EFFECTS OF NINTEDANIB IN PATIENTS WITH PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASE ASSOCIATED WITH RHEUMATOID ARTHRITIS (RA-ILD) IN THE INBUILD TRIAL
Authors: C. Kelly et al.
This is a subgroup analysis of the larger INBUILD trial that enrolled subjects with progressive fibrosing ILDs. A total of 89 with RA-ILD were enrolled, 42 on nintedanib, 47 on placebo, of whom 87% had a usual interstitial pneumonia (UIP)-like pattern on lung CT. The adjusted mean rate of decline in FVC over 52 weeks was -82.6 mL/year in the nintedanib group versus -199.3 mL/year in the placebo group. The most common adverse event in subjects with RA-ILD was diarrhoea (55% on nintedanib, 26% on placebo).
Interstitial lung disease associated with RA is a serious extra-articular complication of longstanding RA, for which no specific treatment existed and associated with a strong increase in mortality (relative risk ~ 3.1, see OP0099). Nintedanib demonstrated a slowing of the decline in lung function in this population, which should allow to prolong life-expectancy in this population. Most of these RA patients were able to continue their underlying DMARD therapy, while taking nintedanib, but ~ one in five patients had to stop the anti-fibrotic therapy because of adverse events (digestive++).