Does Switching Colchicine Preparations Have a Role in The Treatment of Familial Mediterranean Fever?

Abstract

Objective: The aim of this study was to evaluate the treatment response of compressed colchicine tablets in familial Mediterranean fever (FMF) patients with resistance or intolerance to coated colchicine. Another objective was to determine the demographic and clinical characteristics of the group that responded to compressed colchicine preparations. Methods: In this retrospective study, the files of 1574 patients with FMF in our center were reviewed. Sixty-one patients who did not respond to coated colchicine and were switched to compressed colchicine treatment were evaluated. The number of attacks and the International Severity Score for FMF (ISSF) during the 6 months before and 3, 6, 9, 12, and 24 months after switching from coated colchicine to compressed colchicine were recorded. Results: Of the 61 patients, 36 (59%) were boys, and 25 (41%) were girls. The mean age of symptom onset was 34±22 months. The mean age at diagnosis was 8.4±5.1 years. The mean age at the time of switching from coated colchicine to compressed colchicine was 11.8±3.5 years. Among 61 patients whose treatments were switched to compressed colchicine, 12 had intolerance, while 49 had uncontrolled attacks and persistent subclinical inflammation. The problems of 12 patients who were switched to compressed colchicine due to intolerance were resolved. Response to compressed colchicine was observed in 25/49 patients with uncontrolled attacks and persistent subclinical inflammation. The frequency of attacks decreased significantly at the 3rd and 6th months after switching from coated colchicine to compressed colchicine (p<0.05). The mean ISSF score of the patients in the last 3 months while receiving coated colchicine was 5.4±2.3. The mean ISSF scores of the patients at the 3rd and 6th months after switching to compressed colchicine were 3.2±2.1 and 2.6±1.7, respectively. Twenty-four of the 49 patients did not respond to compressed colchicine. Anakinra was added to the treatments of 14 of the 24 patients, and canakinumab was added to the treatments of 10. The frequency of attacks and ISSF scores of the patients who did not respond to compressed colchicine significantly decreased after the addition of IL-1-targeting drugs to their treatments. At the end of the two-year follow-up, 42 patients were tolerant to compressed colchicine, and 19 patients (4 anakinra, 15 canakinumab) were on compressed colchicine plus IL-1-targeting drugs. Conclusions: Compressed colchicine was shown to be a useful treatment option before initiating biological agents in patients who were unresponsive to coated colchicine, especially those with side effects.

IL-1 Inhibitors in the Treatment of Familial Mediterranean Fever: Treatment Indications and Clinical Features in a Large Real-World Cohort

“…In addition, drug formulation might have an impact on intolerance as well as resistance. Several studies from Turkey pointed out that switching coated colchicine preparations to compressed forms could yield additional benefits on disease control and drug intolerance [ 18 , 19 , 20 ]. Notwithstanding the lack of concrete pharmacokinetic evidence, it seems like embracing an akin approach in daily clinical practice helped us to improve drug tolerance.…”

“…Dietary changes or anti-diarrheal/spasmolytic medications were also advised for persistent gastrointestinal adverse effects. Additionally, since several studies have suggested that changing the type of colchicine tablet could help to improve intolerance and lessen side effects [ 18 , 19 , 20 ], the form of colchicine tablet is changed once before starting anti-IL-1 in the routine clinical practice of the study center. In such circumstances, coated colchicine tablets (Colchicum-Dispert ® [Recordati Ilac Sanayi, Istanbul, Turkey] and Kolsin ® [Ibrahim Etem Ulagay Ilac Sanayi, Istanbul, Turkey]) were switched to compressed colchicine preparations (Colchicine Opocalcium ® [Laboratories Mayoly Spindler, Chatou, France], Colchicine Lirca ® [Acarpia Farmaceutici S.R.L, Milano, Italy], and Colchicine Seid ® [Seid S.A., Barcelona, Spain]) with the approval of the Turkish Pharmacists Association.…”