Evidence map›Paper›PMID 33373480›Full record

Trial reportThe Journal of dermatology2021

Efficacy and safety of brodalumab in the Korean population for the treatment of moderate to severe plaque psoriasis: A randomized, phase III, double-blind, placebo-controlled study.

Seong Jun Seo, Bong Seok Shin, Joo-Heung Lee, Haeyoun Jeong

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 6 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

14 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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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

4 authors.

Seong Jun SeoDepartment of Dermatology, Chung-Ang University Hospital, Seoul, South Korea.
Bong Seok ShinDepartment of Dermatology, Chosun University Hospital, Gwangju, South Korea.
Joo-Heung LeeDepartment of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.ORCID https://orcid.org/0000-0002-1121-2055
Haeyoun JeongClinical Development Department, Kyowa Kirin Korea Co., Ltd., Seoul, South Korea.

Funding

Kyowa Kirin Korea Co., Ltd.
6 · The paper itself

Abstract

Psoriasis, a chronic inflammatory skin disease, negatively impacts patients' quality of life (QoL). This randomized, phase III, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of brodalumab, a human anti-interleukin-17 receptor A monoclonal antibody, in Korean patients with moderate to severe plaque psoriasis. Coprimary end-points were the percentage of patients with 75% or more improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (sPGA) success (score 0/1) at week 12. Secondary end-points included the percentage improvement from baseline in PASI score and proportion of patients with PASI 50/75/90/100 responses. QoL was assessed with the Dermatology Life Quality Index (DLQI). Eligible patients were randomized to receive brodalumab 210 mg (N = 40) or placebo (N = 22) every 2 weeks (Q2W) at a 2:1 ratio for 12 weeks. Subsequently, all patients entered an open-label extension phase and received brodalumab 210 mg Q2W until week 62. At week 12, the proportion of patients who achieved the coprimary end-points, PASI 75 and sPGA success, was significantly higher in the brodalumab 210 mg Q2W group compared with the placebo group (92.5% vs 0%). At week 12, the mean ± SD percentage improvement in the PASI score was 96.87 ± 6.01% in the brodalumab 210 mg Q2W group, which was maintained until study end (week 64). PASI 50/75/90 responses were achieved by 100% of patients receiving brodalumab 210 mg Q2W at weeks 6, 13, and 24, respectively; PASI 100 was achieved by 82.8% of patients at week 64. Brodalumab treatment rapidly improved DLQI scores. The most common treatment-emergent adverse events were nasopharyngitis, upper respiratory tract infections, tinea pedis, and urticaria. Overall, treatment with brodalumab 210 mg Q2W resulted in a rapid and significant clinical benefit and was well tolerated in patients with moderate to severe plaque psoriasis in Korea.

Indexed as

PsoriasisQuality of LifeAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansRepublic of KoreaSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedbrodalumabbrodalumabefficacyKoreapsoriasissafety

Identifiers

PMID33373480
PMCPMC8246806

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Registered trials

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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.