POS0225 PROGNOSTIC VALUE OF CHANGE IN FORCED VITAL CAPACITY (FVC) AT WEEK 12 OR 24 IN PATIENTS WITH AUTOIMMUNE DISEASE-RELATED INTERSTITIAL LUNG DISEASES (ILDs)

Background: Clinical trials in patients with ILDs generally include a 52-week treatment period. Shorter trials would help speed up drug development and reduce the time that patients receive placebo. Objectives: To assess the prognostic value of change in FVC at week 12 or 24 for change in FVC at week 52, and for ILD progression over 52 weeks, in patients with autoimmune disease-related ILDs. Methods: Data were pooled from the placebo group of the SENSCIS trial in patients with fibrosing ILD associated with systemic sclerosis and the patients with progressive fibrosing autoimmune disease-related ILDs in the placebo group of the INBUILD trial. Using a linear regression model, we assessed the prognostic ability of absolute changes in FVC % predicted at week 12 or 24 for absolute change in FVC % predicted at week 52. Using a logistic regression model, we assessed absolute changes in FVC % predicted at week 12 or 24 as predictors of ILD progression (absolute decline in FVC % predicted ≥5% or death) over 52 weeks. Results: The correlation with absolute change in FVC % predicted at week 52 was stronger for the change at week 24 (r=0.59; n=328) than for the change at week 12 (r=0.46; n=326) (Figures 1A and B). The risk of ILD progression over 52 weeks was lower for each 2.5% increase in FVC % predicted from baseline to week 12 (odds ratio 0.51 [95% CI 0.42, 0.62]; p<0.001]) and for each 2.5% increase in FVC % predicted from baseline to week 24 (odds ratio 0.41 [95% CI 0.33, 0.51]; p<0.001]). Conclusion: In clinical trials in patients with autoimmune disease-associated ILDs, changes in FVC at week 12 and 24 were moderately correlated with changes in FVC at week 52, and were associated with the risk of ILD progression or death over 52 weeks. REFERENCES: NIL. Acknowledgements: The SENSCIS and INBUILD trials were supported by Boehringer Ingelheim International GmbH. Disclosure of Interests: Anna-Maria Hoffmann-Vold Dr Hoffmann-Vold reports being a paid instructor for Boehringer Ingelheim., Dr Hoffmann-Vold reports speaker fees from Boehringer Ingelheim, Janssen, Medscape, Merck Sharp & Dohme, Novartis and Roche., Dr Hoffmann-Vold reports consulting fees from ARXX, Bristol-Myers Squibb, Boehringer Ingelheim, Genentech, Janssen, Medscape, Merck Sharp & Dohme and Roche., Dr Hoffmann-Vold reports grant/research support from Boehringer Ingelheim and Janssen., Margarida Alves Margarida Alves is an employee of Boehringer Ingelheim., Corinna Miede Corinna Miede is an employee of mainanalytics GmbH, Sulzbach (Taunus), Germany, which was contracted by Boehringer Ingelheim to assist with these analyses., Oliver Distler Professor Distler reports speaker fees from Bayer, Boehringer Ingelheim, Janssen and Medscape., Professor Distler reports consulting fees from 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant Siences, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galapagos, Glenmark, Horizon, Inventiva, Kymera, Lupin, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Pfizer, Prometheus, Redxpharna, Roivant, Sanofi and Topadur., Professor Distler reports grant/research support from Kymera and Mitsubishi Tanabe.