Evidence map›Paper›PMID 31722059›Full record

Observational studyDigestive diseases and sciences2020

Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis.

Fabrizio Bossa, Giuseppe Biscaglia, Maria Rosa Valvano, Giuseppe Costantino, Angelo Lauria, Rocco Clemente, Concetta Ferracane, Endrit Shahini, Marco Mendolaro, Laurino Grossi and 25 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–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

10 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Observational
  10. Observational
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

35 authors.

Fabrizio BossaGastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy. kostu.diamantopulu@gmail.com.ORCID 0000-0002-4518-9949
Giuseppe BiscagliaGastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy.
Maria Rosa ValvanoGastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy.
Giuseppe CostantinoClinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy.
Angelo LauriaGrande Ospedale Metropolitano Reggio Calabria, Reggio Calabria, Italy.
Rocco ClementeUOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy.
Concetta FerracaneIBD Unit Azienda Ospedaliera per l'Emergenza "Cannizzaro", Catania, Italy.
Endrit ShahiniEmergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy.
Marco MendolaroGastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy.
Laurino GrossiGastroenterology Unit, University of Pescara, Pescara, Italy.
Silvia MazzuoliGastroenterology and Artificial Nutrition Department, "San Nicola Pellegrino" Hospital, Trani, Italy.
Antonio RispoClinical Medicine and Surgery Department, Section of Gastroenterology, University "Federico II" of Naples, Naples, Italy.
Giuseppe PranzoSurgery Unit, Valle D'Itria Hospital, Martina Franca, Italy.
Ladislava SebkovaGastroenterology Unit, Pugliese Ciaccio Hospital, Catanzaro, Italy.
Antonio TursiGastroenterology Service, ASL BAT, Andria, Italy.
Agnese Miranda"F. Magrassi" Clinical and Experimental Medicine Department, Università della Campania "Luigi Vanvitelli", Naples, Italy.
Marta PatturelliUOSD Gastroenterologia, Università della Campania "Luigi Vanvitelli", Naples, Italy.
Rocco SpagnuoloGastroenterology and Digestive Endoscopy Department, University of Catanzaro, Catanzaro, Italy.
Cristina RicciardelliGastroenterology Unit, Poggiardo Hospital, Poggiardo, Italy.
Caterina SgarroGastroenterology and Digestive Endoscopy Unit, OORR, Foggia, Italy.
Pietro PaeseGastroenterology Unit, Ospedale Annunziata, Cosenza, Italy.
Gaetano InserraInternal Medicine, Medical and Pediatric Sciences Department, University of Catania, Catania, Italy.
Alessandro AzzaroneGastroenterology Unit, Ospedale San Paolo, Bari, Italy.
Olga NardoneClinical Medicine and Surgery Department, Section of Gastroenterology, University "Federico II" of Naples, Naples, Italy.
Walter FriesClinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy.
Nello BucciantiUOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy.
Antonino Carlo PriviteraIBD Unit Azienda Ospedaliera per l'Emergenza "Cannizzaro", Catania, Italy.
Maria Beatrice PrincipiEmergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy.
Maria CappelloGastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy.
Francesco William GuglielmiGastroenterology and Artificial Nutrition Department, "San Nicola Pellegrino" Hospital, Trani, Italy.
Marco Romano"F. Magrassi" Clinical and Experimental Medicine Department, Università della Campania "Luigi Vanvitelli", Naples, Italy.
Gabriele RieglerUOSD Gastroenterologia, Università della Campania "Luigi Vanvitelli", Naples, Italy.
Libera FanigliuloGastroenterology Unit, Ospedale Santissima Annunziata, Taranto, Italy.
Raffaele MelinaGastroenterology Unit, Ospedale San Giuseppe Moscati, Avellino, Italy.
Angelo AndriulliGastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGolimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis.

aimsTo assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response.

methodsConsecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system.

resultsA total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p < 0.001). Multivariate analysis revealed that a higher total Mayo score (p < 0.001, OR 1.5, 95% CI 1.2-1.8) and naïve status to anti-TNF-alpha (p = 0.015, OR 3.0, 95% CI 1.2-7.5) were predictive of a favorable response. Seventy-seven (39.3%) of the 130 responders maintained a response at month 12 of therapy. There were 17 adverse events, 28 patients needed hospitalization, and 15 patients underwent surgery. Self-administration of the drug was appreciated by most patients.

conclusionsThe efficacy and safety of golimumab in daily clinical practice were confirmed for the short- and long-term treatment of patients with active ulcerative colitis. Patients naïve to the anti-TNF-alpha monoclonal antibody and those with a higher total Mayo score were more likely to respond to golimumab.

Indexed as

AdultAntibodies, MonoclonalCohort StudiesColitis, UlcerativeDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedYoung AdultAntibodies, MonoclonalgolimumabAnti-TNF-alphaBiologicsGolimumabInflammatory bowel diseaseUlcerative colitis

Identifiers

PMID31722059

What OpenQuestion holds

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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.