Evidence map›Paper›PMID 30317671›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2019

Long-term efficacy and safety of ixekizumab in Japanese patients with erythrodermic or generalized pustular psoriasis: subgroup analyses of an open-label, phase 3 study (UNCOVER-J).

Y Okubo, T Mabuchi, K Iwatsuki, H Elmaraghy, H Torisu-Itakura, Y Morisaki, K Nakajo

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01624233 (A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT01624233 phase3completednot on this map

A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2017Enrolled91ConditionsPsoriasisArms80 mg ixekizumab
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
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  16. Use of Biological Therapies for the Management of Pustular Psoriasis: A New Era?Clinical, cosmetic and investigational dermatology · 2023
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Y OkuboDepartment of Dermatology, Tokyo Medical University, Shinjuku, Tokyo, Japan.
T MabuchiDepartment of Dermatology, Tokai University School of Medicine, Kanagawa, Japan.
K IwatsukiDepartment of Dermatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
H ElmaraghyEli Lilly and Company, Indianapolis, IN, USA.
H Torisu-ItakuraEli Lilly Japan K.K., Kobe, Japan.
Y MorisakiEli Lilly Japan K.K., Kobe, Japan.
K NakajoEli Lilly Japan K.K., Kobe, Japan.
Eli Lilly (Japan) · JPEli Lilly (United States) · USOkayama University · JPTokai University · JPTokyo Medical University · JP

Funding

Eli Lilly Japan K.K.
6 · The paper itself

Abstract

backgroundErythrodermic and generalized pustular psoriasis are rare, difficult to treat forms of psoriasis. In previous reports, we documented 24- and 52-week findings of an open-label, phase 3 trial (UNCOVER-J) of ixekizumab in Japanese patients with erythrodermic or generalized pustular psoriasis; most patients responded to treatment and maintained response through 52 weeks.

objectiveTo assess the long-term (>3 years) efficacy and safety of ixekizumab in Japanese patients with erythrodermic or generalized pustular psoriasis.

methodsThese subgroup analyses were of a partial population of patients from UNCOVER-J (NCT01624233; Sponsored by Eli Lilly and Company), specifically those with erythrodermic psoriasis (N = 8) or generalized pustular psoriasis (N = 5). These patients received 160 mg ixekizumab at Week 0, ixekizumab 80 mg every 2 weeks through Week 12, and ixekizumab 80 mg every 4 weeks thereafter up to Week 244. This regimen is consistent with the regimen approved in Japan for plaque, erythrodermic, and generalized pustular psoriasis and psoriatic arthritis. Efficacy assessments included Global Improvement Score (GIS), Psoriasis Area and Severity Index (PASI), dermal symptoms (for patients with generalized pustular psoriasis), Dermatology Life Quality Index (DLQI) and Itch Numeric Rating Scale (NRS). Safety assessments included treatment-emergent adverse events and adverse events of special interest.

resultsMost patients had a GIS of resolved or improved from Week 12 onwards, and all patients had early and sustained improvement in PASI and dermal symptom (generalized pustular psoriasis only) scores. Mean improvements in DLQI and Itch NRS at Week 12 were sustained through Week 244. Ixekizumab was well tolerated over 3 years of treatment in patients with erythrodermic psoriasis or generalized pustular psoriasis, and no new safety concerns were identified.

conclusionThese findings suggest that ixekizumab can be an effective long-term treatment option for erythrodermic or generalized pustular psoriasis.

Indexed as

Patient SafetyAdultAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, SubcutaneousJapanMaleMiddle AgedPsoriasisRisk AssessmentSeverity of Illness IndexTime FactorsAntibodies, Monoclonal, Humanizedixekizumab

Identifiers

PMID30317671
PMCPMC6587497
OpenAlexW2897155783

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.