Fig 1.
Study design.
Table 1.
Patient demographics and baseline characteristics (analysis set).
Fig 2.
eCRF, electronic case report form; BID, twice daily administration; QD, once daily administration.
Fig 3.
Kaplan–Meier plot for the relapse in patients with ulcerative colitis who achieved clinical remission and mucosal healing by treatment with budesonide foam for 6 weeks in the phase 2 or phase 3 clinical trials in Japan.
The median survival time (year) without relapse was 0.82 (95% CI: 0.51 to 1.52).
Table 2.
Proportion of patients with/without relapse during the observation period by covariates.
Table 3.
Estimated hazard ratio (HR) with Cox regression model.
Fig 4.
Kaplan–Meier plot for the relapse in patients with ulcerative colitis who achieved clinical remission and mucosal healing by treatment with budesonide foam in phase 2 or phase 3 clinical trials in Japan by a covariate.
(A) endoscopic subscore: MES = 0 (broken line) and MES = 1 (solid line) at start of this study, each median survival time (year) was 1.02 (95% CI: 0.61 to 1.66) and 0.54 (95% CI: 0.23 to 1.95), respectively. There was no significant difference between the groups (log-rank test, P = 0.275). (B) The disease duration: duration of <1 year(broken line), duration of 1–5 years (solid line), duration of ≥5 years (thin solid line). Each median survival times (year) were 0.28 (95% CI: 0.17 to 1.03), 0.97 (95% CI: 0.49 to 1.97), 0.93 (95% CI: 0.40 to 1.66), respectively. There was no significant difference between Group 1, 2 and 3 (log-rank test, P = 0.055). (C) Patients receiving budesonide foam, QD (broken line) and BID (solid line), each median survival times (year) were 0.54 (95% CI: 0.19 to 1.02) and 1.03 (95% CI: 0.61 to 1.83), respectively. There was no significant difference between Group 1 and Group 2 (log-rank test, P = 0.106).