Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome. Export

@article{citeulike:4762191, abstract = {BACKGROUND: The cryopyrin-associated periodic syndrome (CAPS) is a rare inherited inflammatory disease associated with overproduction of interleukin-1. Canakinumab is a human anti-interleukin-1beta monoclonal antibody. METHODS: We 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). RESULTS: In 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. CONCLUSIONS: Treatment with subcutaneous canakinumab once every 8 weeks was associated with a rapid remission of symptoms in most patients with CAPS. (ClinicalTrials.gov number, NCT00465985.) Copyright 2009 Massachusetts Medical Society.}, author = {Lachmann, Helen J J. and Kone-Paut, Isabelle and Kuemmerle-Deschner, Jasmin B B. and Leslie, Kieron S S. and Hachulla, Eric and Quartier, Pierre and Gitton, Xavier and Widmer, Albert and Patel, Neha and Hawkins, Philip N N. and {}}, citeulike-article-id = {4762191}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0810787}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19494217}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19494217}, day = {4}, doi = {10.1056/NEJMoa0810787}, issn = {1533-4406}, journal = {The New England journal of medicine}, keywords = {rheum}, month = {June}, number = {23}, pages = {2416--2425}, posted-at = {2009-06-06 18:26:53}, priority = {2}, title = {Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome.}, url = {http://dx.doi.org/10.1056/NEJMoa0810787}, volume = {360}, year = {2009} }

TY - JOUR ID - citeulike:4762191 L3 - citeulike-article-id:4762191 N2 - BACKGROUND: The cryopyrin-associated periodic syndrome (CAPS) is a rare inherited inflammatory disease associated with overproduction of interleukin-1. Canakinumab is a human anti-interleukin-1beta monoclonal antibody. METHODS: We 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). RESULTS: In 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. CONCLUSIONS: Treatment with subcutaneous canakinumab once every 8 weeks was associated with a rapid remission of symptoms in most patients with CAPS. (ClinicalTrials.gov number, NCT00465985.) Copyright 2009 Massachusetts Medical Society. IS - 23 JF - The New England journal of medicine SN - 1533-4406 EP - 2425 TI - Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome. VL - 360 SP - 2416 KW - rheum AU - Lachmann, Helen J AU - Kone-Paut, Isabelle AU - Kuemmerle-Deschner, Jasmin B AU - Leslie, Kieron S AU - Hachulla, Eric AU - Quartier, Pierre AU - Gitton, Xavier AU - Widmer, Albert AU - Patel, Neha AU - Hawkins, Philip N PY - 2009/06/04/ UR - http://dx.doi.org/10.1056/NEJMoa0810787 ER -