Evidence map›Paper›PMID 37001911›Full record

Trial reportBMJ open gastroenterology2023

Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis.

Marla C Dubinsky, Vipul Jairath, Brian G Feagan, April N Naegeli, Jay Tuttle, Nathan Morris, Mingyang Shan, Vipin Arora, Trevor Lissoos, Noah Agada and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02589665 (A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.1field-weighted citation impact, top 8% 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.

NCT02589665 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2019Enrolled249ConditionsUlcerative ColitisArmsMirikizumab, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. A Practical Guide to the Use of Mirikizumab.The American journal of gastroenterology · 2024
    Article
  5. Review
  6. Article
  7. 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 4 institutions in 3 countries.

Marla C DubinskyDepartment of Pediatrics, Icahn School of Medicine, New York, New York, USA marla.dubinsky@mssm.edu.
Vipul JairathAlimentiv, Inc, London, Ontario, Canada.ORCID 0000-0001-8603-898X
Brian G FeaganAlimentiv, Inc, London, Ontario, Canada.
April N NaegeliEli Lilly and Company, Indianapolis, Indiana, USA.
Jay TuttleLilly Biotechnology Center, San Diego, California, USA.
Nathan MorrisEli Lilly and Company, Indianapolis, Indiana, USA.
Mingyang ShanEli Lilly and Company, Indianapolis, Indiana, USA.
Vipin AroraEli Lilly and Company, Indianapolis, Indiana, USA.
Trevor LissoosEli Lilly and Company, Indianapolis, Indiana, USA.
Noah AgadaEli Lilly and Company, Indianapolis, Indiana, USA.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Tokyo, Japan.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Eli Lilly (United States) · USIcahn School of Medicine at Mount Sinai · USWestern University · CAKitasato Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab's impact on health-related quality of life (HRQoL).

designHRQoL was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and 36-Item Short Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS). Mixed effects models for repeated measures compared score changes between mirikizumab and placebo groups. Additional analyses evaluated associations between HRQoL score changes and achievement of efficacy endpoints at weeks 12 and 52.

resultsAt week 12, IBDQ improved compared with placebo for all mirikizumab groups except mirikizumab 50 mg (50 mg, p=0.073; 200 mg, p<0.001; 600 mg, p<0.001). SF-36 PCS was significantly higher in all mirikizumab groups at week 12 (50 mg, p=0.011; 200 mg, p=0.022; 600 mg, p=0.002); MCS was significantly higher in mirikizumab 200 and 600 mg groups compared with placebo (50 mg, p=0.429; 200 mg, p=0.028; 600 mg, p<0.001). Achievement of clinical response and remission were associated with greater HRQoL improvements at week 12. Improvements in HRQoL scores were sustained through week 52. Of the clinical symptoms evaluated, reduction in rectal bleeding was associated with greater improvements in IBDQ and SF-36 scores.

conclusionMirikizumab improved HRQoL in patients with moderately-to-severely active UC.

Indexed as

Colitis, UlcerativeInflammatory Bowel DiseasesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansQuality of LifeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedmirikizumabIMMUNOTHERAPYQUALITY OF LIFEULCERATIVE COLITIS

Identifiers

PMID37001911
PMCPMC10069555
OpenAlexW4362466661

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.