Evidence map›Paper›PMID 39412631›Full record

Observational studyAdvances in therapy2024

Real-World Safety and Effectiveness of Infliximab in 255 Patients with Intestinal, Neurological, and Vascular Behçet's Disease: A Post-Marketing Surveillance.

Toshifumi Hibi, Shunsei Hirohata, Tadakazu Hisamatsu, Hirotoshi Kikuchi, Mitsuhiro Takeno, Noriko Sato, Naomi Mizuno, Mayumi Tashiro, Yutaka Susuta, Yoshiaki Ishigatsubo

Abstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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

10 authors.

Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, 5-9-1, Shirokane, Minato-ku, Tokyo, 108-8642, Japan. thibi@insti.kitasato-u.ac.jp.ORCID 0000-0002-6256-1204
Shunsei HirohataDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, 1-15-1, Kitazato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374, Japan.ORCID 0000-0003-1911-7383
Tadakazu HisamatsuDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan.ORCID 0000-0002-1178-3536
Hirotoshi KikuchiGeneral Medical Education and Research Center, Teikyo University, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.ORCID 0000-0002-1864-1098
Mitsuhiro TakenoDepartment of Allergy and Rheumatology, Nippon Medical School Musashi Kosugi Hospital, 1-383, Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa, 211-8533, Japan.ORCID 0000-0002-9212-7046
Noriko SatoMedical Affairs Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, 1-1-1, Marunouchi, Chiyoda-ku, Tokyo, 100-8205, Japan.ORCID 0000-0003-2660-0808
Naomi MizunoMedical Affairs Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, 1-1-1, Marunouchi, Chiyoda-ku, Tokyo, 100-8205, Japan.ORCID 0000-0002-1326-9792
Mayumi TashiroPharmacovigilance Department, Quality and Vigilance Division, Mitsubishi Tanabe Pharma Corporation, 3-2-10, Dosho-machi, Chuo-ku, Osaka, 541-8505, Japan.
Yutaka SusutaData Science Department, Development and Medical Affairs Division, Mitsubishi Tanabe Pharma Corporation, 1-1-1, Marunouchi, Chiyoda-ku, Tokyo, 100-8205, Japan.ORCID 0000-0003-1621-9261
Yoshiaki IshigatsuboDepartment of Internal Medicine and Clinical Immunology, Yokohama City University, Graduate School of Medicine, 22-2, Seto, Kanazawa-ku, Yokohama-shi, Kanagawa, 236-0027, Japan.ORCID 0000-0002-2908-1452

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBehçet's disease (BD) with intestinal, neurological (NBD), and vascular (VBD) manifestations often leads to poor outcomes. Infliximab is approved for the treatment of intestinal BD, NBD, and VBD in Japan; however, evidence regarding its safety and effectiveness in these patients is limited. We conducted a 2-year post-marketing surveillance to evaluate the safety and effectiveness of infliximab in patients with intestinal BD, NBD, and VBD in Japan.

methodsThis 2-year, multicenter, prospective, observational study included all patients with intestinal BD, NBD, or VBD, who had experienced an insufficient response to conventional therapies (e.g., glucocorticoids and immunosuppressants/immunomodulators), and initiated infliximab for the first time at participating medical institutions. The safety endpoints included adverse events and adverse drug reactions (ADRs), and the effectiveness endpoints included global improvement, and for patients with acute NBD, acute attacks.

resultsBetween October 2015 and August 2018, 255 patients (171 intestinal BD, 49 NBD, and 51 VBD; including 16 with two disease types) were enrolled from 133 medical centers and treated with infliximab. Adverse events, ADRs, and serious ADRs occurred in 100 (39.2%), 72 (28.2%), and 38 (14.9%) patients, respectively; incidences were generally similar across intestinal BD, NBD, and VBD groups. No new safety concerns were identified. At the final evaluation, 68.8% of patients with intestinal BD showed improvement, most patients with chronic progressive NBD and VBD had not worsened (100% and 91.7%, respectively), and 93.3% of patients with acute NBD had no new acute attacks during the observation period.

conclusionThese results confirmed the safety and effectiveness of infliximab in clinical practice in 255 patients with intestinal BD, NBD, and VBD. There were no new safety concerns.

Indexed as

Behcet SyndromeInfliximabProduct Surveillance, PostmarketingAdultFemaleHumansIntestinal DiseasesJapanMaleMiddle AgedNervous System DiseasesProspective StudiesTreatment OutcomeVascular DiseasesYoung AdultInfliximabAnti-TNFα monoclonal antibodyInfliximabIntestinal Behçet’s diseaseNeurological Behçet’s diseasePost-marketing surveillanceReal-world evidenceVascular Behçet’s disease

Identifiers

PMID39412631
PMCPMC11550226

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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.