Tuesday, September 6, 2016

Alternatives to Sulfasalazine

  • Four 5-aminosalicylic acid derivatives are currently available for use in the US:
  • balsalazide, mesalamine, olsalazine, and sulfasalazine.
  • The 5-ASA derivatives are available in oral and topical formulations and are indicated in the treatment and/or maintenance of remission of ulcerative colitis.
  • The 5-ASA derivatives are the core of drug therapy for ulcerative colitis.
  • Current ulcerative colitis practice guidelines recommend oral 5-ASA agents for achieving and maintaining remission.
  • Sulfasalazine is still recognized as the preferred first-line agent and balsalazide, mesalamine, and olsalazine are listed as effective alternatives.
Adverse Drug Reactions
  • The most common adverse events reported with the agents are headache and gastrointestinal upset.
  • Adverse events are reported more frequently in patients taking sulfasalazine.
  • Sulfasalazine is an arylamine sulfonamide with antibiotic activity. It therefore may exhibit cross-reactivity with other arylamine sulfonamide antibiotics
  • Adverse effects are reported in up to 45% of patients taking sulfasalazine and are thought to be related primarily to the sulfa moiety
  • Adverse events reported with sulfasalazine treatment can be dose related, including headache, nausea, and fatigue, and may be minimized by taking the medicine with food or by reducing the dose
  • Allergic reactions can occur with sulfasalazine treatment and may include rash, including Stevens-Johnson syndrome, or other serious reactions like hepatitis,
  • pneumonitis, and hemolytic anemia.
  • In addition, sulfasalazine inhibits intestinal folate absorption and patient’s receiving treatment with sulfasalazine may require folate supplementation
Alternatives
  • newer 5-ASA are associated with lower rates of adverse effects compared to sulfasalazine treatment
  • Approximately 90% of those with intolerance to sulfasalazine can tolerate mesalamine. 
  • Mesalamine does not contain the sulfa group
  • There are several mesalamine-based oral 5-ASA agents including, Asacol®HD, Pentasa®, Lialda®, Apriso™, Delzicol™. These agents all use the same mesalamine, but differ in terms of the medication coating.
  • Nephrotoxicity is a rare but serious concern associated with 5-ASA treatment and renal function should be monitored in all patients receiving these agents

References:
  1. CCFA Fact Sheet, January 2015
  2. 5-Aminosalicylic Acid Derivatives Drug Class Review, University of Utah College of Pharmacy, October 2013.

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