Evidence map›Paper›PMID 30689771›Full record

ArticleJournal of Crohn's & colitis2019

Proactive Therapeutic Drug Monitoring of Adalimumab Is Associated With Better Long-term Outcomes Compared With Standard of Care in Patients With Inflammatory Bowel Disease.

Konstantinos Papamichael, Anna Juncadella, Danny Wong, Shana Rakowsky, Lindsey A Sattler, James P Campbell, Byron P Vaughn, Adam S Cheifetz

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Journal of Crohn's & colitis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
15.9field-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

58 citing papers in PubMed, 2 syntheses or guidelines pooled it, 143 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Konstantinos PapamichaelCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Anna JuncadellaCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Danny WongCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Shana RakowskyCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Lindsey A SattlerCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
James P CampbellDepartment of Gastroenterology, Hepatology and Nutrition, University of Minnesota, Minneapolis, MN, USA.
Byron P VaughnDepartment of Gastroenterology, Hepatology and Nutrition, University of Minnesota, Minneapolis, MN, USA.
Adam S CheifetzCenter for Inflammatory Bowel Diseases, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Beth Israel Deaconess Medical Center · USUniversity of Minnesota · US

Funding

RESEARCH TRAINING IN GASTROENTEROLOGYT32DK007760 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KELLY, CIARAN P · 1999 to 2019
$4.6M
NIDDK NIH HHS T32 DK007760
6 · The paper itself

Abstract

BACKGROUND AND

aimsTherapeutic drug monitoring [TDM] has proven to be effective for optimising anti-tumour necrosis factor [TNF] therapy in inflammatory bowel disease [IBD]. Nevertheless, the majority of data refer to infliximab and reactive testing or association studies. We aimed to compare the long-term outcome of patients with IBD who received at least one proactive TDM of adalimumab, with standard of care, defined as empirical dose escalation and/or reactive TDM.

methodsThis was a multicentre retrospective cohort study. Patients on maintenance adalimumab therapy from June 2006 to December 2015 were eligible. We analysed time to treatment failure from start of adalimumab until the end of follow-up [July 2016]. Treatment failure was defined as drug discontinuation for secondary loss of response or serious adverse event or need for IBD-related surgery. Serum adalimumab concentrations and antibodies to adalimumab were measured using the Prometheus homogeneous mobility shift assay.

resultsA total of 382 patients with IBD [Crohn's disease, n = 311, 81%] were included and received either at least one proactive TDM [n = 53] or standard of care [empirical dose escalation, n = 279; reactive TDM, n = 50]. Patients were followed for a median of 3.1 years [interquartile range, 1.4-4.8 years]. Multiple Cox regression analyses showed that at least one proactive TDM was independently associated with a reduced risk for treatment failure (hazard ratio [HR]: 0.4; 95% confidence interval [CI]: 0.2-0.9; p = 0.022).

conclusionsThis multicentre, retrospective cohort study reflecting real-life clinical practice provides the first evidence that proactive TDM of adalimumab may be associated with a lower risk of treatment failure compared with standard of care in patients with IBD.

Indexed as

AdalimumabInflammatory Bowel DiseasesAdultCohort StudiesDose-Response Relationship, DrugDrug MonitoringFemaleGastrointestinal AgentsHumansMaleMiddle AgedOutcome and Process Assessment, Health CareRemission InductionRetrospective StudiesStandard of CareTreatment FailureAdalimumabGastrointestinal AgentsTumor Necrosis Factor-alphaanti-tumour necrosis factor therapyCrohn’s diseasedrug concentrationsimmunogenicityulcerative colitis

Identifiers

PMID30689771
PMCPMC6939875
OpenAlexW2914225473

What OpenQuestion holds

Textmetadata
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.