Evidence map›Paper›PMID 37351831›Full record

ArticleDermatology and therapy2023

Integrated Safety Analysis on Skin Cancers among Patients with Psoriasis Receiving Ixekizumab in Clinical Trials.

Saxon D Smith, Alexandros Stratigos, Matthias Augustin, Jose Manuel Carrascosa, Susanne Grond, Elisabeth Riedl, Wen Xu, Himanshu Patel, Mark Lebwohl

Open access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
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  4. Review
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

9 authors at 7 institutions in 6 countries.

Saxon D SmithANU Medical School, ANU College of Health and Medicine, The Australian National University, Canberra, Australian Capital Territory, Australia. dr.saxon.smith@gmail.com.ORCID http://orcid.org/0000-0003-0995-4372
Alexandros StratigosDepartment of Dermatology, University of Athens, School of Medicine, Andreas Sygros Hospital, Athens, Greece.
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jose Manuel CarrascosaDepartment of Dermatology, Hospital Universitari Germans Trias I Pujol, Badalona, Universidad Autónoma de Barcelona, IGTP, Badalona, Spain.
Susanne GrondEli Lilly and Company, Indianapolis, IN, USA.
Elisabeth RiedlDepartment of Dermatology, Medical University of Vienna, Vienna, Austria.
Wen XuEli Lilly and Company, Indianapolis, IN, USA.
Himanshu PatelEli Lilly and Company, Indianapolis, IN, USA.
Mark LebwohlDepartment of Dermatology, Mount Sinai Hospital, New York, NY, USA.
Eli Lilly (United States) · USAustralian National University · AUMedical University of Vienna · ATMount Sinai Hospital · USNational and Kapodistrian University of Athens · GRUniversitat Autònoma de Barcelona · ESUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLimited data exist on skin cancer risk in patients with psoriasis using biologics. Here, we report treatment-emergent adverse events (TEAEs) of skin cancer in patients treated with ixekizumab from psoriasis clinical trials.

methodsIntegrated safety databases from 17 clinical trials of adults with moderate-to-severe psoriasis treated with ≥ 1 dose of ixekizumab for ≤ 5 years were used to analyze exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) and clinically characterize dermatologist-adjudicated skin cancer TEAEs.

resultsOf 6892 patients, 58 presented with ≥ 1 skin cancer TEAE (IR 0.3) with IRs remaining stable with longer ixekizumab exposure. Non-melanoma skin cancer (NMSC) was the most common event (IR 0.3) affecting 55 patients; of those, 44 had basal cell carcinoma (IR 0.2) and 16 had squamous cell carcinoma (IR 0.1). Two treatment-emergent melanoma events were identified; neither were classified as serious AEs.

conclusionsIncidence of skin neoplasms in patients with psoriasis treated with ixekizumab for ≤ 5 years was low, and among those events, NMSC was most common. Limitations included that longer exposure may be required to confirm risk of skin cancer and that the study exclusion criteria of several studies, which excluded patients with skin cancer events within 5 years prior to baseline, might limit interpretation of skin cancer risk in this cohort. These findings support the safety profile of ixekizumab for patients requiring long-term psoriasis control.

Indexed as

IxekizumabLong-termMalignancyMelanomaNon-melanoma skin cancerPsoriasisSafetySkin cancerSkin neoplasm

Identifiers

PMID37351831
PMCPMC10366039
OpenAlexW4381715253

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.