Evidence map›Paper›PMID 35305254›Full record

ArticleOphthalmology and therapy2022

Long-Term Safety and Effectiveness of Adalimumab in Japanese Patients with Noninfectious Intermediate, Posterior, or Panuveitis: Post-Marketing Surveillance of 251 Patients.

Kenichi Namba, Toshikatsu Kaburaki, Hidekazu Tsuruga, Yohei Ogawa, Eri Iwashita, Hiroshi Goto

Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02916017 (HUMIRA® Special Investigation), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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.

NCT02916017 completednot on this map

HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)

TypeobservationalSponsorAbbVieRan2016 to 2020Enrolled259ConditionsUveitis
3 · Its place in the literature

Who cites it

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

  1. Regional risk ofFrontiers in pharmacology · 2023
    Pooled it
  2. Article
  3. Article
  4. 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

6 authors.

Kenichi NambaDepartment of Ophthalmology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. knamba@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0002-5016-851X
Toshikatsu KaburakiDepartment of Ophthalmology, University of Tokyo School of Medicine, Tokyo, Japan.
Hidekazu TsurugaAbbVie GK, Tokyo, Japan.
Yohei OgawaAbbVie GK, Tokyo, Japan.
Eri IwashitaAbbVie GK, Tokyo, Japan.
Hiroshi GotoDepartment of Ophthalmology, Tokyo Medical University, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this nationwide, prospective post-marketing surveillance was to assess the safety and effectiveness of up to 52 weeks of adalimumab treatment in patients with noninfectious intermediate, posterior, or panuveitis in Japanese clinical practice.

methodsThis post-marketing surveillance was conducted at 60 medical facilities in Japan from October 2016 to June 2020. Patients with noninfectious intermediate, posterior, or panuveitis who were administered adalimumab (Humira

resultsDuring 52 weeks of surveillance, AEs and ADRs occurred in 70 (27.9%) and 47 (18.7%) of 251 patients, respectively. The most common ADR was infection (21/251 patients; 8.4%), including serious infections in eight (3.2%) patients. ADRs were more frequent in patients ≥ 65 years of age, those with concurrent diseases, and those with past medical history. Four patients developed tuberculosis. The uveitis recurrence rate was 24.8% (61/246 patients). All effectiveness measures tended to improve from baseline to week 52, and mean corticosteroid doses decreased. Clinically meaningful changes were observed for most VFQ-25 subscales.

conclusionsThe safety profile of adalimumab was generally consistent with previous reports, and no new safety concerns were identified.

trial registrationClinicalTrials.gov: NCT02916017.

Indexed as

AdalimumabBehçet’s DiseaseSarcoidosisUveitisVogt-Koyanagi-Harada Disease

Identifiers

PMID35305254
PMCPMC9114192

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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.