METHODS: A post-hoc analysis of two duplicate placebo (PBO)-controlled 52-week phase 3 RES trials was performed in the overall population and in four subgroups: adult patients with severe asthma (APSA) (Subgroup 1), APSA and on high-dose ICS plus another controller (Subgroup 2), APSA and ≥2 exacerbations in the previous year (Subgroup 3), and APSA and ≥3 exacerbations in the previous year (Subgroup 4). Duration of CAE requiring hospitalization and/or emergency room (ER) visit and/or systemic corticosteroids (SCS) for ≥3 days were compared between RES and PBO groups.
RESULTS: Of 953 randomized overall patients (RES 477, PBO 476), 744 (RES 372, PBO 372), 322 (RES 159, PBO 163), 307 (RES 148, PBO 159), and 158 (RES 67, PBO 91) patients were included in the analysis of Subgroups 1, 2, 3 and 4, respectively. Compared with PBO, the duration of CAE requiring hospitalization and/or ER visit and/or SCS for ≥3 days was significantly shorter in the RES group in the overall population (15.4 vs. 17.3 days, p=0.0002) and in all four subgroups (Subgroup 1: 15.7 vs. 17.5, p=0.0021; Subgroup 2: 15.8 vs. 18.4, p=0.0029; Subgroup 3: 15.9 vs. 18.2, p=0.0058; Subgroup 4: 15.9 vs. 18.8, p=0.0081).
CONCLUSIONS: Treatment with RES significantly reduced duration of exacerbations in the overall population and in the subgroups of adult patients with severe asthma.