Evidence map›Paper›PMID 33203342›Full record

Observational studyUnited European gastroenterology journal2021

Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study.

Daniela Pugliese, Giuseppe Privitera, Francesca Rogai, Angela Variola, Anna Viola, Lucrezia Laterza, Antonino C Privitera, Mariangela Allocca, Fabrizio Bossa, Maria Cappello and 22 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in United European gastroenterology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 15% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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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

32 authors at 20 institutions in 2 countries.

Daniela PuglieseCEMAD - IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-7930-5402
Giuseppe PriviteraDipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0002-7020-5808
Francesca RogaiGastroenterology Department, IBD Referral Centre, Careggi University Hospital, Florence, Italy.
Angela VariolaIBD Unit, IRCCS Sacro Cuore Don Calabria, Negrar, Italy.
Anna ViolaInflammatory Bowel Disease Unit, A.O.U. Policlinico G. Martino, Messina, Italy.ORCID 0000-0002-1733-6489
Lucrezia LaterzaCEMAD - IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Antonino C PriviteraInflammatory Bowel Disease Unit, A.O. Cannizzaro, Catania, Italy.
Mariangela AlloccaIBD Centre, Humanitas Clinical and Research Centre, Milan, Italy.
Fabrizio BossaGastroenterology Unit, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Maria CappelloAO Ordine Mauriziano, SC Gastroenterologia, Turin, Italy.
Marco DapernoGastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy.
Greta LorenzonDivision of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, Gastroenterology Section, University Hospital of Padua, Padua, Italy.
Silvia MazzuoliGastroenterology and Artificial Nutrition Department, 'San Nicola Pellegrino' Hospital, Trani, Italy.
Mariabeatrice PrincipiEmergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy.
Renato SablichGastroenterology Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.
Luisa MoserGastroenterology Unit, Department of Medicine, University of Verona, Policlinico G.B. Rossi, Verona, Italy.
Antonio FerronatoDigestive Endoscopy Unit, ULSS7 Pedemontana, Santorso, Italy.
Sara TrainiUOC Gastroenterologia ed Endoscopia Digestiva Ospedale Civile A, Murri, Italy.
Gherardo TapeteDepartment of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Giorgia BodiniGastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.
Maria Di GirolamoDepartment of Internal Medicine, Gastroenterology Unit, University of Modena and Reggio Emilia, Modena, Italy.
Laurino GrossiGastroenterology Unit, University of Pescara, Pescara, Italy.
Giammarco MocciDivision of Gastroenterology, 'Brotzu' Hospital, Cagliari, Italy.
Chiara RicciDepartment of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Simone SaibeniGastroenterology Unit, Rho Hospital, ASST Rhodense, Garbagnate, Milanese, Italy.ORCID 0000-0001-5677-2534
Stefano FestaIBD Unit, San Filippo Neri Hospital, Rome, Italy.ORCID 0000-0002-4635-3050
Rocco SpagnuoloGastroenterology and Digestive Endoscopy Department, University of Catanzaro, Catanzaro, Italy.
Claudio C CortelezziGastroenterology Unit, 'Ospedale di Circolo', Varese, Italy.
Filippo MocciaroGastroenterology and Endoscopy Unit, A.R.N.A.S Civico-Di Cristina- Benfratelli Hospital, Palermo, Italy.
Fernando RizzelloDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Alessandro ArmuzziCEMAD - IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)
Agostino Gemelli University Polyclinic · ITUniversità Cattolica del Sacro Cuore · ITA. O. Ordine Mauriziano di Torino · ITATS Sardegna (Italy) · ITAULSS 2 Marca Trevigiana · ITAzienda di Rilievo Nazionale ed Alta Specializzazione · ITAzienda Ospedaliera G. Brotzu · ITAzienda Ospedaliera Santa Maria Degli Angeli · ITAzienda Ospedaliera Universitaria Policlinico "G. Martino" · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITAzienda USL di Pescara · ITCasa Sollievo della Sofferenza · ITHumanitas University · ITMagna Graecia University · ITOspedale Cannizzaro · ITOspedale dei Pellegrini · ITOspedale Sacro Cuore Don Calabria · ITOspedale San Filippo Neri · ITSociedad Española de Endoscopia Digestiva · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFew data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response.

objectiveThis study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.

methodsConsecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy.

resultsA total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44-6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34-8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08-8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients.

conclusionsBiological-naïve status and not requiring steroids at Weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalColitis, UlcerativeFemaleFollow-Up StudiesGastrointestinal AgentsHumansMaleMiddle AgedProspective StudiesRetrospective StudiesTumor Necrosis Factor-alphaYoung AdultAntibodies, MonoclonalGastrointestinal AgentsgolimumabTumor Necrosis Factor-alphagolimumabnaïvepersistenceremissionulcerative colitis

Identifiers

PMID33203342
PMCPMC8259241
OpenAlexW3105870543

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.