Evidence map›Paper›PMID 32200512›Full record

ArticleDermatology and therapy2020

Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.

Craig Leonardi, Kristian Reich, Peter Foley, Hideshi Torii, Sascha Gerdes, Lyn Guenther, Melinda Gooderham, Laura K Ferris, Christopher E M Griffiths, Hany ElMaraghy and 8 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT01474512 phase3completednot on this map

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2011 to 2018Enrolled1,296ConditionsPsoriasisArms80 mg Ixekizumab Dosing Regimens 1, 2, and 3, Placebo
NCT01597245 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2019Enrolled1,224ConditionsPsoriasisArms80 mg ixekizumab Dosing Regimen, 50 mg etanercept, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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  20. Nail Psoriasis: An Updated Review of Currently Available Systemic Treatments.Clinical, cosmetic and investigational dermatology · 2023
    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

18 authors at 11 institutions in 6 countries.

Craig LeonardiCentral Dermatology, St. Louis, MO, USA.
Kristian ReichCenter for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0001-5248-4332
Peter FoleySt. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.ORCID https://orcid.org/0000-0001-5891-5607
Hideshi ToriiDivision of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.
Sascha GerdesPsoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Lyn GuentherGuenther Dermatology Research Centre, London, ON, Canada.ORCID https://orcid.org/0000-0001-9286-1534
Melinda GooderhamSkiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.ORCID https://orcid.org/0000-0001-8926-0113
Laura K FerrisUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA.ORCID https://orcid.org/0000-0003-3000-2165
Christopher E M GriffithsDermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.
Hany ElMaraghyEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Heidi CraneEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Himanshu PatelEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Russel BurgeEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Gaia GalloEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
David ShromEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. shrom_david_stanley@lilly.com.
Ann LeungSyneos Health, Morrisville, NC, USA.
Chen-Yen LinEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Kim PappK. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.ORCID https://orcid.org/0000-0001-9557-3642
Eli Lilly (United States) · USProbity Medical Research · CACentral Dermatology · USClinical Research Center Kiel · DEGuenther Dermatology Research Centre · CASyneos Health (United States) · USThe University of Melbourne · AUTokyo Yamate Medical Center · JPUniversität Hamburg · DEUniversity of Manchester · GBUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIxekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years.

methodsData were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI ≤ 5/ ≤ 3/ ≤ 2/ ≤ 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A modified non-responder imputation method was used to account for missing data. Supplemental analyses include patients who escalated to every-2-week dosing and observed and multiple imputation results. Exposure-adjusted safety outcomes are also reported.

resultsOf 206 patients who entered the LTE periods, 172 completed treatment. At Week 60, PASI 75/90/100 responses were 94.7%, 85.0% and 62.1%, respectively, and at year 5 were 90.3%, 71.3% and 46.3%, respectively. Similarly, meaningful responses were achieved for the other efficacy and health measures. Among patients with PASI 100 through 5 years, 92% achieved DLQI (0,1), indicating no impact of skin disease on quality of life. During the LTE period, exposure-adjusted incidence rates were 31.4 per 100 patient-years for treatment-emergent adverse events and 6.8 per 100 patient-years for serious adverse events. No deaths were reported. No new or unexpected safety findings were noted.

conclusionsThe results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in patients with moderate-to-severe plaque psoriasis through 5 years of treatment.

trial registrationClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.

Indexed as

5 yearsIxekizumabLong-term efficacyLong-term safetyMaintainPsoriasisQuality of life

Identifiers

PMID32200512
PMCPMC7211779
OpenAlexW3012894524

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.