Evidence map›Paper›PMID 41609057›Full record

ArticlePharmacoepidemiology and drug safety2026

Comparing Different As-Treated Approaches: A Methodological Study Using Real-World Data on Psoriasis Treatments.

Sejun Kim, Andreas Jensen, Alexander Egeberg, Lone Graff Stensballe

Abstract readComparative Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2026. 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

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

4 authors.

Sejun KimDepartment of Children and Adolescent Medicine, Danish National University Hospital "Rigshospitalet", Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-7150-4685
Andreas JensenDepartment of Children and Adolescent Medicine, Danish National University Hospital "Rigshospitalet", Copenhagen, Denmark.
Alexander EgebergDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Lone Graff StensballeDepartment of Children and Adolescent Medicine, Danish National University Hospital "Rigshospitalet", Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccurate pharmaco-epidemiological assessment of the safety of biological treatments is essential but methodologically challenging.

aimsThis study evaluated how different assumptions regarding treatment switching and treatment episode definitions affect outcome estimates in psoriasis patients, focusing on malignancies and serious infections.

methodsData from Danish national registers (2009-2022) were analyzed for hospitalized psoriasis patients treated with ustekinumab, non-biologics, tumor necrosis factor-α inhibitors, and other interleukin inhibitors excluding ustekinumab. Various as-treated approaches were assessed and compared to the Intention-to-Treat (ITT) approach. The as-treated approaches included: (1) RC-switch, considering switching only between ustekinumab and the comparator in question, (2) Bio-switch, considering switches among all biologics, (3) Multi-switch, analyzing all groups simultaneously, and (4) Hierarchy-switch, analyzing switching by a predefined hierarchy. Hazard ratios (HRs) and 95% confidence intervals (CIs) were analyzed using Cox models. Sensitivity analyses incorporated treatment episodes based on the defined daily dose (DDD) and grace periods.

resultsBroader treatment switching allowances affected outcome estimates. For malignancies, the Bio-switch approach yielded the largest HR changes relative to the ITT. For serious infections, also, Bio-switch produced the largest HR shifts, for example, HR 1.32 (CI 1.09, 1.58) versus ITT HR 1.08 (CI 0.91, 1.29). Sensitivity analyses showed that accounting for episode gaps influenced HRs and widened CIs.

conclusionThe number of events within the exposure group varied by approaches, influencing the HR estimates. The multi-switch approach effectively captured treatment switching and reduced statistical uncertainty, supporting clearer safety conclusions. Tracking each treatment period with gaps reflects real-world practice but may lower statistical power and should be carefully considered in analyses.

Indexed as

Biological ProductsDermatologic AgentsDrug SubstitutionPsoriasisDenmarkFemaleHumansIntention to Treat AnalysisMaleNeoplasmsRegistriesTreatment OutcomeUstekinumabBiological ProductsDermatologic AgentsUstekinumabas‐treated approachcomparative safetyestimand frameworksmalignanciespsoriasisreal‐world dataserious infectionstreatment persistencetreatment switching

Identifiers

PMID41609057
PMCPMC12853409

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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.