OP0124 EFFECTS OF NINTEDANIB IN PATIENTS WITH PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASE ASSOCIATED WITH RHEUMATOID ARTHRITIS (RA-ILD) IN THE INBUILD TRIAL

Background: In the INBUILD trial in subjects with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF), nintedanib reduced rate of decline FVC (mL/year) over 52 weeks by 57% compared placebo. Objectives: To assess RA-ILD trial. Methods: Subjects had a chronic ILD IPF, reticular abnormality traction bronchiectasis (with or without honeycombing) >10% extent on high-resolution computed tomography (HRCT), forced vital capacity (FVC) ?45% predicted, diffusing lungs for carbon monoxide ?30%–<80% and met criteria progression within 24 months before screening, despite management deemed appropriate clinical practice. Patients taking stable doses approved medications to treat RA connective tissue disease could participate, except that protocol excluded those azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, rituximab, cyclophosphamide, oral glucocorticoids >20 mg/day. We analysed adverse events RA-ILD. Results: Of 663 who received medication, 89 (42 nintedanib, 47 placebo), whom 60.7% were male, 64.0% current former smokers, 86.5% usual interstitial pneumonia (UIP)-like pattern HRCT; 93.3% confirmation their diagnosis from rheumatologist. At baseline, 21.3% biologic disease-modifying anti-rheumatic drugs (DMARDs), 53.9% non-biologic DMARDs 73.0% (?20 mg/day prednisone equivalent). mean (SD) age was 66.9 (9.6) years, time since 9.9 (9.4) 3.6 (3.2) 71.5 (16.2) % predicted C-reactive protein 13.7 (22.5) mg/L. The adjusted (SE) -82.6 (41.3) mL/year group versus -199.3 (36.2) placebo (difference 116.7 [95% CI 7.4, 226.1]; nominal p=0.037), consistent findings overall population (Figure). As population, most common event diarrhoea (reported 54.8% 25.5% group). Adverse led permanent discontinuation drug 19.0% 12.8% group. Conclusion: trial, slowed patients RA-ILD, manageable patients. efficacy safety observed population. Acknowledgements: funded Boehringer Ingelheim. Medical writing support provided Fleishman Hillard Fishburn, London, UK. authors meet authorship as recommended International Committee Journal Editors (ICMJE). Disclosure Interests: Clive Kelly Speakers bureau: Ingelheim, Consultant of: Eric Matteson Ingelheim Gilead Sciences, Grant/research from: Sun Pharmaceuticals Pfizer, Martin Aringer AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, Gilead, GlaxoSmithKline, HEXAL, Lilly, MSD, Novartis, Roche, Sanofi UCB, Merck Sharp & Dohme, Gerd Rüdiger Burmester Roche Sanofi, Heiko Mueller Employee Currently an employee Lizette Moros Klaus Rohr Kolb Algernon, Pieris Prometic