Evidence map›Paper›PMID 36271912›Full record

Trial reportJournal of Crohn's & colitis2023

Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain.

Laura Targownik, Marla C Dubinsky, Flavio Steinwurz, Andrew G Bushmakin, Joseph C Cappelleri, Elaine Tai, Sean Gardiner, Peter Hur, Julian Panés

3 registry-linked trialsAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of Crohn's & colitis, 2023. 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 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

Laura TargownikDivision of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Marla C DubinskySusan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0003-4968-5795
Flavio SteinwurzUnit of Inflammatory Bowel Disease, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Andrew G BushmakinPfizer Inc, Groton, CT, USA.
Joseph C CappelleriPfizer Inc, Groton, CT, USA.
Elaine TaiPfizer Canada Inc, Kirkland, QC, Canada.
Sean GardinerPfizer Inc, New York, NY, USA.
Peter HurPfizer Inc, New York, NY, USA.
Julian PanésFormerly: Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We evaluated the relationship between Mayo/Inflammatory Bowel Disease Questionnaire [IBDQ] scores and Work Productivity and Activity Impairment-UC [WPAI-UC] components in patients with UC.

methodsAll available pooled data from three Phase 3 tofacitinib studies [OCTAVE Induction 1 and 2 and OCTAVE Sustain] were included. Relationships were estimated using repeated measures regression models with Mayo score/subscores or IBDQ total/domain scores as a separate anchor predictor and WPAI-UC components as the outcome.

resultsEvidence for linear relationships was confirmed between Mayo/IBDQ scores and WPAI-UC components. Robust relationships between total Mayo score/IBDQ total score and WPAI-UC presenteeism, work productivity loss, and activity impairment were observed; relationships with absenteeism were weak. Total Mayo scores of 0 and 12 corresponded, on average, to WPAI-UC component scores of < 15% and ≥ 60%, respectively, and IBDQ total scores of 224 and 32 corresponded, on average, to WPAI-UC component scores of < 6% and ≥ 90%, respectively. Presenteeism, work productivity loss, and activity impairment [all 0-100%], respectively, improved on average by 14.7, 13.6, and 16.4 percentage points for every 3-point improvement in total Mayo score, and by 8.1, 7.9, and 8.8 percentage points for every 16-point improvement in IBDQ total score.

conclusionRobust relationships between Mayo/IBDQ scores with WPAI-UC presenteeism, work productivity loss, and activity impairment suggest that patient productivity and non-work activities are strongly associated with disease activity and HRQoL. The weak relationships with absenteeism suggest that patients attend work regardless of their disease activity/poor HRQoL. ClinicalTrials.gov: NCT01465763;NCT01458951;NCT01458574.

Indexed as

Colitis, UlcerativeJanus Kinase InhibitorsHumansPiperidinesQuality of LifeSurveys and QuestionnairesJanus Kinase InhibitorsPiperidinesJanus kinase inhibitorspatient-reported outcomesquality of lifetofacitinibulcerative colitiswork productivity

Identifiers

PMID36271912
PMCPMC10115234

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.