Evidence map›Paper›PMID 33290538›Full record

Trial reportJournal of Crohn's & colitis2021

Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial.

Séverine Vermeire, Chinyu Su, Nervin Lawendy, Taku Kobayashi, William J Sandborn, David T Rubin, Irene Modesto, Sean Gardiner, Nicole Kulisek, Haiying Zhang and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 3% 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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Major cardiovascular event risk of advanced therapies in inflammatory bowel diseases: systematic review and meta-analysis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Review
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Article
  17. Upfront tofacitinib in patients with biological-naïve ulcerative colitis - An Indian multicentric experience.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Article
  18. Tofacitinib use in ulcerative colitis: An expert consensus for day-to-day clinical practice.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 4 countries.

Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Chinyu SuPfizer Inc, Collegeville, PA, USA.
Nervin LawendyPfizer Inc, Collegeville, PA, USA.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
David T RubinUniversity of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA.ORCID 0000-0001-5647-1723
Irene ModestoPfizer Inc, New York, NY, USA.
Sean GardinerPfizer Inc, New York, NY, USA.
Nicole KulisekPfizer Inc, Collegeville, PA, USA.
Haiying ZhangPfizer Inc, Collegeville, PA, USA.
Wenjin WangPfizer Inc, Collegeville, PA, USA.
Julian PanésHospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Pfizer (United States) · USHospital Clínic de Barcelona · ESKitasato Institute Hospital · JPKU Leuven · BEUniversity of California San Diego · USUniversity of Chicago · US

Funding

ULTRASTRUCTURE AND CYTOMORPHOLOGY COREP30DK042086 · NIDDK · UNIVERSITY OF CHICAGO · PI LIU, CAMBRIAN YANGSHAO · 1990 to 2025
$29.8M
NIDDK NIH HHS P30 DK042086Pfizer Inc
6 · The paper itself

Abstract

BACKGROUND AND

aimsTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present primary completion analysis from RIVETING, an ongoing, double-blind, randomised, parallel-group trial evaluating efficacy and safety of tofacitinib dose reduction to 5 mg twice daily [BID] versus remaining on 10 mg BID in patients in stable remission on tofacitinib 10 mg BID maintenance therapy.

methodsPatients had received tofacitinib 10 mg BID for ≥ 2 consecutive years and been in stable remission for ≥ 6 months before enrolment. The primary endpoint was modified Mayo score remission at Month 6. Safety was assessed up to February 20, 2020 [data cut-off].

resultsIn all, 140 patients were randomised [1:1] to tofacitinib 5 or 10 mg BID; 77.1% and 90.0% of patients in the 5 and 10 mg BID groups, respectively, were in modified Mayo score remission at Month 6 (adjusted difference 12.9%; 95% confidence interval [CI] 0.5-25.0). Smaller differences between treatment groups were seen in patients with baseline endoscopic subscore of 0 versus 1 [9.8%; -3.0-22.6, and 21.1%; -6.1-48.2, respectively], and in patients without versus with prior tumour necrosis factor inhibitor [TNFi] failure [9.5%; -6.6-25.6, and 17.4%; -1.6-36.3, respectively]. Adverse events [AE] and serious AE rates were similar across treatment groups; no deaths were reported.

conclusionsMost patients in stable remission on 10 mg BID maintenance therapy maintained remission following dose de-escalation. For patients who dose de-escalated, those in deep endoscopic remission and those without prior TNFi failure were more likely to maintain remission. Efficacy data were limited to the first 6 months; a longer duration of follow-up during RIVETING will further characterise the impact of dose reduction on maintenance of remission. Safety findings were consistent with the established safety profile of tofacitinib.

Indexed as

Administration, OralColitis, UlcerativeDouble-Blind MethodDrug TaperingFemaleHumansMaintenance ChemotherapyMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPyrimidinesRemission InductionPiperidinesProtein Kinase InhibitorsPyrimidinestofacitinibDose adjustmentmaintenancetofacitinib

Identifiers

PMID33290538
PMCPMC8256630
OpenAlexW3112731988

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.