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Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome

Lachmann, HJ; Kone-Paut, I; Kuemmerle-Deschner, JB; Leslie, KS; Hachulla, E; Quartier, P; Gitton, X; ... Canakinumab CAPS Study Grp, ; + view all (2009) Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome. NEW ENGL J MED , 360 (23) 2416 - 2425.

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Abstract

BACKGROUNDThe cryopyrin-associated periodic syndrome ( CAPS) is a rare inherited inflammatory disease associated with overproduction of interleukin-1. Canakinumab is a human anti-interleukin-1 beta monoclonal antibody.METHODSWe performed a three-part, 48-week, double-blind, placebo-controlled, randomized withdrawal study of canakinumab in patients with CAPS. In part 1, 35 patients received 150 mg of canakinumab subcutaneously. Those with a complete response to treatment entered part 2 and were randomly assigned to receive either 150 mg of canakinumab or placebo every 8 weeks for up to 24 weeks. After the completion of part 2 or at the time of relapse, whichever occurred first, patients proceeded to part 3 and received at least two more doses of canakinumab. We evaluated therapeutic responses using disease-activity scores and analysis of levels of C-reactive protein (CRP) and serum amyloid A protein (SAA).RESULTSIn part 1 of the study, 34 of the 35 patients (97%) had a complete response to canakinumab. Of these patients, 31 entered part 2, and all 15 patients receiving canakinumab remained in remission. Disease flares occurred in 13 of the 16 patients (81%) receiving placebo (P<0.001). At the end of part 2, median CRP and SAA values were normal (<10 mg per liter for both measures) in patients receiving canakinumab but were elevated in those receiving placebo (P<0.001 and P = 0.002, respectively). Of the 31 patients, 28 (90%) completed part 3 in remission. In part 2, the incidence of suspected infections was greater in the canakinumab group than in the placebo group (P=0.03). Two serious adverse events occurred during treatment with canakinumab: one case of urosepsis and an episode of vertigo.CONCLUSIONSTreatment with subcutaneous canakinumab once every 8 weeks was associated with a rapid remission of symptoms in most patients with CAPS. (ClinicalTrials.gov number, NCT00465985.)

Type: Article
Title: Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome
Keywords: MUCKLE-WELLS-SYNDROME, ANTI-IL-1-BETA MONOCLONAL-ANTIBODY, ONSET STILLS-DISEASE, RHEUMATOID-ARTHRITIS, ANAKINRA, INTERLEUKIN-1, ACZ885, AMYLOIDOSIS, EFFICACY, DEAFNESS
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation
URI: http://discovery.ucl.ac.uk/id/eprint/168655
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