Background Approximately in 5 to 10% of FMF patients there is insufficient response and/or intolerance to colchicine treatment. Several reports have pointed out the efficacy of IL-1 blockade in colchicine resistant FMF subgroup.
Objectives To review the patients followed in our center with FMF who received Anakinra, an anti-IL-1 receptor antagonist, in terms of outcome and side effects.
Methods 43 FMF patients who were treated with Anakinra were retrospectively reviewed with regard to indication, effect on disease activity and acute phase response, adverse events and patient global assessment.
Results There were 43 patients with FMF (20 M/ 23 F) who were treated with Anakinra for various indications (colchicine resistant recurrent febrile attacks in 39, colchicine related side effects in 3, both in 1). The mean age of the patients was 31.73±9.56 years. The mean duration of the disease was 19.90±10.52 years. There were various co-existing pathologies among this study group like Ankylosing Spondylitis (4), Psoriasis (1), Behçet's disease (1), Gout (1), Vasculitis (1), Adult-onset Still's disease (1), Polyarthritis Nodosa (1) and Celiac disease (1). The mean colchicine dose was 1.84±0.31 mg/d. As for the dosage, 35 patients were on 100 mg/day, 6 were 100 mg on alternate days, 2 were on 200 mg/day. The mean duration of anakinra treatment was 10.76±13.64 months. After the initiation of anakinra 29 patients became attack-free, 9 patients reported more than 50% decrease, 3 patients less than 50% decrease, and 2 patients no change in the frequency of the attacks. Mean patient global assessment decreased from 7.55±2.34 to 2.82±2.63 under Anakinra treatment (p<0.001).
As for the adverse events, eight patients (%18) had allergic reactions under Anakinra treatment (severe disseminated rash in 1 patient and severe injection site reaction in 4 patients and tolerable injection side reaction in 3) which necessitated termination of treatment in 5 patients. Anakinra was stopped because of genital warts and urinary tract infection in one other patient. Worsening of psoriatic lesions was observed in another patient. There were no adverse events in the remaining 41 patients during the course of treatment. On the other hand, treatment was terminated due to inadequate response in 11 (25%), remission in 2 and patient preference in 3 patients. Nineteen patients are still on Anakinra treatment for 10.09±14.51 months.
Conclusions Anakinra is an effective and relatively safe alternative treatment in FMF patients with inadequate response or intolerance to colchicine, however approximately one fourth of the patients stop anakinra for insufficient response.
Disclosure of Interest None declared