Universität zu Köln

Ruperto, Nicolino ORCID: 0000-0001-8407-7782, Brunner, Hermine I., Quartier, Pierre, Constantin, Tamas, Wulffraat, Nico M., Horneff, Gerd, Kasapcopur, Ozgur ORCID: 0000-0002-1125-7720, Schneider, Rayfel, Anton, Jordi ORCID: 0000-0002-8792-4219, Barash, Judith, Berner, Reinhard ORCID: 0000-0002-6216-9173, Corona, Fabrizia, Cuttica, Ruben, Fouillet-desjonqueres, Marine, Fischbach, Michel, Foster, Helen E., Foell, Dirk, Radominski, Sebastiao C., Ramanan, Athimalaipet V., Trauzeddel, Ralf, Unsal, Erbil, Levy, Jeremy, Vritzali, Eleni, Martini, Alberto and Lovell, Daniel J. (2018). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann. Rheum. Dis., 77 (12). S. 1710 - 1720. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2060

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Abstract

Objectives To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA). Methods Patients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population. Results 144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/ day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed. Conclusion Response to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ruperto, Nicolino UNSPECIFIED orcid.org/0000-0001-8407-7782 UNSPECIFIED Brunner, Hermine I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Quartier, Pierre UNSPECIFIED UNSPECIFIED UNSPECIFIED Constantin, Tamas UNSPECIFIED UNSPECIFIED UNSPECIFIED Wulffraat, Nico M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Kasapcopur, Ozgur UNSPECIFIED orcid.org/0000-0002-1125-7720 UNSPECIFIED Schneider, Rayfel UNSPECIFIED UNSPECIFIED UNSPECIFIED Anton, Jordi UNSPECIFIED orcid.org/0000-0002-8792-4219 UNSPECIFIED Barash, Judith UNSPECIFIED UNSPECIFIED UNSPECIFIED Berner, Reinhard UNSPECIFIED orcid.org/0000-0002-6216-9173 UNSPECIFIED Corona, Fabrizia UNSPECIFIED UNSPECIFIED UNSPECIFIED Cuttica, Ruben UNSPECIFIED UNSPECIFIED UNSPECIFIED Fouillet-desjonqueres, Marine UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischbach, Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Foster, Helen E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Foell, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Radominski, Sebastiao C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramanan, Athimalaipet V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Trauzeddel, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Unsal, Erbil UNSPECIFIED UNSPECIFIED UNSPECIFIED Levy, Jeremy UNSPECIFIED UNSPECIFIED UNSPECIFIED Vritzali, Eleni UNSPECIFIED UNSPECIFIED UNSPECIFIED Martini, Alberto UNSPECIFIED UNSPECIFIED UNSPECIFIED Lovell, Daniel J. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-163450
DOI:	10.1136/annrheumdis-2018-213150
Journal or Publication Title:	Ann. Rheum. Dis.
Volume:	77
Number:	12
Page Range:	S. 1710 - 1720
Date:	2018
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-2060
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PLACEBO-CONTROLLED TRIAL; MACROPHAGE ACTIVATION SYNDROME; DISEASE-ACTIVITY; DOUBLE-BLIND; PRELIMINARY DEFINITION; SELECT CATEGORIES; CRITERIA; EFFICACY; CHILDREN; SAFETY Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16345