Evidence map›Paper›PMID 40535533›Full record

ArticleTherapeutic advances in gastroenterology2025

Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase.

Lisa Nyberg, Jonas Halfvarson, Jonas Söderling, Ola Olén, Hans Strid, Charlotte R H Hedin, Sara B Jónsdóttir, Henrik Hjortswang, Susanna Jäghult, Joseph C Cappelleri and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04338204 (OBSERVATIONAL STUDY OF TOFACITINIB IN ULCERATIVE COLITIS IN SWEDEN), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04338204 completednot on this map

Observational study of tofacitinib in ulcerative colitis in sweden (oden)

TypeobservationalSponsorPfizerRan2020 to 2025Enrolled102ConditionsUlcerative ColitisArmstofacitinib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

15 authors.

Lisa NybergDepartment of Gastroenterology, Skåne University Hospital, Jan Waldenströms gata 16, 205 02 Malmö, Sweden.ORCID https://orcid.org/0000-0001-8102-4458
Jonas HalfvarsonDepartment of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.ORCID https://orcid.org/0000-0003-0122-7234
Jonas SöderlingDivision of Clinical Epidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-9006-2835
Ola OlénDivision of Clinical Epidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-5478-7019
Hans StridKarolinska University Hospital, Centre for Digestive Health, Stockholm, Sweden.ORCID https://orcid.org/0000-0003-4651-6769
Charlotte R H HedinDepartment of Gastroenterology, Dermatovenereology and Rheumatology, Centre for Digestive Health, Karolinska University Hospital, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-4921-8516
Sara B JónsdóttirDepartment of Gastroenterology, Dermatovenereology and Rheumatology, Centre for Digestive Health, Karolinska University Hospital, Stockholm, Sweden.
Henrik HjortswangDepartment of Health, Medicine and Caring Sciences, division of Gastroenterology and Hepatology, Linköping University, Linköping, Sweden.ORCID https://orcid.org/0000-0001-6352-5419
Susanna JäghultDepartment of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-6352-5419
Joseph C CappelleriPfizer Inc., Statistical Research and Data Science Center, Groton, CT, USA.ORCID https://orcid.org/0000-0001-9586-0748
Dan HenrohnDepartment of Medical Affairs, Pfizer AB, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-9514-1153
Maria SeddighzadehDepartment of Medical Affairs, Pfizer AB, Stockholm, Sweden.ORCID https://orcid.org/0009-0006-7059-5128
Jan MarsalDepartment of Clinical Sciences, Lund University, Lund, Sweden.ORCID https://orcid.org/0000-0003-4808-0014
Olof GripDepartment of Gastroenterology, Skåne University Hospital, Malmö, Sweden.ORCID https://orcid.org/0000-0001-5033-7451
SWIBREG ODEN Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Tofacitinib is a Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Prospective real-world data are scarce. Objectives: To collect data on clinical outcomes, including health-related quality of life (HRQoL) and fatigue during treatment with tofacitinib. Design: This is a prospective observational multicentre study in Sweden. In this analysis, outcomes at weeks 2, 8 and 16 are reported. Methods: Patients with active UC confirmed with endoscopy or faecal calprotectin (FC) were enrolled during 2020-2023 when starting tofacitinib therapy. Results: In total, 103 patients were included. After 2 weeks of treatment, 50% (39/78) had achieved symptomatic response and at week 16, 39% (35/89) had achieved corticosteroid-free clinical remission according to the partial Mayo score. At week 16, a reduction in FC by ⩾50% was seen in 49% (35/71) and 24% (11/46) were in endoscopic remission. The frequency of arthralgia decreased from 29% (30/103) at baseline to 11% (10/89) at week 16. Regarding HRQoL at week 16; each of the four Short Health Scale dimensions (symptoms, social function, disease-related worry and general well-being) had improved by a median of 1 point ( Conclusion: Induction therapy with tofacitinib therapy was associated with improvements in patient-reported outcome measures of symptoms, endoscopic activity, arthralgia, HRQoL and fatigue. These real-world data illustrate that tofacitinib is a fast-acting drug with broad therapeutic effects in UC. ClinicalTrial registration number: NCT04338204.

Indexed as

fatiguehealth-related quality of lifeJAK inhibitortofacitinibulcerative colitis

Identifiers

PMID40535533
PMCPMC12174757

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.