Evidence map›Paper›PMID 37750995›Full record

ArticleDermatology and therapy2023

Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2.

Byung Soo Kim, Seong Jin Jo, SangWoong Youn, Kristian Reich, Carine Saadoun, Chia-Ling Chang, Ya-Wen Yang, Yu-Huei Huang, Tsen-Fang Tsai

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. 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 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Observational
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

9 authors at 8 institutions in 5 countries.

Byung Soo KimDepartment of Dermatology, College of Medicine, Pusan National University, 179, Gudeok-ro, Seo-gu, Busan, 49241, Republic of Korea.
Seong Jin JoDepartment of Dermatology, Seoul National University Hospital, Seoul National University College of Medicine, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
SangWoong YounDepartment of Dermatology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82 Gumi-ro 173Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Republic of Korea.
Kristian ReichTranslational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Carine SaadounRegional Medical Affairs Janssen Asia Pacific, Janssen, a division of Johnson & Johnson Pte Ltd., 2 Science Park Drive, #07-13, Ascent, Singapore Science Park 1, Singapore, 118222, Singapore.
Chia-Ling ChangRegional Medical Affairs Janssen Asia Pacific, Janssen, a division of Johnson & Johnson Pte Ltd., 2 Science Park Drive, #07-13, Ascent, Singapore Science Park 1, Singapore, 118222, Singapore.
Ya-Wen YangGlobal Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, LLC, Horsham, PA, USA.
Yu-Huei HuangDepartment of Dermatology, Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Guishan District, Taoyuan City, Taiwan.
Tsen-Fang TsaiDepartment of Dermatology, National Taiwan University Hospital, No. 7, Chung-Shan S. Road, Taipei, 100, Taiwan. tftsai@yahoo.com.ORCID http://orcid.org/0000-0002-1498-1474
Singapore Science Park · SGChang Gung University · TWJohnson & Johnson (United States) · USNational Taiwan University Hospital · TWPusan National University · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGuselkumab is a human monoclonal antibody against IL-23 used in the treatment of moderate-to-severe psoriasis. This post-hoc analysis evaluated the efficacy and safety of guselkumab in the Asian subpopulation of VOYAGE 1 and VOYAGE 2 through 5 years.

methodsThe proportions of guselkumab-treated Asian patients (VOYAGE 1 and 2) achieving Psoriasis Area and Severity Index (PASI) 90 and PASI 100, Investigator's Global Assessment (IGA) scores of 0/1 and 0, and Dermatology Life Quality Index (DLQI) scores of 0/1 (week 100 through week 252) were assessed. Non-responders were patients who met the treatment failure rules. Efficacy endpoints were analyzed using the as-observed methodology (no missing data imputation) for both studies and using non-responder imputation (for patients with any missing data) in VOYAGE 1. Safety outcomes were based on pooled data through week 252.

resultsResponse rates through week 252 for 199 Asian patients in the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 76.8% and 80.6% (PASI 90), 26.8% and 38.7% (PASI 100), 64.3% and 87.1% (IGA 0/1), and 26.8% and 45.2% (IGA 0). DLQI (0/1) at week 252 was achieved by 52.7% of patients in VOYAGE 1 and 61.3% in VOYAGE 2, while DLQI (0) at week 252 was achieved by 32.7% of patients in VOYAGE 1 and 40.3% in VOYAGE 2. The safety profile was similar to the global population and remained consistent through 5 years. Asian patients were followed for a total of 814 patient-years (PY). Over 85% of the guselkumab-treated patients continued treatment through week 264. The rate of serious adverse events (AEs) at week 252 was 3.07/100 PY. Rates of AEs of interest were low: serious infections, 0.74/100 PY; nonmelanoma skin cancer (NMSC), no patients; malignancies other than NMSC, 0.12/100 PY; and no major adverse cardiovascular events (MACE).

conclusionThese analyses confirm a continuous response over 5 years, indicating that guselkumab shows therapeutic longevity in Asian patients requiring long-term treatment for moderate-to-severe psoriasis.

trial registrationClinicalTrials.gov identifiers: VOYAGE 1 [NCT02207231] and VOYAGE 2 [NCT02207244].

Indexed as

AsianBiologicsGuselkumabModerate-to-severePsoriasis

Identifiers

PMID37750995
PMCPMC10613179
OpenAlexW4387033572

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.