Evidence map›Paper›PMID 30142791›Full record

Observational studyMedicine2018

Effectiveness and safety of adalimumab to treat outpatient ulcerative colitis: A real-life multicenter, observational study in primary inflammatory bowel disease centers.

Antonio Tursi, Walter Elisei, Roberto Faggiani, Leonardo Allegretta, Nicola Della Valle, Giacomo Forti, Marilisa Franceschi, Antonio Ferronato, Sara Gallina, Tiziana Larussa and 13 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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

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

  1. Pooled it
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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

23 authors at 11 institutions in 2 countries.

Antonio TursiTerritorial Gastroenterology Service, ASL BAT, Andria Division of Gastroenterology, ASL Roma 6, Albano Laziale (Roma) Division of Gastroenterology, "Belcolle" Hospital, Viterbo Division of Gastroenterology, "Santa Caterina Novella" Hospital, Galatina (LE) Division of Gastroenterology, A.O. "Ospedali Riuniti," Foggia Division of Digestive Endoscopy, "S. Maria Goretti" Hospital, Latina Digestive Endoscopy Unit, ULSS4 Alto Vicentino, Santorso (VI) Department of Health Science, University of Catanzaro, Catanzaro Division of Gastroenterology, PTP "Nuovo Regina Margherita," Roma Division of Gastroenterology, "Brotzu" Hospital, Cagliari Division of Gastroenterology, "S. Paolo" Hospital, Bari Division of Gastroenterology, "Ciaccio-Pugliese" Hospital, Catanzaro Territorial Gastroenterology Service, PST Catanzaro Lido, Catanzaro Ambulatory for IBD Treatment, "Valle D'Itria" Hospital, Martina Franca (TA) Division of Gastroenterology, "Veris Delli Ponti" Hospital, Scorrano (LE) Division of General Surgery, "P. Colombo" Hospital, ASL Roma 6, Velletri (Roma), Italy.
Walter Elisei
Roberto Faggiani
Leonardo Allegretta
Nicola Della Valle
Giacomo Forti
Marilisa Franceschi
Antonio Ferronato
Sara Gallina
Tiziana Larussa
Francesco Luzza
Roberto Lorenzetti
Giammarco Mocci
Antonio Penna
Stefano Rodino'
Ladislava Sebkova
Antonio de Medici
Giuseppe Pranzo
Cristina Ricciardelli
Giuseppina Grasso
Stefano Scorza
Costantino Zampaletta
Marcello Picchio
Ospedali Riuniti di Foggia · ITAzienda Ospedaliera Pugliese Ciaccio · ITMicro Focus (United States) · USOspedale di Belcolle · ITASL Roma · ITAzienda Ospedaliera G. Brotzu · ITAzienda Sanitaria Locale Roma 3 · ITOspedale L. Bonomo · ITOspedale Regina Margherita · ITOspedale Santa Maria Goretti · ITOspedale Veris Delli Ponti Scorrano · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adalimumab (ADA) was approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments in 2014, but no data from real life are currently available. The aim of the present study was to assess the real-life efficacy and safety of ADA in managing UC outpatients in some Italian primary inflammatory bowel disease (IBD) centers after approval of ADA reimbursement.Consecutive UC outpatients with at least 3-month follow-up were retrospectively evaluated. The primary end point was the induction and maintenance of remission in UC, defined as Mayo score ≤2.One hundred seven patients were included. At 3-month follow-up, obtained in 102 (95.3%) patients, 56 (54.9%) patients achieved a clinical remission. At univariate analysis, both Mayo partial score >7 and Mayo subscore for endoscopy = 3 at entry showed to be significantly associated with the lack of remission induction.During a median (95% confidence interval [CI]) follow-up of 18 (12-24) months, 56.6% of patients were under clinical remission; clinical response was achieved in 89.2% of cases. Mucosal healing was achieved in 66 (76.7%) patients, and colectomy occurred in 3 (2.8%) patients. Both C-reactive protein and fecal calprotectin values significantly decreased during follow-up. Steroids discontinuation occurred in 67 (66.7%) patients, and ADA dose escalation was adopted in 9 (16.1%) patients under remission. No factor was significantly related to the maintenance of clinical remission.This first Italian experience found ADA safe and effective to induce and maintain remission in real-life UC outpatients.

Indexed as

AdalimumabAdultAnti-Inflammatory AgentsColitis, UlcerativeColonoscopyC-Reactive ProteinFemaleHumansItalyLeukocyte L1 Antigen ComplexMaleMiddle AgedOutpatientsRetrospective StudiesTreatment OutcomeAdalimumabAnti-Inflammatory AgentsC-Reactive ProteinLeukocyte L1 Antigen Complex

Identifiers

PMID30142791
PMCPMC6112877
OpenAlexW2888182383

What OpenQuestion holds

Textmetadata
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.