Evidence map›Paper›PMID 39843709›Full record

ArticleDermatology and therapy2025

Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events.

Mark Lebwohl, Atul Deodhar, Sergio Schwartzman, Carlo Salvarani, Meghan Feely McDonald, Natalia Bello, Elsie L Grace, Elsa Inman, Andris Kronbergs, Marcus Ngantcha and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

15 authors.

Mark LebwohlMount Sinai Hospital, New York, NY, USA.
Atul DeodharOregon Health and Science University, Portland, OR, USA.
Sergio Schwartzman72nd Street Medical Associates, Scarsdale, NY, USA.
Carlo SalvaraniSOC Reumatologia, Azienda USL-IRCCS, Reggio Emilia, Italy.
Meghan Feely McDonaldMount Sinai Hospital, New York, NY, USA. meghan.feely@gmail.com.
Natalia BelloEli Lilly and Company, Indianapolis, IN, USA.
Elsie L GraceEli Lilly and Company, Indianapolis, IN, USA.
Elsa InmanEli Lilly and Company, Indianapolis, IN, USA.
Andris KronbergsEli Lilly and Company, Indianapolis, IN, USA.
Marcus NgantchaEli Lilly and Company, Indianapolis, IN, USA.
Proton RahmanMemorial University of Newfoundland, St. John's, NL, Canada.
Kim A PappAlliance Clinical Trials and Probity Medical Research, Waterloo, Division of Dermatology, Temerty School of Medicine, The University of Toronto, Toronto, ON, Canada.
Joseph F MerolaDivision of Rheumatology, Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, USA.
Alice B GottliebDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Andrew BlauveltBlauvelt Consulting, LLC, Lake Oswego, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPsoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with these conditions are often exposed for extended time periods to biologics, such as ixekizumab (IXE). Therefore, understanding the risk of CV events, especially MACE, in patients with PsO, PsA, and axSpA exposed to IXE is important.

methodsThe incidence of MACE (i.e., adjudicated cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), DVT, and PE was assessed in adults who received ≥ 1 dose of IXE across 25 randomized clinical trials (17 PsO, 4 PsA, 4 axSpA). Rates of CV events were analyzed for pooled studies by indication and analyzed from treatment initiation up to the end of the study program. Exposure-adjusted incidence rates per 100 patient-years (IR/100 PY) are reported.

resultsThis integrated safety analysis included 6892 patients with PsO, 1401 with PsA, and 932 with axSpA. The median duration of IXE exposure was 478.5 days (1.3 years) for patients with PsO, 504.5 days (1.4 years) for patients with PsA, and 981.0 days (2.7 years) for patients with axSpA. The incidence of adjudicated MACE was low (IR/100 PY: PsO = 0.5; PsA = 0.5; axSpA = 0.3) and stable over the treatment periods. The most common types of MACE reported were non-fatal myocardial infarction (IR/100 PY: PsO = 0.3; PsA = 0.3; axSpA = 0.3), followed by non-fatal stroke (IR/100 PY: PsO = 0.1; PsA = 0.2; axSpA = 0.0), and cardiovascular death (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.0). The incidences of DVT (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.1) and PE (IR/100 PY: PsO = 0.1; PsA = 0.0; axSpA = 0.0) were low.

conclusionThis integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult patients with PsO, PsA, and axSpA and that the rates did not increase with increasing IXE exposure.

trial registrationThe supplementary Table S1 provides a comprehensive list of clinical trials and their registration numbers.

Indexed as

Axial spondyloarthritisCerebro-cardiovascularIxekizumabLong-term safetyMACEPsoriasisPsoriatic arthritis

Identifiers

PMID39843709
PMCPMC11785857

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.