Dr Yamamoto and colleagues from Japan evaluated long-term efficacy and safety of tacrolimus in patients with refractory ulcerative colitis.
The team randomized 27 patients to conventional therapy tacrolimus with trough whole-blood levels of 10-15 ng/mL to induce remission, and 5-10 ng/mL to maintain remission.
|Colectomy-free survival was estimated as 62% at 65 months|
|Alimentary Pharmacology & Therapeutics|
The team reported that the median treatment duration was 11 months, and median follow-up duration was 17 months.
Evaluation of the clinical response was based on a modified Truelove-Witts severity index.
The researchers found that tacrolimus produced a clinical response in 78% of patients, and remission in 70% of these within 30 days.
Overall cumulative colectomy-free survival was estimated as 62% at 65 months.
In 18 of 19 patients treated with corticosteroids at the initiation of tacrolimus therapy, corticosteroids were discontinued or tapered.
The research team observed that adverse events included tremor, renal function impairment, infectious disease, and hot flashes.
Hyperkalemia, headache, epigastralgia, and nausea also occurred in some patients, but no deaths.
Dr Yamamoto's team concluded, "Long-term administration of tacrolimus appears to be an effective and well-tolerated treatment for Japanese patients with refractory ulcerative colitis."