Evidence map›Paper›PMID 35697000›Full record

ArticleDigestion2022

Therapeutic Drug Monitoring of Golimumab for the Prediction of Long-Term Clinical Remission in Patients with Ulcerative Colitis.

Hideki Tawa, Kazuki Kakimoto, Keijiro Numa, Naohiko Kinoshita, Yuka Kawasaki, Yoshihiro Tatsumi, Ryoji Koshiba, Satoshi Nakata, Yuki Hirata, Kazuhiro Ota and 10 more

Abstract read
In one paragraph

Article in Digestion, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

20 authors.

Hideki Tawa2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Kazuki Kakimoto2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Keijiro Numa2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Naohiko Kinoshita2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Yuka Kawasaki2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Yoshihiro Tatsumi2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Ryoji Koshiba2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Satoshi Nakata2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Yuki Hirata2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Kazuhiro Ota2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Naokuni Sakiyama2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Yuichi Kojima2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Eiko Koubayashi2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Hiroki Nishikawa2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Toshihisa Takeuchi2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Takuya Inoue2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Shinya Fukunishi2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Takako Miyazaki2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Shiro Nakamura2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Kazuhide Higuchi2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsA considerable number of patients with ulcerative colitis (UC) who initially respond to golimumab (GLM), an anti-TNF-α antibody, gradually lose clinical response. Therapeutic drug monitoring has been proposed to optimize serum anti-TNF-α antibody concentrations before the loss of response; however, little is known about ideal serum GLM concentrations. We aimed to evaluate whether the serum GLM trough levels (TLs) early after the initiation of induction therapy affect the long-term outcomes in UC and to identify the early GLM TLs that should be targeted for better long-term outcomes.

methodsThirty-one patients were prospectively evaluated. The primary outcome was clinical remission at 54 weeks, and we measured the serum GLM TLs at weeks 6, 10, and 14. Receiver operating characteristic (ROC) curves were constructed to identify optimal GLM TL thresholds early after induction therapy that were associated with clinical remission at week 54.

resultsThe GLM TL at week 14, but not at weeks 6 or 10, was significantly associated with clinical remission at week 54 (median [IQR] 1.6 [1.3-1.6] μg/mL vs. 0.9 [0.6-1.3] μg/mL; p = 0.04). The area under the ROC curve for GLM TLs at week 14 was 0.78. We identified a week-14 GLM TL of 1.1 μg/mL as the target threshold for achieving clinical remission at week 54.

conclusionOur results demonstrate the value of early serum GLM TLs in predicting the long-term outcomes of GLM for patients with UC.

Indexed as

Colitis, UlcerativeAntibodies, MonoclonalDrug MonitoringHumansRemission InductionTreatment OutcomeTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAntibodies, MonoclonalgolimumabTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsGolimumabTherapeutic drug monitoringTumor necrosis factor-alphaUlcerative colitis

Identifiers

PMID35697000
PMCPMC9932821

What OpenQuestion holds

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LicenceCC BY-NC
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.