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THE VIRTUAL CELIAC SYMPTOMS STUDY: REPORTED SYMPTOMS OVER 12 WEEKS IN ADULTS

Lisa Meckley 1, Jessica R. Marden 2, Sakshi Sethi 2, Sanjana Sundaresan 2, Marilyn G. Geller 3, Dawn Adams 4, Edwin Liu 5, Daniel Leffler 1

Affiliations

1 Takeda Development Center Americas, Inc., Cambridge, United States

2 Analysis Group, Inc., Boston, United States

3 Celiac Disease Foundation, Woodland Hills, United States

4 Vanderbilt University Medical Center, Nashville, United States

5 Digestive Health Institute, Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, United States

Summary

AI Generated

A 12-week prospective observational study of 338 adults with celiac disease on a gluten-free diet found that nearly all participants experienced gastrointestinal symptoms frequently, with bloating and abdominal pain occurring on over half of follow-up days.

All 338 adult participants reported at least one gastrointestinal symptom during the 12-week follow-up period despite adherence to a gluten-free diet, with bloating occurring in 98.5% of participants, abdominal pain in 99.1%, diarrhea in 95.0%, nausea in 94.4%, and vomiting in 42.0%.
Among adults who experienced bloating or abdominal pain, these symptoms occurred on more than 50% of follow-up days, while diarrhea and nausea occurred on more than 30% of days among those who experienced them.
At baseline, 58% of adult participants reported celiac disease-related symptoms in the past week, and 21% reported never eating gluten accidentally or on purpose while 71% reported rarely eating gluten accidentally.
The authors suggest that gastrointestinal symptoms such as diarrhea, nausea, bloating and abdominal pain may be appropriate endpoints for clinical trials of potential celiac disease therapies and highlight an unmet need for additional treatments beyond a gluten-free diet.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Celiac disease (CeD) is a chronic, immune-mediated, systemic disorder characterized by inflammation of the small intestine, antibody formation and villous damage in response to gluten ingestion. The only current management/treatment option for CeD is a gluten-free diet (GFD), which has major limitations, not least that patients following a GFD may still experience symptoms. The US Food and Drug Administration guidance ‘Celiac disease: developing drugs for adjunctive treatment to a GFD’ indicates that symptom monitoring should be a co-primary endpoint with histology for the assessment of disease improvement in clinical trials.

Aims & Methods

This US prospective observational study (Virtual Celiac Symptoms Study, NCT05309330) aimed to assess experience with a GFD and celiac-related symptoms in patients with CeD. Eligible participants were aged ≥12 years, had a CeD diagnosis for ≥1 year confirmed via self-reported biopsy (biopsy or serology for participants aged <18 years), were on a GFD for ≥6 months and reported CeD-related symptoms in the past 3 months. Participants were recruited with the assistance of the Celiac Disease Foundation via digital advertisements and data were collected using an electronic patient-reported outcomes platform. Study participants were followed up for 12 weeks and CeD-related symptoms and gluten exposure were assessed daily. Quality of life and healthcare resource utilization were also assessed. This analysis focuses on the gastrointestinal (GI) symptoms of diarrhea, abdominal pain, bloating, nausea and vomiting experienced by adults during the study.

Results

The study was conducted from July 25, 2022 to March 4, 2023. Adults comprised 338 of the 480 participants (88% female; 99% White) with a median age of 37 years (range 18–71). At baseline, 58% of adult participants reported CeD-related symptoms in the past week. All adult participants reported following a GFD; 21% reported “never eating gluten accidentally or on purpose” and 71% reported “rarely eating gluten accidentally”. The remaining 8% reported “rarely eating gluten on purpose”. During the 12-week study, all of the adults reported at least one GI symptom, with each GI symptom (with the exception of vomiting), occurring at least once in over 90% of adults (abdominal pain 99%, bloating 99%, diarrhea 95%, nausea 94% and vomiting 42%). Frequency of GI symptoms was high. For adults who experienced abdominal pain or bloating, these symptoms occurred on >50% of the follow-up days. For adults who experienced diarrhea and nausea, these symptoms occurred on >30% of days (Table 1).

Table 1. GI symptom occurrence among adult participants (N = 338)

Symptom	Participants with GI symptom(s) over the 12-week follow-up period, n (%)	Proportion of days with symptom occurrence over the 12-week follow-up period, %^a
Bloating	333 (98.5)	60.5
Abdominal pain	335 (99.1)	52.9
Diarrhea	321 (95.0)	32.0
Nausea	319 (94.4)	30.2
Vomiting	142 (42.0)	6.0

^aAmong participants who experienced each symptom.
GI, gastrointestinal.

Conclusion

Despite participants adhering to a GFD, symptom frequency in this adult population with CeD was high. GI symptoms such as diarrhea, nausea, bloating and abdominal pain may be appropriate endpoints for inclusion in clinical trials of potential CeD therapies. This study further highlights the unmet need for additional treatments for patients with CeD on a GFD.

Disclosure

LMM and DAL are employees of Takeda Development Center Americas, Inc. and receive stock or stock options. JRM, SSe and SSu are employees of Analysis Group, Inc., which received research support from Takeda Development Center Americas, Inc. MG is an employee of the Celiac Disease Foundation, which received financial support from Takeda Development Center Americas, Inc. EL and DA serve as consultants for Takeda Pharmaceuticals.
Funding statement: This study was sponsored by Takeda Development Center Americas, Inc. Medical writing support was provided by Christina Nikolakopoulou, PhD, of Oxford PharmaGenesis, Oxford, UK and was funded by Takeda Pharmaceuticals.