Treatment Options Overview: Corticosteroids

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


Prednisone / Teva Canada Ltd.7 (2015)

Prednisone / Apotex Inc.8 (1982)

INDICATION

Treatment of patients with:

  • Severe active ulcerative colitis to induce complete remission.
  • Mild-to-moderate ulcerative colitis who fail to respond to 5-ASA therapy recommended as a second line.
  • Mild to moderate active left-sided ulcerative colitis or proctitis who fail to respond to rectal 5-ASA therapy.
 

Not recommended for maintenance of remission.

Treatment of patients with:

Moderate-to-severe Crohn’s disease for induction of clinical response. Should not be used as a maintenance of remission.

           

Logistics and Monitoring: Corticosteroids

METHOD OF ADMINISTRATION

Oral

DOSING - ADULTS

The recommended daily dose for oral prednisolone/prednisone is 1 mg/kg−1/day−1 (max 40 mg) once daily for 2 to 3 weeks followed by a tapering period of up to 8 to 10 weeks.

Once-daily administration of steroids in the morning is as effective as the same dose given in multiple divided doses.

DOSING - PEDIATRIC

Recommended daily dose for oral prednisone is 1 mg/kg/day to a maximum of 40 mg once daily for 2 to 3 weeks followed by a tapering period up to 8 to 10 weeks.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.

• Adrenal suppression
• Hypertension
• Fluid retention
• Decreased serum potassium, sodium retention
• Arrythmias
• Mood changes
• Insomnia
• Cushingoid appearance
• Peptic ulcer
• Dyspepsia
• Gastritis
• Hyperglycemia
• Increased risk of infection
• Osteoporosis
• Avascular necrosis
• Glaucoma

           

IBD: inflammatory bowel disease

Special Populations: Corticosteroids

PEDIATRICS

Oral steroids should be used as second-line treatment for mild-moderate ulcerative colitis not responding to 5-ASA (oral ± or rectal) and may be considered as first line in the higher end of the moderate disease range.

Severe ulcerative colitis should normally be treated with intravenous steroids.

Second-generation oral steroids with lower systemic effect such as BDP and budesonide-MMX (the evidence for budesonide-MMX is supportive only for left-sided colitis) may be considered in patients with mild disease refractory to 5-ASA before oral prednisolone.

Steroids are not recommended for maintaining remission; steroid-sparing strategies should be applied.12,13

ELDERLY

Recommendations15:

All available data indicate a higher risk of serious adverse events with prolonged use of corticosteroids in elderly patients with IBD when compared to younger adult patients.

Increased risk of infections, osteoporosis-related fractures, alteration in mental status, fluid retention, ocular problems, and drug interactions.

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:

In women with IBD who are pregnant, the use of corticosteroid therapy when clinically necessary with appropriate monitoring (conditional recommendation).

The recommendations emphasize the importance of controlling disease activity before and during pregnancy with steroid sparing therapy.

Important considerations

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.

Reference studies did note with corticosteroid use there is an increased risk for preterm birth, low birth weight, gestational diabetes.

In women with IBD who are pregnant, the use of corticosteroid therapy when clinically necessary with appropriate monitoring (conditional recommendation).

Recommendations

  • Minimize use
  • Employ steroid sparing therapy

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