Evidence map›Paper›PMID 28884856›Full record

Trial reportAlimentary pharmacology & therapeutics2017

Significance of measurement of serum trough level and anti-drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn's disease: a subanalysis of the DIAMOND trial.

H Nakase, S Motoya, T Matsumoto, K Watanabe, T Hisamatsu, N Yoshimura, T Ishida, S Kato, T Nakagawa, M Esaki and 9 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
10.6field-weighted citation impact, top 1% 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

40 citing papers in PubMed, 77 citations in OpenAlex.

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  4. Safety and efficacy of weekly adalimumab 80 mg therapy in pediatric Crohn's disease.Journal of pediatric gastroenterology and nutrition · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 1 country.

H NakaseSapporo, Japan.ORCID 0000-0003-2848-6586
S MotoyaSapporo, Japan.
T MatsumotoMorioka, Japan.
K WatanabeNishinomiya, Japan.
T HisamatsuMitaka, Tokyo, Japan.
N YoshimuraShinjuku-ku, Tokyo, Japan.
T IshidaOita, Japan.
S KatoSaitama, Japan.
T NakagawaChuo-ku, Chiba, Japan.
M EsakiHigashi-ku, Fukuoka, Japan.ORCID 0000-0002-1195-0074
M NagahoriBunkyo-ku, Tokyo, Japan.
T MatsuiChikushino, Fukuoka, Japan.
Y NaitoKyoto, Japan.
T KanaiShinjuku-ku, Tokyo, Japan.
Y SuzukiSakura, Chiba, Japan.
M NojimaMinato-Ku, Tokyo, Japan.
M WatanabeBunkyo-ku, Tokyo, Japan.
T HibiMinato-Ku, Tokyo, Japan.
DIAMOND study group
Bunkyo University · JPJapan Institute for Advanced Dentistry · JPShinjuku Yamabuki High School · JPChiba University · JPFukuoka College of Agriculture · JPFukuoka Institute of Technology · JPMitaka Kohki (Japan) · JPOita University · JPToho University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSignificance of monitoring adalimumab trough levels and anti-adalimumab antibodies (AAA) for disease outcome in Crohn's disease (CD) patients remained unclear.

aimTo evaluate the association of adalimumab trough levels and AAA at week 26 with clinical remission at week 52, the effect of azathiopurine on AAA and factors influencing trough levels in CD patients in the DIAMOND trial.

methodsWe performed this study using adalimumab trough levels, AAA at week 26 and 6-thioguanine nucleotide (TGN) in red blood cells at week 12. A multiple regression model and receiver operating analysis was performed to identify factors influencing adalimumab trough levels and AAA, and adalimumab thresholds for predicting disease activity.

resultsThere was a significant difference of adalimumab trough level at week 26 between patients with disease remission and without at week 52 (7.7 ± 3.3 μg/mL vs 5.4 ± 4.3 μg/mL: P <.001). Adalimumab trough level of 5.0 μg/mL yielded optimal sensitivity and specificity for remission prediction (80.2% and 55.6%, respectively). AAA development at week 26 significantly affected remission at week 52 (P = .021), which was strongly associated with adalimumab trough levels. Female gender and increasing body weight were independently associated with low adalimumab trough levels, and female gender was associated with AAA development. A cut-off 6TGN level of >222.5 p mol/8 ×10

conclusionAdalimumab trough levels and AAA occurrence were significantly associated with clinical remission. Higher 6TGN affected AAA negativity. The combination therapy is beneficial in some relevant aspects for CD patients. (UMIN Registration No. 000005146).

Indexed as

AdalimumabAntibodiesAnti-Inflammatory AgentsCrohn DiseaseDrug Therapy, CombinationFemaleGuanine NucleotidesHumansMaleMercaptopurineSensitivity and SpecificityThionucleotidesTreatment Outcome6-thioguanylic acidAdalimumabAntibodiesAnti-Inflammatory AgentsazathiopurineGuanine NucleotidesMercaptopurineThionucleotides

Identifiers

PMID28884856
PMCPMC5656923
OpenAlexW2751270953

What OpenQuestion holds

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LicenceCC BY-NC
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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.