Early Oral & Topical Anti-inflammatory Therapies for IBD
ENEMA budesonide / A registered trademark owned by Tillotts Pharma AG, used under license by Pendopharm, division of Pharmascience Inc (2018)
Induction of remission in patients with mild-to-moderate distal ulcerative colitis (rectum, sigmoid, and descending colon).
Rectal enema
Rectal suspension (enema)
0.02 mg/mL enema given nightly for 4 weeks; if remission not induced may continue for additional 4 weeks.
No pediatric data, provider judgement.
RCTs: randomized clinical trials, IV: intravenous, BDP: beclomethasone dipropionate
For more detailed information regarding side effects, please refer to the appropriate product monograph.
• Hyperglycemia
• Adrenocortical insufficiency
• Acne vulgaris
• Agitation
• Allergic dermatitis
• Mood changes
• Hypertension
• Insomnia
IBD: inflammatory bowel disease
Entocort® safety and effectiveness has not been established and is not recommended.
Turner D. et al. suggest12:
Rectal steroid preparations are useful for patients who are 5-ASA intolerant. Meta-analysis data consistently supports the superiority of rectal mesalamine over rectal steroids.
Second-generation topical steroids have a more favourable safety profile and may be considered before systemic steroids.
Product monograph has no acknowledgement of the older population.
Recommendations14:
Topical corticosteroids may be effective for distal colonic disease but may be poorly tolerated in older patients with limited mobility or weak sphincter tone.
The Global Consensus Statement on the management of Pregnancy in Inflammatory Bowel Disease by Mahadevan, U. et al suggest16:
Controlling disease activity during pregnancy among women with inflammatory bowel disease is critical to reduce adverse outcomes.
The recommendations emphasize the importance of controlling disease activity before and during pregnancy with steroid sparing therapy.
Guidelines suggest,
“Rectal corticosteroids have not demonstrated benefit over topical aminosalicylates for clinical, endoscopic, or histologic outcomes, but there is no increased safety concern.”
The Global Consensus Statement on the management of Pregnancy in Inflammatory Bowel Disease by Mahadevan, U. et al suggest16:
IBD: inflammatory bowel disease, 5-ASA: 5-aminosalicylic acid, ECCO: European Crohn’s and Colitis Organization, EEN: enteral nutrition