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2015 ; 17
(1
): 243
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Efficacy and safety of canakinumab in adolescents and adults with
colchicine-resistant familial Mediterranean fever
#MMPMID26337145
Gül A
; Ozdogan H
; Erer B
; Ugurlu S
; Kasapcopur O
; Davis N
; Sevgi S
Arthritis Res Ther
2015[Sep]; 17
(1
): 243
PMID26337145
show ga
INTRODUCTION: This open-label pilot study aimed to investigate the efficacy of
canakinumab in colchicine-resistant familial Mediterranean fever (FMF) patients.
METHOD: Patients with one or more attacks in a month in the preceding 3 months
despite colchicine were eligible to enter a 30-day run-in period. Patients who
had an attack during the first run-in period advanced to a second 30-day period.
At the first attack, patients started to receive three canakinumab 150 mg
subcutaneous injections at 4-week intervals, and were then followed for an
additional 2 months. Primary efficacy outcome measure was the proportion of
patients with 50 % or more reduction in attack frequency. Secondary outcome
measures included time to next attack following last canakinumab dose and changes
in quality of life assessed by SF-36. RESULTS: Thirteen patients were enrolled in
the run-in period and 9 advanced to the treatment period. All 9 patients achieved
a 50 % or more reduction in attack frequency, and only one patient had an attack
during the treatment period. C-reactive protein and serum amyloid A protein
levels remained low throughout the treatment period. Significant improvement was
observed in both physical and mental component scores of the Short Form-36 at Day
8. Five patients had an attack during the 2-month follow-up, occurring median 71
(range, 31 to 78) days after the last dose. Adverse events were similar to those
observed in the previous canakinumab trials. CONCLUSION: Canakinumab was
effective at controlling the attack recurrence in patients with FMF resistant to
colchicine. Further investigations are warranted to explore canakinumab's
potential in the treatment of patients with colchicine resistant FMF. TRIAL
REGISTRATION: ClinicalTrials.gov NCT01088880 . Registered 16 March 2010.
|*Drug Resistance
[MESH]
|Adolescent
[MESH]
|Adult
[MESH]
|Antibodies, Monoclonal, Humanized
[MESH]
|Antibodies, Monoclonal/adverse effects/*therapeutic use
[MESH]