OBJECTIVE: To evaluate the efficacy and safety of weekly intravenous (IV) colchicine, in addition to oral colchicine therapy, in a subset of patients with familial Mediterranean fever (FMF) unresponsive to oral colchicine prophylaxis. METHODS: Thirteen patients with frequent FMF attacks, despite oral doses of 2-3 mg/day colchicine, were treated with weekly IV injections of 1 mg colchicine for 12 weeks in an open-label pilot study. Patients were evaluated periodically for the number and severity of their attacks, use of analgesics, and erythrocyte sedimentation rate (ESR). RESULTS: A 50% reduction in attack frequency and attack severity in at least one site was achieved by 10 and 6 of the 13 study patients, respectively (p < 0.001 and p < 0.01). Mean number of abdominal attacks declined significantly from 4.2 +/- 3.0 per patient at baseline to 1.9 +/- 2.6 attacks at the end of the third month of the study (p = 0.0002). The mean severity of abdominal attacks declined from a baseline of 6.1 +/- 0.95 to 3.9 +/- 2.8 after 3 months (p = 0.02). Comparable significant change was observed in chest attacks, ESR, and number of analgesic tablets used. Joint attacks were unrelieved during the study period. The treatment was safe and well tolerated, without side effects. CONCLUSION: Treatment with weekly IV colchicine injections in addition to oral colchicine therapy is effective and safe in patients with FMF refractory to oral colchicine.
OBJECTIVE: To evaluate the efficacy and safety of weekly intravenous (IV) colchicine, in addition to oral colchicine therapy, in a subset of patients with familial Mediterranean fever (FMF) unresponsive to oral colchicine prophylaxis. METHODS: Thirteen patients with frequent FMF attacks, despite oral doses of 2-3 mg/day colchicine, were treated with weekly IV injections of 1 mg colchicine for 12 weeks in an open-label pilot study. Patients were evaluated periodically for the number and severity of their attacks, use of analgesics, and erythrocyte sedimentation rate (ESR). RESULTS: A 50% reduction in attack frequency and attack severity in at least one site was achieved by 10 and 6 of the 13 study patients, respectively (p < 0.001 and p < 0.01). Mean number of abdominal attacks declined significantly from 4.2 +/- 3.0 per patient at baseline to 1.9 +/- 2.6 attacks at the end of the third month of the study (p = 0.0002). The mean severity of abdominal attacks declined from a baseline of 6.1 +/- 0.95 to 3.9 +/- 2.8 after 3 months (p = 0.02). Comparable significant change was observed in chest attacks, ESR, and number of analgesic tablets used. Joint attacks were unrelieved during the study period. The treatment was safe and well tolerated, without side effects. CONCLUSION: Treatment with weekly IV colchicine injections in addition to oral colchicine therapy is effective and safe in patients with FMF refractory to oral colchicine.