Evidence map›Paper›PMID 38425446›Full record

ArticleCrohn's & colitis 3602024

Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis.

David T Rubin, Joana Torres, Miguel Regueiro, Walter Reinisch, Lani Prideaux, Paulo G Kotze, Fiona H Tan, Sean Gardiner, Rajiv Mundayat, Mary Jane Cadatal and 1 more

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

Article in Crohn's & colitis 360, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.2field-weighted citation impact, top 13% 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.

NCT00787202 phase2completednot on this map

A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

TypeinterventionalSponsorPfizerRan2008 to 2010Enrolled195ConditionsUlcerative ColitisArmsCP- 690 550, placebo
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
NCT01470612 phase3completednot on this map

A multi-center, open-label study of cp-690,550 in subjects with moderate to severe ulcerative colitis

TypeinterventionalSponsorPfizerRan2012 to 2020Enrolled944ConditionsUlcerative ColitisArmsCP-690,550
NCT03281304 phase4terminatednot on this map

A phase 3b/4, multi-center, double-blind, randomized, parallel group study of tofacitinib (cp-690,550) in subjects with ulcerative colitis in stable remission

TypeinterventionalSponsorPfizerRan2017 to 2022Enrolled140ConditionsUlcerative ColitisArmsCP-690,500 5 mg, CP-690,550 10 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

11 authors at 9 institutions in 6 countries.

David T RubinInflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.
Joana TorresGastroenterology Division, Hospital Beatriz Ângelo, Loures, Portugal.ORCID https://orcid.org/0000-0003-2895-5821
Miguel RegueiroDepartment of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0002-7681-8111
Walter ReinischDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0002-2088-091X
Lani PrideauxDepartment of Gastroenterology and Hepatology, Monash Medical Centre, Melbourne, Victoria, Australia.
Paulo G KotzeIBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná, Curitiba, Brazil.
Fiona H TanPfizer Australia, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1599-0997
Sean GardinerPfizer Inc, New York, NY, USA.ORCID https://orcid.org/0009-0008-9193-9844
Rajiv MundayatPfizer Inc, New York, NY, USA.
Mary Jane CadatalPfizer Inc, Manila, Philippines.
Siew C NgDepartment of Medicine and Therapeutics, Institute of Digestive Disease, LKS Institute of Health Science, Chinese University of Hong Kong, Sha Tin, Hong Kong, China.
Pfizer (United States) · USChinese University of Hong Kong · HKCleveland Clinic · USMedical University of Vienna · ATMonash Medical Centre · AUPfizer (Australia) · AUPontifícia Universidade Católica do Paraná · BRUniversity of Chicago · USUniversity of Lisbon · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). This analysis assessed the impact of cigarette smoking on tofacitinib efficacy and safety in the UC clinical program. Methods: Efficacy endpoints and adverse events (AEs) were evaluated by smoking status (ever smokers [current and ex-smokers] and never smokers) in the phase (P)2 induction study (baseline demographics and safety only), P3 studies (OCTAVE Induction 1&2, OCTAVE Sustain, OCTAVE Open), and P3/4b RIVETING study. Results: This post hoc analysis included 1156 patients (ever smokers, Conclusions: Efficacy and safety of tofacitinib were generally similar in ever smokers and never smokers. Overall, serious AEs and, as expected, infections were more frequent in ever smokers versus never smokers. This may inform treatment selection and monitoring strategies. ClinicalTrialsgov: NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304.

Indexed as

cigaretteinflammatory bowel diseaseJanus kinase inhibitorulcerative colitis

Identifiers

PMID38425446
PMCPMC10904100
OpenAlexW4391067546

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.