Evidence map›Paper›PMID 30611312›Full record

Trial reportArthritis research & therapy2019

Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet's disease: a large-scale, long-term postmarketing surveillance in Japan.

Shigeaki Ohno, Itsuro Umebayashi, Miyuki Matsukawa, Takashi Goto, Toshiro Yano

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% 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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Network meta-analysis of immunomodulatory therapies for Behçet's disease-associated uveitis: comparative evaluation of safety and efficacy profiles.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Pooled it
  2. Pooled it
  3. Regional risk ofFrontiers in pharmacology · 2023
    Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Treatment of Behçet Uveitis in Türkiye.Turkish journal of ophthalmology · 2024
    Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Microbiome in Immune-Mediated Uveitis.International journal of molecular sciences · 2022
    Review
  19. Article
  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

5 authors at 2 institutions in 1 country.

Shigeaki OhnoDepartment of Ophthalmology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, N 15, W 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. sohno@med.hokudai.ac.jp.ORCID 0000-0001-6964-6094
Itsuro UmebayashiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 3-16-89, Kashima, Yodogawa-ku, Osaka, Japan.
Miyuki MatsukawaIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 3-16-89, Kashima, Yodogawa-ku, Osaka, Japan.
Takashi GotoIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 3-16-89, Kashima, Yodogawa-ku, Osaka, Japan.
Toshiro YanoIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 3-2-10, Dosho-machi, Chuo-ku, Osaka, Japan.
Mitsubishi Group (Japan) · JPHokkaido University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfliximab, an anti-tumor necrosis factor-alpha antibody, has been reported to have excellent efficacy for refractory uveoretinitis in Behçet's disease (RUBD), and was approved for this indication in Japan. However, the long-term safety profile and efficacy in real-world clinical settings in patients with RUBD have not been fully clarified. The BRIGHT study, a prospective, large-scale, long-term postmarketing surveillance (PMS) study, was conducted to investigate the long-term safety and efficacy of infliximab in Japanese patients with RUBD.

methodsAll patients with RUBD who started infliximab treatment between January 2007 and January 2010 were enrolled. Safety was evaluated every 6 months for up to 24 months after initiation of therapy in 656 patients, and efficacy was evaluated in 650 patients. Patient characteristics were compared using the chi-square or Fisher's exact test. The frequency of ocular attacks before and after infliximab treatment was compared using the Wilcoxon signed-rank test. Independent associated factors for safety or efficacy were identified using multiple logistic regression analysis. A two-sided p value <0.05 was considered significant.

resultsAmong the 656 patients evaluated for safety, 555 (84.6%) completed the 24-month study period. The incidence of adverse drug reactions (ADRs) and serious ADRs were 32.32% and 6.10%, respectively, and the safety profile was comparable to that of Japanese PMS of infliximab for other diseases. The most common ADRs and serious ADRs were infections (11.89% and 3.66%). Tuberculosis was reported in two patients, and Pneumocystis jirovecii in one. Identified independent associated factors for infections were comorbid respiratory disease, history of allergic disease, and concomitant use of glucocorticoids. Although infusion reactions were observed in 11.13% of patients, most were non-serious. The response rate at 24 months by physician global assessment was 80.7%. Median frequency of ocular attacks per 6 months significantly decreased compared with that before infliximab treatment (2.0 to 0.0), and corrected visual acuity was maintained during the study.

conclusionsInfliximab treatment had good tolerability and efficacy in Japanese patients with RUBD in this large-scale, long-term PMS. Infliximab treatment seemed to be a good treatment option for RUBD in real-world clinical settings.

trial registrationUMIN Clinical Trials Registry, UMIN000027733 . Retrospectively registered on 6 June 2017.

Indexed as

AdolescentAdultAgedBehcet SyndromeDermatologic AgentsFemaleHumansInfliximabJapanMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesRetinitisRetrospective StudiesTime FactorsDermatologic AgentsInfliximabTumor Necrosis Factor-alphaAssociated factorBehçet’s diseaseBiological therapiesEfficacyInfliximabPostmarketing surveillanceSafetyUveoretinitis

Identifiers

PMID30611312
PMCPMC6321670
OpenAlexW2908513563

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.