Results from a new pharmacokinetic (PK) study presented at the annual meeting of the American College of Rheumatology (ACR) provide new evidence-based guidance for healthcare providers on using colchicine for gout flare prophylaxis in the presence of renal impairment.
The findings demonstrate that colchicine can be administered safely in patients with moderate or severe renal impairment for the prevention of gout flares with appropriate dosing adjustments. In patients with mild renal impairment or end-stage renal disease (ESRD) dosing adjustments are not necessary.
The study “Colchicine Dosing Guidance for Gout Patients with Varying Degrees of Renal Impairment Based on Pharmacokinetic Data,” is part of URL Pharma’s ongoing clinical research program for colchicine. Colcrys® (colchicine, USP), the only single-ingredient colchicine product approved by the U.S. Food and Drug Administration (FDA) is held by AR Holdings, a URL Pharma company. Colcrys® is designed as a prophylaxis and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF).
In the randomized study, the researchers divided a total of 40 participants ranging from patients with normal renal function to those with end-stage renal disease (ESRD) into five groups depending on creatinine clearance (CrCl) levels, which is a key measure of kidney function. Each study participant was administered with a single 0.6 mg dose of colchicine.
After the PK analyses and post-dose modeling the researchers concluded that patients with moderate or severe renal impairment should receive half of the traditional dose of one tablet (0.6 mg) of colchicine once or twice daily for the prophylaxis of gout flares, in particular those taking two tablets (1.2 mg) daily should reduce the dosage to one tablet (0.6 mg) daily and those taking one tablet (0.6 mg) per day should cut the dosage to half a tablet (0.3 mg) per day.
In addition the conclusion, they also said it is unnecessary to adjust dosage for flare prophylaxis in patients who are on dialysis
Matthew W. Davis, M.D., R.Ph., Chief Medical Officer, URL Pharma explained:
“Traditional clinical guidance on colchicine dosing in patients with renal impairment is based on empirical data, as was the case with most of what we once knew about colchicines. These results clearly identify for physicians and other healthcare providers the stages of renal impairment that require dosing adjustments, and when the standard recommended dosage could be safely administered. This guidance is critically important to ensure optimal therapeutic benefit for all patients, including those with renal impairment.”