Evidence map›Paper›PMID 34988493›Full record

ArticleJAAD international2022

A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysis.

Norito Katoh, Yukihiro Ohya, Hiroyuki Murota, Masanori Ikeda, Xiaofei Hu, Kimitoshi Ikeda, John Liu, Takuya Sasaki, Alvina D Chu, Henrique D Teixeira and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JAAD international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% 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.

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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Oral Janus Kinase Inhibitors in Pediatric Atopic Dermatitis.Current allergy and asthma reports · 2024
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Optimal Use of Jak Inhibitors and Biologics for Atopic Dermatitis on the Basis of the Current Evidence.JID innovations : skin science from molecules to population health · 2023
    Review
  19. Review
  20. Article
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

11 authors at 7 institutions in 2 countries.

Norito KatohDepartment of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, 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.
Masanori IkedaDepartment of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Xiaofei HuAbbVie Inc, North Chicago, Illinois.
Kimitoshi IkedaAbbVie GK, Tokyo, Japan.
John LiuAbbVie Inc, North Chicago, Illinois.
Takuya SasakiAbbVie GK, Tokyo, Japan.
Alvina D ChuAbbVie Inc, North Chicago, Illinois.
Henrique D TeixeiraAbbVie Inc, North Chicago, Illinois.
Hidehisa SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.
AbbVie (United States) · USABB (Japan) · JPKyoto Prefectural University of Medicine · JPNagasaki University · JPNational Center For Child Health and Development · JPNippon Medical School · JPOkayama University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSystemic atopic dermatitis treatments that have acceptable safety are needed.

objectiveTo evaluate the safety of the oral Janus kinase inhibitor upadacitinib in combination with topical corticosteroids (TCSs) for the treatment of atopic dermatitis.

methodsIn this phase 3, double-blind study (Rising Up), Japanese patients (12-75 years) with moderate-to-severe atopic dermatitis were randomized in a 1:1:1 ratio to receive 15 mg of upadacitinib + TCS, 30 mg of upadacitinib + TCS, or a placebo + TCS (rerandomized in a 1:1 ratio to receive either 15 or 30 mg of upadacitinib + TCS at week 16). Adverse events and laboratory data were assessed for safety.

resultsIn 272 treated patients, the serious adverse event rates were similar for 15- and 30-mg upadacitinib + TCS at week 24 (15 mg, 56%; 30 mg, 64%) but greater than those for placebo + TCS (42%). Acne (all mild or moderate; none leading to discontinuation) occurred more frequently with upadacitinib + TCS (15 mg, 13.2%; 30 mg, 19.8%) than with placebo + TCS (5.6%). Furthermore, herpes zoster infection (4.4% vs 0%), anemia (1.1% vs 0%), neutropenia (4.4% vs 1.1%), and creatine phosphokinase elevations (2.2% vs 1.1%) occurred more frequently with 30-mg upadacitinib + TCS than with 15-mg upadacitinib + TCS; none of these events were reported with placebo + TCS. No thromboembolic events, malignancies, gastrointestinal perforations, active tuberculosis, or deaths occurred. LIMITATIONS: The limitations included a small sample size and short observation period as well as nongeneralizability of the results beyond Japanese populations.

conclusionsThe results were generally consistent with those of previous reports; no new safety risks were detected.

Indexed as

AD, atopic dermatitisAE, adverse eventAESI, adverse event of special interestatopic dermatitisclinical trialCPK, creatine phosphokinaseEASI 50, ≥50% improvement in eczema area and severity indexEASI 75, ≥75% improvement in Eczema Area and Severity IndexEASI 90, ≥90% improvement in Eczema Area and Severity IndexEASI, Eczema Area and Severity IndexeczemaJAK, Janus kinaseJanus kinase inhibitorsSAE, serious adverse eventsafetyTCS, topical corticosteroidTEAE, treatment-emergent adverse eventtopical corticosteroidsupadacitinibvIGA-AD, validated Investigator's Global Assessment for Atopic Dermatitis

Identifiers

PMID34988493
PMCPMC8693619
OpenAlexW4200348523

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.