Treatment Options Overview: Corticosteroids

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

Budesonide MMX / Ferring Inc. (2016)

INDICATION

Delayed and extended-release tablets are indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

           

Logistics and Monitoring: Corticosteroids

METHOD OF ADMINISTRATION

Oral

DOSING - ADULTS

9 mg daily for up to 8 weeks.

DOSING - PEDIATRIC

In patients >30 kg, BDP is 5 mg once daily for 4 weeks and budesonide MMX 9 mg for 8 weeks.

Dosing for children <30 kg has not been established.

There is no evidence to support tapering. While abrupt discontinuation has been practiced in RCT’s, alternate day tapering over 2-4 weeks has been proposed by some.12

           

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.

• Increased risk of infection
• Hypertension
• Diabetes mellitus
• Osteoporosis
• Peptic ulcer
• Glaucoma or cataracts
• Cushing syndrome
• Mood changes

           

IBD: inflammatory bowel disease

Special Populations: Corticosteroids

PEDIATRICS

Safety and efficacy in children have not been established. No data available.

Turner D. et al. suggest12:

May be considered for left-sided colitis with mild disease refractory to 5-ASA before oral prednisone.

ELDERLY

There is insufficient and adequate data in patients >65. Caution should be used due to potential decreased hepatic, renal, or cardiac function, or due to concomitant disease or therapies.

Recommendations14:

May be preferred in older patients with left-sided ulcerative colitis.

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.

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.”

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