Evidence map›Paper›PMID 28635026›Full record

Trial reportThe Journal of dermatology2017

Efficacy and safety of ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis: Subgroup analysis of a placebo-controlled, phase 3 study (UNCOVER-1).

Shinichi Imafuku, Hitoe Torisu-Itakura, Atsushi Nishikawa, Fangyi Zhao, Gregory S Cameron, Japanese UNCOVER-1 Study Group

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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

16 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Review
  9. Review
  10. Review
  11. Clinical Disease Measures in Generalized Pustular Psoriasis.American journal of clinical dermatology · 2022
    Review
  12. Challenge of Nail Psoriasis: An Update Review.Clinical reviews in allergy & immunology · 2021
    Review
  13. Article
  14. Article
  15. Review
  16. Combined administration of anti-IL-13 and anti-IL-17A at individually sub-therapeutic doses limits asthma-like symptoms in a mouse model of Th2/Th17 high asthma.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019
    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

6 authors.

Shinichi ImafukuDepartment of Dermatology, Faculty of Medicine, Fukuoka University, Fukuoka.ORCID http://orcid.org/0000-0001-8568-4349
Hitoe Torisu-ItakuraLilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Hyogo, Japan.ORCID http://orcid.org/0000-0002-3200-2882
Atsushi NishikawaLilly Research Laboratories, Eli Lilly Japan K.K., Kobe, Hyogo, Japan.
Fangyi ZhaoLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Gregory S CameronLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Japanese UNCOVER-1 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The present study describes a subgroup analysis of 33 Japanese patients participating in UNCOVER-1, an international, placebo-controlled, phase 3 study of ixekizumab in patients with moderate-to-severe psoriasis. Patients were randomized to a placebo (n = 13) or ixekizumab 80 mg every 4 (IXEQ4W, n = 12) or 2 (IXEQ2W, n = 8) weeks, from week 0-12. At week 12, ixekizumab-treated patients with a static Physician Global Assessment score 0 or 1 (sPGA [0,1]; n = 16) were re-randomized to a placebo (n = 6), ixekizumab 80 mg every 12 (IXEQ12W, n = 5) or 4 (IXEQ4W, n = 5) weeks, from week 12-60. At week 12, more ixekizumab-treated versus placebo-treated patients achieved sPGA (0,1) (≥66.7% vs 0%), ≥75% improvement in Psoriasis Area and Severity Index (≥75% vs 0%), and sPGA (0) or 100% improvement in Psoriasis Area and Severity Index (both ≥33.3% vs 0%), with improved symptoms and quality of life. At week 60, 100% (IXEQ4W), 40.0% (IXEQ12W) and 16.7% (placebo) had maintained sPGA (0,1). From week 0-12, treatment-emergent adverse events were 76.9% (placebo), 75.0% (IXEQ4W) and 87.5% (IXEQ2W), and from week 12-60 were 66.7% (placebo) and 100% (IXEQ12W, IXEQ4W). Ixekizumab-treated patients had no severe treatment-emergent adverse events, and one serious TEAE (IXEQ4W); infection was the most frequent treatment-emergent adverse event. In conclusion, ixekizumab for 60 weeks was effective and safe for Japanese patients with moderate-to-severe psoriasis, in line with the overall findings from UNCOVER-1.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedDermatologic AgentsFemaleHumansMaleMiddle AgedPsoriasisTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentsixekizumabinterleukin-17AixekizumabJapanpsoriasisrandomized controlled trial

Identifiers

PMID28635026
PMCPMC5697664

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.