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Abstract Background and Aim Early treatment response of ulcerative colitis (UC) symptom resolution is desirable. This post hoc analysis evaluated efficacy outcomes, including endoscopic remission, by responder status and the influence of once‐daily (QD) versus twice‐daily (BID) budesonide foam dosing in patients with UC. Methods Data were pooled from phase 2 and phase 3 clinical trials of budesonide rectal foam QD or BID or placebo for up to 12 weeks. Outcomes were evaluated by treatment and budesonide administration regimen and by responder group: early (rectal bleeding subscore RBS 0 from Week 2 through Week 6), delayed (RBS 0 at Week 6), and nonresponder (RBS > 0 at Week 6). Results The main analysis set included 55 (QD) and 120 (BID) budesonide‐treated patients and 116 placebo‐treated patients. At Week 6, the trend in early response rate was significant among treatment groups (BID, 45.3%; QD, 32.1%; placebo, 12.8%; P < 0.0001). Among BID recipients, trends for complete endoscopic remission rate (Mayo endoscopic score MES = 0) and endoscopic remission rate (MES = 0 or 1) were significant among responder status groups (early responder, 67.4% and 95.4%, respectively; delayed responder, 48.1% and 85.2%; nonresponder, 24.0% and 64.0%; P < 0.001 for both). Regardless of the administration regimen, most early responders achieved endoscopic remission at Week 6. Among responder status groups, early responders' cumulative non‐relapse period was greatest ( P = 0.07). Conclusion A BID budesonide administration regimen is preferred to increase the probability of early response and, following endoscopic remission, a better prognosis after stopping treatment.
Watanabe et al. (Sun,) studied this question.