Artikel
In Children With Systemic Juvenile Idiopathic Arthritis With And Without Fever Canakinumab is Long Term Safe and Efficacious
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Veröffentlicht: | 1. September 2015 |
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Introduction: Rapid and sustained efficacy of canakinumab (CAN) were previously demonstrated in patients with systemic juvenile idiopathic arthritis (SJIA)1. However, little is known about potential differences in response to CAN treatment between pts with vs. without SJIA associated fever. The objective is to evaluate the long-term efficacy and safety profile of CAN-naïve SJIA pts with and without SJIA associated fever.
Methods: Pts aged 2-20 years with SJIA with and without SJIA associated fever at enrollment received open-label CAN 4mg/kg s.c. every 4 wks. Every 3 months, response to CAN was measured by adapted JIA ACR response criteria (aACR/JIA); juvenile arthritis disease activity score [JADAS]; clinical inactive disease; clinical remission on medication [CRM, 6 months continuous clinical inactive disease]. Safety was assessed monthly.
Results: Data on 122/267 pts, 53 (43%) with and 69 (57%) without SJIA associated fever, were available for analysis with a median 94 wk study duration. At Wk4, ~75% of both subgroups had responded (≥aACR/JIA30), increasing to 90% at Wk12. At Wk2, ~21% of both subgroups had inactive disease; 44% at Wk8; 60% at Wk20 and then 60-70% for the remainder of the trial. CRM was achieved in about 29% of pts in both subgroups with ~22% maintaining it for ≥12 consecutive months. At baseline, the median JADAS score was 21.5 with 8 (7.5%) and 99 (92.5%) pts meeting the criteria for moderate (JADAS >3.8 and ≤10.5) and high disease activity (JADAS >10.5), respectively. At the last assessment, 53 (48%) pts had inactive disease (JADAS≤ 1); 10 (9%) with low active disease activity (JADAS >1 and ≤3.8); while 14 (13%) had moderate and 31 (28%) with high disease activity. Infection (0.56 infections/100 PT-days), typically involving upper respiratory tract was the most common type of adverse event. Fifteen pts discontinued due to an AE and 40 had >1 SAE (mostly infections, macrophage activation syndrome [MAS], or flare-associated) and no deaths.
Conclusion: Canakinumab provides similar efficacy in SJIA pts with and without SJIA associated fever at treatment onset. The long-term safety profile was acceptable and similar to the pivotal program in SJIA children with fever at enrollment.