Evidence map›Paper›PMID 32313451›Full record

ArticleGastroHep2019

Latiglutenase Treatment for Celiac Disease: Symptom and Quality of Life Improvement for Seropositive Patients on a Gluten-Free Diet.

Jack A Syage, Peter H R Green, Chaitan Khosla, Daniel C Adelman, Jennifer A Sealey-Voyksner, Joseph A Murray

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in GastroHep, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01917630 (A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

NCT01917630 phase2unknown statusnot on this map

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet

TypeinterventionalSponsorAlvine Pharmaceuticals Inc.Ran2013 to 2015Enrolled500ConditionsCeliac DiseaseArmsALV003, placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Harnessing gut microbiome enzymes:Microbiology spectrum · 2026
    Article
  3. Review
  4. Review
  5. The follow-up of patients with celiac disease.Journal of translational autoimmunity · 2025
    Review
  6. Review
  7. Article
  8. A Composite Morphometric Duodenal Biopsy Mucosal Scale for Celiac Disease Encompassing Both Morphology and Inflammation.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. The global burden of coeliac disease: opportunities and challenges.Nature reviews. Gastroenterology & hepatology · 2022
    Review
  17. Review
  18. Review
  19. Review
  20. Novel Therapeutic Strategies for Celiac Disease.Middle East journal of digestive diseases · 2020
    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

6 authors at 5 institutions in 2 countries.

Jack A SyageImmunogenX, Newport Beach, CA, United States.ORCID 0000-0002-6336-7198
Peter H R GreenCeliac Disease Center, Columbia University, New York, NY, United States.
Chaitan KhoslaStanford University, Stanford, CA, United States.
Daniel C AdelmanAimmune Therapeutics, Brisbane, CA, United States.
Jennifer A Sealey-VoyksnerImmunogenX, Newport Beach, CA, United States.
Joseph A MurrayMayo Clinic, Rochester, MN, United States.ORCID 0000-0003-1941-9090
Immunogenics (United States) · USAimmune Therapeutics (United Kingdom) · GBColumbia University · USMayo Clinic in Arizona · USStanford University · US

Funding

Role of Transglutaminase 2 in Celiac SprueR01DK063158 · NIDDK · STANFORD UNIVERSITY · PI CHAITAN KHOSLA · 2003 to 2026
$11.2M
NIDDK NIH HHS R01 DK063158
6 · The paper itself

Abstract

backgroundCeliac disease (CD) is a widespread autoimmune disease triggered by dietary gluten that can lead to severe gastrointestinal symptoms. Because there is no available treatment other than a lifelong gluten-free diet, many patients continue to experience chronic symptoms.

aimIn this analysis we report on the efficacy of latiglutenase, an orally administered enzyme treatment, for improving multiple gluten-induced symptoms and consequent quality of life (QOL) due to inadvertent gluten consumption.

methodsThis analysis is based on data from the CeliAction study of symptomatic patients (ALV003-1221; NCT01917630). Patients were treated with latiglutenase or placebo for 12 weeks and instructed to respond to a symptom diary daily and to multiple QOL questionnaires at weeks 0, 6, and 12 of the treatment periods as secondary endpoints. The results were stratified by serostatus.

results398 patients completed the 12-week CDSD study. In seropositive, but not seronegative, CD patients a statistically significant and dose-dependent improvement was seen in the severity and frequency of abdominal pain, bloating, tiredness, and constipation. In subjects receiving 900 mg latiglutenase, improvements (p-values) in the severity of these symptoms for week 12 were 58% (0.038), 44% (0.023), 21% (0.164), and 104% (0.049) respectively, relative to placebo-dosed subjects. The reduction in symptoms trended higher for more symptomatic patients. Similar results were observed for the QOL outcome measures.

conclusionsAlthough this study was not powered to definitively establish the benefit of latiglutenase in seropositive CD patients, such patients appear to show symptomatic and QOL benefit from using latiglutenase with meals.

Indexed as

Celiac diseaselatiglutenasesymptomstherapy

Identifiers

PMID32313451
PMCPMC7169937
OpenAlexW2980268811

What OpenQuestion holds

Textmetadata
LicenceTDM
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.