Evidence map›Paper›PMID 31919919›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2020

Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis.

J F Merola, P-D Ghislain, J N Dauendorffer, A Potts Bleakman, A J M Brnabic, R Burge, E Riedl

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02718898 (A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 23% 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.

NCT02718898 phase3completednot on this map

A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2018Enrolled149ConditionsGenital Psoriasis, PsoriasisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  10. A conundrum of recurrent pustular lesions of the glans.Indian journal of sexually transmitted diseases and AIDS
    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

7 authors at 4 institutions in 4 countries.

J F MerolaBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
P-D GhislainDepartment of Dermatology, Cliniques Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
J N DauendorfferDepartment of Dermatology, Saint-Louis Hospital, Paris, France.
A Potts BleakmanEli Lilly and Company, Indianapolis, IN, USA.
A J M BrnabicEli Lilly and Company, Indianapolis, IN, USA.
R BurgeEli Lilly and Company, Indianapolis, IN, USA.
E RiedlEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USBrigham and Women's Hospital · USCliniques Universitaires Saint-Luc · BEHôpital Saint-Louis · FR

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundEpithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health.

objectiveTo evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12.

methodsThis post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ).

resultsAt baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.

conclusionIxekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.

Indexed as

Dermatologic AgentsPsoriasisSexual HealthAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodGenitaliaHumansPainSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentsixekizumab

Identifiers

PMID31919919
PMCPMC7318177
OpenAlexW2999046156

What OpenQuestion holds

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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.