Evidence map›Paper›PMID 35448957›Full record

ArticleBMC gastroenterology2022

Ustekinumab trough levels predicting laboratory and endoscopic remission in patients with Crohn's disease.

Hisashi Hirayama, Yasuhiro Morita, Takayuki Imai, Kenichiro Takahashi, Atsushi Yoshida, Shigeki Bamba, Osamu Inatomi, Akira Andoh

Open access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
7.5field-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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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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

8 authors at 2 institutions in 1 country.

Hisashi HirayamaDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Yasuhiro MoritaDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Takayuki ImaiDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Kenichiro TakahashiDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Atsushi YoshidaCenter for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kamakura, Japan.
Shigeki BambaDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Osamu InatomiDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Akira AndohDepartment of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan. andoh@belle.shiga-med.ac.jp.
Shiga University of Medical Science · JPGunma Chuo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsOptimal concentration of ustekinumab (UST) predicting endoscopic remission has not been fully investigated in Crohn's disease (CD). We aimed to identify the optimal UST trough levels predicting clinical, laboratory and endoscopic remission in CD patients.

methodsTwenty-eight patients with CD were enrolled and investigated (27 patients by enteroscopy and 1 by colonoscopy). The endoscopic activity was assessed using the scoring system that applied the Rutgeerts score to observed intestine. Serum UST trough levels and anti-UST antibodies (AUAs) levels were determined by in-house immunoassays.

resultsEndoscopic activity was negatively correlated with serum UST trough levels (Spearman's rank correlation coefficient (ρ) = - 0.66, P = 0.0001) and serum albumin levels (ρ = - 0.60, P = 0.0007). The endoscopic activity was positively and significantly correlated with CRP (ρ = 0.59, P = 0.0009) and ESR (ρ = 0.44, P = 0.033). There was no significant association between the endoscopic score and AUA levels and/or Crohn's disease activity index (CDAI). Serum UST trough levels and albumin levels were significantly higher in the endoscopic remission group (scores of 0 and 1) than in the non-endoscopic remission group (UST trough, mean 3.3 vs. 1.8 μg/mL). No significant difference was observed in AUAs between the endoscopic remission and non-remission groups. Receiver operation curve (ROC) analysis revealed that the optimal cutoff value of UST trough levels predicting normal CRP and serum albumin levels was 1.7 μg/mL for each, and the optimal cutoff value predicting endoscopic remission was 2.0 μg/mL (AUC: 0.80, 95% CI 0.64-0.96).

conclusionAchievement of endoscopic remission requires higher UST trough levels than required for normalization of CRP and serum albumin levels.

Indexed as

Crohn DiseaseUstekinumabColonoscopyEndoscopy, GastrointestinalHumansRemission InductionSerum AlbuminSerum AlbuminUstekinumabEnteroscopyTherapeutic drug monitoringUstekinumab

Identifiers

PMID35448957
PMCPMC9027696
OpenAlexW4225984357

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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.