Evidence map›Paper›PMID 35624407›Full record

ArticleDermatology and therapy2022

Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: Data from 17 Clinical Trials with Over 18,000 Patient-Years of Exposure.

Christopher E M Griffiths, Melinda Gooderham, Jean-Frederic Colombel, Tadashi Terui, Ana P Accioly, Gaia Gallo, Danting Zhu, Andrew Blauvelt

Open access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.5field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 30 citations in OpenAlex.

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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

8 authors at 6 institutions in 4 countries.

Christopher E M GriffithsThe Dermatology Centre, Salford Royal Hospital, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK.
Melinda GooderhamSKiN Centre for Dermatology, Peterborough, ON, Canada.
Jean-Frederic ColombelIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Tadashi TeruiDepartment of Dermatology, Nihon University School of Medicine, Tokyo, Japan.
Ana P AcciolyEli Lilly and Company, Indianapolis, IN, USA.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Danting ZhuEli Lilly and Company, Indianapolis, IN, USA.
Andrew BlauveltOregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, USA. ablauvelt@oregonmedicalresearch.com.ORCID http://orcid.org/0000-0002-2633-985X
Eli Lilly (United States) · USIcahn School of Medicine at Mount Sinai · USNihon University · JPOregon Medical Research Center · USSKiN Health · CAUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe report a comprehensive summary of the safety outcomes in adult patients with moderate-to-severe psoriasis with up to 5 years of exposure to ixekizumab.

methodsLong-term safety of the IL-17A antagonist ixekizumab was assessed from 17 randomized trials. Treatment-emergent adverse events (TEAEs)-adjusted incidence rates (IRs) per 100 patient-years (PY) within 1-year time periods through 19 March 2021 were calculated for all patients treated with at least one dose of ixekizumab. Reported cases of major adverse cerebro-cardiovascular events (MACE) and inflammatory bowel disease (IBD) were adjudicated.

resultsA total of 6892 adult patients with a cumulative exposure of 18,025.7 PY were included. The IRs per 100 PY for any TEAE and serious adverse events (AEs) were 32.5 and 5.4. IR of discontinuation because of AE was 2.9. A total of 36 deaths were reported. IR of serious infections was low (1.3). There were no confirmed cases of reactivation of tuberculosis (TB). IR of Candida infections (IR 1.9) was low; most cases of Candida were localized, and no systemic cases were reported. IRs of injection site reactions and allergic/hypersensitivity were 5.9 and 5.6, respectively. No confirmed cases of anaphylaxis were observed. IRs were low for malignancies, depression, cytopenia, and MACE (all ≤ 1.2). IBD events were uncommon, although a total of 31 patients (IR 0.2) had confirmed IBD (ulcerative colitis, n = 18; Crohn disease, n = 13). Across safety topics, IRs decreased or remained constant over time.

conclusionsThe long-term safety profile for ixekizumab is consistent with that previously reported in patients with psoriasis. No new or unexpected safety events were detected.

Indexed as

IxekizumabLong-termPsoriasisSafety

Identifiers

PMID35624407
PMCPMC9209552
OpenAlexW4281731899

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.