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Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials - 12/01/22

Doi : 10.1016/j.clinre.2021.101782 
Gilles Jadd Hoilat a, Abdulaziz Khalaf Altowairqi b, Mohamad Fekredeen Ayas c, Noor Tariq Alhaddab d, Razan Abdulkarim Alnujaidi d, Hadeel Abdulaziz Alharbi d, Naseem Alyahyawi e, Aminah Kamal f, Habeeb Alhabeeb g, Ebraheem Albazee h, Sami Almustanyir f, Ahmed Abu-Zaid d, i,
a Department of Medicine, SUNY Upstate Medical University, Syracuse, NY, United States 
b Department of Medicine, Alhada Armed Forces Hospital, Taif, Saudi Arabia 
c Department of Internal Medicine, Ascension St. John Hospital, Detroit, MI, United States 
d College of Medicine, Alfaisal University, Riyadh, Saudi Arabia 
e Department of Pediatrics, King Abdulaziz University Hospital, Jeddah, Saudi Arabia 
f Department of Medicine, Ministry of Health, Riyadh, Saudi Arabia 
g Research Center, King Fahad Medical City, Riyadh, Saudi Arabia 
h Faculty of Medicine, Hashemite University, Zarqa, Jordan 
i College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States 

Corresponding author at: College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United StatesCollege of Graduate Health SciencesUniversity of Tennessee Health Science CenterMemphisTNUnited States

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Highlights

Larazotide acetate is a novel, synthetic, eight-amino acid peptide that antagonizes zonulin, a key tight junction protein implicated in celiac disease pathogenesis.
Larazotide acetate is safe and superior to placebo in alleviating gastrointestinal symptoms among patients undergoing gluten challenge.
Larazotide acetate is less probable to offer a definitive cure to patients with celiac disease. However, it may be co-administered to complement rather than displace the standard of care gluten-free diet.
Larazotide acetate has already entered phase III trials as the first pharmacologic agent to manage patients with celiac disease.

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Abstract

Purpose

The standard of care for treatment of celiac disease (CD) is a stringent lifetime gluten-free diet (GFD). Larazotide acetate (AT-1001) is an anti-zonulin which functions as a gut permeability regulator for treatment of CD. We endeavored to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which studied the efficacy and safety of AT-1001 in patients with CD.

Methods

We examined four databases from inception to 20-August-2020. We pooled continuous outcomes as mean difference and dichotomous outcomes as risk ratio with 95% confidence interval under the fixed-effects meta-analysis model.

Results

Four RCTs met our eligibility criteria, comprising 626 patients (AT-1001, n=465, placebo, n=161). Three and two RCTs reported outcomes of patients undergoing gluten challenge (intake of 2.4–2.7 grams of gluten/day) and GFD, respectively. For change in lactulose-to-mannitol ratio, the endpoint did not significantly differ between AT-1001 and placebo groups, irrespective of the gluten status. Subgroup analysis of patients undergoing gluten challenge showed AT-1001 treatment (compared with placebo) significantly correlated with better symptomatic improvement in the two endpoints of change in total gastrointestinal symptom rating scale (total GSRS) and CD-specific GSRS (CD-GSRS). However, no significant difference was noted among patients undergoing GFD for the abovementioned two efficacy endpoints. Compared with placebo, AT-1001 favorably reduced the adverse event (AE) of gluten-related diarrhea in patients who underwent gluten challenge. Other AEs were comparable between both AT-1001 and placebo groups.

Conclusions

AT-1001 is largely well-endured and seems somehow superior to placebo in alleviating gastrointestinal symptoms among CD patients undergoing gluten challenge. Nevertheless, additional RCTs are warranted to validate these findings.

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Keywords : Celiac disease, Larazotide acetate, AT-1001, Gluten, Meta-analysis


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Vol 46 - N° 1

Article 101782- janvier 2022 Retour au numéro
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