Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

Area of Science:

• Gastroenterology
• Clinical pharmacology
• Inflammatory bowel disease research

Background:

• Proctitis, a limited form of ulcerative colitis, causes significant symptoms.
• Topical mesalamine is the standard treatment but lacks consistent efficacy.
• Novel therapeutic strategies are needed for effective proctitis management.

Purpose of the Study:

• To evaluate the efficacy and safety of budesonide suppositories in treating active proctitis.
• To compare two doses of budesonide suppositories against mesalamine suppositories and combination therapy.

Main Methods:

• A prospective, double-blind, double-dummy, multicenter trial involving 337 patients with active proctitis.
• Patients received 2 mg budesonide suppositories (BUS), 4 mg BUS, 1 g mesalamine suppositories (MES), or combination therapy.
• The primary endpoint was the time to resolution of clinical symptoms (rectal bleeding and stool frequency).

Main Results:

• Mean time to symptom resolution was similar for 4 mg BUS (29.8 days), combination therapy (29.3 days), and 1 g MES (29.2 days).
• The 2 mg BUS group showed a longer time to resolution (35.5 days).
• Clinical, endoscopic remission, and mucosal healing rates were comparable between 1 g MES, 4 mg BUS, and combination groups, but lower in the 2 mg BUS group. No safety concerns were identified.

Conclusions:

• Four mg budesonide suppositories demonstrated comparable efficacy and safety to 1 g mesalamine suppositories for active proctitis.
• Budesonide suppositories represent a viable alternative to mesalamine for topical proctitis treatment.
• The study was registered with ClinicalTrialsregister.eu (no: 2012-003362-41).