Evidence map›Paper›PMID 35380664›Full record

ArticleInflammatory bowel diseases2023

Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program.

Marla C Dubinsky, Fernando Magro, Flavio Steinwurz, David P Hudesman, Jami A Kinnucan, Ryan C Ungaro, Markus F Neurath, Nicole Kulisek, Jerome Paulissen, Chinyu Su and 2 more

4 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 12% 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
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
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. C-Reactive Protein Is Not the Driver Factor in Ulcerative Colitis.Gastroenterology research and practice · 2024
    Article
  9. 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

12 authors at 8 institutions in 4 countries.

Marla C DubinskyIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0003-4968-5795
Fernando MagroUniversity of Porto and Centro Hospitalar São João, Porto, Portugal.ORCID 0000-0003-2634-9668
Flavio SteinwurzUnit of Inflammatory Bowel Disease, Hospital Israelita Albert Einstein, São Paulo, Brazil.
David P HudesmanNew York University, New York, NY, USA.
Jami A KinnucanMayo Clinic Division of Gastroenterology and Hepatology, Jacksonville, FL, USA.
Ryan C UngaroDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Markus F NeurathDepartment of Medicine, University of Erlangen-Nürnberg, University Hospital, Erlangen, Germany.
Nicole KulisekPfizer Inc, Collegeville, PA, USA.
Jerome PaulissenPfizer Inc, New York, NY, USA.
Chinyu SuPfizer Inc, Collegeville, PA, USA.
Dario Ponce de LeonPfizer Inc, Lima, Peru.
Miguel RegueiroDepartment of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-7681-8111
Pfizer (United States) · USIcahn School of Medicine at Mount Sinai · USCleveland Clinic · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHospital Israelita Albert Einstein · BRJacksonville College · USNew York University · USUniversidade do Porto · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). These post hoc analyses assessed associations between C-reactive protein (CRP), partial Mayo score (PMS), and efficacy outcomes during tofacitinib induction in UC.

methodsPatients received tofacitinib 10 mg twice daily (BID) in an 8-week, phase 2 induction study and 2 identical, 8-week, phase 3 induction studies (OCTAVE Induction 1&2); induction nonresponders (IndNR) received an additional 8 weeks of tofacitinib 10 mg BID in an open-label, long-term extension study. Associations between CRP and PMS, and efficacy outcomes (clinical response, clinical remission, endoscopic improvement, and endoscopic remission) were analyzed using univariate and multivariable logistic regression and receiver operating characteristic curves.

resultsChanges from baseline in the logarithm of CRP ([log]CRP) and PMS at week 4 were associated with clinical response at week 8 (univariate: per unit, odds ratio [OR], 0.55 [95% confidence interval (CI), 0.48-0.62]; and 0.42 [0.37-0.47], respectively). Among IndNR, change from baseline in PMS at week 8 was associated with clinical response at week 16 (univariate: per unit, OR, 0.59; 95% CI, 0.46-0.75). C-reactive protein at week 4 (area under the curve [AUC] > 0.6) and PMS at weeks 2 and 4 (AUC, > 0.7) generally exhibited predictive value for week 8 efficacy outcomes.

conclusionsPatients who achieved clinical response at week 8 had larger decreases in CRP and PMS at week 4 than patients who did not. IndNR who achieved clinical response at week 16 with extended tofacitinib induction had a larger decrease in PMS at week 8 vs those who did not. ClinicalTrials.gov:NCT00787202;NCT01465763;NCT01458951;NCT01470612.

Indexed as

Colitis, UlcerativeJanus Kinase InhibitorsC-Reactive ProteinHumansInduction ChemotherapyPiperidinesPyrimidinesRemission InductionTreatment OutcomeC-Reactive ProteinJanus Kinase InhibitorsPiperidinesPyrimidinestofacitinibC-reactive proteininflammatory bowel diseasepartial Mayo score

Identifiers

PMID35380664
PMCPMC9825285
OpenAlexW4226046485

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.