Performance of the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 Instrument as a Clinical Decision Aid in the Routine Clinical Care of Patients With Systemic Sclerosis

Norina Zampatti; Alexandru Garaiman; Suzana Jordan; Rucsandra Dobrota; Mike Oliver Becker; Britta Maurer; Oliver Distler; Carina Mihai

Disclosures

Arthritis Res Ther. 2021;23(125) 

In This Article

Abstract and Introduction

Abstract

Background and Objectives: The University of California Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument 2.0 (UCLA GIT 2.0) is validated to capture gastrointestinal (GI) tract morbidity in patients with systemic sclerosis (SSc). The aims of this study were to determine in a large SSc cohort if the UCLA GIT 2.0 is able to discriminate patients for whom a rheumatologist with experience in SSc would recommend an esophago-gastro-duodenoscopy (EGD), and if it could identify patients with endoscopically proven esophagitis or with any pathologic finding on EGD.

Methods: We selected patients fulfilling the ACR/EULAR 2013 criteria for SSc from our EUSTAR center having completed at least once the UCLA GIT 2.0 questionnaire, and we collected data on gastrointestinal symptoms and EGD from their medical charts. We analyzed by general linear mixed effect models several parameters, including UCLA GIT 2.0, considered as potentially associated with the indication of EGD, as well as with endoscopic esophagitis and any pathologic finding on EGD.

Results: We identified 346 patients (82.7% female, median age 63 years, median disease duration 10 years, 23% diffuse cutaneous SSc) satisfying the inclusion criteria, who completed UCLA GIT 2.0 questionnaires at 940 visits. EGD was recommended at 169 visits. In multivariable analysis, UCLA GIT 2.0 and some of its subscales (reflux, distention/bloating, social functioning) were associated with the indication of EGD. In 177 EGD performed in 145 patients, neither the total ULCA GIT 2.0 score nor any of its subscales were associated with endoscopic esophagitis, nor with any pathologic EGD findings.

Conclusions: In a real-life setting, the UCLA GIT 2.0 and its reflux subscale were able to discriminate patients with SSc who had an indication for EGD, but did not correlate with findings in EGD. We conclude that, while using the UCLA GIT 2.0 in the routine care of patients with SSc may help the rheumatologist to better understand the burden of GI symptoms in the individual patient, it should not be used as a stand-alone instrument to identify an indication of EGD.

Introduction

In patients with systemic sclerosis (SSc), the gastrointestinal (GI) tract is the most common internal organ involvement, with over two thirds of patients reporting GI symptoms.[1] SSc GI tract involvement is a major cause of serious morbidity, affecting health-related quality of life (HRQoL) and survival of these patients.[2,3] The most prevalent GI manifestation is esophageal involvement due to hypomotility and gastroesophageal reflux, the latter often leading to esophagitis and in later stages to Barrett's esophagus.[4] Another GI manifestation of SSc is gastric antral vascular ectasia (GAVE) which may cause severe anemia.[5] To date, there are no recommendations or guidelines when to perform endoscopic and functional investigation of the upper GI tract in patients with SSc. Esophago-gastro-duodenoscopy (EGD) plays a major role in the diagnosis of reflux esophagitis, esophageal strictures, Barrett's esophagus, and adenocarcinoma of the esophagus.

The University of California at Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 instrument (UCLA GIT 2.0) is a patient-completed questionnaire validated to assess GI symptoms severity and related HRQoL in SSc.[6] Originally developed in English, and with a minimal clinically important difference previously determined,[6] it has been validated in different languages.[7–11] Several clinical trials of GI treatments in patients with SSc already used this instrument as an outcome measurement.[12–14] The UCLA GIT 2.0 is an excellent candidate to guide the need for further investigation of the GI tract by endoscopy and/or functional tests. Constructed to reflect the burden of GI symptoms including reflux, it is attractive to hypothesize that it is able to identify patients with endoscopic esophagitis or other clinically significant findings on EGD.

In this study, we aimed to determine, in an unselected, real-life cohort of patients with SSc, whether the UCLA GIT 2.0 could discriminate patients for whom a rheumatologist with experience in SSc would recommend an EGD, and if the UCLA GIT 2.0 could identify patients at risk for endoscopic esophagitis or other clinically significant EGD findings.

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