Corticosteroids

IBD Curriculum Topic 6.1-6.11

Potent anti-inflammatory agents, primarily used for moderate to severe relapses of Crohn’s Disease.

Benefit & risk (Crohn's Disease)

Response and remission

  • Effective at inducing remission (NNT 2-3), with remission rates of 60-83% (c.f. 30-38% placebo).
  • More effective than placebo, mesalazine or budesonide.

Maintenance of remission

  • Steroids have no role in maintaining remission, when assessed at 6, 12, or 24 months.
  • Remission only persists in 1 in 4 patients after one year.
  • Therefore, immunomodulators (azathioprine/mercaptopurine or methotrexate) and/or anti-TNF are frequently used as maintenance therapy, after steroid-induced remission.

Major side effects

  • 50% of patients report no adverse effects.
  • Side effects are common and can be severe; therefore patients should avoid prolonged (>3 months) or repeated treatment.
  • Early side-effects:
    • Cosmetic (acne, moon face, oedema, striae)
    • Sleep & mood disturbance
    • Dyspepsia
    • Glucose intolerance
    • >/= 20mg Prednisolone for > 6 weeks increases surgical complications (see ECCO 7K beneath)
  • Side-effects with > 12 weeks use:
    • Cataracts
    • Osteoporosis (provide prophylactic therapy, at least Ca++ and vitamin D)
    • Osteonecrosis of the femoral heah
    • Myopathy
    • Infection susceptibility
  • Side-effects on (too rapid) withdrawal:
    • Adrenal insufficiency
    • Pseudo-rheumatism
    • Raised intra-cranial pressure
  • National Formularly should be consulted to review adverse drug reactions and drug interactions.

 

Benefit & risk (Ulcerative Colitis)

Response

Effective at inducing remission in ambulatory patients (NNT 2). The usual initial dose of oral prednisolone is 0.5-1 mg/kg/d PO. Parenteral therapy comprises methyl prednisolone 60 mg/24h (IVI) or hydrocortisone 100 mg qds( IV). Calcium / vitamin D should be co-administered to reduce iatrogenic osteopaenia. Adjunctive topical steroids can be used in acute severe colitis; a proven regime is twice daily hydrocortisone (100 mg in 100 ml normal saline) given over 30 minutes, administered via a soft rectal cannula (e.g. Foley™ catheter).

Response in proctitis

Topical steroids (e.g. prednisolone 20 mg od PR) are second line to 5-ASA therapy, although combined 3 mg beclomethasone dipropionate and 2 g mesalazine enema is superior to either agent alone.

Left sided and extensive colitis

Corticosteroids are the main therapy for acute severe colitis although 30% do not respond and would require colectomy without 2nd-line therapy. IV steroids should not be continued for > 7 days as mortality increases with delayed surgery.

Maintenance

Corticosteroids should not be used for maintenance therapy. After 1 year, outcomes of continuous corticosteroid therapy are poor, with ≈⅓ undergoing colectomy and ≈⅓ being corticosteroid-dependent.

Prevention

Corticosteroids provide no prophylactic benefit, conversely increase infection risk.

Dose and administration

  • No dose response relationship or tapering regimes tested (major studies used Prednisone 0.5-0.75 mg/kg/d or 6-methylprednisolone 1 mg/kg/d).
  • Once disease stabilized, usually after ≈2 weeks, reduce dose gradually, stopping therapy after ≈2 months (relapse more common with rapid dose reduction).

Special situations

Pregnancy and lactation

  • Corticosteroids (especially prednisone) are rapidly metabolized by the placenta, resulting in low fetal concentrations, and are considered safe in pregnancy, though cleft lip/palate has been associated with their use in the first trimester.
  • Enemas and suppositories may be difficult to administer in the 3rd trimester.
  • Prednisone appears in low concentration in breast milk, so consider discarding expressed milk for 4 hours after dosing.

Surgery (side-effect of drugs when surgery contemplated)

  • Prednisolone 20 mg/d or equivalent for more than 6 weeks increases the risk of surgical complications (see ECCO 7K above).
  • Before surgery for UC, try if possible to wean steroid doses equivalent to < 20mg/d prednisolone. Following surgery, rapidly reduce steroids to an equivalent of prednisolone 5 mg (am) / 2.5 mg (pm) except in those having taken steroids for > 6 months who require a dose reduction of 1 mg/week. Dose reduction below a total daily dose of 7.5 mg depends on withdrawal symptoms.
ECCO Statement 7T (UC 2012)

Prednisolone 20 mg daily or equivalent for more than six weeks is a risk factor for surgical complications [EL3b, RG C]. Therefore, corticosteroids should be weaned if possible

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