The Collaborative National Quality and Efficacy Registry for Scleroderma: Association of Medication Use on Gastrointestinal Tract Symptoms in Early Disease and the Importance of Tobacco Cessation

Authors

Sarah Luebker
Tracy M Frech
Shervin Assassi
Jessica K Gordon
Elana J Bernstein
Virginia D Steen
Ami A Shah
Laura K Hummers
Carrie Richardson
Dinesh Khanna
Flavia V Castelino
Lorinda Chung
Faye N Hant
Victoria K Shanmugam
John M VanBuren
Jessica Alvey
Monica Harding
Nora Sandorfi

Language

English

Publication Date

8-1-2023

Journal

Clinical and Experimental Rheumatology

DOI

10.55563/clinexprheumatol/04rauu

PMID

37497718

Abstract

Objectives: Systemic Sclerosis (SSc) is frequently associated with gastrointestinal tract (GIT) involvement. The Collaborative National Quality and Efficacy Registry (CONQUER) is a US-based collaborative study collecting longitudinal follow up data on SSc patients with less than 5-years disease duration enrolled at Scleroderma centres of excellence. This manuscript presents the GIT natural history and outcomes in relation to other scleroderma manifestations and medication exposures.

Methods: CONQUER participants that had completed a minimum of two serial Scleroderma Clinical Trials Consortium GIT Questionnaires (GIT 2.0) were included in this analysis. Patients were categorised by total GIT 2.0 severity at baseline, and by category change: none-to-mild (0.49); moderate (0.50-1.00), and severe-to-very severe (1.01-3.00) at the subsequent visit. Based on this data, four groups were identified: none-to-mild with no change, moderate-to-severe with no change, improvement, or worsening. Clinical features and medications, categorised as gastrointestinal tract targeted therapy, anti-fibrotic, immunosuppression, or immunomodulatory drugs, were recorded. Analysis included a proportional odds modelaccounting for linear and mixed effects of described variables.

Results: 415 enrolled CONQUER participants met project inclusion criteria. Most participants had stable mild GIT symptoms at baseline and were on immunomodulatory and anti-reflux therapy. In most patients, anti-reflux medication and immunosuppression initiation preceded the baseline visit, whereas anti-fibrotic initiation occurred at or after the baseline visit. In the proportional odds model, worsening GIT score at the follow-up visit was associated with current tobacco use (odds ratio: 3.48 (1.22, 9.98, p 0.020).

Conclusions: This report from the CONQUER cohort, suggests that most patients with early SSc have stable and mild GIT disease. Closer follow-up was associated with milder, stable GIT symptoms. There was no clear association between immunosuppression or anti-fibrotic use and severity of GIT symptoms. However, active tobacco use was associated with worse GIT symptoms, highlighting the importance of smoking cessation counselling in this population.

Keywords

Humans, Tobacco Use Cessation, Quality of Life, Gastrointestinal Diseases, Scleroderma, Systemic, Gastroesophageal Reflux, Scleroderma, Localized, Registries

Published Open-Access

yes

Recommended Citation

Luebker, Sarah; Frech, Tracy M; Assassi, Shervin; et al., "The Collaborative National Quality and Efficacy Registry for Scleroderma: Association of Medication Use on Gastrointestinal Tract Symptoms in Early Disease and the Importance of Tobacco Cessation" (2023). Faculty, Staff and Student Publications. 5308.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/5308