Measuring response in the gastrointestinal tract in systemic sclerosis

Area of Science:

• Gastroenterology
• Rheumatology
• Clinical Trials

Background:

• Gastrointestinal tract (GIT) involvement is the most frequent internal complication in systemic sclerosis (SSc), commonly known as scleroderma.
• GIT complications significantly contribute to morbidity and diminish the quality of life for SSc patients.

Purpose of the Study:

• To review and discuss the current outcome measures for assessing GIT involvement in systemic sclerosis (SSc).
• To provide recommendations for the design and evaluation of GIT involvement in SSc clinical trials.

Main Methods:

• This is a review article, synthesizing existing literature on outcome measures for SSc-GIT.
• The review focuses on both patient-reported outcome measures (PROMs) and objective measures.

Main Results:

• Validated PROMs, including the UCLA Scleroderma Clinical Trial Consortium GIT 2.0 and NIH PROMIS scales, are available for SSc-GIT.
• Several objective measures exist for assessing GIT mucosal involvement and motility, but require further validation specifically for SSc in clinical trial settings.

Conclusions:

• Gastrointestinal involvement is a major cause of morbidity and negatively impacts quality of life in systemic sclerosis.
• Recommendations are provided for optimizing clinical trial design and the evaluation of GIT involvement in SSc management.