Evidence map›Paper›PMID 29905383›Full record

Trial reportThe Journal of dermatology2018

Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study.

Mamitaro Ohtsuki, Hiroshi Kubo, Hitomi Morishima, Ryosuke Goto, Richuan Zheng, Hidemi Nakagawa

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2018. 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 58 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 20 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.

NCT00773734 phase2completednot on this map

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

TypeinterventionalSponsorAmgenRan2008 to 2015Enrolled352ConditionsPsoriasis, Plaque-type PsoriasisArmsApremilast 10mg, Apremilast 20mg, Apremilast 30 mg, Placebo, Apremilast 30mg
NCT01988103 phase2completednot on this map

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis

TypeinterventionalSponsorAmgenRan2013 to 2015Enrolled254ConditionsPsoriasis, Psoriatic Arthritis, Psoriasis ArthropaticaArmsApremilast, Placebo
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 20 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. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Guideline
  19. Pooled it
  20. Pooled it
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.

Mamitaro OhtsukiDepartment of Dermatology, Jichi Medical University, Tochigi, Japan.
Hiroshi KuboJanssen Pharmaceutical K.K., Tokyo, Japan.ORCID http://orcid.org/0000-0001-6097-4542
Hitomi MorishimaJanssen Pharmaceutical K.K., Tokyo, Japan.ORCID http://orcid.org/0000-0001-8118-1197
Ryosuke GotoJanssen Pharmaceutical K.K., Tokyo, Japan.
Richuan ZhengJanssen Pharmaceutical K.K., Tokyo, Japan.
Hidemi NakagawaThe Jikei University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Previous global studies of guselkumab have demonstrated clinical benefits in patients with psoriasis. The aim of this 52-week, phase 3 study was to evaluate efficacy and safety of guselkumab in Japanese patients with moderate to severe plaque-type psoriasis. Patients randomly received guselkumab 50 mg or 100 mg at weeks 0, 4 and every 8 weeks, or placebo with cross-over to guselkumab 50 mg or 100 mg at week 16. Co-primary end-points were the proportion of patients achieving Investigator's Global Assessment (IGA) cleared/minimal (0/1) and 90% or more improvement in Psoriasis Area and Severity Index (PASI-90) at week 16. Overall, 192 patients were randomized to placebo, guselkumab 50 mg or 100 mg. At week 16, patients in the placebo group were crossed over to guselkumab 50 mg or 100 mg. At week 16, a significantly (P < 0.001) higher proportion of patients receiving guselkumab 50 mg and 100 mg versus placebo achieved IGA 0/1 (92.3% and 88.9% vs 7.8%) and PASI-90 (70.8% and 69.8% vs 0%). Patients in guselkumab 50 mg and 100 mg groups achieved significant improvement versus placebo in PASI-75 (89.2% and 84.1% vs 6.3%, P < 0.001) at week 16; improvement was maintained through week 52. Incidences of treatment-emergent adverse events were comparable among the groups through week 16; the most commonly reported was nasopharyngitis. No new safety concerns were observed until week 52. In conclusion, guselkumab treatment demonstrated superior efficacy over placebo and was well tolerated in Japanese patients with moderate to severe plaque-type psoriasis.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansIncidenceInterleukin-23 Subunit p19MaleMiddle AgedNasopharyngitisPlacebosPsoriasisSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedguselkumabIL23A protein, humanInterleukin-23 Subunit p19Placebosguselkumabinterleukin-23Japanlong termplaque psoriasis

Identifiers

PMID29905383
PMCPMC6175099

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.