Evidence map›Paper›PMID 27995400›Full record

Observational studyDigestive diseases and sciences2017

Adalimumab Maintenance Treatment in Ulcerative Colitis: Outcomes by Prior Anti-TNF Use and Efficacy of Dose Escalation.

Carlos Taxonera, Eva Iglesias, Fernando Muñoz, Marta Calvo, Manuel Barreiro-de Acosta, David Busquets, Xavier Calvet, Antonio Rodríguez, Ramón Pajares, Javier P Gisbert and 9 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
–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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  20. Maneuvering Clinical Pathways for Ulcerative Colitis.Current gastroenterology reports · 2019
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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

19 authors.

Carlos TaxoneraInflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos, c/Profesor Martín Lagos s/n, 28040, Madrid, Spain. carlos.taxonera@salud.madrid.org.ORCID 0000-0001-9166-7350
Eva IglesiasHospital Reina Sofia, Córdoba, Spain.
Fernando MuñozHospital Virgen Blanca, León, Spain.
Marta CalvoHospital Puerta de Hierro, Madrid, Spain.
Manuel Barreiro-de AcostaHospital Clínico, Santiago de Compostela, Spain.
David BusquetsHospital Josep Trueta, Girona, Spain.
Xavier CalvetCorporació Sanitària Universitària Parc Taulí, Sabadell, Spain.
Antonio RodríguezHospital Clínico, Salamanca, Spain.
Ramón PajaresHospital Infanta Sofia, Madrid, Spain.
Javier P GisbertCorporació Sanitària Universitària Parc Taulí, Sabadell, Spain.
Pilar López-SerranoHospital Universitario Fundación Alcorcón, Madrid, Spain.
José Luís Pérez-CalleHospital Universitario Fundación Alcorcón, Madrid, Spain.
Ángel PonferradaHospital Infanta Leonor, Madrid, Spain.
Cristóbal De la CobaHospital de Cabueñes, Gijón, Spain.
Fernando BermejoHospital de Fuenlabrada, Madrid, Spain.
María ChaparroCorporació Sanitària Universitària Parc Taulí, Sabadell, Spain.
David OlivaresInflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos, c/Profesor Martín Lagos s/n, 28040, Madrid, Spain.
Cristina AlbaInflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos, c/Profesor Martín Lagos s/n, 28040, Madrid, Spain.
Ignacio Fernández-BlancoHospital Moncloa, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe impact of prior anti-TNF use on "real-life" outcomes of adalimumab therapy in ulcerative colitis (UC) is not well known.

aimTo compare the influence of prior anti-TNF use on the outcomes of adalimumab maintenance treatment in UC patients. We also assessed the effectiveness of adalimumab dose escalation.

methodsThis retrospective multicenter cohort study included consecutive UC who advanced to an adalimumab maintenance regimen. Patients in whom adalimumab was discontinued prior to week eight of treatment were excluded. The co-primary efficacy endpoints were the cumulative probabilities of adalimumab failure-free survival and colectomy-free survival. We also assessed the need for and the effectiveness of adalimumab dose escalation.

resultsOf 184 UC on maintenance treatment with adalimumab, 116 (63%) had previous anti-TNF use. After a median follow-up of 23 months (interquartile range 13-49), 112 patients (60%) maintained corticosteroid-free clinical response. Sixty-nine patients (37%) had adalimumab failure, and 22 (12%) needed colectomy. Anti-TNF-naïve patients had significantly lower adjusted rates of adalimumab failure (hazard ratio [HR] 0.65; p < 0.001), adalimumab dose escalation (HR 0.35; p = 0.002), and need for colectomy (HR 0.26; p < 0.004). Seventy-six patients (41%) needed dose escalation after secondary loss of response, and 47% of these regained response after escalation. Short-term response after escalation was identified as a significant predictor of colectomy avoidance (HR 0.53; p = 0.007).

conclusionsIn this "real-life" cohort of UC patients on maintenance treatment with adalimumab, anti-TNF-naïve patients had significantly better long-term outcomes. Adalimumab dose escalation enabled recovery of response in nearly half of patients.

Indexed as

AdalimumabAdultAntirheumatic AgentsCohort StudiesColectomyColitis, UlcerativeDose-Response Relationship, DrugDrug SubstitutionFemaleHumansInfliximabMaintenance ChemotherapyMaleMiddle AgedProportional Hazards ModelsRetrospective StudiesAdalimumabAntirheumatic AgentsInfliximabTumor Necrosis Factor-alphaAdalimumabColectomyDose escalationInfliximabSecondary loss of responseUlcerative colitis

Identifiers

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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.