Evidence map›Paper›PMID 38530500›Full record

Observational studyDigestive diseases and sciences2024

Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study.

Anna Maria Carvalhas Gabrielli, Francesca Ferretti, Camilla Maria Monico, Enrico Tombetti, Giovanni Maconi, Samanta Romeo, Nicole Piazza O Sed, Flavio Caprioli, Anna Maria Mazzola, Saverio Alicante and 8 more

Open access · greenAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.2field-weighted citation impact, top 13% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Observational
  2. 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

18 authors at 7 institutions in 1 country.

Anna Maria Carvalhas GabrielliGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy. amcgabrielli@gmail.com.
Francesca FerrettiGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Camilla Maria MonicoGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Enrico TombettiInternal Medicine and Rheumatology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.
Giovanni MaconiGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Samanta RomeoGastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy.
Nicole Piazza O SedGastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy.
Flavio CaprioliGastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy.
Anna Maria MazzolaDepartment of Clinical and Sperimental Sciences, University of Brescia, Brescia, Italy.
Saverio AlicanteGastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy.
Roberto BertèGastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy.
Elisabetta LolliGastroenterology Department, Policlinico Tor Vergata, Rome, Italy.
Maria Lia ScribanoVilla Stuart Multi-Speciality Clinic, Rome, Italy.
Elisabetta BuscariniGastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy.
Chiara RicciDepartment of Clinical and Sperimental Sciences, University of Brescia, Brescia, Italy.
Stefania CarmagnolaGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Sandro ArdizzoneGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Rosanna CannatelliGastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
ASST Fatebenefratelli Sacco · ITAzienda Ospedaliera Ospedale Maggiore · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITUniversity of Brescia · ITUniversity of Milan · ITPoliclinico Tor Vergata · ITVilla Melitta · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral Janus kinase inhibitor recently approved to induce and maintain remission in ulcerative colitis (UC).

aimsConsidering the number of anti-TNF non-responders, this study aims to assess the effectiveness and safety of tofacitinib in a cohort of multi-failure patients with moderate-to-severe UC at 52 weeks.

methodsFrom January 2021 to March 2023, we performed a prospective multicenter study observing adult patients with moderate-to-severe UC starting tofacitinib after an anti-TNF failure for a 52-week-long period. Effectiveness and safety were assessed in terms of colectomy rate, clinical remission and response, endoscopic remission, steroid-free clinical remission, and rate of adverse events.

resultsWe included 58 patients with UC with an age of 42 ± 14.4 years, 59% males, 96.6% left-sided or pancolitis, who were failure to a single (65.5%) or more than one anti-TNF (34.5%). Only 6 (10.3%) patients underwent colectomy. Colectomy was clinically associated with the necessity and the number of extra cycles of tofacitinib 10 mg bid at W8 (p = 0.023) and W24 (p = 0.004), and with a higher partial Mayo score at W8 (p = 0.025). At W52, clinical remission, clinical response, and steroid-free clinical remission were 53.4%, 43.1%, and 48.3%, respectively. Of 22 performed colonoscopies at W52, 11 (50%) showed endoscopic remission. Adverse events occurred in 14 (24.1%) patients, but only 2 (3.4%) led to tofacitinib discontinuation.

conclusionsIn a real-life setting of patients with anti-TNF refractory UC, tofacitinib has proved to be effective in preventing colectomy and inducing clinical and endoscopic remission at 52 weeks with a good safety profile.

Indexed as

ColectomyColitis, UlcerativePiperidinesPyrimidinesAdultFemaleHumansItalyJanus Kinase InhibitorsMaleMiddle AgedProspective StudiesProtein Kinase InhibitorsRemission InductionTreatment OutcomeTumor Necrosis Factor InhibitorsJanus Kinase InhibitorsPiperidinesProtein Kinase InhibitorsPyrimidinestofacitinibTumor Necrosis Factor InhibitorsBiologic therapyInflammatory bowel diseaseJAK-inhibitorSurgery

Identifiers

PMID38530500
OpenAlexW4393192002

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.