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A BASELINE SEVERITY INFLATION ANALYSIS IN STUDY VP-VLY-686-3301 OF TRADIPITANT IN GASTROPARESIS

Jesse L. Carlin 1, Christos Polymeropoulos 1, Changfu Xiao 1, Gunther Birznieks 1, Mihael H. Polymeropoulos 1

Affiliations

1 Vanda Pharmaceuticals, Inc., Washington, United States

Summary

AI Generated

In a phase 3 trial, tradipitant (an NK-1 receptor antagonist) demonstrated statistically significant improvements in nausea, patient global impression of change, and overall patient benefit versus placebo in a Baseline Severity Inflation analysis subgroup of diabetic and idiopathic gastroparesis patients over 12 weeks.

Tradipitant showed greater reduction in nausea than placebo at week 12 (-1.98 versus -1.28, p=0.028) and at week 2 (-0.99 versus -0.50, p=0.013) in the BSI subgroup.
A higher proportion of tradipitant-treated patients demonstrated improvement on the Patient Global Impression of Change scale at week 2 (86% versus 53%, p=0.002) and week 12 (84% versus 65%, p=0.056).
For the Overall Patient Benefit scale, more tradipitant patients showed benefit at week 2 (95% versus 68%, p=0.003) and week 12 (92% versus 68%, p=0.009).
The BSI analysis subgroup included patients with 1 to less than 7 average vomiting episodes, excluding those with zero or highest severity vomiting, to minimize placebo effect.
The study was sponsored by Vanda Pharmaceuticals and authors are company employees.

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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

Tradipitant is a NK-1 receptor antagonist that showed efficacy in improving nausea, vomiting and gastroparesis symptoms in a phase 2 study (VLY-2301) of diabetic and idiopathic gastroparesis. Efficacy was further evaluated in a phase 3 study (VLY-3301). A large placebo effect may have masked the true size of tradipitant benefit. Large placebo responses can be driven by Baseline Severity Inflation (BSI) especially on parameters used for inclusion into the study.

Aims & Methods

Idiopathic and diabetic gastroparesis patients with delayed gastric emptying, moderate to severe nausea, and at least 1 vomiting episode were randomized to tradipitant or placebo for 12 weeks. Nausea was assessed using the 5-point Gastroparesis Core Symptom Daily Diary. Overall gastroparesis symptoms was evaluated using the Patient Global Impression of Change (PGI-C) and the Overall Patient Benefit (OPB) scales. The BSI analysis subgroup included ITT subjects with at least 1 but less than 7 average vomiting episodes and excluded subjects whose vomiting severity was zero or highest severity. This baseline threshold allows for censoring of patients with minimal or very high frequency of vomiting and uses a symptom scale for censoring other than the primary endpoint scale. This is an accepted strategy to minimize placebo effect, and allows for a less biased estimation of true treatment effect.

Results

A responder analysis of PGI-C and OPB Score in the BSI subgroup showed a larger proportion of tradipitant treated patients improved versus placebo at start (Week 2) and end (Week 12) of study. Similarly, at the same timepoints nausea was improved. For the primary endpoint of change in nausea from baseline at week 12, tradipitant treated patients reported a greater reduction in nausea than placebo treated patients (-1.98 v. -1.28, p=.028). Improvement in tradipitant treated patients versus placebo was also seen at week 2 (-.99 v. -.50, p=.013). In the PGI-C scale more tradipitant treated patients demonstrated improvement as compared to placebo at week 2 (86% v. 53%, p=.002) and at week 12 (84% v. 65%, p=.056). For the OPB scale, more tradipitant treated patients demonstrated benefit compared to placebo at week 2 (95% v. 68%, p=.003) and week 12 (92% v. 68%, p=.009).

Conclusion

Tradipitant treatment in the Baseline Severity Inflation Analysis subpopulation resulted in improvements in nausea, PGI-C, and OPBS both the earliest (Week 2) and last (Week 12) timepoints.

Disclosure

Study was sponsored by Vanda Pharmaceuticals, Inc. Authors are employees of Vanda Pharmaceuticals, Inc.

Conference

UEG Week Copenhagen 2023

Topics

Oesophagus

Submission format

Abstract

Session

PP 01 Oesophageal, gastric and duodenal disorders (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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