Evidence map›Paper›PMID 38451423›Full record

ArticleDermatology and therapy2024

Safety of Secukinumab from 1 Million Patient-Years of Exposure: Experience from Post-Marketing Setting and Clinical Trials.

Rui Sun, Mercedes Bustamante, Venkatesh Kumar Gurusamy, Mark Lebwohl, Alice B Gottlieb, Philip J Mease, Atul Deodhar, Weibin Bao, Meryl Mendelson, Brian Porter and 2 more

Open access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
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  9. IL-23 blockade in a patient with psoriasis andSAGE open medical case reports · 2025
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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

12 authors at 7 institutions in 3 countries.

Rui SunNovartis Pharmaceuticals Corporation, Bannockburn, IL, USA.
Mercedes BustamanteNovartis Pharma, Barcelona, Spain.
Venkatesh Kumar GurusamyNovartis Pharma AG, Basel, Switzerland.
Mark LebwohlDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Alice B GottliebDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Philip J MeaseDepartment of Rheumatology, Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, USA.
Atul DeodharOregon Health and Science University, Portland, OR, USA.
Weibin BaoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Meryl MendelsonNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Brian PorterNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Deepa ChandNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Victor DongNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. victor.dong@novartis.com.
Novartis (United States) · USIcahn School of Medicine at Mount Sinai · USNovartis (Switzerland) · CHNovartis (Spain) · ESOregon Health & Science University · USSwedish Medical Center · USTris Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSecukinumab is an anti-interleukin (IL)-17A monoclonal antibody indicated for multiple immunological disorders. Here, we aim to summarize secukinumab safety in clinical trials (CTs) and post-marketing setting (PMS) until 25 June 2022.

methodsAdverse events (AEs) were summarized with crude reporting rate (RR) per 100 patient-years (PY) in PMS for all reported indications and with exposure-adjusted incident rates (EAIR) per 100 PY in pooled 47 CTs for approved indications.

resultsSecukinumab exposure totaled 1,159,260 PY in PMS and 27,765 PY in CTs. AEs were mostly (> 80%) non-serious in PMS. EAIR for serious AEs was 7.0/100 PY. Nasopharyngitis (RR 0.59/100 PY, EAIR 16.08/100 PY) and pneumonia (RR 0.14/100 PY, EAIR 0.17/100 PY) were the most common infection and serious infection, respectively. Candida infections (RR 0.20/100 PY, EAIR 2.16/100 PY) were the most common fungal infections. Inflammatory bowel disease (IBD) was observed in PMS (0.14/100 PY) and CTs (0.26/100 PY). Most (76%) patients with prior IBD did not report IBD flare during CTs. PMS monitoring identified paradoxical skin reactions including dyshidrotic eczema (RR 0.006/100 PY) and pyoderma gangrenosum (RR 0.003/100 PY).

conclusionSecukinumab safety profile with increased patient exposure remained favorable. Paradoxical skin reactions were identified in post-marketing monitoring.

Indexed as

Clinical trialsIL-17APatient-yearPost-marketing settingSafetySecukinumab

Identifiers

PMID38451423
PMCPMC10965838
OpenAlexW4392563982

What OpenQuestion holds

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LicenceCC BY-NC
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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.