POS0854 BASELINE CHARACTERISTICS OF PATIENTS WITH IMPROVEMENT OR PROGRESSION OF SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSc-ILD) DURING THE SENSCIS TRIAL

Abstract

BackgroundThe course of SSc-ILD is variable, and may include periods of stability or even improvement in forced vital capacity (FVC) as well as periods of decline.ObjectivesTo investigate the baseline characteristics of patients with SSc-ILD in the placebo group of the SENSCIS trial whose ILD improved or progressed over 52 weeks.MethodsThe SENSCIS trial enrolled patients with SSc with first non-Raynaud symptom in the prior ≤7 years, extent of fibrotic ILD on high-resolution computed tomography (HRCT) ≥10% and FVC ≥40% predicted. Patients who had been taking a stable dose of mycophenolate for ≥6 months were allowed to participate. We investigated the baseline characteristics of patients in the placebo group whose ILD showed improvement (absolute increase in FVC ≥5% predicted), stability (absolute decline or increase in FVC <5% predicted), progression (absolute decline in FVC ≥5% predicted), or significant progression (absolute decline in FVC ≥10% predicted) over 52 weeks. P-values based on ANOVA or Chi-squared tests were used to compare the baseline characteristics of the patients who showed improvement, stability and progression.ResultsOf 288 patients, 21 (7.3%) showed improvement, 166 (57.6%) stability, and 101 (35.1%) ILD progression, of whom 37 (12.8% of all patients) had significant ILD progression over 52 weeks. Most baseline characteristics were similar across the groups based on progression, but there were differences in DLCO % predicted (p=0.02) and in the proportion of patients taking mycophenolate (p=0.09) among patients who showed improvement, stability and progression (Table 1).Table 1.Baseline characteristics of patients in the placebo group of the SENSCIS trial in subgroups based on course of SSc-ILD over 52 weeks.Improvement (n=21)Stability (n=166)Progression (n=101)Significant progression (n=37) (subset of Progression)P-value for comparison of Improvement, Stability, ProgressionAge, years55.9 ± 12.053.2 ± 12.653.1 ± 12.855.3 ± 11.80.64Female71.475.970.373.00.59Years since first non-Raynaud symptom3.7 ± 1.73.5 ± 1.73.5 ± 1.93.6 ± 1.90.81Diffuse cutaneous SSc47.649.453.556.80.78Anti-topoisomerase I antibody positive61.958.466.356.80.44High sensitivity C-reactive protein, mg/L5.1 ± 8.97.8 ± 23.05.6 ± 9.94.2 ± 4.40.62Modified Rodnan skin score9.3 ± 7.310.5 ± 8.411.9 ± 9.712.7 ± 11.30.29History of gastroesophageal reflux disease (GERD)76.272.978.278.40.62Extent (%) of fibrotic ILD on HRCT*26.4 ± 16.235.5 ± 20.436.6 ± 21.840.8 ± 23.50.12Presence of honeycombing on HRCT14.316.815.526.50.94Presence of ground glass opacities on HRCT81.086.689.784.80.51FVC % predicted77.1 ± 18.071.7 ± 17.273.3 ± 15.274.2 ± 14.80.33DLco % predicted61.5 ± 14.953.4 ± 14.851.1 ± 15.147.3 ± 14.50.02Taking mycophenolate71.448.245.535.10.09Data are mean ± SD or % at baseline. Missing data were excluded. *Assessed visually in whole lung to nearest 5%. The assessment did not include pure (non-fibrotic) ground glass opacities.ConclusionThese findings suggest that in the SENSCIS trial, patients who had higher DLCO % predicted or who were taking mycophenolate at baseline were less likely to show progression of SSc-ILD over 52 weeks.AcknowledgementsThe SENSCIS trial was funded by Boehringer Ingelheim. Oliver Distler was a member of the SENSCIS trial Steering Committee.Disclosure of InterestsAnna-Maria Hoffmann-Vold Speakers bureau: Actelion, Boehringer Ingelheim, Lilly, Medscape, Merck Sharp & Dohme, Roche, Paid instructor for: Boehringer Ingelheim, Consultant of: Actelion, ARXX, Bayer, Boehringer Ingelheim, Lilly, Medscape, Merck Sharp & Dohme, Roche, Grant/research support from: Boehringer Ingelheim, Eric Hachulla Speakers bureau: Johnson & Johnson, GlaxoSmithKline, Roche-Chugai; and research funding from CSL Behring, GlaxoSmithKline, Johnson & Johnson, Roche-Chugai, Consultant of: Bayer, Boehringer Ingelheim, GlaxoSmithKline, Johnson & Johnson, Roche-Chugai, Sanofi-Genzyme, Grant/research support from: GlaxoSmithKline, Roche-Chugai, Sanofi-Genzyme, Ariane Herrick Speakers bureau: Janssen, Consultant of: Arena, Boehringer Ingelheim, Camurus, CSL Behring, Gesynta, Grant/research support from: Gesynta, Teng Moua: None declared, Gabriela Riemekasten Speakers bureau: Boehringer Ingelheim, Janssen, Consultant of: Boehringer Ingelheim, Janssen, Madelon Vonk Speakers bureau: Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, MSD, Novartis, Roche, Consultant of: Boehringer Ingelheim, Corbus, Janssen, Grant/research support from: Boehringer Ingelheim, Ferrer, Galapagos, Janssen, Alexandra James Employee of: Alexandra James is an employee of Elderbrook solutions GmbH that is contracted by Boehringer Ingelheim, Margarida Alves Employee of: Margarida Alves is employee of Boehringer Ingelheim, Oliver Distler Speakers bureau: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Speaker fee: Bayer, Boehringer Ingelheim, Janssen, Medscape, Consultant of: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Consultancy fee: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, 4P Science, Galapagos, Glenmark, Horizon, Inventiva, Kymera, Lupin, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus, Roivant, Sanofi and TopadurOD has/had relationships with the following companies in the area of potential treatments for arthritides in the last three calendar years:Consultancy fee: Abbvie, Grant/research support from: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Research Grants: Boehringer Ingelheim, Kymera, Mitsubishi Tanabe