Evidence map›Paper›PMID 33845784›Full record

ArticleBMC gastroenterology2021

Golimumab improves work productivity in patients suffering from moderate to severe ulcerative colitis: results of a prospective study over 24 months.

Niels Teich, Harald Grümmer, Eric Jörgensen, Thomas Liceni, Frank Holtkamp-Endemann, Tim Fischer, Susanne Hohenberger

Open access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Golimumab Ameliorates Pancreatic Inflammatory Response in the Cerulein-Induced Acute Pancreatitis in Rats.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2022
    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

7 authors at 1 institution in 1 country.

Niels TeichInternistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten Leipzig Und Schkeuditz, Nordstraße 21, 04105, Leipzig, Sachsen, Germany. teich@igvs.de.
Harald GrümmerPraxis Für Innere Medizin/Gastroenterologie, Allee Nach Sanssouci 7, 14471, Potsdam, Germany.
Eric JörgensenMagen-Darm-Zentrum Remscheid, Rosenhügelerstraße 2, 42859, Remscheid, Germany.
Thomas LiceniMVZ Für Gastroenterologie Am Bayerischen Platz, Innsbrucker Straße 58, 10825, Berlin, Germany.
Frank Holtkamp-EndemannGastroenterologische Gemeinschaftspraxis Am Germania-Campus, An der Germania Brauerei 6, 48159, Münster, Germany.
Tim FischerMedical Affairs, MSD Sharp & Dohme GmbH, Lindenplatz 1, 85540, Haar, Germany.
Susanne HohenbergerMedical Affairs, MSD Sharp & Dohme GmbH, Lindenplatz 1, 85540, Haar, Germany.
MSD (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUlcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany.

methodsUsing the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed.

resultsThis prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of - 17.3% (p < 0.0001) and - 14.4% (p < 0.0001), respectively. Results persisted over 24 months (mean change TWPI score: - 24.5%, mean change activity impairment score: - 30.0%). Disease- and health-related QoL also improved significantly under golimumab treatment as indicated by increased IBDQ [mean change: 28.0 (SD: ± 36.1, month 3), 42.1 (SD: ± 39.5, month 24)] and SF-12 scores [PCS-12: 45.9 (SD: ± 8.5), MCS-12: 4.9 (SD: ± 10.6, month 3), PCS-12: 5.9 (SD: ± 9.0), MCS-12: 6.4 (SD: ± 11.1, month 24)]. Disease-related hospitalization rate decreased from 16.0% (BL) to 4.3% at month 24 and the mean number of missed working days due to UC decreased from 8.2 (SD: 17.6, BL) to 0.7 (SD: 2.1) after golimumab induction.

conclusionsGolimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC.

trial registrationPEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 ( https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html ).

Indexed as

Colitis, UlcerativeQuality of LifeAntibodies, MonoclonalGermanyHumansProspective StudiesSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalgolimumabGolimumabHealth care resource utilization (HCRU)HospitalizationQuality of lifeUlcerative colitisWork productivity and activity impairment (WPAI)

Identifiers

PMID33845784
PMCPMC8042988
OpenAlexW3156412953

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.