Evidence map›Paper›PMID 38127188›Full record

ArticleDermatology and therapy2024

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: Analysis of the 3-Year Phase 3 Rising Up Study.

Norito Katoh, Masanori Ikeda, Yukihiro Ohya, Hiroyuki Murota, Xiaofei Hu, John Liu, Hayato Niiyama, Takuya Sasaki, Eliza M Raymundo, Hidehisa Saeki

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03661138 (A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT03661138 phase3completednot on this map

A Phase 3 Randomized, Multicenter, Double-Blind Study to Evaluate the Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects in Japan With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorAbbVieRan2018 to 2022Enrolled272ConditionsAtopic DermatitisArmsUpadacitinib, Placebo for upadacitinib, Topical Corticosteroids (TCS)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Oral Janus Kinase Inhibitors in Pediatric Atopic Dermatitis.Current allergy and asthma reports · 2024
    Review
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

10 authors at 7 institutions in 2 countries.

Norito KatohDepartment of Dermatology, Kyoto Prefectural University, Kyoto, Japan.
Masanori IkedaOkayama University School of Medicine, Okayama, Japan.
Yukihiro OhyaAllergy Center, National Center for Child Health and Development, Tokyo, Japan.
Hiroyuki MurotaDepartment of Dermatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Xiaofei HuAbbVie Inc., 1 North Waukegan Road, Dept R086, Bldg AP31-2, North Chicago, IL, 60064, USA.
John LiuAbbVie Inc., 1 North Waukegan Road, Dept R086, Bldg AP31-2, North Chicago, IL, 60064, USA.
Hayato NiiyamaAbbVie GK, Tokyo, Japan.
Takuya SasakiAbbVie GK, Tokyo, Japan.
Eliza M RaymundoAbbVie Inc., 1 North Waukegan Road, Dept R086, Bldg AP31-2, North Chicago, IL, 60064, USA. eliza.raymundo@abbvie.com.
Hidehisa SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.
AbbVie (United States) · USAbbVie (Japan)Fukuyama City Hospital · JPKyoto Prefectural University · JPNagasaki University · JPNational Center For Child Health and Development · JPNippon Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUpadacitinib is an oral Janus kinase inhibitor approved in multiple countries for moderate-to-severe atopic dermatitis (AD). Here we present long-term data for up to 3 years of continuous upadacitinib treatment in Japanese patients with AD.

methodsRising Up was a phase 3, randomized, multicenter study in Japan investigating the safety and efficacy of upadacitinib in patients with moderate-to-severe AD. Patients aged 12-75 years (weight ≥ 40 kg if < 18 years) were randomized 1:1:1 to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo through week 16 (all in combination with topical corticosteroids). At week 16, patients who received placebo were rerandomized 1:1 to upadacitinib 15 mg or 30 mg; topical corticosteroids were optional per investigator discretion from weeks 16-160. Safety was assessed by monitoring adverse events (AEs). Efficacy assessments included patients who achieved ≥ 75%/≥ 90% improvement from baseline in Eczema Area and Severity Index (EASI 75/90), clear/almost clear on the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD 0/1), or a ≥ 4-point improvement from baseline in Worst Pruritus Numerical Rating Scale (WP-NRS).

resultsOf 272 patients enrolled, 230 completed the study. Through week 160, the long-term incidence rate of overall AEs was numerically higher with upadacitinib 30 mg than 15 mg; rates of serious AEs, AEs considered possibly related to study drug, AEs leading to discontinuation, and AEs of special interest were generally low and similar between dose groups. EASI 75, EASI 90, vIGA-AD 0/1, and WP-NRS response rates were generally greater with upadacitinib 30 mg than 15 mg and maintained through week 160 with either dose.

conclusionFor up to 3 years of continuous treatment, upadacitinib was well tolerated in Japanese patients, with a similar safety profile to that of short-term studies and durable long-term response rates for skin clearance and itch improvement.

trial registrationClinicalTrials.gov identifier, NCT03661138.

Indexed as

Atopic dermatitisClinical trialEczemaJanus kinase inhibitorsSafetyTopical corticosteroidsUpadacitinib

Identifiers

PMID38127188
PMCPMC10828480
OpenAlexW4390052717

What OpenQuestion holds

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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.