Evidence map›Paper›PMID 40387023›Full record

ArticlePharmacoepidemiology and drug safety2025

Implementing Negative Control Outcomes to Assess Comparability of Treatments for Psoriasis and Psoriatic Arthritis.

Mary E Horner, Alexis Ogdie, Kate K Orroth, Shia T Kent, Kathy V Tran, Cynthia Deignan, Myriam Cordey, M Alan Brookhart

Abstract readComparative Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 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

8 authors.

Mary E HornerDermatology Consultants of Sacramento, Sacramento, California, USA.
Alexis OgdieHospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-4639-0775
Kate K OrrothAmgen Inc., Thousand Oaks, California, USA.ORCID https://orcid.org/0000-0002-4950-3149
Shia T KentAmgen Inc., Thousand Oaks, California, USA.
Kathy V TranAmgen Inc., Thousand Oaks, California, USA.ORCID https://orcid.org/0000-0001-5118-782X
Cynthia DeignanAmgen Inc., Thousand Oaks, California, USA.
Myriam CordeyAmgen Inc., Thousand Oaks, California, USA.ORCID https://orcid.org/0009-0004-1797-0510
M Alan BrookhartDuke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0003-1572-0564

Funding

Amgen Inc
6 · The paper itself

Abstract

purposeTreatment selection is typically associated with prognosis, leading to potential confounding in comparative studies. We used negative control outcomes (NCOs) to identify potential residual confounding when comparing apremilast initiators to other psoriasis (PsO) or psoriatic arthritis (PsA) treatment initiators.

methodsAdults with PsO/PsA who initiated treatment from September 23/March 21, 2016, respectively, with apremilast, topicals, methotrexate, interleukin (IL)-17 inhibitor (i), IL-12/23i, or tumor necrosis factor inhibitor (TNFi) were identified in the OPTUM Clinformatics DataMart database. Follow-up ended at treatment switch/discontinuation, NCO, end of enrollment, or September 30, 2022. NCOs addressed confounding for healthy users (wellness visit, herpes zoster vaccine, colon cancer screening, pelvic screening), functional status (accidents), and channeling. The 1-year relative risk (RR) for each NCO was estimated for all treatment comparisons using an inverse probability of treatment and censoring weighted estimator.

resultsIn PsO, potential healthy user bias was detected in apremilast vs. IL-17i initiators, with a higher likelihood of herpes zoster vaccine and colon cancer screening (RR [95% CI]: 2.01 [1.41, 2.88] and 1.42 [1.13, 1.77], respectively). Wellness visits and pelvic exams were less likely among apremilast vs. topical initiators (0.84 [0.72, 0.98] and 0.83 [0.70, 0.98], respectively). The wellness visit RR was attenuated in individuals with ≥ 1 pre-index topical prescription (0.90 [0.78, 1.04]). In PsA, minimal residual confounding was observed between apremilast and other treatments.

conclusionsEligibility criteria (prior topicals) and weighting reduced residual confounding when comparing apremilast vs. other treatments for PsO and PsA. Integration of NCOs into comparative effectiveness/safety studies of PsO/PsA treatments may help identify unmeasured confounding.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalArthritis, PsoriaticPsoriasisThalidomideAdultAgedConfounding Factors, EpidemiologicDatabases, FactualFemaleHumansMaleMiddle AgedAnti-Inflammatory Agents, Non-SteroidalapremilastThalidomideapremilastbiologicsmethotrexatenegative control outcomepsoriasispsoriatic arthritistopicals

Identifiers

PMID40387023
PMCPMC12087269

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.