Evidence map›Paper›PMID 30417277›Full record

Trial reportAmerican journal of clinical dermatology2019

Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies.

April W Armstrong, Kristian Reich, Peter Foley, Chenglong Han, Michael Song, Yaung-Kaung Shen, Yin You, Kim A Papp

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of clinical dermatology, 2019. 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 16 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 5 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT02207231 phase3completednot on this map

Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2020Enrolled837ConditionsPsoriasisArmsGuselkumab 100 mg, Placebo for guselkumab, Adalimumab, Placebo for adalimumab
NCT02207244 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2020Enrolled992ConditionsPsoriasisArmsGuselkumab 100 mg, Placebo for guselkumab, Adalimumab, Placebo for adalimumab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 5 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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  16. Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project).Journal of the European Academy of Dermatology and Venereology : JEADV · 2021
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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 5 institutions in 4 countries.

April W ArmstrongKeck School of Medicine of USC, University of Southern California, 1975 Zonal Avenue, Keith Administration Building, Room 510, Los Angeles, CA, 90089, USA. aprilarmstrong@post.harvard.edu.
Kristian ReichDermatologikum Berlin, Berlin, Germany.
Peter FoleyThe University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy and Probity Medical Research Inc., and Skin & Cancer Foundation Inc., Carlton, VIC, Australia.
Chenglong HanJanssen Research & Development, LLC, Spring House, PA, USA.
Michael SongJanssen Research & Development, LLC, Spring House, PA, USA.
Yaung-Kaung ShenJanssen Research & Development, LLC, Spring House, PA, USA.
Yin YouJanssen Research & Development, LLC, Spring House, PA, USA.
Kim A PappK Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.ORCID http://orcid.org/0000-0001-9557-3642
Janssen (United States) · USDermatologikum Hamburg · DEProbity Medical Research · CASt Vincent's Hospital Melbourne · AUUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHealth-related quality of life (HRQoL) may be markedly impaired in patients with moderate-to-severe psoriasis.

objectivesOur objectives were to compare improvements in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) scores between patients receiving guselkumab compared with placebo or adalimumab and to correlate these improvements with skin clearance.

methodsPooled phase III VOYAGE 1 and VOYAGE 2 data were evaluated through week 24. At baseline, patients were randomized to guselkumab 100 mg, placebo, or adalimumab 40 mg. At week 16, patients receiving placebo switched to guselkumab. Assessment measures included DLQI percent change from baseline, DLQI 0/1, DLQI minimal clinically important difference (MCID), individual domain scores, PSSD symptoms and signs score = 0, DLQI association with PSSD, Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI).

resultsSignificantly greater improvements from baseline DLQI were observed with guselkumab versus placebo (weeks 8 and 16) and versus adalimumab (week 24; p < 0.001). The proportion of patients achieving DLQI 0/1 ("no impact") at week 24 was higher with guselkumab than with adalimumab (58.9 vs. 40.2%; p < 0.001), and more patients attained a ≥ 4-point reduction in DLQI (MCID) at this timepoint (p < 0.001). Changes in individual DLQI domains were significantly greater for patients receiving guselkumab than for those receiving adalimumab, and among patients with individual baseline domain scores = 3 or 6 (severest impact), more guselkumab recipients than those receiving adalimumab achieved a score = 0 across all domains at week 24. DLQI 0/1 scores were associated with a PSSD symptom or sign score = 0 (no impact) and greater improvement of PASI and IGA (week 24).

conclusionsPooled VOYAGE 1/VOYAGE 2 data demonstrated that guselkumab was superior to adalimumab in improving HRQoL, which was associated with greater skin clearance. CLINICAL

trial registrationNCT02207231 and NCT02207244.

Indexed as

Patient Reported Outcome MeasuresAdalimumabAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsDrug Administration ScheduleFemaleHumansInterleukin-23 Subunit p19MaleMiddle AgedPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsguselkumabIL23A protein, humanInterleukin-23 Subunit p19TNF protein, humanTumor Necrosis Factor-alpha

Identifiers

PMID30417277
PMCPMC6513809
OpenAlexW2901523494

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.