THU0189 EFFICACY AND SAFETY OF NINTEDANIB IN PATIENTS WITH AUTOIMMUNE DISEASE-RELATED INTERSTITIAL LUNG DISEASE TREATED WITH DMARDS AND/OR GLUCOCORTICOIDS AT BASELINE
Authors: M. Aringer, J. Pope, C. Kelly, A. M. Hoffmann-Vold, J. Belperio, A. James, C. Coeck, M. Quaresma, E. Matteson
Journal: Annals of the Rheumatic Diseases (2020)

Background: In the INBUILD trial in patients with progressive fibrosing ILDs, nintedanib reduced the rate of decline in forced vital capacity (FVC) vs placebo over 52 weeks in the overall population and in the subgroup with autoimmune disease-related ILDs. Patients taking stable doses of medications to treat RA or CTD were eligible, but the protocol excluded enrolment of patients treated with azathioprine, cyclosporine, mycophenolate, tacrolimus, rituximab, cyclophosphamide, or oral glucocorticoids &gt;20 mg/day. Objectives: Assess the influence of DMARDs and/or glucocorticoids at baseline on the efficacy and safety of nintedanib in patients with progressive autoimmune disease-related ILDs. Methods: In patients with progressive autoimmune disease-related ILDs in the INBUILD trial, the rate of decline in FVC (mL/year) and adverse events (AEs) over 52 weeks of treatment (or until 28 days after last trial drug intake for patients who discontinued drug before week 52) were assessed in subgroups by use of DMARDs and/or glucocorticoids (any dose) at baseline (yes/no). Results: 170 patients in the INBUILD trial (82 nintedanib, 88 placebo) had autoimmune disease-related ILDs (89 RA-ILD, 39 SSc-ILD, 19 MCTD-ILD, 23 other). The baseline characteristics of patients taking (n=131) and not taking (n=39) DMARDs and/or glucocorticoids are shown in the Table. All but 1 patient taking glucocorticoids at baseline was taking &lt;20 mg/day. The mean (SE) annual rate of decline in FVC in the placebo group was numerically greater in patients taking vs not taking DMARDs and/or glucocorticoids at baseline (Figure). The effect of nintedanib vs placebo on reducing the rate of decline in FVC was numerically more pronounced in patients taking vs not taking DMARDs and/or glucocorticoids at baseline, but the treatment-by-subgroup-by-time interaction p-values did not indicate heterogeneity in the effect of nintedanib between subgroups (Figure). In patients taking vs not taking DMARDs and/or corticosteroids at baseline, respectively, diarrhoea was reported in 59.4% and 77.8% of patients treated with nintedanib and 28.4% and 23.8% of patients treated with placebo. Serious AEs were more frequent in patients taking vs not taking DMARDs and/or glucocorticoids at baseline in both the nintedanib (39.1% vs 16.7%) and placebo (35.8% vs 19.0%) groups. Conclusion: In the INBUILD trial, the rate of FVC decline was numerically greater in placebo-treated patients who were taking DMARDs and/or glucocorticoids at baseline than in those who were not. The rate of FVC decline was slower in patients treated with nintedanib than placebo both in patients who were and were not taking DMARDs and/or glucocorticoids at baseline. Nintedanib had an acceptable safety profile both in patients who were and were not using DMARDs and/or glucocorticoids at baseline. DMARDs and/or glucocorticoids at baseline Yes (n=131) No (n=39) Male, % 51.9 30.8 FVC, mL, mean (SD) 2372 (718) 2188 (619) ILD diagnosis, % RA-ILD 60.3 25.6 SSc-ILD 15.3 48.7 MCTD-ILD 10.7 12.8 Other 13.7 12.8 Biologic DMARDs, % 15.3 – Non-biologic DMARDs, % 46.6 – Glucocorticoids, % 87.8 – Most common biologic DMARDs, non-biologic DMARDs and glucocorticoids were abatacept (4.6%), hydroxychloroquine/hydroxychloroquine sulphate (19.8%) and prednisone (37.4%), respectively. Disclosure of Interests: Martin Aringer Consultant of: Boehringer Ingelheim, Roche, Speakers bureau: Boehringer Ingelheim, Roche, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly &amp; Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly &amp; Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Clive Kelly Consultant of: Boehringer Ingelheim, Speakers bureau: Boehringer Ingelheim, Anna-Maria Hoffmann-Vold Grant/research support from: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Actelion, Bayer, GlaxoSmithKline, Speakers bureau: Boehringer Ingelheim, Actelion, Roche, John Belperio: None declared, Alexandra James Employee of: Employee of Boehringer Ingelheim, Carl Coeck Employee of: Employee of Boehringer Ingelheim, Manuel Quaresma Employee of: Employee of Boehringer Ingelheim, Eric Matteson Grant/research support from: Pfizer, Consultant of: Boehringer Ingelheim, Gilead, TympoBio, Arena Pharmaceuticals, Speakers bureau: Simply Speaking