Author’s reply: can budesonide form be alterative treatment for ulcerative proctosigmoiditis?

Excerpt

We read with great interest the comment from Dr. Pokrotnieks et al. regarding our manuscript entitled “Complete mucosal healing of distal lesions induced by twice-daily budesonide 2-mg foam promoted clinical remission of mild-to-moderate ulcerative colitis with distal active inflammation: double-blind, randomized study”. Through recent clinical trials [1, 2], we have confirmed that the proportion of patients with clinical remission and complete mucosal healing in budesonide group was significantly higher than those in placebo group. The first trial was conducted as a Phase II clinical trial involving 165 patients with mild-to-moderate proctitis or proctosigmoiditis in 2012–2013 [1]. The rate of clinical remission in the twice-daily budesonide form group (48.2%) was significantly higher than that in the placebo group (20.4%). The greatest impact in this trial was that the proportion of patients with complete mucosal healing (Mayo endoscopic score of 0 at week 6) was absolutely high (46.4%) in the twice-daily group. This rate was particularly higher in patients without the history of 5-ASA rectal treatment than in those with the history of 5-ASA rectal treatment. In the previous large control trial by Dr. Sandborn et al. [3], although the rate of complete mucosal healing was not investigated, they reported that the rate of mucosal healing (Mayo endoscopic score of 0–1) was 55.8%. This rate was lower than mucosal healing rate in our study. In Sandborn’s study, budesonide form was administered twice a day for the first 2 weeks, and then, once a day for the following 4 weeks, whereas budesonide form was administered twice a day for 6 weeks in our study. In the point of view of mucosal healing, it may be critical that the treatment of budesonide twice a day is continued for 6 weeks. …