Background/Purpose: According to a recent pilot study Canakinumab reduced the frequency of attacks in 9 patients with Familial Mediterranean Fever (FMF) resistant to colchicine with no apparent side effects(1). We present our experience with Canakinumab in FMF patients resistant or intolerant  to colchicine 

Methods: The charts of the patients with FMF who were on Canacinumab were evaluated retrospectively with regard to response and safety

Results: There were 30 patients with FMF (16 F/14 M) receiving canakinumab for various indications. Here we report 28 (15 F/13 M) who had at least 3 injections. Six patients had concomitant diseases such as psoriasis (1), ankylosing spondylitis (3), polyarteritis nodosa (1), ankylosing spondylitis and polyarteritis nodosa (1). The indications for canakinumab (150mg/mo) were insufficient response to colchicine in 15 (>1 attack/month), amyloidosis in 6, injection site reaction to anakinra in 5, oligospermia in one and myopathy in one patient, both being adverse effects of colchicine. The mean age of the patients was 34,67 ± 13,45 years, the disease duration was 16,75 ± 9,42 years, the mean injection number was 7,00 ± 3,62 and the mean duration of canakinumab  therapy was 10,98 ± 6,06 months. Twenty of the patients had no attacks after canakinumab, six patients’ attack frequency was reduced more than %50 while two patient’s attack frequency did not change. In 6 cases with FMF amyloidosis, proteinuria decreased in 2 (from 15020 mg/dl to 910 mg/dl, and from 6135 mg/dl to 4610 mg/dl), increased in 2 (from 1700mg/dl to 4700mg/dl and from 5001 mg/dl to  7061 mg/dl), and did not change in the other 2. Eleven of the 24 patients with severe myalgia and calf pain unresponsive to colchicine treatment, improved significantly on canakinumab. According to patient global assessment the mean score decresed from 7,9 ± 2,6 to 2.1 ± 2.9 (p<0.001). Canacinumab was stopped because of remission (no attacks at least for 3 months) in 5 and for pregnancy demand in one. The treatment was also stopped in the patient with oligospermia after being fertile, and he is without attacks for 5 months. Attacks recurred after 4, 6, 12 months from discontinuation of the therapy in 3 patients, and 3 patients are attack-free for 5, 6 and 13 months till now. None of the patients had injection site reactions. The patient with psoriasis reported a flare in psoriatic plaques, which responded to local treatment. Therapy was discontinued temporarily in one patient who developed mild leucopenia, which did not recur on a 2-monthly regimen. Treatment was switched to another biological agent in 2 patients with amyloidosis because of increasing proteinuria. One other patient with amyloidosis whose proteinuria was stable, developed lichen planus lesions and the treatment had to be stopped. One patient had  pnomonia, also he is attack-free for three months untill last dose

Conclusion: Canacinumab is effective in controlling the attacks in patients with inadequate response to colchicine. In a selected group of FMF patients, Canacunimab may serve as a treatment alternative with a favorable side effect profile. For better understanding the drug’s efficacy and safety in the long term there is a need for controlled trials

References: Gul A, et al. Arthritis Rheum 2013;64: S322

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/canakinumab-therapy-in-patients-with-familial-mediterranean-fever/