Monitoring

Treatment safety

  • Despite the safety of long-term use and overall good tolerability, colchicine can be very toxic.[92] Patients should be monitored for side effects, including gastrointestinal toxicities, bone marrow suppression (usually develops in the first week of exposure), acute renal failure, myopathy, neuropathy, seizure, multiple organ failure, and death. FBC, LFTs, and kidney functions should be checked no later than the first 2 weeks of therapy (preferably in the first week).[129]

  • Physicians should be aware of the important potential drug-drug interactions of colchicine with CYP3A4 or P-glycoprotein inhibitors as these can limit colchicine safety and tolerance, especially in patients treated with high doses. It is of paramount importance to avoid toxicity due to concomitant administration of CYP3A4 or P-glycoprotein inhibitors, because co-prescriptions with such drugs may lead to severe complications (including death).[130][131]

Disease activity

  • Under colchicine treatment patients should be nearly asymptomatic, and the dosage of colchicine should be adjusted according to disease activity as judged by symptoms and inflammatory markers. The optimal dosage of colchicine should reduce the frequency of attacks, and normalise ESR, serum amyloid A, CRP, and fibrinogen levels during the attack-free periods.

  • In order to assess accurately a patient’s clinical condition, clinical signs and symptoms should be self-reported in a diary and brought to the treating physician during every follow-up visit. Number of clinical episodes is a helpful measure of disease activity.[132]

  • Inflammatory markers (acute-phase reactants) and proteinuria should be monitored at least once a year during follow-up visits.

Disease severity

  • Frequent and severe FMF attacks may result in serious complications such as development of secondary amyloidosis, growth and puberty delay, chronic arthritis, anaemia, and compromise of quality of life. A widely accepted measure, rationally ranking disease expression according to the degree of disease severity, would be useful in the management of this lifelong disease. An international group of experts developed and validated an international severity scoring system both in children and in adults with FMF. Authors anticipate that it will provide a robust tool to objectively define disease severity for clinical trials, future research, and therapeutic decisions in managing patients with FMF.[133]

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