"Vigilant" monitoring needed for adverse events with cyclosporine for IBD

NEW YORK (Reuters Health) - Cyclosporine therapy for inflammatory bowel disease (IBD) is associated with a high frequency of minor and major adverse events, according to a retrospective study.

"Although not all these events can be clearly attributed to cyclosporine use alone, we suggest vigilant monitoring at tertiary care centers with experience in the treatment of severe IBD as well as experience with the use of cyclosporine," write the researchers in the April issue of the...

NEW YORK (Reuters Health) - Cyclosporine therapy for inflammatory bowel disease (IBD) is associated with a high frequency of minor and major adverse events, according to a retrospective study.

"Although not all these events can be clearly attributed to cyclosporine use alone, we suggest vigilant monitoring at tertiary care centers with experience in the treatment of severe IBD as well as experience with the use of cyclosporine," write the researchers in the April issue of the American Journal of Gastroenterology.

Moderate- to high-dose cyclosporine is known to be effective in the acute treatment of IBD; however, data on the adverse effects of cyclosporine in this patient population are lacking, Dr. Daniel H. Present from Mount Sinai Medical Center, New York, and colleagues note in the report.

They reviewed the records of 111 consecutive patients with IBD (64 ulcerative colitis, 47 Crohn's disease) who were treated with intravenous cyclosporine (4 mg/kg/day) followed by oral cyclosporine (8 mg/kg/day), with dose adjustment as needed based on serum creatinine. The average treatment duration was 9.3 months.

Major adverse events occurred in 17 patients (15.3%), including two deaths (1.8%), one of which was clearly related to complications of cyclosporine therapy, the team reports.

Nephrotoxicity occurred in 27 patients (24%), but in 21 patients serum creatinine returned to normal with dose adjustment. Nephrotoxicity severe enough to warrant discontinuation of therapy occurred in 6 patients (5.4%). "We strictly defined nephrotoxicity as a serum creatinine of greater than 1.4 mg/dL (123 micromoles per liter) or a rise by at least 33% over baseline creatinine," the authors note.

Seven patients (6.3%) developed severe infections, four had seizures (3.6%) and one developed anaphylaxis (0.9%).

Minor adverse events associated with cyclosporine therapy were frequent but did not require dose adjustment in most cases. Minor adverse events comprised: paresthesias (51%), hypomagnesemia (42%), hypertension (39%), hypertrichosis (27%), headache (23%), minor nephrotoxicity (19%), abnormal liver function tests (19%), minor infections (15%), hyperkalemia (13%) and gingival swelling (4%).

The researchers add: "The role of cyclosporin versus biological treatments in severe ulcerative colitis remains to be defined since both agents have a significant toxicity profile."

Am J Gastroenterol 2008;103:937-943.