Treatment Options Overview: Corticosteroids

PRODUCT DETAILS / COMPANY (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Budesonide / Bausch Health Canada Inc. (2020)

INDICATION

Induction of remission in patients with mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

           

Logistics and Monitoring: Corticosteroids

METHOD OF ADMINISTRATION

Rectal foam

DOSING - ADULTS

Rectal foam
2 mg/actuation or metered dose.

One metered dose rectally twice daily for 2 weeks followed by 1 metered dose once daily for 4 weeks; may be extended an additional 2 weeks if symptoms persist.

DOSING - PEDIATRIC

No pediatric data, provider judgement.

           

RCTs: randomized clinical trials, IV: intravenous, BDP: beclomethasone dipropionate

Side Effects: Corticosteroids

SIDE EFFECTS

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

Special Populations: Corticosteroids

PEDIATRICS

No data are available to Health Canada and therefore it is not authorized for pediatric use.

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.

ELDERLY

There is insufficient and inadequate data in clinical studies for patients age 65 and older. Should be used with caution. 

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.

PREGNANCY

For access to the full guidelines click here

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.”

BREASTFEEDING

For access to the full guidelines click here

The Global Consensus Statement on the management of Pregnancy in Inflammatory Bowel Disease by Mahadevan, U. et al suggest16:

  • Breastfeeding as it is NOT associated with an increased risk of disease exacerbation in women with inflammatory bowel disease.
  • Mothers with IBD currently on corticosteroids may breastfeed
           

IBD: inflammatory bowel disease, 5-ASA: 5-aminosalicylic acid, ECCO: European Crohn’s and Colitis Organization, EEN: enteral nutrition