Evidence map›Paper›PMID 42227576›Full record

Observational studyCanadian journal of gastroenterology & hepatology2026

Clinical Response and Improvement of the Quality of Life, Fatigue, Mood, and Sleep Disturbances During Vedolizumab Induction Therapy in Polish Patients With Moderate-to-Severe Ulcerative Colitis or Crohn's Disease.

Agata Michalak, Iwona Zawada, Anna Deskur, Maria Kopertowska-Majchrzak, Renata Talar-Wojnarowska, Danuta Domżał-Magrowska, Piotr Eder, Kamila Stawczyk-Eder, Katarzyna Waszak, Grażyna Rydzewska-Wyszkowska and 17 more

Abstract readObservational Study
In one paragraph

Observational study in Canadian journal of gastroenterology & hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

27 authors.

Agata MichalakDepartment of Gastroenterology With Endoscopic Unit, Medical University of Lublin, Lublin, Poland, umlub.pl.ORCID https://orcid.org/0000-0003-4426-6321
Iwona ZawadaDepartment of Gastroenterology, Prof. Tadeusz Sokołowski's University Clinical Hospital No. 1 of the Pomeranian Medical University, Szczecin, Poland.ORCID https://orcid.org/0000-0002-6379-0164
Anna DeskurDepartment of Gastroenterology, Prof. Tadeusz Sokołowski's University Clinical Hospital No. 1 of the Pomeranian Medical University, Szczecin, Poland.ORCID https://orcid.org/0000-0001-6809-5243
Maria Kopertowska-MajchrzakDepartment of Internal Diseases, General Hospital, Międzychód, Poland, ghlagos.org.ng.ORCID https://orcid.org/0000-0002-7102-2720
Renata Talar-WojnarowskaDepartment of Digestive Tract Diseases, Medical University of Lodz, Lodz, Poland, umed.pl.ORCID https://orcid.org/0000-0003-3887-2712
Danuta Domżał-MagrowskaDepartment of Digestive Tract Diseases, Medical University of Lodz, Lodz, Poland, umed.pl.ORCID https://orcid.org/0000-0001-5937-0944
Piotr EderDepartment of Gastroenterology, Dietetics and Internal Medicine, Poznan University Clinical Hospital, Poznan University of Medical Sciences, Poznan, Poland, ump.edu.pl.ORCID https://orcid.org/0000-0001-9306-5038
Kamila Stawczyk-EderDepartment of Gastroenterology, Dietetics and Internal Medicine, Poznan University Clinical Hospital, Poznan University of Medical Sciences, Poznan, Poland, ump.edu.pl.ORCID https://orcid.org/0000-0001-9368-0188
Katarzyna WaszakDepartment of Gastroenterology, Dietetics and Internal Medicine, Poznan University Clinical Hospital, Poznan University of Medical Sciences, Poznan, Poland, ump.edu.pl.ORCID https://orcid.org/0000-0001-9385-2234
Grażyna Rydzewska-WyszkowskaDepartment of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland.ORCID https://orcid.org/0000-0002-1267-7620
Katarzyna MaciejewskaDepartment of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland.ORCID https://orcid.org/0000-0002-8127-6118
Katarzyna KarłowiczDepartment of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland.ORCID https://orcid.org/0000-0002-1310-3274
Anita GąsiorowskaDepartment of Gastroenterology, Medical University of Lodz, Lodz, Poland, umed.pl.ORCID https://orcid.org/0000-0001-8288-3721
Aleksandra KaczkaDepartment of Gastroenterology, Medical University of Lodz, Lodz, Poland, umed.pl.ORCID https://orcid.org/0000-0002-9041-5706
Łukasz KoneckiDepartment of Gastroenterology, Military Institute of Medicine, Warsaw, Poland, wim.mil.pl.ORCID https://orcid.org/0000-0002-7731-2358
Michał KroguleckiDepartment of Gastroenterology, Military Institute of Medicine, Warsaw, Poland, wim.mil.pl.ORCID https://orcid.org/0000-0002-9060-7652
Aleksandra FilipiukDepartment of Gastroenterology, Military Institute of Medicine, Warsaw, Poland, wim.mil.pl.ORCID https://orcid.org/0000-0002-6700-2719
Maria KłopockaDepartment of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Poland, umk.pl.ORCID https://orcid.org/0000-0003-2149-5826
Ariel LiebertDepartment of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Poland, umk.pl.ORCID https://orcid.org/0000-0002-1020-4707
Marek HartlebDepartment of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland, sum.edu.pl.ORCID https://orcid.org/0000-0001-5301-8931
Magdalena Gawron-KiszkaDepartment of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland, sum.edu.pl.ORCID https://orcid.org/0000-0002-0885-6351
Elżbieta PoniewierkaDepartment of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland, umed.wroc.pl.ORCID https://orcid.org/0000-0002-2074-976X
Iga GromnyDepartment of Gastroenterology, Hepatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, umed.wroc.pl.ORCID https://orcid.org/0000-0001-6858-176X
Edyta ZagórowiczDepartment of Oncological Gastroenterology, The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, karolinska.se.ORCID https://orcid.org/0000-0003-3488-2593
Rafał FilipDepartment of Gastroenterology of the Centre for Comprehensive Treatment of Inflammatory Bowel Diseases, Clinical Regional Hospital No. 2, Rzeszow, Poland.ORCID https://orcid.org/0000-0002-5954-151X
Eliza MajewskaMedical Department, Takeda Pharma sp. z o.o, Warsaw, Poland.ORCID https://orcid.org/0009-0000-3626-4006
Halina Cichoż-LachDepartment of Gastroenterology With Endoscopic Unit, Medical University of Lublin, Lublin, Poland, umlub.pl.ORCID https://orcid.org/0000-0002-7337-835X

