Long-Term Canakinumab Safe, Effective for Colchicine-Resistant Familial Mediterranean Fever

June 10, 2020

By Eric Ramos

CHICAGO -- June 9, 2020 -- Long-term treatment with canakinumab was safe and effective for patients with colchicine-resistant familial Mediterranean fever, according to a study presented at the 2020 Virtual Meeting of the European League Against Rheumatism (EULAR).

“Patients with colchicine-resistant familial Mediterranean fever treated with canakinumab during 72 weeks experienced a minimal incidence of flares and good control of clinical disease activity, with no new safety signals reported,” said Seza Özen, MD, Hacettepe University, Ankara, Turkey.

Although colchicine is the cornerstone of therapy for familial Mediterranean fever, a subset of patients are resistant or intolerant to it.

For the current study, patients with active (baseline flare) colchicine-resistant familial Mediterranean fever received open-label canakinumab 150 or 300 mg every 4 or 8 weeks. Stepwise up-titration of canakinumab was allowed in patients who experienced a flare, to a maximum dose of 300 mg every 4 weeks. Patients reported a median of 17.5 flares per year at baseline.

Of the 57 patients, 23 (40%) were able to remain in the low-dose group until the end of the study; 9 (16%) required the highest dose allowed. Patients with higher body weight had an increased probability of requiring up-titration of canakinumab to control disease activity.

During the 72-week period, 58.3% of patients experienced no flares, and 38.3% had a single flare.

No opportunistic infections, renal disease caused by amyloidosis, new or unexpected adverse events were reported.

[Presentation title: Long-Term Efficacy and Safety of Canakinumab in Patients With Colchicine-Resistant Familial Mediterranean Fever: Results From the Randomised Phase 3 Cluster Trial. Abstract OP0272]