Esophageal Involvement and Gastroesophageal Reflux Disease in Patients with SSc-ILD: Data from a Sub-Study of the SENSCIS Trial

Michael Kreuter¹, Dinesh Khanna², Christopher Ryerson³, Stephen Humphries⁴, Tohru Takeuchi⁵, Mark Hamblin⁶, Dag Wormanns⁷, Carina Ittrich⁸, Frank Risse⁸, Margarida Alves⁹ and David Lynch⁴, ¹Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany, ²University of Michigan, Ann Arbor, MI, ³Department of Medicine & Centre for Heart Lung Innovation, University of British Columbia, Vancouver, BC, Canada, Vancouver, BC, Canada, ⁴Department of Radiology, National Jewish Health, Denver, CO, ⁵Osaka Medical and Pharmaceutical University, Osaka, Japan, ⁶University of Kansas Hospital, Kansas City, KS, ⁷Evangelische Lungenklinik, Berlin, Germany, ⁸Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, ⁹Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim, Germany

Meeting: ACR Convergence 2021

Keywords: Comorbidity, interstitial lung disease, Systemic sclerosis

Session Information

Date: Saturday, November 6, 2021

Title: Systemic Sclerosis & Related Disorders – Clinical Poster I (0387–0413)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: Upper gastrointestinal involvement such as esophageal dilation is frequently observed in patients with SSc-ILD and may be associated with the presence or severity of SSc-ILD. We assessed the characteristics of patients with SSc-ILD based on the presence of esophageal distension and gastroesophageal reflux disease (GERD), and based on widest esophageal diameter, using data from the SENSCIS trial.

Methods: Patients in the SENSCIS trial had SSc with first non-Raynaud symptom ≤7 years before screening and an extent of fibrotic ILD on HRCT (based on visual assessment of the whole lung) ≥10%. In a sub-study, the presence of esophageal distension and the widest esophageal diameter (i.e. the largest distance between internal esophageal mucosal limits for three diameter measurements) were assessed at baseline using high-resolution computed tomography (HRCT). In descriptive analyses, we assessed the characteristics of patients in subgroups by the presence (yes/no) of esophageal distension and GERD, and by widest esophageal diameter ≤15mm vs >15mm at baseline.

Results: Of 576 patients in the SENSCIS trial, 150 participated in the HRCT sub-study, of whom 117 had data available on esophageal distension at baseline. Of these, 85 (72.6%) had both esophageal distension and GERD, 25 (21.4%) had esophageal distension and no GERD, and 7 (6.0%) had GERD and no esophageal distension. Compared with patients with esophageal distension but no GERD, the subgroup of patients with both esophageal distension and GERD had a greater proportion of patients with diffuse cutaneous SSc, worse modified Rodnan skin scores, greater extent of fibrotic ILD on HRCT, worse lung function, and worse quality of life based on the St George’s Respiratory Questionnaire (SGRQ) total score (Table 1). Of 116 patients with data available on esophageal diameter at baseline, 75 (64.7%) had a widest esophageal diameter >15mm. Compared with patients with a smaller esophageal diameter, the subgroup of patients with a widest esophageal diameter >15mm had a greater proportion of patients with GERD, greater proportion of patients with diffuse cutaneous SSc, worse modified Rodnan skin scores, greater extent of fibrotic ILD on HRCT, worse lung function, and worse quality of life based on the SGRQ total score (Table 2).

Conclusion: Exploratory analyses of data from a sub-study of the SENSCIS trial suggest that the combination of esophageal involvement and GERD, and a widest esophageal diameter >15 mm, were associated with worse disease severity in patients with SSc-ILD.

Disclosures: M. Kreuter, Boehringer Ingelheim, 2, 5, Galapagos NV, 2, Roche, 2, 5; D. Khanna, AbbVie, 2, Acceleron, 2, Actelion, 2, Amgen, 2, Bayer, 2, 5, Boehringer Ingelheim, 2, Bristol-Myers Squibb, 5, CiviBioPharma/Eicos Sciences, Inc, 12, Leadership/Equity position (Chief Medical Officer), Corbus, 2, CSL Behring, 2, Eicos Sciences, Inc, 11, Galapagos NV, 2, Genentech/Roche, 2, Gilead, 2, GlaxoSmithKline, 2, Horizon Therapeutics, 2, 5, Immune Tolerance Network, 5, Merck Sharp & Dohme, 2, Mitsubishi Tanabe Pharma, 2, National Institutes of Health, 5, Pfizer, 5, Sanofi-Aventis, 2, United Therapeutics, 2, Prometheus, 2, Theraly, 2, AstraZeneca, 2; C. Ryerson, Boehringer Ingelheim, 5, 6, Hoffmann-La Roche, 5, 6; S. Humphries, Boehringer Ingelheim, 2, 5, Veracyte, 1, 5, Imidex, 1, Lyra Therapeutics, 2, Calyx Inc, 12, Service contracts; T. Takeuchi, Boehringer Ingelheim, 6; M. Hamblin, Biogen, 5, Boehringer Ingelheim, 5, 6, FibroGen, 5, Galapagos NV, 5, Galecto, 5, Genentech, 6, Global Blood Therapeutics, 5, Promedior, 5, Mallinckrodt Pharmaceuticals, 5, United Therapeutics, 1; D. Wormanns, AstraZeneca, 6, Boehringer Ingelheim, 6, Roche, 7, General Electric, 6; C. Ittrich, Boehringer Ingelheim, 3; F. Risse, Boehringer Ingelheim, 3; M. Alves, Boehringer Ingelheim, 3; D. Lynch, AstraZeneca, 2, Boehringer Ingelheim, 2, Daiichi Sankyo, 2, Parexel, 2, Veracyte, 2, US patent #10,706,533 'System and method for automatic detection and quantification of pathology using dynamic feature classification', 10.

To cite this abstract in AMA style:

Kreuter M, Khanna D, Ryerson C, Humphries S, Takeuchi T, Hamblin M, Wormanns D, Ittrich C, Risse F, Alves M, Lynch D. Esophageal Involvement and Gastroesophageal Reflux Disease in Patients with SSc-ILD: Data from a Sub-Study of the SENSCIS Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/esophageal-involvement-and-gastroesophageal-reflux-disease-in-patients-with-ssc-ild-data-from-a-sub-study-of-the-senscis-trial/. Accessed .

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