Funding

Hanna Kurlanda-Witek of Proper MedicalTakeda Pharmaceutical Company
6 · The paper itself

Abstract

backgroundInflammatory bowel disease (IBD) encompasses chronic gastrointestinal disorders that significantly impact patients' quality of life (QoL). While clinical trials support the efficacy and safety of vedolizumab, real-world data linking its effectiveness to QoL-related patient-reported outcomes remain limited. This prospective observational study assessed the effects of 14-week vedolizumab induction therapy on QoL (i.e., fatigue, mood, and sleep disturbances), clinical response, safety, and predictors of response.

methodsA total of 257 patients with ulcerative colitis (UC; n = 205) and Crohn's disease (CD; n = 52) received 14-week vedolizumab induction therapy. Disease activity, QoL (assessed using the total Inflammatory Bowel Disease Questionnaire [IBDQ]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), mood and sleep disturbances (PROMIS Depression and Sleep Disturbance scales), and selected biomarkers were evaluated. Clinical response was assessed using the Mayo score for UC and Crohn's Disease Activity Index (CDAI) score for CD.

resultsAt Week 14, clinical response was observed in 82% of UC patients and 82.7% of CD patients. Median total IBDQ scores increased by 45.0 points in UC and 31.5 points in CD (p < 0.001). Median prorated FACIT-Fatigue scores increased by 5.0 points in both groups (p < 0.001), while median prorated PROMIS Sleep Disturbance and Depression T-scores decreased (p < 0.05). Improvement in QoL was moderately correlated with clinical response (r = 0.5). In logistic regression analysis, baseline patient characteristics indicative of advanced disease were associated with a reduced likelihood of clinical and QoL response to treatment. A total of 28 adverse events were reported, including 11 serious events and four treatment-related events.

conclusionsVedolizumab reduced disease activity and led to a rapid improvement in QoL during the 14-week induction therapy in patients with IBD. Clinical response was positively correlated with QoL improvement. Predictors of reduced response were consistent with features of advanced disease.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeCrohn DiseaseFatigueGastrointestinal AgentsQuality of LifeSleep Wake DisordersAdultAffectFemaleHumansMaleMiddle AgedPolandProspective StudiesSeverity of Illness IndexAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabCrohn’s diseaseinflammatory bowel diseasequality of lifeulcerative colitisvedolizumab

Identifiers

PMID42227576
PMCPMC13580841

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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.