STARLINER study, disease behaviour assessed by a wide range of parameters including patient-reported outcomes (PRO) results

Introduction: The STARLINER study (NCT03261037) used a novel digital platform and assessed disease behaviour by a wide range of parameters (including PROs) during the peri-diagnostic period in patients with suspected ILD. Here, we report the PRO results. Methods: Study outcomes included various PROs including EQ-5D-5L, K-BILD, Visual Analogue Scales (Table). All results were analysed using descriptive statistics. Results: 178 patients were enrolled with 130 patients diagnosed with ILD. The study results (pulmonary function, physical activity) presented at ERS2020 demonstrated the more progressive nature of IPF vs. non-IPF ILD during the early stages of disease. No clinically meaningful differences in change of PROs were reported for either IPF or non-IPF ILD; however, IPF patients trended to more worsening of some PROs over time (Table). The differences observed for EQ-5D and KBILD psychological are in the range of the minimal important difference (MID). Conclusions: STARLINER provides valuable insights into disease behaviour. Due to the limited duration of observation, changes in PROs were generally not clinically meaningful, but trended worse in patients with IPF. Assessing disease behaviour by a wide range of parameters may facilitate diagnosis as patients with IPF appear to decline/worsen more rapidly in the early stages of disease than patients with non-IPF ILD.