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.
- Cosmetic (acne, moon face, oedema, striae)
- Sleep & mood disturbance
- Glucose intolerance
- >/= 20mg Prednisolone for > 6 weeks increases surgical complications (see ECCO 7K beneath)
Side-effects with > 12 weeks use:
- Osteoporosis (provide prophylactic therapy, at least Ca++ and vitamin D)
- Osteonecrosis of the femoral heah
- Infection susceptibility
Side-effects on (too rapid) withdrawal:
- Adrenal insufficiency
- Raised intra-cranial pressure
- National Formularly should be consulted to review adverse drug reactions and drug interactions.
Benefit & risk (Ulcerative Colitis)
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.
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.
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).
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.