Evidence map›Paper›PMID 34035832›Full record

ArticleTherapeutic advances in gastroenterology2021

Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis.

David T Rubin, Walter Reinisch, Thomas Greuter, Paulo G Kotze, Marcia Pinheiro, Rajiv Mundayat, Eric Maller, Marc Fellmann, Nervin Lawendy, Irene Modesto and 2 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT01458574 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

TypeinterventionalSponsorPfizerRan2012 to 2016Enrolled593ConditionsUlcerative ColitisArmsPlacebo, CP690,550, CP-690,550
NCT01458951 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

TypeinterventionalSponsorPfizerRan2012 to 2015Enrolled547ConditionsUlcerative ColitisArmstofacitinib, Placebo
NCT01465763 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

TypeinterventionalSponsorPfizerRan2012 to 2015Enrolled614ConditionsUlcerative ColitisArmstofacitinib, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Updated review of Janus kinase inhibitors for the management of inflammatory bowel disease.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. User's guide to JAK inhibitors in inflammatory bowel disease.Current research in pharmacology and drug discovery · 2022
    Review
  14. JAK1 inhibition and inflammatory bowel disease.Rheumatology (Oxford, England) · 2021
    Review
  15. 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

12 authors at 7 institutions in 4 countries.

David T RubinUniversity of Chicago Medicine, Inflammatory Bowel Disease Center, 5841 S. Maryland Avenue, MC4076, Chicago, IL 60637, USA.
Walter ReinischMedical University of Vienna, Vienna, Austria.
Thomas GreuterDepartment of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.
Paulo G KotzeIBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil.ORCID https://orcid.org/0000-0002-9632-6691
Marcia PinheiroPfizer Inc., São Paulo, Brazil.
Rajiv MundayatPfizer Inc., New York, NY, USA.
Eric MallerPfizer Inc., Collegeville, PA, USA.
Marc FellmannPfizer Switzerland AG, Zürich, Switzerland.
Nervin LawendyPfizer Inc., Collegeville, PA, USA.
Irene ModestoPfizer Inc., New York, NY, USA.
Stephan R VavrickaDepartment of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.
Gary R LichtensteinDivision of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Pfizer (United States) · USUniversity Hospital of Zurich · CHMedical University of Vienna · ATPfizer (Switzerland) · CHPontifícia Universidade Católica do Paraná · BRUniversity of Chicago · USUniversity of Pennsylvania · US

Funding

ULTRASTRUCTURE AND CYTOMORPHOLOGY COREP30DK042086 · NIDDK · UNIVERSITY OF CHICAGO · PI CHANG, EUGENE B · 1990 to 2025
$29.8M
NIDDK NIH HHS P30 DK042086
6 · The paper itself

Abstract

introductionExtraintestinal manifestations (EIMs) in patients with ulcerative colitis (UC) are common. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. We evaluated the efficacy of tofacitinib in patients with EIMs, and the impact of tofacitinib on EIMs in patients with UC in the OCTAVE clinical program.

methodsData from two 8-week induction studies (OCTAVE Induction 1 and 2) and a 52-week maintenance study (OCTAVE Sustain) were analyzed. The effect of tofacitinib on efficacy outcomes stratified by EIM status, proportion of predefined prior and active EIMs at baseline, and change from baseline in EIMs were determined at the end of the treatment period (weeks 8 or 52), or at early termination.

resultsAt baseline of OCTAVE Induction 1 and 2, and OCTAVE Sustain, 27.0% and 9.0% of patients had a history of EIMs (prior or active), respectively. Patients treated with tofacitinib 10 mg twice daily (BID) achieved remission and had endoscopic improvement in all studies, irrespective of any history of EIMs. A greater proportion of patients had active peripheral arthritis at baseline of OCTAVE Induction 1 and 2

conclusionAny history of EIMs did not influence the efficacy of tofacitinib 10 mg BID for induction or maintenance of UC. The most common active EIM was peripheral arthritis, for which many patients in OCTAVE Induction 1 and 2, and OCTAVE Sustain, reported improvement or no change from baseline with tofacitinib treatment.Clinicaltrials.gov:NCT01465763; NCT01458951; NCT01458574.

Indexed as

extraintestinal manifestationstofacitinibulcerative colitis

Identifiers

PMID34035832
PMCPMC8132089
OpenAlexW3163340018

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.