ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0918

Decline in Forced Vital Capacity in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) with and Without Gastroesophageal Reflux Disease: Further Analyses of the SENSCIS Trial

Kristin Highland1, Gerard Criner2, Petros Sfikakis3, Hilario Nunes4, Wendy Stevens5, Corinna Miede6, Margarida Alves7 and Michael Kreuter8, 1Cleveland Clinic, Cleveland, Ohio, USA, Cleveland, OH, 2Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, 3National Kapodistrian University of Athens Medical School, Athens, Greece, 4Department of Pulmonology, Hôpital Avicenne, APHP, Bobigny, France, Bobigny, France, 5Department of Rheumatology, St Vincent's Hospital, Melbourne, Victoria, Australia, Fitzroy, Victoria, Australia, 6mainanalytics GmbH, Sulzbach (Taunus), Germany, Sulzbach (Taunus), Germany, 7Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, 8Center 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, Heidelberg, Germany

Meeting: ACR Convergence 2020

Keywords: , ,

Session Information

Date: Saturday, November 7, 2020

Title: Systemic Sclerosis & Related Disorders – Clinical Poster II

Session Type: Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Gastroesophageal reflux disease (GERD) is a common comorbidity in patients with SSc-ILD and may be associated with progression of SSc-ILD. In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo, with an adverse event profile characterized mainly by gastrointestinal events. We investigated the efficacy and safety of nintedanib in subgroups by presence of GERD at baseline.

Methods: In the SENSCIS trial, patients with SSc-ILD with first non-Raynaud symptom ≤7 years before screening, extent of fibrotic ILD ≥10% on HRCT and FVC ≥40% predicted were randomized to receive nintedanib or placebo until the last patient had reached week 52 but for ≤100 weeks. In post-hoc analyses, we analysed the annual rate of decline in FVC (mL/year) over 52 weeks and adverse events in subgroups by presence of GERD prior to and/or at screening. GERD was defined as present if it was noted as a present or past comorbidity on the SSc-related medical history page of the case report form.

Results: Of 576 patients who received ≥1 dose of trial medication, 74.3% had GERD prior to and/or at screening. At baseline, in patients with and without GERD, respectively, mean (SD) FVC was 2532 (787) and 2405 (744) mL and 72.3 (16.7) and 73.1 (16.7) % predicted; 88.8% and 52.0% of patients were taking anti-acid therapy. In the placebo group, the adjusted annual rate of FVC decline was numerically more pronounced in patients with than without GERD (-97.3 vs -81.6 mL/year). The effect of nintedanib versus placebo on reducing the rate of FVC decline (mL/year) was numerically more pronounced in patients with than without GERD (difference: 48.2 [95% CI: 3.9, 92.5] vs 20.2 [-54.6, 95.0]), but the exploratory interaction p-value did not indicate heterogeneity in the treatment effect of nintedanib between these subgroups (p=0.53) (Figure). The most frequent adverse event reported in all the subgroups was diarrhea (Table). In the nintedanib and placebo groups, respectively, the proportions of patients who had adverse events leading to treatment discontinuation were 14.6% and 9.7% in patients with GERD and 19.7% and 5.6% in patients without GERD.

Conclusion: In the SENSCIS trial in patients with SSc-ILD, nintedanib slowed the rate of FVC decline versus placebo both in patients with and without GERD. The adverse event profile of nintedanib was similar in patients with and without GERD.

Disclosure: K. Highland, Actelion Pharmaceuticals, 1, 2, 3, Bayer, 1, 2, Boehringer Ingelheim, 1, 2, 3, Eiger BioPharmaceuticals, 1, Genentech, 1, Gilead Sciences, 1, Gossamer Bio, 1, Reata Pharmaceuticals, 1, United Therapeutics, 1, 2, 3, Viela Bio, 1; G. Criner, Amgen, 1, AstraZeneca, 1, Boehringer Ingelheim, 1, Broncus Medical, 1, CSA Medical, 1, Eolo Medical, 1, Gala Therapeutics, 1, GlaxoSmithKline, 1, HGE Health Care Solutions, 1, Helios Medical, 1, Merck, 1, Medtronic, 1, Mereo BioPharma, 1, NGM Biopharmaceuticals, 1, Novartis, 1, Olympus, 1, PulmonX, 1, Philips Respironics, 1, Respivant Sciences, 1, The Implementation Group, 1, Verona Pharma, 1; P. Sfikakis, Abbvie, 2, 5, Amgen, 2, 5, Boehringer Inglheim, 2, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5; H. Nunes, Boehringer Ingelheim, 1, 2, 3, Roche, 1, 2, 3, Galapagos, 1; W. Stevens, Janssen, 5, 8, Boehringer Ingelheim, 5, Actelion Pharmaceuticals, 2; C. Miede, Boehringer Ingelheim, 9; M. Alves, Boehringer Ingelheim, 3; M. Kreuter, Boehringer Ingelheim, 1, 2, Galapagos, 1, Roche, 1, 2.

To cite this abstract in AMA style:

Highland K, Criner G, Sfikakis P, Nunes H, Stevens W, Miede C, Alves M, Kreuter M. Decline in Forced Vital Capacity in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) with and Without Gastroesophageal Reflux Disease: Further Analyses of the SENSCIS Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/decline-in-forced-vital-capacity-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild-with-and-without-gastroesophageal-reflux-disease-further-analyses-of-the-senscis-tr/. Accessed .

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