Early Oral & Topical Anti-inflammatory Therapies for IBD
Budesonide / A registered trademark owned by Tillotts Pharma AG, used under license by Pendopharm, division of Pharmascience Inc. (2016)
Controlled ileal release capsules indicated for the treatment of mild-to-moderate active Crohn’s disease involving the ileum and/or the ascending colon.
Oral
Induction: 9 mg daily for up to 8 weeks.
Maintenance: 6 mg daily for up to 3 months for maintenance of clinical remission.
Induction10-11: 9 mg once daily for 8 weeks, followed by 6 mg daily for 4 weeks.
Maintenance: Not recommended.
RCTs: randomized clinical trials, IV: intravenous, BDP: beclomethasone dipropionate
For more detailed information regarding side effects, please refer to the appropriate product monograph.
• Hypertension
• Acne vulgaris
• Cushingoid appearance
• Nausea
• Bruising
• Headache
• Respiratory tract infection
• Dysuria
• Infection
• Mood changes
• Peptic ulcer
IBD: inflammatory bowel disease
Safety and effectiveness in children have not been established.
No data for Health Canada to review.
ECCO Crohn’s guidelines13:
In children with mild to moderate ileo-cecal Crohn’s disease budesonide may be used as an alterative to systemic corticosteroids for induction of remission.
Product monograph: no acknowledgement of the older population.
Recommendations14:
May be preferred over conventional corticosteroids in older patients with ileocolonic or right sided luminal Crohn’s disease.
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.
Very little data available on the use of ileal and colonic release corticosteroids.
The guidelines suggest,
“The decision to use second-generation steroids vs conventional corticosteroids requires an assessment of disease severity, given that timely and effective induction of remission is paramount in a pregnant individual with active disease to reduce adverse maternofetal outcomes.”
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