). Descriptive statistics were used to summarize the dose escalation measures (frequency and magnitude of dose escalation, incremental cost due to dose escalation, and time-to-first dose escalation).

resultsOf 1,812 patients with UC who were on biologics during the maintenance phase, 56.3% had dose escalation. Overall, magnitude of dose escalation was 119.9% adalimumab, 34.9% infliximab, 81.6% ustekinumab, and 55.4% vedolizumab. Overall, median time-to-first dose escalation after initiating maintenance therapy ranged from nearly a month to 5 months (adalimumab: 0.8, infliximab: 5.1, ustekinumab: 1.3, and vedolizumab: 5.1). Estimated incremental annual cost per patient incurred due to dose escalation in US dollars was USD 37,359 for adalimumab (bio-naïve: USD 36,367; bio-experienced: USD 44,180) and USD 73,765 for ustekinumab (bio-naïve: USD 74,554; bio-experienced: USD 73,599).

conclusionsDose escalation with biologics for UC in the USA is common. This practice has substantially increased the average medication cost of biologics to payers/patients compared to their approved doses. </p>.

Indexed as

Biological ProductsColitis, UlcerativeAdalimumabAdultAgedAntibodies, Monoclonal, HumanizedDatabases, FactualDose-Response Relationship, DrugFemaleHumansInfliximabMaleMiddle AgedRetrospective StudiesUnited StatesUstekinumabAdalimumabAntibodies, Monoclonal, HumanizedBiological ProductsInfliximabUstekinumabvedolizumabBiologicsDose escalationIncremental costUlcerative colitis

Identifiers

PMID40820417
PMCPMC12503804

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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 Socratic graph.