Evidence map›Paper›PMID 30325534›Full record

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

Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab.

Y Umezawa, H Torisu-Itakura, Y Morisaki, H ElMaraghy, K Nakajo, N Akashi, H Saeki, Japanese Ixekizumab Study Group

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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Observational
  9. Review
  10. Article
  11. The Relapse of Psoriasis: Mechanisms and Mysteries.JID innovations : skin science from molecules to population health · 2022
    Review
  12. Article
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  14. Article
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  16. 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

8 authors at 4 institutions in 2 countries.

Y UmezawaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
H Torisu-ItakuraEli Lilly Japan K.K., Kobe, Japan.
Y MorisakiEli Lilly Japan K.K., Kobe, Japan.
H ElMaraghyEli Lilly and Company, Indianapolis, IN, USA.
K NakajoEli Lilly Japan K.K., Kobe, Japan.
N AkashiEli Lilly Japan K.K., Kobe, Japan.
H SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.
Japanese Ixekizumab Study Group
Eli Lilly (Japan) · JPEli Lilly (United States) · USJikei University School of Medicine · JPNippon Medical School · JP

Funding

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

Abstract

backgroundLong-term management of moderate-to-severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment.

objectiveTo assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis.

methodsThis single-arm, open-label study (UNCOVER-J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160-mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks.

resultsAt Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment-emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period.

conclusionIn patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDermatologic AgentsFemaleHumansJapanMaleMiddle AgedPsoriasisRecurrenceRetreatmentSeverity of Illness IndexTime FactorsTreatment OutcomeWithholding TreatmentAntibodies, Monoclonal, HumanizedDermatologic Agentsixekizumab

Identifiers

PMID30325534
PMCPMC6587494
OpenAlexW2895932838

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.